chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from the healthcare worker refers to a patient of unknown age and gender. No medical history, drug allergy and concurrent condition was reported. On 09-MAR-2015, the patient was vaccinated with expired dose of PNEUMOVAX 23 lot # K005957 with the expiration date of 08-MAR-2015, 0.5 ml, subcutaneous for an unknown indication. No adverse effect was reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health professional via a company representative refers to 2 patients of unknown age and gender. On an unknown date, also reported as "a while ago for one of the patients", the patients were vaccinated with 2 doses of ZOSTAVAX (dose and route of administration were not reported). The second doses of ZOSTAVAX were administered due to staff error only. No adverse effects were reported. It was reported that both patients were fine. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-FEB-2015 a dose of ZOSTAVAX (0.65 ml, lot # not reported) was administered in the area of patient's arm that was slightly different than was recommended in prescribing information and pharmacist suspected that dose might had been administered intramuscularly rather than subcutaneously due to location of administration. The pharmacist could not be certain if dose was administered intramuscularly but stated that area of the arm used for injection was slightly different than deltoid region of upper arm. The pharmacist did not specify the exact location of administration. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 14-JUN-2014, the patient was vaccinated with first dose of GARDASIL (0.5 ml) (lot number unspecified), intramuscularly. Concomitant medications were not reported. On 22-AUG-2014, the patient was vaccinated with second dose of GARDASIL (0.5 ml), intramuscularly. On 24-OCT-2014, the patient was vaccinated with third dose of GARDASIL (0.5 ml), intramuscularly which was much earlier than the recommended schedule. No adverse effect was reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site nodule, Injection site rash
Clinical narrative: This spontaneous report as received from a patient (a pharmacist) via a company representative refers to a male patient of unknown age. On an unknown date in November 2014 the patient was vaccinated with ZOSTAVAX (0.65 ml dose, route and lot # not reported). No concomitant therapy was reported. On an unknown date in November 2014, within 48 hours after receiving ZOSTAVAX, the patient developed headache that lasted 24 hours. And within 7 to 10 days of receiving ZOSTAVAX vaccine, the patient had a large rash at the injection site on his left arm that developed into a knot. That had since healed on an unspecified date, approximately in 2014 (also reported as recovered after 7-10 days). There was no treatment given for the events and the patient did not seek medical attention. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Information has been received from a physician referring to a female patient of unknown age. On an unknown date (reported as "a couple of years ago") the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route were not provided). On an unknown date the patient experienced ophthalmic shingles. The patient sought medical attention by saw physician. The outcome of event was resolved on an unknown date. Additional information has been requested.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a female patient of unknown age. No medical history and current conditions were reported. On 10-FEB-2015, the patient at her six to eight weeks gestation, was vaccinated with VARIVAX (Merck) dose 1, 0.5 ml, subcutaneous and with M-M-R II (0.5 ml, dose 1, subcutaneous) on the same day. The Last menstrual period (LMP) and estimated date of delivery (EDD) are not reported. No lab data was reported. Patient sought medical attention, called to the physician's office. The outcome of exposure during pregnancy was unknown. Pregnancy outcome was pending. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 25-FEB-2015 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, lot # J013452, subcutaneously which was expired (expiration date 24-JAN-2015). The dose was supported. No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, an unspecified patients were vaccinated with a dose of improperly stored VAQTA (dose, route, lot number and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, an unspecified patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (dose, route, therapy type, lot number and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, an unspecified patients were vaccinated with a dose of improperly stored GARDASIL, measles, mumps (dose, route, lot number and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, an unspecified patients were vaccinated with a dose of improperly stored ROTATEQ (route oral, dose, lot number and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, an unspecified patients were vaccinated with a dose of improperly stored M-M-R II (dose, route, therapy type, lot number and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via a employee referring to a male patient of unknown age. Two years ago (in approximately 2013) the patient was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported). On approximately 19-FEB-2015 (reported as two weeks ago) the patient was diagnosed with shingles by his unspecified provider. The patient sought medical attention by visiting with unspecified provider. The patient was prescribed NORCO for treatment. At the time of reporting, the patient did not recover from this event. Causality between the event and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Secondary immunodeficiency
Clinical narrative: This literature marketed report was received on 02-MAR-2014 from a physician regarding a retrospective analysis of the utility of preimmunization and postimmunization titers to 23 serotypes of streptococcus pneumoniae. Aim: To identify a subset of 23-PPV serotypes with high diagnostic utilities for the diagnosis of Specific antibody deficiency (SAD). Rationale: SAD was diagnosed by lack of response to 23-PPV. It was unknown if each of the 23-PPV serotypes had similar diagnostic utilities for SAD. Method: The physician reported that they retrospective identified 126 patients aged between 2 to 18 years that had two sets of 23-PPV titers, which were drawn on an unspecified date 4-12 weeks apart. These patients did not have another identifiable cause of immunodeficiency. The adequate immunization response post vaccination of 23 PPV was defined as greater or equal to 4 fold rises in response for greater than 70 percent of serotypes (50 percent for 2-5years age group) and postimmunization titers or less than or equal to 1.3 microgram per milliliter. The calculations for sensitivity, specificity and area under the curve (AUC) were done for each serotype. This report refers to a group of 25 patients from the 126 patients identified retrospectively. On an unknown dates, the patients were vaccinated with 23-PPV (manufacturer unknown) (dose, route and frequency were unknown). No concomitant medications were reported. The author reported that 25 patients had inadequate responses and were diagnosed with SAD. The physician reported that the remaining 101 patients had an adequate response to 23-PPV. Post immunization titer to serotype 6B provided the best diagnostic utility, with an AUC of 0.91 (sensitivity 48%, specificity 98%). The following serotypes had AUC >=0.8 with corresponding sensitivity/specificity, 9N (AUC=0.87, 58%/93%), 9V (AUC=0.87, 48%/91%), 18C (AUC=0.85, 56%/92%), 4 (AUC=0.84, 56%/94%), 7F (AUC=0.81, 54%/85%), 17F (AUC=0.80, 54%/87%), 19F (AUC=0.80, 28%/99%), and 5 (AUC=0.80, 71%/76%). CONCLUSIONS: The authors identified a subset of pneumococcal serotypes that provide high diagnostic utility for the diagnosis of SAD, A further prospective study was required to investigate whether the diagnosis of SAD could be established based on a limited panel of pneumococcal serotypes. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker refers to an unspecified number of patients of unknown age. The healthcare worker reported the patients were administered an unspecified number of improperly stored doses of GARDASIL (dose, route and lot# not reported). No adverse effect was reported. It was unknown if the patients sought medical attention. This is one of the several reports with the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Bartonellosis
Clinical narrative: Information has been received from a registered nurse via field representative referring to a female patient of unknown age. It was reported that an unspecified article in Facebook stated a patient developed Bartonella Syndrome after receiving GARDASIL. The source of this document was not available. The outcome of the event was unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Patient experienced about 3 inch diameter rash near injection site. Was given rx for triamcinolone cream by MD and given oral BENADRYL.
Sex: F
Vaccine: VARZOS
Symptoms: Multiple sclerosis relapse
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, lot number not provided) and at the reporting time, she was experiencing multiple sclerosis flares. She saw doctor for medical attention and was not given treatment for the adverse event. The outcome of multiple sclerosis flares was unknown. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Fall, Laceration, Vomiting
Clinical narrative: After patient had the shot did not want to wait 10 minutes but decided to go shopping. After leaving the pharmacy became lightheaded and fell. Had a cut on back of his head. Did vomit a little but did not want to us to call 911.
Age: 58.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Staphylococcal infection
Clinical narrative: Case number PHHY2015US015340 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 549046) on 03 Feb 2015 and with follow up information received from the quality assurance department (QA reference number: 351467) on 12 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 351467) on 06 Mar 2015. This report refers to a 58 years old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1413501) intramuscularly and PNEUMOVAX (other manufacturer, batch number: K005798) subcutaneously; both vaccines administered in the right arm on 05 Oct 2014. On 06 Oct 2014, the patient had staphylococcal infection as per Primary Care Physician (PCP). The events outcome was unknown. The events were reported as non-serious, but the event staphylococcal infection was upgraded as medically significant based on the information available in the NVS-IME list. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1413501) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 351467) on 12 Feb 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 351467) on 06 Mar 2015: Updated FLUVIRIN vaccine batch review report.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Discomfort
Clinical narrative: Case number PHHY2015US015260, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549436) website on 03 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 351440) on 06 Mar 2015. This report refers to a 61-year-old female patient. Medical history was not reported. Concomitant medications included NORVASC and NAPROSYN. She was vaccinated with FLUVIRIN (batch number: 1455223) intramuscularly into left arm on 02 Oct 2014. On the same day, she was also vaccinated with ZOSTAVAX (batch number: H003603, other manufacturer) subcutaneously into left arm. On 21 Oct 2014, the patient developed pressure and consulted physician who told her she had a cellulitis and not to worry about it. Outcome of the events was recovered. The case was assessed as non-serious. Seriousness assessment of cellulitis was upgraded based on the NVS-IMS list. Causality of the event was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1455223) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up information received from the Quality Assurance Department (reference number: 351440) on 06 Mar 2015: Updated FLUVIRIN vaccine batch review report.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2015US013423, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 549455) on 03 Feb 2015 and with follow up information received from the quality assurance department (reference number: 350539) on 09 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 350539) on 05 Mar 2015. This report refers to a 43-year-old female patient. Medical history and concomitant medications were not reported. On 11 Oct 2014, the patient was vaccinated with FLUVIRIN (batch number: 145402) and PNEUMOVAX (batch number: K006681, other manufacturer); both intramuscularly into left arm with 1 inch and 3 hours apart. On the same day, after vaccinations, the patient experienced swelling in arm and later pain in arm in the evening. The patient went to emergency department of hospital and was admitted for cellulitis in arm. Duration in hospital was reported as 3 days. Outcome of the events was recovered. The case was assessed as serious (hospitalization). Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 145402) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 350539) on 09 Feb 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 350539) on 05 Mar 2015: Updated FLUVIRIN vaccine batch review report.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Inflammation, Pain in extremity
Clinical narrative: Case number PHHY2015US015383 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 549726) on 03 Feb 2015 and with follow up information received from the quality assurance department (QA reference number: 351474) on 12 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 351474) on 06 Mar 2015. This report refers to a 59 years old male patient. His medical history included insomnia, erectile dysfunction, glaucoma, reflux and trauma. His current conditions were hypertension, polyarthralgia, chronic obstructive pulmonary disorder (COPD), depressed mood, left eye blindness due to trauma when he was a child and anal fissure. His concomitant medications were meloxicam, NORCO, gabapentin, trazodone, lisinopril, Albuterol, cyclobenzaprine and BENADRYL. He was vaccinated with FLUVIRIN (batch number: 1410801) and PNEUMOVAX (other manufacturer, batch number: J009833); both vaccines administered intramuscularly in the right arm on 12 Oct 2014. On 13 Oct 2014, he had pain, inflammation and cellulitis in the right arm. He went to the emergency room. The events outcome was unknown. The events were reported as non-serious, but the event cellulitis was upgraded as medically significant based on the information available in the NVS-IME list. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1410801) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 351474) on 12 Feb 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 351474) on 06 Mar 2015: Updated FLUVIRIN batch review report.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Inflammation, Peripheral swelling
Clinical narrative: Case number PHHY2015US013951, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 551678) website on 03 Feb 2015 and with follow up information received from the quality assurance department (reference number: 350541) on 09 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 350541) on 05 Mar 2015. The report refers to a 62-year-old female patient. On 22 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 1413701) along with PNEUMOVAX (other manufacturer, batch number: K007773), in the left arm intramuscularly on 22 Oct 2014. On the same date, after vaccination she experienced redness, swelling and inflammation in the injection arm and she was hospitalized for cellulitis. The outcome of the events reported as recovered. The events reported as serious (hospitalization). The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1413701) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 350541) on 09 Feb 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 350541) on 05 Mar 2015: Updated FLUVIRIN batch review report.
Age: 91.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Disorientation, Fall, Injection site cellulitis
Clinical narrative: Case number PHHY2015US013965, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551791) on 03 Feb 2015 and with follow up information received from the quality assurance department (QA reference number: 350238) on 06 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 350238) on 04 Mar 2015. This report refers to a 91-year-old male patient. Medical history and concomitant medications were not reported. On 02 Oct 2014, the patient was vaccinated with FLUVIRIN (batch number: 1412601) and PNEUMOVAX (batch number: K009809, other manufacturer); both intramuscularly into left arm. On 03 Oct 2014, the patient experienced cellulitis at injection site. The patient became disoriented and fell. The patient was hospitalized for 5 days due to these events. The patient was on rehabilitation at nursing home at the time of this report. Outcome of the events was recovered. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1412601) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 350238) on 06 Feb 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 350238) on 04 Mar 2015: Updated FLUVIRIN vaccine batch review report.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Discomfort, Electromyogram, Hypoaesthesia
Clinical narrative: Shoulder pain down to elbow, weakness, pain, throbbing, numbing. Trouble lifting left arm above head to dress and wash hair. Turning to put safety belt on in vehicle lack of sleep due to the discomfort and pain.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Insomnia, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Shoulder pain down to elbow, weakness, pain, throbbing, numbing. Trouble lifting left arm above head to dress and wash hair. Turning to put safety belt on in vehicle lack of sleep due to the discomfort and pain.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: Shoulder pain down to elbow, weakness, pain, throbbing, numbing. Trouble lifting left arm above head to dress and wash hair. Turning to put safety belt on in vehicle lack of sleep due to the discomfort and pain.
Age: 67.0
Sex: M
Vaccine: FLUC3, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2015US017391 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 552660) on 03 Feb 2015 and with follow up information received from the quality assurance department (QA reference number: 352179) on 16 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 352179) on 05 Mar 2015. This report refers to a 67 years old male patient. His current conditions included hypertension and hypercholesterolemia. His concomitant medications were RAPAFLO, lisinopril, pravastatin, gabapentin and VIAGRA. He was vaccinated with FLUCELVAX (batch number: 017021A) and PNEUMOVAX (other manufacturer, batch number: K004487); both vaccines administered intramuscularly in the left arm on 29 Oct 2014. On 29 Oct 2014, he complained of pain in arm. BENADRYL and ibuprofen were recommended. He presented to the pharmacy on 30 Oct 2014 with redness, swelling and heat in his arm. He was seen by drop in emergency room of the clinic and was prescribed doxycycline and prednisone for cellulitis. His arm was much better on 01 Nov 2014. The events outcome was reported as complete recovery. The events were reported as non-serious, but the event cellulitis was upgraded as medically significant based on the information available in the NVS-IME list. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUCELVAX vaccine (batch number: 017021A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 352179) on 16 Feb 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 352179) on 05 Mar 2015: Updated FLUCELVAX vaccine batch review report.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Case number PHHY2015US018080, is an initial spontaneous report received from a physician via Vaccine Adverse Event Reporting System (VAERS reference number: 553563) website on 03 Feb 2015 and with follow up information received from the quality assurance department (QA reference number: 352588) on 18 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 352588) on 11 Mar 2015. This report refers to an 11 years old male patient. Concurrent condition included shellfish allergy and non-tobacco user. Concomitant medications included EPIPEN, SINGULAIR, PROVENTIL and ORAPRED. His vaccination history included administration of fifth dose of FLUZONE (batch number: unknown, other manufacturer) on 05 Sep 2014. On 22 Sep 2014, prior to vaccination, a routine child examination was performed. The patient's review of systems, interval history, nutrition, developmental assessment, key family checks, vital signs and general examinations resulted normal. The patient was vaccinated with first dose of MENVEO (batch number: M14044) intramuscularly into right arm along with second dose of GARDASIL (batch number: K008335, expiry date: 23 Jun 2016, other manufacturer) intramuscular into left arm on 22 Sep 2014 at 14:47. On the same day, couple of hours after vaccinations, the patient's right arm was hard and swollen, extending to below the elbow. On 25 Sep 2014, the patient consulted physician due to these events. The patient's review of systemic and vital signs was normal. On general examination, regarding extremities, it was reported that the patient experienced swelling from shoulder joint down to below the right elbow and circumference with redness to below the right elbow. The patient had a normal range of motion and limb was non-tender but hard throughout to palpation, no evidence of compartment syndrome was noted. The physician assessment was reported as cellulitis (primary). The patient was aseptic post immunization with MENVEO. The patient was treated with clindamycin hydrochloride capsule 300 mg, 1 capsule, orally, every 8 hours, for 10 days and MEDROL tablet, 4 mg, orally, for 7 days. The patient was instructed to follow up at the physician's office if the events worsened. At the time of the report, the patient's outcome was not provided. The case was assessed as non-serious. The relatedness between GARDASIL and adverse events was not provided. It was reported that these were allergies to MENVEO. Seriousness assessment of cellulitis was upgraded based on the NVS-IMS list. Based on the investigation performed, the QA department stated that, MENVEO (batch number: M14044) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 352588) on 18 Feb 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 352588) on 04 Mar 2015: Updated MENVEO batch review report.
Age: 53.0
Sex: F
Vaccine: PNC
Symptoms: Arthralgia, Blood glucose increased, Decreased appetite, Headache, Myalgia
Clinical narrative: Fever, muscle and joint aches, headache, elevated blood glucose, loss of appetite.
Age: 53.0
Sex: F
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Fever, muscle and joint aches, headache, elevated blood glucose, loss of appetite.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Confusional state, Dehydration, Delirium febrile, Headache
Clinical narrative: This clinical study case (initial receipt 02-Oct-2014) concerns a 7 year old male subject. At the time of the event, the subject had concomitant disease attention deficit/hyperactivity disorder and asthma. Concomitant medications included dexmethylphenidate hydrochloride for attention deficit/hyperactivity disorder, and montelukast and albuterol for asthma. The subject last received influenza vaccination in Oct-2013. The subject had received > 2 seasonal influenza vaccination since Jul-2010. On 23-Sep-2014 at 17:44, the subject received study vaccine (CSL TIV or comparator QIV, batch 0690) 0.5 ml in the left deltoid via the intramuscular route. On day 1 the patient did not have any symptoms of tonsillitis. On 24-Sep-2014, the patient developed moderate viral syndrome. On 24-Sep-2014 to 27-Sep-2014, the subject received oral paracetamol 80 mg, 4 times a day for treatment of viral syndrome, headache and malaise. On 24-Sep-2014 to 27-Sep-2014 the patient also received oral ibuprofen 80 mg, 4 times a day, for the treatment of viral syndrome, temperature and headache. On 25-Sep-2014, the subject experienced severe febrile delirium. He had a temperature of 101.6 with confusion upon awaking, characterized by inability to completely wake up. The subject had confused speech and was lethargic that persisted for 30-45 minutes. The parents stated the subject was very hard to wake up and was not making (sic) since when speaking. Parent stated that the child seemed like they were not fully awake. This lasted for about 30-45 minutes and then the child was fine. On 26-Sep-2014, the subject was seen in the emergency room and viral tonsillitis was confirmed. Throat cultures were obtained and were negative for strep. No antibiotics given. The subject received oral acetaminophen at 285 mg once for the treatment of viral syndrome, intravenous normal saline at 20 ml/kg once for treatment of dehydration and intravenous ondansetron at 4 mg once for the treatment of nausea. On 28-Sep-2014, the subject received oral paracetamol 80 mg, 4 times per day and oral ibuprofen 80 mg, 4 times per day for the treatment of viral syndrome, temperature and malaise. The outcome for febrile delirium recovered on 25-Sep-2014. Action taken in response to this adverse event was concomitant medication. No nasal viral respiratory PCR (Polymerase Chain Reaction) was done. The outcome was viral syndrome recovered on 28-Sep-2014. Action taken in response to this adverse event was medication advice sought and concomitant medication. Investigator's assessment: The investigator assessed the event of 'Febrile delirium' as serious due medically important event. The event was assessed as severe and related to study vaccine. The event 'viral syndrome' was assessed as non-serious and not related to study vaccine. Follow up (17-Feb-2015) Tests completed (PCR not done). Follow-up (23-Feb-2015) Study vaccine unblinded. Case correction (04-Mar-2015) Case upgraded to unlisted.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Lethargy, Malaise, Nausea, Somnolence, Speech disorder
Clinical narrative: This clinical study case (initial receipt 02-Oct-2014) concerns a 7 year old male subject. At the time of the event, the subject had concomitant disease attention deficit/hyperactivity disorder and asthma. Concomitant medications included dexmethylphenidate hydrochloride for attention deficit/hyperactivity disorder, and montelukast and albuterol for asthma. The subject last received influenza vaccination in Oct-2013. The subject had received > 2 seasonal influenza vaccination since Jul-2010. On 23-Sep-2014 at 17:44, the subject received study vaccine (CSL TIV or comparator QIV, batch 0690) 0.5 ml in the left deltoid via the intramuscular route. On day 1 the patient did not have any symptoms of tonsillitis. On 24-Sep-2014, the patient developed moderate viral syndrome. On 24-Sep-2014 to 27-Sep-2014, the subject received oral paracetamol 80 mg, 4 times a day for treatment of viral syndrome, headache and malaise. On 24-Sep-2014 to 27-Sep-2014 the patient also received oral ibuprofen 80 mg, 4 times a day, for the treatment of viral syndrome, temperature and headache. On 25-Sep-2014, the subject experienced severe febrile delirium. He had a temperature of 101.6 with confusion upon awaking, characterized by inability to completely wake up. The subject had confused speech and was lethargic that persisted for 30-45 minutes. The parents stated the subject was very hard to wake up and was not making (sic) since when speaking. Parent stated that the child seemed like they were not fully awake. This lasted for about 30-45 minutes and then the child was fine. On 26-Sep-2014, the subject was seen in the emergency room and viral tonsillitis was confirmed. Throat cultures were obtained and were negative for strep. No antibiotics given. The subject received oral acetaminophen at 285 mg once for the treatment of viral syndrome, intravenous normal saline at 20 ml/kg once for treatment of dehydration and intravenous ondansetron at 4 mg once for the treatment of nausea. On 28-Sep-2014, the subject received oral paracetamol 80 mg, 4 times per day and oral ibuprofen 80 mg, 4 times per day for the treatment of viral syndrome, temperature and malaise. The outcome for febrile delirium recovered on 25-Sep-2014. Action taken in response to this adverse event was concomitant medication. No nasal viral respiratory PCR (Polymerase Chain Reaction) was done. The outcome was viral syndrome recovered on 28-Sep-2014. Action taken in response to this adverse event was medication advice sought and concomitant medication. Investigator's assessment: The investigator assessed the event of 'Febrile delirium' as serious due medically important event. The event was assessed as severe and related to study vaccine. The event 'viral syndrome' was assessed as non-serious and not related to study vaccine. Follow up (17-Feb-2015) Tests completed (PCR not done). Follow-up (23-Feb-2015) Study vaccine unblinded. Case correction (04-Mar-2015) Case upgraded to unlisted.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Streptococcus test negative, Viral infection, Viral tonsillitis
Clinical narrative: This clinical study case (initial receipt 02-Oct-2014) concerns a 7 year old male subject. At the time of the event, the subject had concomitant disease attention deficit/hyperactivity disorder and asthma. Concomitant medications included dexmethylphenidate hydrochloride for attention deficit/hyperactivity disorder, and montelukast and albuterol for asthma. The subject last received influenza vaccination in Oct-2013. The subject had received > 2 seasonal influenza vaccination since Jul-2010. On 23-Sep-2014 at 17:44, the subject received study vaccine (CSL TIV or comparator QIV, batch 0690) 0.5 ml in the left deltoid via the intramuscular route. On day 1 the patient did not have any symptoms of tonsillitis. On 24-Sep-2014, the patient developed moderate viral syndrome. On 24-Sep-2014 to 27-Sep-2014, the subject received oral paracetamol 80 mg, 4 times a day for treatment of viral syndrome, headache and malaise. On 24-Sep-2014 to 27-Sep-2014 the patient also received oral ibuprofen 80 mg, 4 times a day, for the treatment of viral syndrome, temperature and headache. On 25-Sep-2014, the subject experienced severe febrile delirium. He had a temperature of 101.6 with confusion upon awaking, characterized by inability to completely wake up. The subject had confused speech and was lethargic that persisted for 30-45 minutes. The parents stated the subject was very hard to wake up and was not making (sic) since when speaking. Parent stated that the child seemed like they were not fully awake. This lasted for about 30-45 minutes and then the child was fine. On 26-Sep-2014, the subject was seen in the emergency room and viral tonsillitis was confirmed. Throat cultures were obtained and were negative for strep. No antibiotics given. The subject received oral acetaminophen at 285 mg once for the treatment of viral syndrome, intravenous normal saline at 20 ml/kg once for treatment of dehydration and intravenous ondansetron at 4 mg once for the treatment of nausea. On 28-Sep-2014, the subject received oral paracetamol 80 mg, 4 times per day and oral ibuprofen 80 mg, 4 times per day for the treatment of viral syndrome, temperature and malaise. The outcome for febrile delirium recovered on 25-Sep-2014. Action taken in response to this adverse event was concomitant medication. No nasal viral respiratory PCR (Polymerase Chain Reaction) was done. The outcome was viral syndrome recovered on 28-Sep-2014. Action taken in response to this adverse event was medication advice sought and concomitant medication. Investigator's assessment: The investigator assessed the event of 'Febrile delirium' as serious due medically important event. The event was assessed as severe and related to study vaccine. The event 'viral syndrome' was assessed as non-serious and not related to study vaccine. Follow up (17-Feb-2015) Tests completed (PCR not done). Follow-up (23-Feb-2015) Study vaccine unblinded. Case correction (04-Mar-2015) Case upgraded to unlisted.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Removal of foreign body, Seizure
Clinical narrative: This spontaneous report as received from a receptionist via a field representative refers to a 17 year old female patient who was not pregnant. Patient's medical history and drug allergies were not specified by the reporter. On an unknown date (reported as years ago), the patient was vaccinated with a dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not specified by the reporter). Concomitant medication was not specified by the reporter. On an unknown date, the patient experienced ongoing seizures after receiving GARDASIL. The reporter stated that seizures had been ongoing for multiple years and that the patient was having metal removed from her (date not specified), but it could not be confirm what metal fragments was being removed from the patient's body. It was reported that the patient experienced significant disability or incapacity due to the adverse events. It was not specified by the reporter if any treatment was given for the adverse events. Laboratory tests were not specified by the reporter. The patient sought medical attention by an unspecified office visit. Product quality complaint (PQC) was not involved. The patient did not recovered from the adverse events at the time of the report. Causality assessment was not provided. Upon internal review the event of seizures was considered to be medically significant. Additional information is not expected due to lack of physician's contact details.
Age: 9.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Myositis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Pain in left arm, some swelling, mild erythema in upper left arm. Myositis in left deltoid from vaccine? No focal abscess found. No surgical intervention needed.
Age: 9.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm, some swelling, mild erythema in upper left arm. Myositis in left deltoid from vaccine? No focal abscess found. No surgical intervention needed.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, redness, fever, joint pain, body aches.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Hypoaesthesia, Induration, Limb discomfort
Clinical narrative: Patient noticed a large, red, bump on tricep that was hard and warm to the touch. Came back in to clinic where the nurse and provider looked at it and marked it with a black pen and was told to put heat packs and compression on arm. Pt was instructed to return to clinic first thing the next morning if it had spread outside the area that was marked by the black pen. Pt returned due to swelling getting bigger, pt now says there is discomfort that feels numb and tingling that radiates up and down tricep. Pt saw provider and nurse this morning and is being treated for cellulitis.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Paraesthesia, Peripheral swelling, Skin warm
Clinical narrative: Patient noticed a large, red, bump on tricep that was hard and warm to the touch. Came back in to clinic where the nurse and provider looked at it and marked it with a black pen and was told to put heat packs and compression on arm. Pt was instructed to return to clinic first thing the next morning if it had spread outside the area that was marked by the black pen. Pt returned due to swelling getting bigger, pt now says there is discomfort that feels numb and tingling that radiates up and down tricep. Pt saw provider and nurse this morning and is being treated for cellulitis.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Rash
Clinical narrative: PATIENT CALLED ON 03/12/15 TO LET US KNOW THAT HE EXPERIENCED ABNORMAL SORENESS/REDNESS AT SITE OF INJECTION.  HE EXPERIENCE CHILLS AND GOT A SMALL RASH THAT LASTED NEARLY A WEEK.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash morbilliform
Clinical narrative: Measles like rash, itching with no resolution with steroids and antihistamines and still has on 3/12/15.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PPV, RV5
Symptoms: Crying, Lethargy, Pyrexia
Clinical narrative: Fever of 102.3, initially lethargic, then with fever spike unconsolable crying for 1+hours until fever went down with Acetaminophen. Low grade fever of 100 in the am. More Acetaminophen was given and temp returned to normal.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red warm to touch upper left arm.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Decreased appetite, Fatigue, Malaise, Myalgia
Clinical narrative: 02/18/2015 5:00PM Malaise, Generalized muscle aches. Mild nausea. To bed 8:00 PM. Wakeful night with significant thirst, racing heart. 02/19/2015 Approximately 7:30 AM Arose to tell my husband I didn't feel well and fainted to the floor. 10:00 AM My husband called the doctors office and told them he thought I was having a reaction to Prevnar.  They told him they had not encountered a similar reaction to the vaccine. Throughout that day I continued to be very thirsty, mild nausea, significant fatigue, weakness and generalized muscle aches (muscle aches relieved by Tylenol). Slept most of day. 02/20/2015 Fatigue, weakness remained, no appetite, thirst normal, mild muscle aches. 5:00 PM able to eat some saltines (2). 02/21/2015 9:00 AM Aches gone, able to eat bagel, soda. Fatigue remains. 4:00 Ate cookie. 7:00 PM Ate half of chicken sandwich. 02/22/2015 Up all day. Feel almost normal. No MD visit offered, no medication or treatment.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Palpitations, Somnolence, Syncope, Thirst
Clinical narrative: 02/18/2015 5:00PM Malaise, Generalized muscle aches. Mild nausea. To bed 8:00 PM. Wakeful night with significant thirst, racing heart. 02/19/2015 Approximately 7:30 AM Arose to tell my husband I didn't feel well and fainted to the floor. 10:00 AM My husband called the doctors office and told them he thought I was having a reaction to Prevnar.  They told him they had not encountered a similar reaction to the vaccine. Throughout that day I continued to be very thirsty, mild nausea, significant fatigue, weakness and generalized muscle aches (muscle aches relieved by Tylenol). Slept most of day. 02/20/2015 Fatigue, weakness remained, no appetite, thirst normal, mild muscle aches. 5:00 PM able to eat some saltines (2). 02/21/2015 9:00 AM Aches gone, able to eat bagel, soda. Fatigue remains. 4:00 Ate cookie. 7:00 PM Ate half of chicken sandwich. 02/22/2015 Up all day. Feel almost normal. No MD visit offered, no medication or treatment.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Cough, Pneumonia, Pyrexia, Sputum discoloured
Clinical narrative: Cough, green phelgm. Augmentin for 7 days, back beginning Feb. Different antibiotic, shot and not better no fever. Xay on 2/20/15 and clear, but cough, 3/1/15 fever, Dr on 3/1/15 xray pneumonia and on Laquin for 10 days. 3/9/15 pneumonia gone.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Lymph node pain, Lymphadenopathy, Oedema peripheral, Vaccination complication
Clinical narrative: Pain and swelling in the armpit and lymph nodes.  Took 2 (200mg) of Advil for pain relief beginning 3/04/05 through 03/07/2015.