chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient without a pertinent medical history or drug reactions/allergies. On 22-MAY-2013 the patient was vaccinated with ZOSTAVAX (vial, lot # H019092, 0.65 ml once, subcutaneous in the left triceps). Concomitant therapies included NEXIUM, simvastatin (manufacturer unknown) and estradiol (manufacturer unknown). On 24-MAY-2013 the patient experienced a "tennis ball size red area" on the back of her arm at the injection site, the area "does not hurt all the time but tender when touched, the area is itchy and the area is warm to touch". The patient sought medical attention by seeing the pharmacist. No treatment was given for the events. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Rash pruritic, Varicella
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 years old patient, who previously had an allergic reaction when she "broke out from" DEPAKOTE (date unspecified). The patient's medical history included chickenpox in childhood. On 26-APR-2013 the patient was vaccinated with ZOSTAVAX (lot number not provided), 0.65 ml (one shot), subcutaneous for shingles prevention. Concomitant therapies included EFFEXOR, ABILFY, TEGRETOL, AMLODIPINE, fish oil (unspecified), lutein, calcium (unspecified), CALCIUM (UNSPECIFIED) (+) VITAMIN D (UNSPECIFIED), unspecified multivitamins and COLACE. On 15-MAY-2013, the patient developed chickenpox. The rash was reported to be itchy, and the blisters had not yet crusted over. Patient received valacyclovir hydrochloride as treatment for chickenpox. None labs diagnostics studies were performed. The outcome of chickenpox was reported as not recovered/not resolved. The patient saw the physician. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a consumer referring to herself, a 61 year old female patient. The patient had no pertinent medical history or allergies. On 31-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date unknown) 1 time vaccine (dose unspecified), via subcutaneous in the left arm. There were no concomitant medications. On 02-JUN-2013, she had a mild reaction to ZOSTAVAX; she stated that she had redness at the injection site on her left arm. The patient did not seek medical attention and no treatment was given and lab diagnostics studies were not performed. The outcome of redness at the injection site on her left arm was unknown. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a healthcare worker, a Certified Medical Assistant (CMA), refers to a 24 year old female patient. The healthcare worker reported that the patient had received first and second dose of GARDASIL on unspecified dates, and the patient should have received her third dose in February 2013. The healthcare worker also reported that the patient was scheduled to receive the third dose " in the next few days". Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient. No medical history provided. On 09-MAY-2013 the patient was vaccinated with ZOSTAVAX (vial; dosing unknown; lot # J000432). No concomitant medications were reported. On 20-MAY-2013 the patient experienced a rash with pain and mild itching. The patient sought medical attention by going back to the pharmacy. No lab diagnostic studies were performed. The event was treated with a dose of BENADRYL (dose unspecified). The outcome of the rash with pain and mild itching is unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from an unspecified reporter via a company representative refers to one or more patients (no patient identifiers were provided). No medical history was provided. During a conference call, the reporter stated that it was possible that GARDASIL may have been given outside the recommended dosing schedule. No other co-suspected or concomitant medications were reported. No details regarding any dosing schedule were provided. Furthermore, it was determined that the call included a possible AE (dates and outcome were unknown). No further details were provided. No causality assessment was provided. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse for GARDASIL a Pregnancy Registry product, refers to a 27 year old female patient who on 28-DEC-2010, was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported) IM and on 17-APR-2013, was vaccinated with the second 0.5 ml dose of GARDASIL (Lot # reported as SH010649, expiration date 20-FEB-2015) IM. The nurse reported that the patient was pregnant for an unspecified amount of time, "7 to 8 weeks pregnant", when she received her second dose of GARDASIL. The patient's LMP was on approximately 13-MAR-2013 and er EDD would be on approximately 18-DEC-2013. No adverse effect was reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: Fever, redness at injection site, body aches, pain at injection site, malaise.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Cellulitis, Varicella virus test negative
Clinical narrative: ER diagnosis of cellulitis on 06/08/13. Prescribed BACTRIM x 10 days.
Age: 0.99
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and high fever (106 degrees Tympanic).
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Pt received Tdap injection 6/3/2013 (L) deltoid. Immediately had pain in (L) upper arm that has worsened. Exam c/w rotator cuff involvement. Referred to sports med. Ibuprofen for pain.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration
Clinical narrative: Induration at injection site 4 x 5 cm (R) deltoid.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt. given MMRV and varicella. There was nothing to recover from.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pruritic swollen erythematous area left upper posterior arm consistent with allergic type reaction.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain, warmth and redness at injection site and anterior to and below site.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Pain, warmth and redness at injection site and anterior to and below site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Patient developed flu like symptoms the night that the vaccine was given. Patient had vomiting, diarrhea, fever and "sniffles". Patient did report that her friends had similar symptoms going around for the previous week and could have caught it from them.
Age: 1.1
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Pt developed discreet diffuse papular rash today after receiving vaccines this morning. Afebrile.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Administered MMR, Varicella, Hep A on 5/30/13 at PCP office. Patient started w/ rash all over body on 6/9/13. Dx rash / MMR related.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: information has been received from a medical assistant, for VARIVAX (Oka/Merck), a Pregnancy Registry product, concoerning a 30 year old female patient, with no drug reactions or allergies and a history of 1 pregnancy and 1 live birth, who "last week" (on approximately 16-SEP-2011) was vaccinated with a 0.5 ml dose of VARIVAX (Oka/Merck) (lot # and route not reported). The medical assistant reported that the patient was 6 weeks pregnant and she received the vaccine. No AE side effects were reported. The patient sought unspecified medical attention, no lab diagnostic tests were performed and no treatment was given for the adverse event. The estimated delivery date is approximately 18-MAY-2012. Addtional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old male patient with no known drug allergies. On 01-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous. The pharmacist reported that the patient had an adverse event at injection site after being administered ZOSTAVAX. It was reported that the pharmacist administered ZOSTAVAX on 01-JUN-2013 to the patient and on an unspecified date in June 2013 the patient experienced redness at injection site. The redness was approximately an itch and a half in diameter around the site of injection. The patient did not seek medical attention. No treatment was given for the patient. At the time of the report, the patient was still experiencing this however it had not gotten any worse. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. In June 1996 (17 years ago), the patient was vaccinated with ROTATEQ could not be ruled out at the time of the call) oral administration (dose and lot # not reported). The physician reported that the patient developed intussusception following administration of a rotavirus vaccine 17 years ago. The physician stated that the intussusception was reported at the time it occurred (17 years ago). The outcome of intussusception was reported as recovered on unspecified date. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Bursitis, Drug ineffective, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Case number PHHY2012US038076 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 447480) website on 07 May 2012 with the follow-up received from Quality Assurance Department (reference number: 231214) on 05 Jun 2013. This case refers to a 75-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 400601) intramuscularly into her left arm on 28 Sep 2011. On the same day about 3 hours after vaccination her left arm hurt. The next day her left thigh was also hurting. The next day pain was so severe that she could not walk. She had a visit to a chiropractor without any relief. Later she had a visit to a doctor who referred to an orthopedic, and she was diagnosed with bursitis. It was also reported that the shot was ineffective. She was on treatment with VICODIN 24/7. She finally had an MRI but the results were not known. Physical therapy was recommended and she was continuing it at the time of this report. She had discussed this with many medical personnel; some have suggested the problem was caused by the needle, not necessarily the vaccine. The outcome was reported as condition unchanged. Batch review report concluded that, a batch specific review could not be performed since the batch number was not valid FLUVIRIN batch number. Based on the Annual Product Review (APR) of FLUVIRIN, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUVIRIN. From this conclusion there was no reason or explanation to account for the reported adverse event. Follow-up received from the Quality Assurance Department on 05 Jun 2013: Updated batch review report.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Eyelid oedema, Flushing, Glossodynia, Lip swelling, Oxygen saturation decreased
Clinical narrative: Case number PHHY2012US098877 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 461885) on 01 Nov 2012 with the follow-up received from the Quality Assurance department (reference number: 209195) on 10 Jun 2013: This report refers to a 12-years-old female patient. Her medical history included latex allergy according to her mother. Her concomitant medications included INTUNIV. She was vaccinated with MENVEO (batch number: A11071) intramuscularly along with BOOSTRIX (other manufacturer, batch number: AC52B079BA) intramuscularly in to the left arm and with GARDASIL (other manufacturer, batch number: 0629AE) intramuscularly along with VARIVAX (other manufacturer, batch number: 0359AC) subcutaneously in to the right arm on 18 Jul 2012. On the same day 20 minutes after vaccination, she began to have burning of tongue which progressed to swelling of lips and eyelids with flushing chest up. Her blood pressure was stable. Pulse oximetry was 94%; she was given epinephrine twice and DEPO MEDROL which led to improvement in her condition. She made a visit to the emergency department and was admitted into a hospital on an undetermined date. The final outcome of the reaction was reported as not yet recovered as on 23 Jul 2012. No further information about causality was provided. Batch review report concluded that, based on the document review, it was stated that, the concerned MENVEO (batch number: A11071) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from the Quality Assurance department on 10 Jun 2013: Updated batch review report.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Fall, Syncope, Tooth fracture
Clinical narrative: Case number PHHY2012US098974, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 462639) website on 01 Nov 2012 with the follow-up received from the Quality Assurance department (reference number: 209179) on 10 Jun 2013. This report refers to 12 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A11071), IM into left arm, ADACEL (batch number: C394AA), IM into right arm and VARIVAX (batch number: 0362AE), subcutaneous on right arm on 15 Aug 2012. After receiving vaccination nurse asked the patient if he was ok, he responded he was. When the patient was leaving the clinic, the patient fainted and as he fell, his tooth struck on door leading to chipping front tooth. Cold compress was given to the patient (ice pack). The outcome of the event was recovered. Seriousness and causality of the event was not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned MENVEO (batch number: A11071) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from the Quality Assurance department on 10 Jun 2013: Updated batch review report.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anxiety, Depression, Dizziness, Headache, Inflammation
Clinical narrative: This spontaneous report as received from a physician (M.D.) via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular (lot # not reported). On an unknown date the patient experienced significant autoimmune reaction after first dose. No specific symptoms were reported. Office visit was made and many tests were performed but any diagnostics and or treatment were unspecified. The patient did not continue with the series of GARDASIL. The outcome of significant autoimmune reaction was not recovered. The physician did not believe the event was related to GARDASIL. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test, Muscle spasms, Myopathy, Nightmare, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from a physician (M.D.) via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular (lot # not reported). On an unknown date the patient experienced significant autoimmune reaction after first dose. No specific symptoms were reported. Office visit was made and many tests were performed but any diagnostics and or treatment were unspecified. The patient did not continue with the series of GARDASIL. The outcome of significant autoimmune reaction was not recovered. The physician did not believe the event was related to GARDASIL. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain, Systemic lupus erythematosus, Thyroxine increased, Tri-iodothyronine increased, Vomiting
Clinical narrative: This spontaneous report as received from a physician (M.D.) via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular (lot # not reported). On an unknown date the patient experienced significant autoimmune reaction after first dose. No specific symptoms were reported. Office visit was made and many tests were performed but any diagnostics and or treatment were unspecified. The patient did not continue with the series of GARDASIL. The outcome of significant autoimmune reaction was not recovered. The physician did not believe the event was related to GARDASIL. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Autoimmune disorder, Incomplete course of vaccination, Laboratory test
Clinical narrative: This spontaneous report as received from a physician (M.D.) via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular (lot # not reported). On an unknown date the patient experienced significant autoimmune reaction after first dose. No specific symptoms were reported. Office visit was made and many tests were performed but any diagnostics and or treatment were unspecified. The patient did not continue with the series of GARDASIL. The outcome of significant autoimmune reaction was not recovered. The physician did not believe the event was related to GARDASIL. Additional information has been requested.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Abasia, Angiogram normal, Basal ganglia infarction, Central nervous system lesion, Ear infection
Clinical narrative: Patient had a fever, was very upset, left side of face was drooping, wouldn't use his left arm or left leg, and crying hysterically for several hours before we took him to the ER.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Electroencephalogram normal, Hemiparesis, Inappropriate affect, Injection site movement impairment, Irritability
Clinical narrative: Patient had a fever, was very upset, left side of face was drooping, wouldn't use his left arm or left leg, and crying hysterically for several hours before we took him to the ER.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Miosis, Nuclear magnetic resonance imaging brain abnormal, Orthopaedic procedure, Posture abnormal, Tremor
Clinical narrative: Patient had a fever, was very upset, left side of face was drooping, wouldn't use his left arm or left leg, and crying hysterically for several hours before we took him to the ER.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: X-ray limb normal
Clinical narrative: Patient had a fever, was very upset, left side of face was drooping, wouldn't use his left arm or left leg, and crying hysterically for several hours before we took him to the ER.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Basal ganglia stroke, Computerised tomogram abnormal, Crying, Echocardiogram abnormal, Electroencephalogram abnormal
Clinical narrative: Patient had a fever, was very upset, left side of face was drooping, wouldn't use his left arm or left leg, and crying hysterically for several hours before we took him to the ER.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Emotional distress, Injection site movement impairment, Mobility decreased, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Patient had a fever, was very upset, left side of face was drooping, wouldn't use his left arm or left leg, and crying hysterically for several hours before we took him to the ER.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Pyrexia, VIIth nerve paralysis
Clinical narrative: Patient had a fever, was very upset, left side of face was drooping, wouldn't use his left arm or left leg, and crying hysterically for several hours before we took him to the ER.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Pruritus
Clinical narrative: This spontaneous report as received from a physician via company representative concerning a female patient in her 60's. The patient's medical history included breast cancer. Drug reactions/allergies were unspecified by the reporter. On approximately 03-MAY-2013, "about two weeks ago", the patient was vaccinated with ZOSTAVAX, 0.65 ml (lot number and route not reported). Concomitant medications were unspecified by the reporter. The physician stated that the patient developed on approximately 10-MAY-2013 a vesicular rash on her arm "about a week" after the administration of ZOSTAVAX. It was also reported that the patient was experiencing "new outbreaks" and the physician reported a "vesicular rash had developed on the patient's face". The patient would be returning to the physician's office on 17-MAY-2013. The patient sought medical attention in the physician's office. At time of reporting, the patient had not recovered of the events. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician via company representative concerning a female patient in her 60's. The patient's medical history included breast cancer. Drug reactions/allergies were unspecified by the reporter. On approximately 03-MAY-2013, "about two weeks ago", the patient was vaccinated with ZOSTAVAX, 0.65 ml (lot number and route not reported). Concomitant medications were unspecified by the reporter. The physician stated that the patient developed on approximately 10-MAY-2013 a vesicular rash on her arm "about a week" after the administration of ZOSTAVAX. It was also reported that the patient was experiencing "new outbreaks" and the physician reported a "vesicular rash had developed on the patient's face". The patient would be returning to the physician's office on 17-MAY-2013. The patient sought medical attention in the physician's office. At time of reporting, the patient had not recovered of the events. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This spontaneous report as received from a healthcare worker (a billing department employee) via company representative, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route, indication and lot number were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced syncope after receiving GARDASIL series at the pediatric office. On an unspecified date, the patient were recovered from the syncope. The relationship between GARDASIL and seizure was not reported. This case is linked to case 1306USA002091 and case # 1306USA003568 via same reporter link. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report as received from a healthcare worker (a billing department employee) via company representative, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route, indication and lot number were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced syncope after receiving GARDASIL series at the pediatric office. On an unspecified date, the patient were recovered from the syncope. The relationship between GARDASIL and seizure was not reported. This case is linked to case 1306USA002091 and case # 1306USA003568 via same reporter link. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a healthcare worker (a billing department employee) via company representative, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route, indication and lot number were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced syncope after receiving GARDASIL series at the pediatric office. On an unspecified date, the patient were recovered from the syncope. The relationship between GARDASIL and seizure was not reported. This case is linked to case 1306USA002091 and case # 1306USA003568 via same reporter link. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site bruising, Pyrexia
Clinical narrative: High Fever (102.5), vomiting, severe headache, fatigue warm,red and hard knot at injection site. Dr visits, 6/3/13, 6/5/13, 6/10/13. Antibiotic injection and 10 day oral antibiotics.
Age: 72.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Feeling abnormal, Injection site bruising, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: High Fever (102.5), vomiting, severe headache, fatigue warm,red and hard knot at injection site. Dr visits, 6/3/13, 6/5/13, 6/10/13. Antibiotic injection and 10 day oral antibiotics.
Age: 72.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Pyrexia
Clinical narrative: High Fever (102.5), vomiting, severe headache, fatigue warm,red and hard knot at injection site. Dr visits, 6/3/13, 6/5/13, 6/10/13. Antibiotic injection and 10 day oral antibiotics.
Age: 72.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Chest X-ray, Erythema, Face and mouth X-ray, Fatigue, Headache
Clinical narrative: High Fever (102.5), vomiting, severe headache, fatigue warm,red and hard knot at injection site. Dr visits, 6/3/13, 6/5/13, 6/10/13. Antibiotic injection and 10 day oral antibiotics.
Age: 72.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site nodule, Pyrexia, Skin warm, Urine analysis, Vomiting
Clinical narrative: High Fever (102.5), vomiting, severe headache, fatigue warm,red and hard knot at injection site. Dr visits, 6/3/13, 6/5/13, 6/10/13. Antibiotic injection and 10 day oral antibiotics.
Age: 72.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: White blood cell count increased
Clinical narrative: High Fever (102.5), vomiting, severe headache, fatigue warm,red and hard knot at injection site. Dr visits, 6/3/13, 6/5/13, 6/10/13. Antibiotic injection and 10 day oral antibiotics.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Dyspnoea, Injection site pain, Injection site rash
Clinical narrative: Fever of 101.8 first night then 100 until Friday night when started prednisone, Claritin and rantidine as prescribed by my doctor. Difficulty breathing briefly 6/5 which went away after a few minutes. Very dizzy, weak, and pale, excruciating pain where arm was injected, unable to lift arm, arm swollen at injection site about size of a golf ball, injection site was hot to touch, rash appeared around injection site on Friday. All symptoms gone by Saturday morning. On Sunday, new symptom was weakness in my arm that recieved the injection and difficulty controlling my arm. That feeling was only on Sunday.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Muscular weakness, Pallor, Pyrexia
Clinical narrative: Fever of 101.8 first night then 100 until Friday night when started prednisone, Claritin and rantidine as prescribed by my doctor. Difficulty breathing briefly 6/5 which went away after a few minutes. Very dizzy, weak, and pale, excruciating pain where arm was injected, unable to lift arm, arm swollen at injection site about size of a golf ball, injection site was hot to touch, rash appeared around injection site on Friday. All symptoms gone by Saturday morning. On Sunday, new symptom was weakness in my arm that recieved the injection and difficulty controlling my arm. That feeling was only on Sunday.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Non-Hodgkin's lymphoma, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 13 month old patient of unknown gender. On 22-MAY-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number and expiry date reported as H017377 and 15-SEP-2014 respectively, dose and route unspecified). Other suspect therapy included a dose of M-M-R II (lot number and expiry date reported as H010133 and 17-MAY-2014 respectively, dose and route unspecified) given on 22-MAY-2013. Concomitant therapy included hepatitis a virus vaccine (unspecified) given on 22-MAY-2013. On 24-MAY-2013, the patient was admitted to a hospital and was diagnosed with acute lymphoblastic lymphoma (previously reported as leukemia by the company representative). On 03-JUN-2013, the patient developed disseminated mild varicella rash on the trunk and extremities. The patient was still in the hospital. It was unspecified if the patient sought any medical attention. It was unspecified if any treatment was given or if any lab tests were performed. The outcome of the events was unknown. The relatedness for the events was unknown for VARIVAX (Merck) and M-M-R II. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, MNQ
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a nurse practitioner (N.P.) via a representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 1, intramuscularly (dose and lot # not provided). After the patient received first dose in the series with GARDASIL, she had a seizure. The outcome of seizure was unknown. Upon internal review, seizure was considered to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, MNQ
Symptoms: Blood glucose normal, Extremity contracture, Hypopnoea, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a nurse practitioner (N.P.) via a representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 1, intramuscularly (dose and lot # not provided). After the patient received first dose in the series with GARDASIL, she had a seizure. The outcome of seizure was unknown. Upon internal review, seizure was considered to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, MNQ
Symptoms: Respiratory arrest, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a nurse practitioner (N.P.) via a representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 1, intramuscularly (dose and lot # not provided). After the patient received first dose in the series with GARDASIL, she had a seizure. The outcome of seizure was unknown. Upon internal review, seizure was considered to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, MNQ
Symptoms: Convulsion
Clinical narrative: Pt received MENACTRA the GARDASIL. Immediately upon removal of GARDASIL needle, pt became unresponsive. Stiffened body, contracted arms, clenched fists. Pupils dilated, breathing became shallow and stopped for several seconds. Episode lasted approx 90 sec. Pt regained consciousness. Was alert and oriented and felt fine after 20 mini. NL  neuro states at that time. BP 110/64 prior to event B/P 98/70 after event. No prior seizures.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, MNQ
Symptoms: Blood glucose normal, Extremity contracture, Hypopnoea, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: Pt received MENACTRA the GARDASIL. Immediately upon removal of GARDASIL needle, pt became unresponsive. Stiffened body, contracted arms, clenched fists. Pupils dilated, breathing became shallow and stopped for several seconds. Episode lasted approx 90 sec. Pt regained consciousness. Was alert and oriented and felt fine after 20 mini. NL  neuro states at that time. BP 110/64 prior to event B/P 98/70 after event. No prior seizures.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, MNQ
Symptoms: Respiratory arrest, Unresponsive to stimuli
Clinical narrative: Pt received MENACTRA the GARDASIL. Immediately upon removal of GARDASIL needle, pt became unresponsive. Stiffened body, contracted arms, clenched fists. Pupils dilated, breathing became shallow and stopped for several seconds. Episode lasted approx 90 sec. Pt regained consciousness. Was alert and oriented and felt fine after 20 mini. NL  neuro states at that time. BP 110/64 prior to event B/P 98/70 after event. No prior seizures.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Anaphylactic reaction, Erythema, Listless, Rash erythematous, Swelling face
Clinical narrative: 6/7/13 - Received 2 mos vaccine, at about 10-1030 AM. 6 PM Parents gave Dye/Flavor free Little Remedies acetaminophen. 645 PM Parents noted redness, facial swelling, tongue swelling, red bumps and listlessness. 911 called. In ER received BENADRYL, steroids, N.S. bolus, Epinephrine, ZANTAC - Dx Anaphylaxis - referred to Allergy.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Swollen tongue
Clinical narrative: 6/7/13 - Received 2 mos vaccine, at about 10-1030 AM. 6 PM Parents gave Dye/Flavor free Little Remedies acetaminophen. 645 PM Parents noted redness, facial swelling, tongue swelling, red bumps and listlessness. 911 called. In ER received BENADRYL, steroids, N.S. bolus, Epinephrine, ZANTAC - Dx Anaphylaxis - referred to Allergy.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Acute myocardial infarction, Discomfort, Dyspnoea, Electrocardiogram abnormal, Incorrect route of drug administration
Clinical narrative: This is a spontaneous report from a contactable lead Medical Assistant who reported for a patient. This 60 year old female patient received PREVNAR 13 (lot number G73023, expiration date 01Oct2014, NDC 0005197102) on 30May2013 at 0.5 ml single dose through a prefilled syringe as she was going to have a cochlear implant on left side of her head. Relevant medical history included cochlear implant on right side of her head, hyperlipidaemia, diabetes and back pain, all since an unknown date. Relevant concomitant medications included FLEXERIL for back pain, vitamin C and vitamin D. The patient received on an unknown date PNEUMOVAX. On 30May2013, the patient was given PREVNAR 13 through a wrong route which was elaborated that instead of intramuscular it got into the blood stream of the patient. On 31May2013 morning, the patient had shortness of breath and stress discomfort and after the electrocardiogram (EKG), it was found that she had acute myocardial infarction on 31May2013 due to which she went to the emergency room and was hospitalized for 3 days from 31May2013 to 02Jun2013. Relevant laboratory data included also several other unspecified tests in which everything was found normal. Therapeutic measures taken included nitroglycerine and aspirin since 31May2013 at an unknown dose and frequency. Clinical outcome was unknown at the time of report.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Laboratory test normal, Stress
Clinical narrative: This is a spontaneous report from a contactable lead Medical Assistant who reported for a patient. This 60 year old female patient received PREVNAR 13 (lot number G73023, expiration date 01Oct2014, NDC 0005197102) on 30May2013 at 0.5 ml single dose through a prefilled syringe as she was going to have a cochlear implant on left side of her head. Relevant medical history included cochlear implant on right side of her head, hyperlipidaemia, diabetes and back pain, all since an unknown date. Relevant concomitant medications included FLEXERIL for back pain, vitamin C and vitamin D. The patient received on an unknown date PNEUMOVAX. On 30May2013, the patient was given PREVNAR 13 through a wrong route which was elaborated that instead of intramuscular it got into the blood stream of the patient. On 31May2013 morning, the patient had shortness of breath and stress discomfort and after the electrocardiogram (EKG), it was found that she had acute myocardial infarction on 31May2013 due to which she went to the emergency room and was hospitalized for 3 days from 31May2013 to 02Jun2013. Relevant laboratory data included also several other unspecified tests in which everything was found normal. Therapeutic measures taken included nitroglycerine and aspirin since 31May2013 at an unknown dose and frequency. Clinical outcome was unknown at the time of report.
Age: 81.0
Sex: M
Vaccine: RAB, TTOX
Symptoms: Condition aggravated, Foaming at mouth, Hemiplegia, Increased upper airway secretion, Paragonimiasis
Clinical narrative: Initial report was received from a consumer on 31 May 2013, who is also the patient. An 81-year-old male patient received the first doses of following vaccinations on 07 March 2013: IMOVAX Rabies (Sanofi Pasteur), Tetanus Toxoid (Manufacturer unknown), and Rabies Immunoglobulin (Manufacturer unknown) (lot numbers were unknown, route and site of administration were not reported). The patient had wound from a cat bite and scratches. The patient had 3 more IMOVAX vaccinies, but did not have dates of vaccinations. An unreported amount of time later, the patient stated his wound infection was worse, he had nasal and throat mucous, "frothy" mucous from the mouth, exacerbation of an old whiplash injury, and worsening of paralysis from a previous stroke. The patient had paralysis of lower extremities and now has paralysis of the entire right side. The patient had his "lung fluke" condition worsen. The patient believed the "rabies vaccine didn't work" but he had not been able to have titers ordered by a healthcare provider. He received healthcare through the hospital. He had seen his doctor in the past for his "lung fluke condition." The patient's allergies included "lyserine cream" for a skin rash. The patient had a history of numerous medical conditions such as history of past stroke, radiation sickness, numerous "infections", and lung fluke condition. The patient had no illness at the time of vaccination and no other vaccinations within 4 weeks of vaccinations given 07 March 2013. The patient's status was reported as not recovered. Documents held by sender: None.
Age: 81.0
Sex: M
Vaccine: RAB, TTOX
Symptoms: Post-traumatic neck syndrome, Rhinorrhoea, Wound infection
Clinical narrative: Initial report was received from a consumer on 31 May 2013, who is also the patient. An 81-year-old male patient received the first doses of following vaccinations on 07 March 2013: IMOVAX Rabies (Sanofi Pasteur), Tetanus Toxoid (Manufacturer unknown), and Rabies Immunoglobulin (Manufacturer unknown) (lot numbers were unknown, route and site of administration were not reported). The patient had wound from a cat bite and scratches. The patient had 3 more IMOVAX vaccinies, but did not have dates of vaccinations. An unreported amount of time later, the patient stated his wound infection was worse, he had nasal and throat mucous, "frothy" mucous from the mouth, exacerbation of an old whiplash injury, and worsening of paralysis from a previous stroke. The patient had paralysis of lower extremities and now has paralysis of the entire right side. The patient had his "lung fluke" condition worsen. The patient believed the "rabies vaccine didn't work" but he had not been able to have titers ordered by a healthcare provider. He received healthcare through the hospital. He had seen his doctor in the past for his "lung fluke condition." The patient's allergies included "lyserine cream" for a skin rash. The patient had a history of numerous medical conditions such as history of past stroke, radiation sickness, numerous "infections", and lung fluke condition. The patient had no illness at the time of vaccination and no other vaccinations within 4 weeks of vaccinations given 07 March 2013. The patient's status was reported as not recovered. Documents held by sender: None.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Computerised tomogram, Fall, Full blood count, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Odd gait when walking/running on 4/1. Feet tingled on 4/2. Limping by 4/3 and began falling frequently. ER on 4/7 and diagnosed with Guillain-Barre Syndrom on 4/8.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Odd gait when walking/running on 4/1. Feet tingled on 4/2. Limping by 4/3 and began falling frequently. ER on 4/7 and diagnosed with Guillain-Barre Syndrom on 4/8.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: She had low grade fever of 102 that lasted approximately 48 hours. She also developed a full body rash - head to toe - the lasted approximately 6 days.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff neck x 48 hours.
Age: 0.44
Sex: F
Vaccine: UNK
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Sm red rash and bump at injection site.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood lead, Full blood count, Rash erythematous, Rash generalised
Clinical narrative: RED RASH ALL OVER BODY.
Age: 10.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Injection site reaction, Urticaria
Clinical narrative: PT HAD YELLOW FEVER VACCINE LT UPPER ARM ON 6/6/13. WAS HAVING A REACTION AT INJECTION SITE ON 6/7/13. HIVES APPEARED ON LT ARM IN AM ON 6/8/13 AND HIVES APPEARED ON RT ARM. PT GIVEN BENADRYL.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blepharospasm, Joint contracture, Malaise, Musculoskeletal stiffness, Tonic clonic movements
Clinical narrative: After receiving an injection of Depo Provera and injection of Gardasil, the client was escorted to the front desk to schedule follow-up appointments. Client stated she felt like she was going to be sick.  She was seated in a chair and became stiff, hands clenched and tonic/clonic movements were noted. Precautions were employed to maintain the airway, 911 was called for transport to the ED. Prior to EMS arrival she became responsive and vomited. She was coherent able to answer questions.  She had slight twitching of her eye.  EMS arrived and transported her to the ED. Later conversation with her revealed that she had been discharged from the ED and was feeling much better with no complaints.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: After receiving an injection of Depo Provera and injection of Gardasil, the client was escorted to the front desk to schedule follow-up appointments. Client stated she felt like she was going to be sick.  She was seated in a chair and became stiff, hands clenched and tonic/clonic movements were noted. Precautions were employed to maintain the airway, 911 was called for transport to the ED. Prior to EMS arrival she became responsive and vomited. She was coherent able to answer questions.  She had slight twitching of her eye.  EMS arrived and transported her to the ED. Later conversation with her revealed that she had been discharged from the ED and was feeling much better with no complaints.
Age: 25.0
Sex: M
Vaccine: HEPA, IPV, MNQ, TDAP, TYP, YF
Symptoms: Oedema mouth, Pruritus generalised, Rash generalised, Swelling face
Clinical narrative: Pt called health department experiencing rash and itching all over body, no breathing problems at that time.  I instructed him to take Benadryl now and if symptoms worsened or signs of anaphylaxis appears, then to go to Emergency Room.  Later in evening he had mouth and facial swelling so he went to ER where he was given Epinepherine and steroids. He states he is feeling better today (6/11/2013).
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Rt arm with mild redness at injection site, swollen and warm to touch.  Induration 12cm x 14cm with prominent itching.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Full blood count, Liver function test, Metabolic function test, Muscular weakness
Clinical narrative: Pt c/o neck pain, myalgias and fevers/chills to 101.5. Started 5 pm 5/31. Rash on ankles. Had weakness of arms that improves over day.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain, Pyrexia, Rash
Clinical narrative: Pt c/o neck pain, myalgias and fevers/chills to 101.5. Started 5 pm 5/31. Rash on ankles. Had weakness of arms that improves over day.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Patient experienced swelling in arm, no pain no itching.  Patient went to urgent care facility was told to apply ice, and wrap the area.  Was then seen here on a follow up, and was told to no longer wrap the arm.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site bruising, Injection site rash
Clinical narrative: Rash and bruising at the site of the ProQuad consistent with varicella.
Age: 43.0
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Tremor
Clinical narrative: DIARRHEA AND TREMBLING LASTING 3 DAYS.
Age: 0.55
Sex: M
Vaccine: HEP
Symptoms: Decreased appetite, Feeling abnormal, Gastrointestinal disorder, Hypersensitivity, Injection site erythema
Clinical narrative: High fever, swelling/redness at site, sleeplessness, foggy/hazy awareness, increased food sensitivity/GI troubles, lack of appetite.
Age: 0.55
Sex: M
Vaccine: HEP
Symptoms: Injection site swelling, Insomnia, Pyrexia, Vision blurred
Clinical narrative: High fever, swelling/redness at site, sleeplessness, foggy/hazy awareness, increased food sensitivity/GI troubles, lack of appetite.
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Vaccination complication
Clinical narrative: Patients mother took child to ER with temperature of 105.5. Was unable to reduce with medication. ER Physician stated adverse reaction to vaccines administered.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MNQ, RV5
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: Patient was given Menactra instead of Prevnar by Medical Assistant. Patient's mother was contacted and asked to observe child closely particularly for fever.  Patient was taken to the ER.