chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Vomiting
Clinical narrative: This case was reported in a literature article and described the occurrence of influenza A (H3N2) in a child female subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). This case refers to patient 4 in the literature article. The subject had an underlying medical condition which was not specified. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (unspecified) (administration site and route unknown, batch number not provided). The subject attended a local agricultural fair in August 2011 and had direct contact with a pig. In August 2011, at an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced influenza A (H3N2), fever, cough, dyspnea, diarrhea and vomiting on 18 August 2011. The subject was hospitalised due to influenza A. At the time of reporting, the events were resolved. Summary of the literature article: During August 2011 until April 2012, 13 human infections with Influenza A (H3N2) variant (H3N2v) virus were identified; 8 occurred in the prior 2 years. This virus differs from previous variant influenza viruses in that it contains the matrix (M) gene from the Influenza A (H1N1) pdm09 pandemic influenza virus. A case was defined as a person with laboratory-confirmed H3N2v virus infection. Cases and contacts were interviewed to determine exposure to swine and other animals and to assess potential person-to-person transmission. The median age of cases was 4 years, and 12 of 13 (92%) were children. Pig exposure was identified in 7 (54%) cases. Six of 7 cases with swine exposure (86%) touched pigs, and 1 (14%) was close to pigs without known direct contact. Six cases had no swine exposure, including 2 clusters of suspected person-to-person transmission. All cases had fever; 12 (92%) had respiratory symptoms, and 3 (23%) were hospitalized for influenza. All 13 cases recovered. The author's conclusion stated that H3N2v virus infections were identified at a high rate from August 2011 to April 2012, and cases without swine exposure were identified in influenza-like illness outbreaks, indicating that limited person-to-person transmission likely occurred. Variant influenza viruses rarely result in sustained person-to-person transmission; however, the potential for this H3N2v virus to transmit efficiently is of concern. With minimal preexisting immunity in children and the limited cross-protective effect from seasonal influenza vaccine, the majority of children are susceptible to infection with this novel influenza virus.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Significant pain at site of injection at right deltoid continued since injection administration.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal pain upper, Crying
Clinical narrative: Stomach pain -- was curled up in a ball and crying off and on for 6 days.  No blood in stool.  Not any more spitty than usual (is a spitty baby per mom).
Age: 1.03
Sex: F
Vaccine: HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Diagnosed with varicella 16 days after receiving the varicella vaccine.
Age: 7.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Herpes zoster in a 2-dose varicella vaccine recipient. Symptoms: painful rash.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dizziness, Malaise, Nervousness, Palpitations
Clinical narrative: Pt c/o dizziness and feeling shaky, denied SOB, felt like heart was racing, BP: 114/78, pulse 65, resp 12, Temp 97.6. Given a glass of water and asked to wait 10 more minutes.  Continued to state not feeling well, A & O x3.  Shaking increased and c/o chills. Stated the only meds taken were Verapamil and Topamax last night. Called EMS and continued to monitor vital signs.  At 10:08, BP 135/90, pulse 90.  At 10:15, 134/86, pulse 102.  EMS arrived, gave O2, and encouraged her in deep breathing.  Patient refused EMS transport to ER. Called patients father who agreed to come and take her to ER. EMS and father escorted patient to vehicle for transport to ER. Patient walked with assistance.  Father texted at 2:15 to state patient was greatly improved, had lunch, and was going home to rest.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Skin got hot, hard, and red around the administration site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Local reaction
Clinical narrative: LT. LEG REDNESS, LIKELY LOCALIZED REACTION TO DTAP INJECTION. WILL GIVE RX BENADRYL AND IBUPROFEN FOR SYMPTOM RELIEF AND NOW NOTE VACCINE REACTION IN CHART.
Age: 15.0
Sex: M
Vaccine: HPVX
Symptoms: Dyskinesia, Immediate post-injection reaction, Skin discolouration, Syncope
Clinical narrative: Immediatally after vaccine my son fainted and began a jerking movement this lasted only about 5 seconds. After that he became responsive, his color was very greenish/yellow at first. After about 5 minutes and some juice he started feeling better.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: On spine just below hairline red raised rash with pimples, also on back left shoulder in two spots and front right shoulder. Treatment from dermatologist cream xerese 5%-1% and valacyclovir 1gm 1 tid x7 days.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Fatigue, Immediate post-injection reaction, Loss of consciousness, Muscle twitching, Nausea
Clinical narrative: Patient fainted immediately after injecting Menveo. Was unconscious 5-10 seconds and while out shoulders started to twitch. After coming to patient was alert but very tired and complained of nausea and ringing in the ears.  These symptoms lasted approximately 5 minutes.  Patient was apparently back to normal after 5 minutes.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Syncope, Tinnitus
Clinical narrative: Patient fainted immediately after injecting Menveo. Was unconscious 5-10 seconds and while out shoulders started to twitch. After coming to patient was alert but very tired and complained of nausea and ringing in the ears.  These symptoms lasted approximately 5 minutes.  Patient was apparently back to normal after 5 minutes.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Large, raised, red swollen spot on arm, hot to touch. Noticed 20 hours after vaccination was administered. Medicated with diphenhydramine. Visited PCP; however no treatment course was provided.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Diet refusal, Discomfort, Flatulence, Irritability
Clinical narrative: Chief Complaint: Patient presents with: Fussy child - pt was seen this morning and got her vaccines has been crying since then. Congestion. Gas.     History of present illness:   Seen today, immunized, 1hr after event (shots) began to screen to the point she could not hold up head. Screen was notably high pitched. (1:30 onset of screaming; given Tylenol) now falling to sleep, baby wakes and screams.  Refuses bottle.  Assessment and Plan   Pain in legs after immunizations Discomfort relieved by defecation No sign of neurologic sequelae after DTaP   PLAN: Cold packs to legs. Tylenol as directed earlier today. Dip nipple in Nature Ease (sucrose,) prn   Discussion:     Follow up instructions given and questions answered.  I have outlined  indications for prompt  return  for re-evaluation, and have encouraged a call if parents themselves have concerns which I have not addressed or anticipated.    Return advised:  Call prn
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pain in extremity, Posture abnormal, Respiratory tract congestion, Screaming
Clinical narrative: Chief Complaint: Patient presents with: Fussy child - pt was seen this morning and got her vaccines has been crying since then. Congestion. Gas.     History of present illness:   Seen today, immunized, 1hr after event (shots) began to screen to the point she could not hold up head. Screen was notably high pitched. (1:30 onset of screaming; given Tylenol) now falling to sleep, baby wakes and screams.  Refuses bottle.  Assessment and Plan   Pain in legs after immunizations Discomfort relieved by defecation No sign of neurologic sequelae after DTaP   PLAN: Cold packs to legs. Tylenol as directed earlier today. Dip nipple in Nature Ease (sucrose,) prn   Discussion:     Follow up instructions given and questions answered.  I have outlined  indications for prompt  return  for re-evaluation, and have encouraged a call if parents themselves have concerns which I have not addressed or anticipated.    Return advised:  Call prn
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received KINRIX on 7-19-13 in left upper thigh. Red, swollen left thigh - to ER on 7-21-13 put on ZANTAC, BENADRYL and Prednisone.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist, via a company representative, refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, dose and route were not provided) 19400 PFU. Concomitant medications were not reported. Pharmacist reported that a patient noted an unspecified rash on his opposite arm at an unspecified time after receiving ZOSTAVAX. Reporter stated that the patient went to the pharmacy and showed the rash to the pharmacist on an unspecified date. The patient told the pharmacist that the rash could have been on his arm prior to receiving the ZOSTAVAX but he did not notice the rash till after receiving the ZOSTAVAX. The outcome of rash on his opposite arm was not reported. The relationship between the ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mother states child had 3 shots on 7/22/13 - KINRIX (L) Deltoid), MMR ((R) upper arm subq), Varicella (L) upper arm Sub. States (L) upper arm in deltoid area is swollen, red, and hot. States he is able to move his arm, play and only complains when the area is touched.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular rash after immunization. Tx BENADRYL. Present x4 days.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Heart rate decreased, Syncope
Clinical narrative: Approximately 15 minutes after vaccination, patient fainted while existing the exam room. She revived within a minute - Her B/P was normal, but her pulse was slow. She received O2 in office and was referred to a cardiologist.
Sex: M
Vaccine: PPV
Symptoms: Adverse event, Cellulitis, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to two patients of unknown age. On an unknown date, the two patients were vaccinated with PNEUMOVAX 23 (lot # H017759) at different unspecified time. The dose, frequency and route of PNEUMOVAX 23 was not specified. At an unspecified time after administered PNEUMOVAX 23, one patient experienced cellulitis and fever, and the other patient just started to develop symptoms similar to the patient just mentioned. The outcome of the patient with cellulitis and fever was unknown; the outcome of the other patient was unknown. The primary reporter required a lot check. No PQC reported. Follow-up information has been requested from a healthcare worker concerning three (previously reported two) unspecified patients vaccinated with PNEUMOVAX 23 on an unspecified date. The patients experienced cellulitis and fever on an unknown date. The healthcare worker did not have any details of the particular adverse effect occurred. There were no patient contact details available. Follow-up information has been received from a registered nurse stated that this report pertains to two patients not three and that one of the two patients was a male patient who was "unable to drive home from down south and had to fly home because of this issue". This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from license vocational nurse (L.V.N), concerning to a patient of unknown age and gender. It was reported that on an unknown date, the patient was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported) and the second dose was received on an unspecified date 2 years after receiving the first dose in the vaccination series. Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: On 16-MAY-2013, the patient was vaccinated with the first dose of GARDASIL Lot # H020910, 0.5 ml, intramuscular (IM), (indication reported as recommendation). Concomitant medication was reported as none. On 17-MAY-2013, the patient broke out in a red rash that was itching on both arms and legs for 2 days. No treatment was given for the event. Laboratories were not performed. The event did not represent a significant disability or incapacity. On an unspecified date, the patient sought medical attention. On 19-MAY-2013, the patient recovered of the red rash that was itching on both arms and legs for 2 days. 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 pharmacist, regarding an unspecified number of patients (age and gender were not provided). The patients pertinent medical history, and drug reactions/allergies were not provided. On an unspecified date, patients received a dose of M-M-R II, HSA (route not provided, lot # reported as J002502, expiration date in 28-FEB-2015). Co-suspect therapy and concomitant medications were not provided. It was reported that an unspecified number of patients at unspecified times might have received doses of  M-M-R II that were exposed to 57F for 41 hours. The pharmacist also reported that there were two doses of M-M-R II that were administered, which might have been improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Adverse drug reaction, Erythema, Local swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a 58 year old female registered nurse patient reporting on herself via a company representative who on 01-APR-2012 was vaccinated with a dose of PNEUMOVAX23 in the left arm (lot # not provided) (therapy specifications not provided). The nurse stated that on an unspecified the nurse's arm because very painful and swollen. The nurse also noted that she had a reaction after she received vitamin B12 injection (dosage and manufacturer unknown) and experienced redness in her arm 48 hours after receiving the shot. There was not treatment given for the events. There were no labs performed. The outcome of the events was reported as recovered. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Incorrect dose administered, Vaccination failure
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 43 year old female patient. In July 2005, "8 years ago", the patient was vaccinated with a first and second dose of VARIVAX (Merck) (route and lot # not reported) and on an unspecified date, received a third dose of VARIVAX (Merck) (route and lot # not reported). The nurse reported that on an unknown date, after the first 2 vaccinations, varicella titers were drawn and were negative. An unspecified amount of time after the third dose of VARIVAX (Merck) titers were drawn again and found to be negative. The outcome of varicella titers were negative was reported as not recovered/not resolved. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 2 days post. site of MCV4 injection became red, itchy, tender and warm to touch. Red area 7 cm x 5 cm and irregular in shape. Diarrhea 1 day post injection also c/o headache.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site warmth
Clinical narrative: 2 days post. site of MCV4 injection became red, itchy, tender and warm to touch. Red area 7 cm x 5 cm and irregular in shape. Diarrhea 1 day post injection also c/o headache.
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: Anxiety, Dizziness, Vomiting
Clinical narrative: Patient felt dizzy, felt feeling of impending doom - however he did not develop any rash / swelling of lips or wheezing. He was placed on 4 L O2 for 1 1/2 hrs and vomiting. His VSS. He was then release without any complications.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Localized redness and swelling surrounding vaccine administration site 1 day later with itchiness.
Age: 57.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Chills, pain at injection site, fever flu like symptoms.
Age: 61.0
Sex: F
Vaccine: HEPA, IPV, TDAP, TYP
Symptoms: Urticaria
Clinical narrative: Urticaria (generalized) next morning after receiving vaccines previous afternoon (7/23/13).
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red circle with small bumps, the bumps merged and formed a large blister. The circle was very warm and arm and hand swelled.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site scar, Local reaction
Clinical narrative: Red circle with small bumps, the bumps merged and formed a large blister. The circle was very warm and arm and hand swelled.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Erythema, Oedema peripheral, Rash, Skin warm
Clinical narrative: Red circle with small bumps, the bumps merged and formed a large blister. The circle was very warm and arm and hand swelled.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain upper, Abnormal behaviour, Activities of daily living impaired, Affect lability, Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Arthralgia, Asthenopia, Bacterial test negative, Balance disorder, Blood iron
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood test normal, Chromatopsia, Confusional state, Conversion disorder, Crying
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Depression, Differential white blood cell count, Disorientation, Dissociation, Drug screen negative
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dysgraphia, Dyspnoea, Ear congestion, Ear discomfort, Electroencephalogram normal
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Encephalitis, Euphoric mood, Eye pain, Fatigue, Feeling abnormal
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Full blood count, Gait disturbance, Hallucination, Headache, Heart rate increased
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Hyperacusis, Hyperaesthesia, Hypertension, Hypoaesthesia, Lethargy
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Lumbar puncture normal, Malaise, Memory impairment, Meningeal disorder, Metabolic function test
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Mood swings, Motor dysfunction, Neck pain, Nervous system disorder, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pain, Pain in extremity, Panic attack, Paraesthesia, Paranoia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Parosmia, Respiration abnormal, Sensation of heaviness, Social avoidant behaviour, Speech disorder
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Spinal pain, Suffocation feeling, Tachycardia, Throat tightness, Toxicologic test normal
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Vision blurred, Visual impairment, Vitamin B12, Walking aid user
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Conversion disorder, Dyspnoea, Hallucination, Hyperventilation, Laboratory test
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Psychiatric evaluation
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Encephalitis
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was provided. On 16-JUL-2013 ("about a week ago") the patient was vaccinated with GARDASIL. Lot number, dose and dose strength were not provided. No concomitant medications were reported. Within 30 minutes after the vaccination the patient experienced encephalitis (medically significant upon internal review). The patient sought medical attention by going to the hospital. The outcome of encephalitis is unknown. The reporter considered the encephalitis to be GARDASIL-induced. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PPV, UNK
Symptoms: Crying, Dysstasia, Injection site movement impairment, Injection site pain, Mobility decreased
Clinical narrative: Child started walking on tiptoes for a few minutes, then started crying in pain and showed stiff legs. Refused to have legs touched. Cried "boo boo" for a half hour or more. Relaxed after being rocked and held. Could not stand. I called the Dr's after hours service and said that my  child had received 6 (!!!!) vaccines that day (they said he needed to catch up because he missed appointments when our insurance changed and we had to change dr's) and her response to that was "oh g-d!". She suggested liquid ibuprofen 1.5 teasp and liquid Tylenol alternating every 3 hours and we were able to administer about half teasp at 9:45pm. Child finally fell asleep. Woke up 2 hours later crying. I took the opportunity to administer another half teasp of ibuprof. Presently, child's legs are stiff when I try to bend them in his sleep. Ankles and knees showing resistence. If child was up and he tried to walk, he would not be able to. He can not roll over in bed.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PPV, UNK
Symptoms: Pain, Toe walking
Clinical narrative: Child started walking on tiptoes for a few minutes, then started crying in pain and showed stiff legs. Refused to have legs touched. Cried "boo boo" for a half hour or more. Relaxed after being rocked and held. Could not stand. I called the Dr's after hours service and said that my  child had received 6 (!!!!) vaccines that day (they said he needed to catch up because he missed appointments when our insurance changed and we had to change dr's) and her response to that was "oh g-d!". She suggested liquid ibuprofen 1.5 teasp and liquid Tylenol alternating every 3 hours and we were able to administer about half teasp at 9:45pm. Child finally fell asleep. Woke up 2 hours later crying. I took the opportunity to administer another half teasp of ibuprof. Presently, child's legs are stiff when I try to bend them in his sleep. Ankles and knees showing resistence. If child was up and he tried to walk, he would not be able to. He can not roll over in bed.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chest pain, Computerised tomogram, Lumbar puncture, Myelitis transverse
Clinical narrative: Awakened at 4:00 am with extreme burning in upper chest. Transported to hospital by emergency squad. Approximately 3 hours after arrival at "ER" I was paralyzed from waist down. "Transverse Myelitis". Treated with steroids.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Paralysis, Ultrasound scan
Clinical narrative: Awakened at 4:00 am with extreme burning in upper chest. Transported to hospital by emergency squad. Approximately 3 hours after arrival at "ER" I was paralyzed from waist down. "Transverse Myelitis". Treated with steroids.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Hyperaesthesia, Pain of skin, Pneumonia, Rash pruritic
Clinical narrative: This spontaneous report was received from a female patient of unknown age. The patient has penicillin allergy. The patients medical history included hip replacement and back surgery which resulted in the residual pain the back. On an unknown date about 2-3 years ago, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route was not reported). Concomitant medications included medication for high blood pressure, thyroid and Detrol. On an unknown date, the patient developed itchy rash and pain about a week ago. The rash appeared on her arms and legs. Her skin was sensitive and painful to the touch especially on the hip. She saw a dermatologist and the dermatologist could not diagnose the symptoms. The patient mentioned that she just recovered from pneumonia. As a treatment the patient was given Benadryl. The outcome of the other reported events were not recovered. The patient sought medical attention. The causality was not provided. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin exfoliation, Skin warm, Swelling
Clinical narrative: Large red, hot area about 2 inches long and 1 1/2 wide. Very hot, swollen, raised, pealing from heat.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Rash, Urticaria
Clinical narrative: Hives/extensive truncal rash.
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling to posterior of left arm with redness, lump, hot, painful and itchy. Employee was seen in the ED on 7/20/13 IV therapy and antibx given (Clindamycin and oral AUGMENTIN).
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth
Clinical narrative: Swelling to posterior of left arm with redness, lump, hot, painful and itchy. Employee was seen in the ED on 7/20/13 IV therapy and antibx given (Clindamycin and oral AUGMENTIN).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Ataxia, Computerised tomogram head normal, Posture abnormal
Clinical narrative: Two days after being vaccinated, she developed an atoxic gait and was unable to sit up. She was taken to medical center.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Pt had high pitch, unconsolable cry about 4 hours after administration of vaccines. Mom tried nursing, warm compress, and TYLENOL. Child is soothed temporarily, but resumes crying. Comfort measures discussed.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Ear discomfort, Hyperhidrosis, Nausea
Clinical narrative: Nauseated, diaphoretic. Dizziness, pressure in ears.
Age: 16.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 16 year old male patient. On 17-JUL-2013 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # not provided), (dose and frequency unspecified), injection. The patient had received MMR (manufacturer unknown) and VARIVAX (Merck) in the past on an unspecified date and was to receive the second dose of both the VARIVAX (Merck) and MMR (manufacturer unknown). No adverse effect reported. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypophagia, Irritability, Vomiting
Clinical narrative: Vomiting, fussiness and decreased oral intake for 12-18 hrs after vaccines were given.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to 40 years old female patient with no drug reactions or allergies. Patient's pertinent medical history was none. Approximately on an unknown date in July 2013(reported as last week), the patient was vaccinated with a dose of M-M-R II (Lot number, expiry date, route and dose were not reported) at an unspecified health department. On 15-JUL-2013, the patient went to the physician's office for an unknown reason and was found to be 10.5 weeks pregnant. Concomitant therapies included vitamins (unspecified) (reported as prenatal vitamins). Lab tests performed was none. The patient sought medical attention by visiting the physician's office. The patient's last menstrual period (LMP) was approximated to be 01-MAY-2013 and estimated date of delivery (EDD) was 05-FEB-2014. No treatment was provided. The outcome of pregnancy was unknown (Outcome pending). Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Lt arm - significant swelling and redness Rt arm measures 11 in - Lt arm measures 13 in.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Area around injection site was red, swollen, and hardened. No fever reported.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a 66 year old female patient with codeine allergy and antihistamines allergy refers to herself. On 16-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX. The patient reported that on 16-JUL-2013, she developed an injection site reaction following vaccination with ZOSTAVAX. The injection site reaction was described as a swollen, red, itchy area (no rash) about the size of a quarter at the injection site of the ZOSTAVAX vaccine. The patient did not seek medication attention. At the time of the report, the outcome of the events was reported as not recovered. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Less than hour after shot, burning pain in (L) shoulder area around joint - pain increased, extremely painful with certain movements (dressing, seat belt, lifting arm). Felt like had badly wrenched shoulder. Long lasting pain, impairment of movement. Pharmacist admin. shot high on shoulder, standing while I sat - 2 1/2 mos. later, still painful. Improving very slowly. (Nearly 8 mos later, still residual pain).
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: Less than hour after shot, burning pain in (L) shoulder area around joint - pain increased, extremely painful with certain movements (dressing, seat belt, lifting arm). Felt like had badly wrenched shoulder. Long lasting pain, impairment of movement. Pharmacist admin. shot high on shoulder, standing while I sat - 2 1/2 mos. later, still painful. Improving very slowly. (Nearly 8 mos later, still residual pain).
Age: 19.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient called morning of 7/22/13, 3 days after vaccination reporting a 3 inch diameter rash around injection site on right deltoid. Instructed patient to apply hydrocortisone cream and all if symptoms persist.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of unknown age. On 16-JUL-2013, the patient was inadvertently vaccinated with both doses of PROQUAD (Merck) and VARIVAX (Merck). No adverse effect was reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: DTAPIPV, MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given KINRIX instead of Tdap on 7/24/13. No adverse effects noted.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood glucose increased, Circulatory collapse, Dizziness, Heart rate decreased, Pulse absent
Clinical narrative: Patient felt dizzy then collapsed and became unresponsive 10 minutes after vaccine shots. Peripheral pulse not palpable HR very low. She was given Epipen 0.3 mg and she responded to this right away. HR, BP, mental status all improved. Transferred to the ER.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient felt dizzy then collapsed and became unresponsive 10 minutes after vaccine shots. Peripheral pulse not palpable HR very low. She was given Epipen 0.3 mg and she responded to this right away. HR, BP, mental status all improved. Transferred to the ER.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On 09-JUL-2013 the patient was vaccinated with PROQUAD (Merck) 0.5 ml, subcutaneously, lot# unspecified. The reporter stated that the PROQUAD (Merck) was stored at 46F for 10 days. The reporter also states that the PROQUAD (Merck) was put into the refrigerator on 09-JUL-2013. No adverse effect reported. The outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Malaise, Pyrexia, Sinusitis
Clinical narrative: 7-24-13 received phone call from client stating he had a fever (but he did not get a temp reading) for 2 days after receiving PNE vaccine on 7-9-13. His arm was also red and "he was very sick". He did go to his Primary Care Physician and was diagnosed and treated for a sinus infection (BACTRIM). He had received PREVENAR 13 on 2-6-13 per current recommendation.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On 18-JUL-2013 the patient was vaccinated with PROQUAD (Merck) (lot# J002931, Exp 12-SEP-2014), 0.5 ml, subcutaneously. The reporter stated that the PROQUAD (Merck) was stored at 46F for 10 days. No adverse effect reported. The outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARZOS, DTAP, IPV, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from an office manager refers to a 5 years old girl was inadvertently vaccinated with a 0.65ml dose of ZOSTAVAX (lot#batch# unspecified), subcutaneous injection at unspecified location instead of VARIVAX (Merck) on 15-JUL-2013. No adverse effects reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARZOS, DTAP, IPV, MMR, VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a 5 years old girl was inadvertently vaccinated with a 0.65ml dose of ZOSTAVAX (lot#batch# unspecified), subcutaneous injection at unspecified location instead of VARIVAX (Merck) on 15-JUL-2013. No adverse effects reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: This spontaneous report as received from a 50 year old female patient who is a physician refers to the patient herself with Ehlers Danlos Syndrome type 3, interstitial lung disease, allergy to sulfa and subcutaneous tissue does not have normal barriers. The patient's medical history included welts developed every time she received a subcutaneous injection. On 17-JUN-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously (lot # not reported). Concomitant therapies included prednisone (manufacturer unknown) 5 mg daily. The patient reported that "within a couple hours" of receiving ZOSTAVAX, on approximately 17-JUN-2013, the developed a red welt. She stated that the red welt "within two days" spread from her shoulder to her elbow. She reported that the reason she developed this welt was not because of the ZOSTAVAX but due to her having Ehlers Danlos Syndrome. She stated that a welt developed "every time" she received a subcutaneous injection because her subcutaneous tissue does not have "normal barriers". The patient emailed her physician for medical attention. She applied ice and took ibuprofen on unspecified days for the event. No lab diagnostics were performed. The outcome of red welt was reported as recovering. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Breast pain, Injection site erythema, Pain in extremity, Tenderness
Clinical narrative: Redness around administration site, tenderness and pain in arm, armpit and radiating into breast.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unknown female patient. Healthcare worker reported that patient was vaccinated with her first 0.5ml dose of GARDASIL (lot#/batch# unspecified), 0.5ml intramuscular injection at unspecified location for prophylaxis in June 2011. On 22-JUL-2013, the patient was in the office today to receive her second dose of GARDASIL. No adverse effect reported. Additional information has been requested.