chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Wheezing
Clinical narrative: Fever, shortness of breath, tired, achy right arm red & swollen, wheezing.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, warm to touch. Measured 60 x 60 mm (R)/deltoid & (L)/deltoid.
Age: 30.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash at injection site.  Treated with topical ice application.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site warmth, Mass, Pruritus, Rash erythematous
Clinical narrative: Pt had a rash extending down the back of his upper arm, measuring approximately 5 by 2 inches. The rash was very red in various clusters and the pt complained of itching in addition to warmth and swelling. The reaction also involved a one-inch lump near the injection site.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Pt had a rash extending down the back of his upper arm, measuring approximately 5 by 2 inches. The rash was very red in various clusters and the pt complained of itching in addition to warmth and swelling. The reaction also involved a one-inch lump near the injection site.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Dyspnoea, Pallor, Vomiting
Clinical narrative: Pt. states can't breath, pale, and vomited. Pt. OK.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Arm hurts at the top of arm and between lower and upper arm.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Pt stated that her arm started to swell and was red. Swelling started to go down within a week.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at the site of injection on right arm.
Age: 0.19
Sex: F
Vaccine: HEP, RV1
Symptoms: Diarrhoea, Rotavirus test positive
Clinical narrative: see previous page
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Abdominal pain, Diarrhoea, Dizziness, Eyelid oedema
Clinical narrative: She got Depo-Provera first shot on the same day, on 7-11-2012 and was fine until over 48 hours later. She had onset of diarrhea with abdominal pain. Low grade/subjective fevers and nausea.  Dizziness and increased "frustration".  Subjective swelling of her face- puffy eyes and lower abdomen.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Frustration, Nausea, Pyrexia, Swelling face
Clinical narrative: She got Depo-Provera first shot on the same day, on 7-11-2012 and was fine until over 48 hours later. She had onset of diarrhea with abdominal pain. Low grade/subjective fevers and nausea.  Dizziness and increased "frustration".  Subjective swelling of her face- puffy eyes and lower abdomen.
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at site treated for cellulitis patient reports at ER.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Convulsion, Syncope
Clinical narrative: Child fainted and may have had a seizure, child transported by EMS to hospital for further evaluation.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Malaise, Upper extremity mass
Clinical narrative: Patient reports she did not feel well after immunization, later in the day experienced shortness of breath and had pea size lump on arm.
Age: 69.0
Sex: F
Vaccine: PNC10
Symptoms: Chills, Pain in extremity
Clinical narrative: Severe pain and dramatic swelling left upper arm, chills.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Auricular swelling, Bradyphrenia, Chest discomfort, Dizziness
Clinical narrative: - within 5 min, felt slightly dizzy - within 1 hour, nausea - within two hours, moderate neck pain; weakness; paleness - within 3 hours, dizziness - enough to have to lay down; increase in neck pain - 6 on a scale of 1-10; slowed speech and thinking; mild tightness in chest and difficulty breathing; mild swelling in throat and ears - within 4 hours - felt as if full on flu - called facility & was advised to go to Hospital - Medical Center determined difficulty breathing was not severe enough and was discharged
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Dyspnoea, Influenza, Nausea, Neck pain, Pallor
Clinical narrative: - within 5 min, felt slightly dizzy - within 1 hour, nausea - within two hours, moderate neck pain; weakness; paleness - within 3 hours, dizziness - enough to have to lay down; increase in neck pain - 6 on a scale of 1-10; slowed speech and thinking; mild tightness in chest and difficulty breathing; mild swelling in throat and ears - within 4 hours - felt as if full on flu - called facility & was advised to go to Hospital - Medical Center determined difficulty breathing was not severe enough and was discharged
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Pharyngeal oedema, Slow speech
Clinical narrative: - within 5 min, felt slightly dizzy - within 1 hour, nausea - within two hours, moderate neck pain; weakness; paleness - within 3 hours, dizziness - enough to have to lay down; increase in neck pain - 6 on a scale of 1-10; slowed speech and thinking; mild tightness in chest and difficulty breathing; mild swelling in throat and ears - within 4 hours - felt as if full on flu - called facility & was advised to go to Hospital - Medical Center determined difficulty breathing was not severe enough and was discharged
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Poor quality sleep, Rash
Clinical narrative: Rash on face and trunk and a few spots on arms and legs for 10 days.  Much worse today-patient not sleeping well. Advised to give Benadryl every 6 hours and to follow up in 5 days if needed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: Large erythematous patch on (R) upper arm. Starting 7/17/12.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Rash pustular, Scab, Skin lesion, Varicella post vaccine
Clinical narrative: Dx. with chicken pox after vaccinated. Presents with approx 50 lesions some crusted some pustule like. Rash has been x 3 days. Denies fever.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Child's arm (L) upper arm reddened, edema, pain - tx with ice, MOTRIN.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Intensive care
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with no pertinent medical history or drug reactions/allergies who in 2010 "two years prior the second dose" was vaccinated with the first dose of GARDASIL (dose, route and lot # not provided, it was not administered in the physician's office) and on 29-MAR-2012 received the second dose of GARDASIL (dose and route not provided) (lot # 669794/1285AA) in the physician's office. Concomitant therapy included birth control pills (unspecified). The physician reported that when his receptionist called the patient's mother to schedule an appointment for the next dose of GARDASIL, the child's mother reported that her daughter had experienced an anaphylactic reaction following the vaccination on 29-MAR-2012, and had been admitted to the intensive care unit for six days. No laboratory tests were performed. On an unknown date, the patient recovered from the event. Anaphylactic reaction was considered to be immediately life-threatening by the reporting physician. A lot check has been initiated. Follow up information has been received from the physician concerning the patient who on 29-MAR-2012, was vaccinated with the second dose of GARDASIL intramuscularly in the right deltoid. The mother had agreed to forward all of her hospital records. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cerebrovascular accident, Dysarthria, Vaccine positive rechallenge
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age, who on an unknown dates was vaccinated with the three 0.5 ml doses of GARDASIL (route and lot numbers not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that five to seven days later after received the first dose of GARDASIL the patient was slurring her speech, which the physician described as a "stroke like symptoms". This experience lasted for a day and then went away. The same thing happened after the patient was vaccinated with the second dose of GARDASIL. It was stated that the patient was given her third dose of GARDASIL but no adverse experience had been reported (the reported could not verify the patient's status). No treatment was given for the experience. At the time of the report the patient was recovered (also reported that the experience improved after stopping therapy). The patient sought unspecified medical attention. The relatedness for slurring her speech-stroke like symptoms was unknown for GARDASIL. Upon internal review stroke like symptoms was considered to be an other important medical event. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Generalized urticaria noted approximately 7 hours following MCV4 and Tdap. BENADRYL, Prednisone given.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Condition aggravated, Injection site erythema, Injection site pruritus, Osteomyelitis
Clinical narrative: Redness, itching at injection site; severe itching (no rash) on face, scalp, neck & arms starting 1-2 days after vaccination - lasted about 10 days. Rash on chest - 2 or 3 "pimples" after that - resolved in a few days. Exacerbation of pain in area of bone infection. Resolving after 2 weeks.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Redness, itching at injection site; severe itching (no rash) on face, scalp, neck & arms starting 1-2 days after vaccination - lasted about 10 days. Rash on chest - 2 or 3 "pimples" after that - resolved in a few days. Exacerbation of pain in area of bone infection. Resolving after 2 weeks.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Vesicular rash, dermatomal pattern (L) trunk developed 7/18/12 after ZOSTAVAX 7/16/12.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: On the evening she received vaccine it became red - raised area, then started to itch. L-6cm x 9cm wide. Seen by NP advised BENADRYL and ice. Rechecked on 7-16-12. Swelling & redness subsided.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site swelling, Oedema peripheral
Clinical narrative: Per mom patient developed swelling/puffiness of both legs and feet the evening of vaccine administration, symptoms resolved in a few hours.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives across chest and neck developed 2 days after vaccination (7-13-12). Pt. took BENADRYL. (Vaccine given on 7-10-12).
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Aunt noticed redness & swelling on the (L) arm at vaccine site 07/18/12 AM. Shot was given 7/17/12 at 1256.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Rash generalised, Rash vesicular, Scab
Clinical narrative: Patient's mother reported approx. 50 pin-sized pox-like areas scattered on bilat. arms, legs, feet, hands, buttocks and mouth appearing approx. 3 hrs. of receiving vaccinations on 7-17-12 at 2:45 pm. Temp of 101 degrees on 7-17-12 (in the evening) but afebrile since then. Areas starting to crust over.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient received two i.m. vaccinations, RD = Tdap, LD = MENACTRA, after placing a band aid over injection site within a few minutes (R) deltoid showed dark pink, irregular rash, approx. 2 x 2 inches, non itchy.
Age: 1.31
Sex: M
Vaccine: DTAP, MMR, PNC13
Symptoms: Rash
Clinical narrative: Pt. had MMR, PCV 13, DAPTACEL on 7/6/12. Mom called yesterday 7/17/12 with concern about rash since 7/16/12 on chest, back and thighs. 7/19/12 Rash resolved.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site haematoma, Injection site inflammation, Syncope
Clinical narrative: Pt became very lightheaded & faint on administration of vaccine. Injection site red and inflamed for few days after admin. and bruising at site of injection continues at this time.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema multiforme, Rash
Clinical narrative: 7 days after 1yr IZ (MMR, Varicella, Hep A#4, PREVNAR 4). Pt developed erythema multiforme rash.
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis bullous, Erythema, Induration
Clinical narrative: Localized redness, induration development of a small 2-3 mm bullous lesions.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema, mild edema at and inferior to injection site on (L) deltoid. Negative pruritis, dyspnea, syncope, pain, fever Tx: family regularly uses hyperbaric O2 chamber.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Electroencephalogram normal, Feeling abnormal, Nuclear magnetic resonance imaging, Somnolence, Syncope
Clinical narrative: Patient had syncopal episode about 5 minutes after vaccine. It took over 1 hour for him to feel like he could sit up and walk. He slept the remainder of the day and did not feel stable the second day. He has seen neurology; EEG nl & MRI pending.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Dark circles under eyes, Erythema, Feeling hot, Local swelling, Musculoskeletal stiffness
Clinical narrative: Within hours after injection, area began to swell & sensitive with movement of my arm next morning extremely stiff & swollen & a little sensitive to movement still. Next day extremely red & hot, started moving downward on my arm, stayed hot & moving down for 2 day - 3 days. Then, lessened in redness & heat, but still visible today, but seeming to get better. Started using ice pack & ZYRTEC 10 mg on 7/5. Then replaced ZYRTEC w/BENADRYL on 7/6 25 mg BID & 7/7, 7/8, 7/9, 7/10. The redness & swelling is improved but now patient is noticing darkness under her eye. I am unsure if this is at all related to the reaction. Left message w/mfg to inquire.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Within hours after injection, area began to swell & sensitive with movement of my arm next morning extremely stiff & swollen & a little sensitive to movement still. Next day extremely red & hot, started moving downward on my arm, stayed hot & moving down for 2 day - 3 days. Then, lessened in redness & heat, but still visible today, but seeming to get better. Started using ice pack & ZYRTEC 10 mg on 7/5. Then replaced ZYRTEC w/BENADRYL on 7/6 25 mg BID & 7/7, 7/8, 7/9, 7/10. The redness & swelling is improved but now patient is noticing darkness under her eye. I am unsure if this is at all related to the reaction. Left message w/mfg to inquire.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Patient receiving rotavirus vaccine on research protocol. Persistent G tube drainage was noted prior to administration of the 3rd and final dose, unrelated to the vaccine.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Petit mal epilepsy, Somnolence, Urinary incontinence
Clinical narrative: Patient given HPV - GARDASIL - injection #2, (L) deltoid. Five minutes after injection. patient complained of feeling dizzy. She sat in chair and had a petite mal seizure. Lasted for about 10 sec, then awoke and complained of feeling very sleepy. She became urinary incontinent. Was transported by w/c to bed. V/S taken and was seen by doctor. After one hour pt was d/c with mother and sister. Feeling well and appt made for f/u with doctor and Neurology at  clinic.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pruritus, Local reaction
Clinical narrative: Local and general signs and symptoms (redness, itching and inflammation, induration at only on injection site but all over upper arm). Suggested to take BENADRYL and contact doc. Pt. was seen by doctor on 6/29/12 and was prescribed steroids.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Pt received GARDASIL #1; approx 15 min later c/o dizziness some sweating altho was not diaphoretic).
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red, hot on LD.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site - red, swollen, tender
Age: 65.0
Sex: M
Vaccine: DTP, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Vaccine administered Friday. Pt. called on Monday to notify of reaction. Also stated reaction has been improving. Notes do not indicate if patient self treated with anything. Patient denied shortness of breath and hives.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Per mother injection area was red on the leg where it was given that evening. The next morning, it was red, hard and hot. Per NP, mother advised to give antihistamine, cool compress and Ibuprofen. To call office if streaking or pus to the site.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dyskinesia, Syncope
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 13 years old male patient with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with the first dose of GARDASIL on 06-JUN-2012 in the immunization series. No concomitant medications were reported. On 06-JUN-2012 while the patient was standing at the front counter of the practice, just before leaving, he collapsed and exhibited jerky movement. No treatment information was given for the adverse events. No lab diagnostics studies performed. The patient examined by the physician, revived on his own and left the practice a short while later. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 years old male patient. The patient was vaccinated with lot # (672932/0599AE) and EXP#(22-JUN-2013) ZOSTAVAX (dose/frequency and route were unspecified) on 05-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 11-JUL-2012, the pharmacist stated that a patient had developed a rash on his hands with "little bumps" since the ZOSTAVAX was given. VZV pachet had been faxed. The patient had sought medical attention via visiting pharmacist. No treatment information was reported. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Encephalopathy, Full blood count normal, Hypotonia, Irritability
Clinical narrative: Infant had prolonged crying, irritability, low grade fever, vomiting x 10 hours, symptoms lasting several days, hypotonic, dullness, lack of responsiveness and irritability sx 7 days - mild encephalopathy per neurology.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Mental impairment, Pyrexia, Unresponsive to stimuli, Urine analysis normal, Vomiting
Clinical narrative: Infant had prolonged crying, irritability, low grade fever, vomiting x 10 hours, symptoms lasting several days, hypotonic, dullness, lack of responsiveness and irritability sx 7 days - mild encephalopathy per neurology.
Age: 8.0
Sex: M
Vaccine: HEP, HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an 8 years old male patient. The patient was vaccinated with the first dose of GARDASIL (lot number was unknown) (dose and route were not reported) on 12-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The reporter stated that on 12-JUL-2012, GARDASIL was administered to the patient who was an 8 year old boy and there was no adverse reaction. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Information has been received from a healthcare worker concerning a female patient who on 19-APR-2012, was sprayed in the eye and mouth with some of her child's VARIVAX (Merck) dose (lot # not reported). The patient experienced irritation in the eye, and sought treatment at an emergency room on 19-APR-2012. It was reported that the patient was not admitted to a hospital. At the time of the report the outcome of the event was unknown. This is one of several reports received from the same source. Follow-up information has been received from the registered nurse (R.N) provided a new information about the 28 student, who on 18-APR-2012 (previously reported on 19-APR-2012) was sprayed in her right eye with some of her child's VARIVAX (Merck) dose (lot # 11410AAV). Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (Lot#unspecified) on 30-DEC-2008 and the second dose on 02-NOV-2010. No adverse event reported. No treatment information was reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated subcutaneously in the right arm with ZOSTAVAX on 02-JUL-2012 (lot # and dose not reported). No other co-suspects and no concomitant medications were reported. On 09-JUL-2012 the patient developed a round, red area at the injection site, 8 days after onset of therapy. The patient called the pharmacy, no treatment was given for the reported event and no lab diagnostic tests were performed. The outcome of round red area the injection site was reported as not recovered. The relatedness for round red area at the injection site was not reported for ZOSTAVAX. 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 medical assistant refers to a patient of unknown age. The patient was vaccinated with dose 1, dose 2 and dose 3 of GARDASIL in June 2008, October 2008 and December 2008. No other co-suspects and no concomitant medications were reported. On 09-JUL-2012 was in the office to have the third dose of vaccine be re-administered. No adverse event reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a patient who on 12-JUN-2012, was vaccinated with an expired dose of ZOSTAVAX (Merck) 0.65ml, SC (lot number 670383/0170AA, expiration date 07-MAY-2012). Follow-up information has been received from the registered nurse (R.N.) concerning the 73 year old patient, who had "sulfa-allergy" and has had none illness at time of vaccination, "it was a immunization update", administered the first dose of ZOSTAVAX (Merck) 0.65ml, SC (lot number 670383/0170AA, expiration date 07-MAY-2012) in left arm on 12-JUN-2012 at 11:37AM. Additional information has not expected.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Pallor, Presyncope
Clinical narrative: This spontaneous report as received from a physician refers to a 16 years old male patient with chronic ear infection and no drug reactions or allergies. The patient was vaccinated intramuscularly with dose 1 of GARDASIL (lot # 0459AE Exp Date 13-DEC-2014; dose not reported) on 09-JUL-2012. No other co-suspects were reported. Concomitant medications included: ZYRTEC. On 09-JUL-2012 the patient almost fainted after receiving the first dose of the vaccine. The patient got very pale and the physician laid down on the bed. The patient recovered with some headaches. The patient sought medical attention by seeing the physician. No treatment information was reported. The outcome of headaches and almost fainted was not reported for GARDASIL. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a female consumer reporting on herself who on an unknown date was vaccinated with a dose of ZOSTAVAX (Dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer stated that she experienced a rash several years ago, on an unspecified date, after receiving ZOSTAVAX. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The relatedness for patient experienced a rash several years ago was unknown for ZOSTAVAX. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 62 years old male patient. The patient was vaccinated subcutaneously with a 0.65 ml dose of lot # (669639/0613AA; Exp date 30-JUN-2012), ZOSTAVAX on 05-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that the patient was inadvertently vaccinated with an expired vaccine. No adverse effects reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site warmth, Localised oedema
Clinical narrative: Information has been received from a healthcare worker concerning a 71 year old female patient with no pertinent medical history or drug reactions/allergies who on 15-MAY-2012 was vaccinated IM with 0.5 mL of PNEUMOVAX 23 (lot # 671607/1169AA). Concomitant therapy included omeprazole, hydrochlorothiazide (+) moexipril hydrochloride, simvastatin (manufacturer unknown) and MIACALCIN. On 15-MAY-2012, the patient developed redness and warmth at the site of the injection on the left arm. On 17-MAY-2012, the patient was diagnosed with cellulitis. No laboratory test was performed. The patient was treated with cephalexin. On an unknown date, the patient recovered from the event. The patient sought medical attention, visited the physician's. This is one of several reports from the same source. Information received from medical records regarding a 71 year old female who on 15-MAY-2012 was vaccinated IM with 0.5 mL of PNEUMOVAX 23 (lot # 671607/1169AA) in her left deltoid. Concurrent conditions reported included: non smoker, esophageal reflux with chronic reflux esophagitis, type II diabetes mellitus, essential hypertension, hyperlipidemia, osteopenia, localized osteoarthritis (vertebral column) and a past medical history of: solitary thyroid nodule an anemia. On 17May2012 the patient was seen by her physician for cellulitis of the left arm. It was reported that the night that the patient received her PNEUMOVAX 23 she noticed some redness and warmth at the injection site. The patient experienced pain and the redness expanded from the injection site to the antecubital fossa. The assessment included: cellulitis with symptoms of skin pain, skin redness, skin warmth and localized edema, but no skin ulceration, no serosanguineous drainage, no purulent drainage and no enlarged lymph nodes. The treatment included: cephalexin 500 mg capsule every 12 hours. It was reported the patient recovered from the cellulitis on 20May2012. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain of skin, Skin warm
Clinical narrative: Information has been received from a healthcare worker concerning a 71 year old female patient with no pertinent medical history or drug reactions/allergies who on 15-MAY-2012 was vaccinated IM with 0.5 mL of PNEUMOVAX 23 (lot # 671607/1169AA). Concomitant therapy included omeprazole, hydrochlorothiazide (+) moexipril hydrochloride, simvastatin (manufacturer unknown) and MIACALCIN. On 15-MAY-2012, the patient developed redness and warmth at the site of the injection on the left arm. On 17-MAY-2012, the patient was diagnosed with cellulitis. No laboratory test was performed. The patient was treated with cephalexin. On an unknown date, the patient recovered from the event. The patient sought medical attention, visited the physician's. This is one of several reports from the same source. Information received from medical records regarding a 71 year old female who on 15-MAY-2012 was vaccinated IM with 0.5 mL of PNEUMOVAX 23 (lot # 671607/1169AA) in her left deltoid. Concurrent conditions reported included: non smoker, esophageal reflux with chronic reflux esophagitis, type II diabetes mellitus, essential hypertension, hyperlipidemia, osteopenia, localized osteoarthritis (vertebral column) and a past medical history of: solitary thyroid nodule an anemia. On 17May2012 the patient was seen by her physician for cellulitis of the left arm. It was reported that the night that the patient received her PNEUMOVAX 23 she noticed some redness and warmth at the injection site. The patient experienced pain and the redness expanded from the injection site to the antecubital fossa. The assessment included: cellulitis with symptoms of skin pain, skin redness, skin warmth and localized edema, but no skin ulceration, no serosanguineous drainage, no purulent drainage and no enlarged lymph nodes. The treatment included: cephalexin 500 mg capsule every 12 hours. It was reported the patient recovered from the cellulitis on 20May2012. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Herpes zoster
Clinical narrative: Information has been received from a literature, concerning Case 2 which is one of anecdotal reports from patients demonstrate the challenges associates with diagnosing  and treating children experiencing multiple herpes zoster (HZ) reactivations. On 05-NOV-2007, parents of a daughter with shingles reported that their oldest daughter who was only 16 year old recently suffered from her second bout with shingles. She first had an episode of shingles at the age of 13. Their daughter never had chickenpox, but was given the varicella vaccine (manufacturer unknown) (lot# not reported) in 1995. The parents were never told or even warned that it could cause shingles. The parents found it unbelievable that the 'solution' they were being provided was to go to the Infectious Disease Department at a local hospital in order to have them 'help us manage' that for the rest of their daughter's life. At present the parents had to remedy the shingles and they were altogether convinced that "there will be many, many other young people adversely affected by what is a dangerous vaccine with awful side effects that stayed with you for a lifetime far worse than chickenpox in one's youth". The daughter missed a week of school each time and suffered incredibly. At the time of reporting, the patient's outcome was not reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: Information has been received from a physician concerning two MMR II (Lot# 0450AA is an invalid lot number for MMR II) might have been given. the vaccine were exposed to 50F for 24 hours and to 28F for 3 hours. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Abdominal pain lower, Cholecystectomy, Gallbladder disorder, Laboratory test abnormal
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 13 July 2012. A 76-year-old female patient had received an injection of FLUZONE HIGH-DOSE, Sanofi pasteur Inc. (lot number unknown) in October of 2011 (site and route of administration not reported). Ten minutes post-vaccination, her abdomen from the waistline down swelled and she had nothing but pain and swelling ever since which happens after eating solid foods. The patient did not seek medical attention for almost five months where tests only showed 11% functioning gallbladder resulting in a cholecystectomy. Physicians told her the vaccine had nothing to do with the event but something could have been triggered. The patient has had multiple doctor and emergency room (ER) visits. The patient told by the emergency department (ED) that she might have adhesions from a hysterectomy years ago. The patient took no concomitant medications and had no illness at the time of vaccination. The patient's outcome was unknown. Documents held by sender: None.
Age: 21.0
Sex: F
Vaccine: MNQ, MEN
Symptoms: Computerised tomogram, Diplopia, Headache, Migraine, Muscle spasms
Clinical narrative: Excruciating Migraines: 3 days after vaccine-4/5-4/22 Stiff Neck: 3 days after vaccine-4/5-4/22 Nausea/Vomiting: 3 days after vaccine-4/5 Double Vision: 8 days after vaccine-4/10-4/28
Age: 21.0
Sex: F
Vaccine: MNQ, MEN
Symptoms: Musculoskeletal stiffness, Nausea, Nuclear magnetic resonance imaging, Vision blurred
Clinical narrative: Excruciating Migraines: 3 days after vaccine-4/5-4/22 Stiff Neck: 3 days after vaccine-4/5-4/22 Nausea/Vomiting: 3 days after vaccine-4/5 Double Vision: 8 days after vaccine-4/10-4/28
Age: 21.0
Sex: F
Vaccine: MNQ, MEN
Symptoms: Blood test, Computerised tomogram, Diplopia, Lumbar puncture, Migraine
Clinical narrative: Excruciating Migraines: 3 days after vaccine-4/5-4/22 Stiff Neck: 3 days after vaccine-4/5-4/22 Nausea/Vomiting: 3 days after vaccine-4/5 Double Vision: 8 days after vaccine-4/10-4/28
Age: 21.0
Sex: F
Vaccine: MNQ, MEN
Symptoms: Musculoskeletal stiffness, Nausea, Nuclear magnetic resonance imaging, Ophthalmological examination, Urine analysis
Clinical narrative: Excruciating Migraines: 3 days after vaccine-4/5-4/22 Stiff Neck: 3 days after vaccine-4/5-4/22 Nausea/Vomiting: 3 days after vaccine-4/5 Double Vision: 8 days after vaccine-4/10-4/28
Age: 21.0
Sex: F
Vaccine: MNQ, MEN
Symptoms: Vomiting
Clinical narrative: Excruciating Migraines: 3 days after vaccine-4/5-4/22 Stiff Neck: 3 days after vaccine-4/5-4/22 Nausea/Vomiting: 3 days after vaccine-4/5 Double Vision: 8 days after vaccine-4/10-4/28
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Dizziness, Dyskinesia, Excoriation, Fall, Headache
Clinical narrative: Patient rec'd HPV & Hep A vaccines about 10 am. Fainted after 5 min in waiting room fell face 1st, hit (L) side of cheek. Pt remained in waiting room lying down - unable to sit up without feeling shaky or nauseated. Moved back into pt. room about 10:40 - BP 138/80. 11 AM BP 122/72; P-60. Slight c/o HA. No nausea or dizziness. Ok to leave at 11:30. Walked to auto accompanied by nurse. 6/28 at 950 am: status: better now. Mom said he passed out with a previous vaccination; did not notify us.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Syncope, Tinnitus, Visual impairment
Clinical narrative: Patient rec'd HPV & Hep A vaccines about 10 am. Fainted after 5 min in waiting room fell face 1st, hit (L) side of cheek. Pt remained in waiting room lying down - unable to sit up without feeling shaky or nauseated. Moved back into pt. room about 10:40 - BP 138/80. 11 AM BP 122/72; P-60. Slight c/o HA. No nausea or dizziness. Ok to leave at 11:30. Walked to auto accompanied by nurse. 6/28 at 950 am: status: better now. Mom said he passed out with a previous vaccination; did not notify us.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Fall, Headache, Nausea, Nervousness, Syncope
Clinical narrative: Patient rec'd HPV & Hep A vaccines about 10 am. Fainted after 5 min in waiting room fell face 1st, hit (L) side of cheek. Pt remained in waiting room lying down - unable to sit up without feeling shaky or nauseated. Moved back into pt. room about 10:40 - BP 138/80. 11 AM BP 122/72; P-60. Slight c/o HA. No nausea or dizziness. Ok to leave at 11:30. Walked to auto accompanied by nurse. 6/28 at 950 am: status: better now. Mom said he passed out with a previous vaccination; did not notify us.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Acne, Anorectal disorder, Chest X-ray normal, Diarrhoea, Dyspnoea
Clinical narrative: 25 yo, male who is taking female hormone treatment but has male external genitalia, had intimate contact (including oral and anal sex) with her ex-boyfriend, a civilian contractor, on 6/15/12. The vaccinee did not have a dressing covering the vaccination site. The pt touched the vaccinated area and felt oozing fluid at least twice during the encounter. On 6/21/12 the pt developed lesions primarily over her anal/gluteal area. They started as "pimple like lesions" and "grew larger and started draining". She developed a lesion ("small pimple") on her upper lip on 6/22/12. She stated that over 24 hours the lesions grew to about the size of a dime and started oozing on 6/24/12. She also complained of feeling feverish, generalized body aches and nausea. On 6/22/12 she had anal sex with her boyfriend. She presented to the ER on 6/24/12 and was admitted (She was afebrile with no leukocytosis or electrolyte abnormalities in the ER). She indicated that she also had a lesion in her left ear which was draining. She also noted a "pimple" on her forehead on the afternoon of 6/25/12. The pt received VIG on 6/25/12. A lesion was noted on the oral mucosa on 6/27/12 which resolved spontaneously on 6/28/12. On 6/27/12 the pt complained of SOB upon awakening (no chest pain or palpitations). CXR, EKG and Troponin I were normal. The pt had no further cardiac symptoms. On 6/28/12 a swab of the lip lesion was obtained which returned on 7/2/12 positive for non-variola Orthopoxvirus. The pt was discharged from the hospital and 6/28/12. She was seen as an outpatient on 7/3 and 7/11/12. The hospital continued with frequent follow-up (education and support). On 7/17/12 the pt reported that all lesions were healed (flat, dry, slightly pink). Symptoms: Shortness of breath, Diarrhea NOS, inv skin/integumentary tissue NEC.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Nausea, Oral disorder, Orthopoxvirus test positive, Pain
Clinical narrative: 25 yo, male who is taking female hormone treatment but has male external genitalia, had intimate contact (including oral and anal sex) with her ex-boyfriend, a civilian contractor, on 6/15/12. The vaccinee did not have a dressing covering the vaccination site. The pt touched the vaccinated area and felt oozing fluid at least twice during the encounter. On 6/21/12 the pt developed lesions primarily over her anal/gluteal area. They started as "pimple like lesions" and "grew larger and started draining". She developed a lesion ("small pimple") on her upper lip on 6/22/12. She stated that over 24 hours the lesions grew to about the size of a dime and started oozing on 6/24/12. She also complained of feeling feverish, generalized body aches and nausea. On 6/22/12 she had anal sex with her boyfriend. She presented to the ER on 6/24/12 and was admitted (She was afebrile with no leukocytosis or electrolyte abnormalities in the ER). She indicated that she also had a lesion in her left ear which was draining. She also noted a "pimple" on her forehead on the afternoon of 6/25/12. The pt received VIG on 6/25/12. A lesion was noted on the oral mucosa on 6/27/12 which resolved spontaneously on 6/28/12. On 6/27/12 the pt complained of SOB upon awakening (no chest pain or palpitations). CXR, EKG and Troponin I were normal. The pt had no further cardiac symptoms. On 6/28/12 a swab of the lip lesion was obtained which returned on 7/2/12 positive for non-variola Orthopoxvirus. The pt was discharged from the hospital and 6/28/12. She was seen as an outpatient on 7/3 and 7/11/12. The hospital continued with frequent follow-up (education and support). On 7/17/12 the pt reported that all lesions were healed (flat, dry, slightly pink). Symptoms: Shortness of breath, Diarrhea NOS, inv skin/integumentary tissue NEC.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Polymerase chain reaction, Pyrexia, Secretion discharge, Skin disorder, Skin lesion
Clinical narrative: 25 yo, male who is taking female hormone treatment but has male external genitalia, had intimate contact (including oral and anal sex) with her ex-boyfriend, a civilian contractor, on 6/15/12. The vaccinee did not have a dressing covering the vaccination site. The pt touched the vaccinated area and felt oozing fluid at least twice during the encounter. On 6/21/12 the pt developed lesions primarily over her anal/gluteal area. They started as "pimple like lesions" and "grew larger and started draining". She developed a lesion ("small pimple") on her upper lip on 6/22/12. She stated that over 24 hours the lesions grew to about the size of a dime and started oozing on 6/24/12. She also complained of feeling feverish, generalized body aches and nausea. On 6/22/12 she had anal sex with her boyfriend. She presented to the ER on 6/24/12 and was admitted (She was afebrile with no leukocytosis or electrolyte abnormalities in the ER). She indicated that she also had a lesion in her left ear which was draining. She also noted a "pimple" on her forehead on the afternoon of 6/25/12. The pt received VIG on 6/25/12. A lesion was noted on the oral mucosa on 6/27/12 which resolved spontaneously on 6/28/12. On 6/27/12 the pt complained of SOB upon awakening (no chest pain or palpitations). CXR, EKG and Troponin I were normal. The pt had no further cardiac symptoms. On 6/28/12 a swab of the lip lesion was obtained which returned on 7/2/12 positive for non-variola Orthopoxvirus. The pt was discharged from the hospital and 6/28/12. She was seen as an outpatient on 7/3 and 7/11/12. The hospital continued with frequent follow-up (education and support). On 7/17/12 the pt reported that all lesions were healed (flat, dry, slightly pink). Symptoms: Shortness of breath, Diarrhea NOS, inv skin/integumentary tissue NEC.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin I, Troponin normal, Vaccination site discharge
Clinical narrative: 25 yo, male who is taking female hormone treatment but has male external genitalia, had intimate contact (including oral and anal sex) with her ex-boyfriend, a civilian contractor, on 6/15/12. The vaccinee did not have a dressing covering the vaccination site. The pt touched the vaccinated area and felt oozing fluid at least twice during the encounter. On 6/21/12 the pt developed lesions primarily over her anal/gluteal area. They started as "pimple like lesions" and "grew larger and started draining". She developed a lesion ("small pimple") on her upper lip on 6/22/12. She stated that over 24 hours the lesions grew to about the size of a dime and started oozing on 6/24/12. She also complained of feeling feverish, generalized body aches and nausea. On 6/22/12 she had anal sex with her boyfriend. She presented to the ER on 6/24/12 and was admitted (She was afebrile with no leukocytosis or electrolyte abnormalities in the ER). She indicated that she also had a lesion in her left ear which was draining. She also noted a "pimple" on her forehead on the afternoon of 6/25/12. The pt received VIG on 6/25/12. A lesion was noted on the oral mucosa on 6/27/12 which resolved spontaneously on 6/28/12. On 6/27/12 the pt complained of SOB upon awakening (no chest pain or palpitations). CXR, EKG and Troponin I were normal. The pt had no further cardiac symptoms. On 6/28/12 a swab of the lip lesion was obtained which returned on 7/2/12 positive for non-variola Orthopoxvirus. The pt was discharged from the hospital and 6/28/12. She was seen as an outpatient on 7/3 and 7/11/12. The hospital continued with frequent follow-up (education and support). On 7/17/12 the pt reported that all lesions were healed (flat, dry, slightly pink). Symptoms: Shortness of breath, Diarrhea NOS, inv skin/integumentary tissue NEC.
Age: 72.0
Sex: F
Vaccine: TTOX
Symptoms: Adverse drug reaction, Dyspnoea, Endoscopy, Feeling abnormal, Headache
Clinical narrative: Initial report received on 09 July 2012 from manufacturer, which was reported by a consumer, under (Manufacturer (MFR) report number: 1-5232013628). A 72-year-old female patient (birth date not reported) received an injection in the arm (side not specified) of TETANUS TOXOID (manufacturer unknown, lot number and rout not reported) on a date not specified. On an unspecified date, the patient developed a fever, which lasted six days and after receiving shot in her arm, (unspecified arm) was also sore. The patient also mentioned that while on Z-PAK (manufacturer unspecified) she was hospitalized with a headache, hives and vomiting from 25 May 2012 to 27 May 2012. The patient reported she previously took CIPRO (manufacturer and date unspecified) and it felt like her tendons were tearing (site where tendons felt like they were tearing was unspecified). The patient also reported she previously took CEFTIN (manufacturer and date unspecified) and experienced seizure-like tremors. She also reported she received Epinephrine (manufacturer and date unspecified) and could not breathe. The patient stated she is currently not taking any of these products. Nor were any of these products reintroduced. She reported she is not longer experiencing any of the adverse experiences mentioned (date unspecified). The patient does not recall any of the doses received or the date she started or stopped her treatment with each medication. All adverse responses apply to TETANUS TOXOID (reported as TD in this portion of narrative) per report. The patient's past medical history and concomitant medications were unspecified by reporter. On an unspecified date the patient had a magnetic resonance imaging (MRI) (site not specified), endoscopy, and a sonogram (site not specified). Other treatments for adverse events were unspecified by reporter. No further information was provided. For query can we contact physician, the patient's response was "no" per the report. The patient's outcome was reported as recovered on date unspecified by reporter. Documents held by sender: None.