chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Expired product administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 21 year old female patient with lightheadedness after injection or when blood is drawn. Patient did not have known allergies. On 22-DEC-2014 the patient was vaccinated with an expired dose of GARDASIL lot # 0131AE, expiration date: 26-OCT-2014, dose 1, 0.5 ml, intramuscular in the left arm. There were no concomitant medication. On 22-DEC-2014 experienced lightheadedness after vaccine was administered. The reporter stated that the patient always experience lightheadedness when she get an injection or blood drawn. The patient was monitored and she was given a glass of water. Patient did not receive any treatment for the adverse event. There were no laboratory diagnostics performed. The outcome of lightheadedness was reported as recovered/resolved on 22-DEC-2014. Additional information is not expected due to the reporter did not want to be contacted again.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 years old male patient. Medical history and current conditions were not reported. On 12-AUG-2014, the patient was vaccinated with (Oka/Merck) VARIVAX, lot # reported as J006106, expiration date: 17-MAY-2015 (route and dose were not reported) that was improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported. Concomitant medications was not reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested. Event, Analysis was updated.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Dizziness, Injection site haemorrhage, Nausea
Clinical narrative: This spontaneous report as received from a pharmacist and mother's patient refers to a 11 year old female patient. Pertinent medical history and drug reactions/allergies were reported as none. On 12-DEC-2014, the patient was vaccinated with the first dose of GARDASIL in the arm (dose, route, lot number and expiry date were not reported). Other suspect therapies included meningococcal vaccine (manufacturer unknown) (dose, route, lot number and expiry date were not reported) in the other arm and ADACEL (dose, route, lot number and expiry date were not provided) in the same arm of GARDASIL vaccination. None concomitant medication reported. Pharmacist reported that during administration of GARDASIL vaccine, her daughter jumped when needle entered her arm and needle actually came out of her arm when she jumped and little bit of blood from injection site trickled down on the arm. After pharmacist daughter calmed down, nurse administered GARDASIL dose using same syringe and needle from initial administration attempt. GARDASIL was the third and last vaccine her daughter received that day (12-DEC-2014) and shortly after GARDASIL dose, pharmacist's daughter felt dizzy and nauseous but pharmacist was not sure if nausea and dizziness were due to GARDASIL or all three vaccines or because her daughter was nervous about incident happened with GARDASIL. Pharmacist also suspected that her daughter might not have received full dose of GARDASIL because her daughter jumped and some vaccine might had been lost during the incident but nurse did not change needle and syringe to complete GARDASIL administration. None lab diagnostics studies performed. The outcome of felt dizzy and felt nauseous was reported as recovered (in December 2014). Additional information has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Case number PHHY2014US050751, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518920) website on 24 Apr 2014. This report refers to a female patient of an unknown age. She was vaccinated with Influenza vaccine (manufacturer and season unknown, batch number: not reported) on an unknown date. On an unknown date, after vaccination she experienced hypersensitive reaction. The outcome and causality of the event were not reported. The seriousness of the event was not reported, however the case was internally upgraded as medically significant by the agency.
Age: 38.0
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a nurse on 01 November 2013. The 38-year-old patient had received DAPTACEL (route, site not provided). Reporter stated that patient received DAPTACEL to 38 year old patient instead of ADACEL. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAP, IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 13 November 2013. The patient had received expired DAPTACEL, IPOL. Considered invalid doses and should be reported, no waiting necessary. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 12 November 2013. An 11-year-old patient received DAPTACEL. (No information regarding patient was provided). No adverse report was reported. List of documents held by sender:  none
Age: 0.83
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Diarrhoea
Clinical narrative: Initial report received from a physician on 15 November 2013. A 10 month old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (Lot number U4693CA) intramuscularly (administration site: Right thigh) on 29 October 2013 and also received DAPTACEL (lot # C4454AA) intramuscularly (administration site: Left thigh) on 29 October 2013. Patient had oral thrush at the time of vaccination. Mother claims child developed diarrhea on 30 October 2013. Mother took child to ER because office was closed and claims the ER Dr stated the diarrhea was due to eggs in the vaccine. Child has no established egg based food issues/allergies. Mother was instructed to bring child in to physician next day 31 October 2013 and did not return for physician evaluation for 2 weeks claiming child still had watery stool. Based on physician evaluation patient was not dehydrated nor had any weight loss. Physician is supposed to see patient again Monday 18 November 2013. Corrective treatment was not reported. At the time of this report the event outcome was unknown. Documents held by sender: none.
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 03 January 2014. A patient had received a third dose of ACTHIB, DAPTACEL on 19 October 2013 and fourth dose on 2 January 2014. It's an inappropriate schedule of vaccine administered. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 13 January 2014. A patient (demographics unknown) had received a dose of DAPTACEL on an unspecified date. It was reported that during vaccination, syringe or needle leaked and patient did not receive full dose resulting in vaccine under dose. No adverse event was reported. List of documents held by sender: none.
Age: 0.2
Sex: U
Vaccine: DTAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial case of medication error was received from a healthcare professional on 10 Feb 2014. A 2 month old infant whose demographics details, medical history and concomitant medication were not reported received, a dose of DAPTACEL vaccine on an unspecified date (Batch number not reported). It was reported that on an unspecified date patient received extra dose of DAPTACEL vaccine on 7 Feb 2014 and then another dose on 10 Feb 2014. No Adverse event was reported. Laboratory investigations and corrective treatment were not reported. At the time of report outcome of event was unknown. List of documents held by sender: None.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 12 November 2013. On unspecified date an 11 year patient received DAPTACEL vaccine instead of ADACEL vaccine. Wrong vaccine was administered. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a health care professional on 05 February 2014. Inadvertently administered intradermal 0.3 ml fifth dose of DAPTACEL to a patient. (No information was provided regarding the patient) thinking it was the TB skin test syringe on an unspecified date.  No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a health care professional on 07 February 2014.  An adult patient (date of birth, age and gender was not reported) had received a dose of DAPTACEL instead of ADACEL. No adverse event was reported. Documents held by sender: none
Sex: U
Vaccine: DTAP, HIBV
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Initial misuse report received from a healthcare professional on 03 January 2014. This is invalid case as the individual patient identifiers missing. Patient received ACTHIB which was missed with DAPTACEL. It a product reconstitution issue. No adverse event was reported. List of documents held by sender: none.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from healthcare professional on 04 March 2014. A '02-month-old male patient', whose medical history and concomitant medication were not reported, had received a intramuscular dose of DAPTACEL in to the left thigh (Lot number C4508AA, expiration date was not provided), Intramuscular dose of ACTHIB in to the left thigh (Lot UH829AA, expiration date was not provided), a dose of IPOL (Lot number, expiration date, route of vaccination was not provided) in to the right thigh, PREVNAR (Lot number, expiration date, route, and site of vaccination was not provided) on 17 January 2014. It was reported that post vaccination of DAPTACEL and ACTHIB patient experienced swelling of left leg from thigh to ankle and large area of redness around left thigh injection site and swelling of left leg from thigh to ankle i.e. on 17 January 2014. The details of laboratory investigation were not provided. The subject had received corrective treatment of cold compress. The event was resolved on an unspecified day. The patient was recovered from adverse event at the time of report. List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse reprot received from a health care professional on 07 January 2014. A child of unspecified age had received 4th dose of DAPTACEL 23 days before the dose was due. The patient did not experience any adverse event. Documents held by sender: none
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via vender refers to 2 patients of unknown age and gender. On 04-DEC-2014 the patients were vaccinated with improperly stored PNEUMOVAX23 (dose, route of administration and lot # were not provided). PNEUMOVAX23 was found to be supported with in-house stability data. No adverse symptoms reported.   Follow up information was received from a nurse and refers to 67 year old male patient. On 04 DEC 2014 the patient was vaccinated with improperly stored PNEUMOVAX23 dose and route of administration were not provided (lot # K008410, expiration date: 26-FEB-2016). The nurse reported that no adverse event have been reported since the time of the vaccination and there was no need for revaccination. No additional information was available at the time of the call. This is one of several reports from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Limb discomfort, Peripheral swelling
Clinical narrative: Swelling of hands and one foot (toes), with discomfort. Was taking acetaminophen, but switched to NAPROSYN.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: Rash on trunk and thighs with severe itching. Rash began approximately 6 hours after receiving vaccination. Treatment prednisone IM and PO.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Presyncope
Clinical narrative: After estimated 10 mins after vaccines administered pt. felt lightheaded. Pale, became weak, wet herself. Pt. was taken to exam room. Laid down, given cool towel, feet elevated, given water. Orange to eat. B/P 96/74 HR 118 upon lying down. Pt. left clinic walking out the door, "feeling normal". Pt says she felt lightheaded immediately after HPV shot however began walking out with mother and then had pre-syncopal episode. No loss of consciousness. Episode was witnessed. 40+ mins - pt felt normal to leaving.
Sex: U
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a physician via other consumer refers to unspecified number of patients of unknown age and gender (however reported as "especially girls"). On an unknown date the patiens were vaccinated with GARDASIL (dose, route, lot # not reported). On an unknown date the patients experienced adverse reactions after receiving GARDASIL. The outcome of the adverse reactions was unknown. Relatedness between adverse reactions and GARDASIL was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: TD
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from health care professional on 13 June 2014. An 8 year old female patient received (DT pediatric) DIPHTHERIA-25/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE. She had 1 dose of DTap in 2006 at the age of 1 and 2nd dose of DTaP at the age of 2. No adverse event was reported. List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Skin warm
Clinical narrative: Vaccine was adminstered on 12/20/14. Patient reports a golf ball size know that has gotten larger over the past 24 hour. It is red and and warm to touch.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Patient reports redness and swelling that began the night of immunization. Patient had symptoms for 3 or 4 days.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Moderate swelling and redne at the injection site. Painful.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swelling and redness and hot to touch. Slight pain (L) arm.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Almost immediately patient broke out with a bubbly reddish rash on left trunk and arm. Rash is slightly itchy, patient denies egg allergy.
Age: 52.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site after injection, approx 30 sec-1 min after. TX w/ ice pack; observed patient in waiting area x 30 min. Swelling/redness subsided. Called pt to follow up in evening, completely resolved.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Disorientation, Tonic clonic movements
Clinical narrative: Tonic clonic movements for approximately 60 seconds. Given fluids placed in Trendelenburg position. Somewhat disoriented for approximately 5 minutes while recovering.
Age: 21.0
Sex: U
Vaccine: MMR, VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a health professional refers to a 21 year old patient of unknown gender. On 26-DEC-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous (lot # not reported). On 26-DEC-2014 the patient received a dose of ZOSTAVAX in error. The patient was intended to receive a dose of VARIVAX (Merck) due to having low titers for VZV. The reporter did not know if the patient had ever received VARIVAX (Merck) in the past because she did not have access to the patient's vaccination records. She stated that the error occurred because a dose of ZOSTAVAX had been removed from the freezer by mistake. There was no confusion between ZOSTAVAX and VARIVAX (Merck). The patient did not report or exhibit any adverse effects. Additional information has been requested.
Age: 21.0
Sex: U
Vaccine: MMR, VARZOS, VARZOS
Symptoms: No adverse event, Viral titre decreased, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health professional refers to a 21 year old patient of unknown gender. On 26-DEC-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous (lot # not reported). On 26-DEC-2014 the patient received a dose of ZOSTAVAX in error. The patient was intended to receive a dose of VARIVAX (Merck) due to having low titers for VZV. The reporter did not know if the patient had ever received VARIVAX (Merck) in the past because she did not have access to the patient's vaccination records. She stated that the error occurred because a dose of ZOSTAVAX had been removed from the freezer by mistake. There was no confusion between ZOSTAVAX and VARIVAX (Merck). The patient did not report or exhibit any adverse effects. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Chronic fatigue syndrome, Fatigue, Headache, Insomnia, Laboratory test normal
Clinical narrative: Developed chronic fatigue syndrome in temporal association to receipt of the anthrax vaccine. Did not seek care or evaluation at the time. Condition worsened and has been identified and diagnosed currently. Malaise and fatigue, Insomnia NEC, Altered Mental Status, Headache.
Age: 24.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Malaise, Mental status changes
Clinical narrative: Developed chronic fatigue syndrome in temporal association to receipt of the anthrax vaccine. Did not seek care or evaluation at the time. Condition worsened and has been identified and diagnosed currently. Malaise and fatigue, Insomnia NEC, Altered Mental Status, Headache.
Age: 50.0
Sex: M
Vaccine: TYP, YF
Symptoms: Rash erythematous
Clinical narrative: Initial report received from a healthcare professional on 18 June 2013. A 50-year-old male patient, whose medical history and concomitant medications were not reported, had received a subcutaneous dose of YF VAX vaccine (batch number - UH598AA, dose number was not reported) in right deltoid on 05 June 2013. On 05 June 2013, after vaccination, the patient experienced the development of a red rash starting under the armpit of the right arm which extended down the right side of the torso and then across the abdomen, like an "L shape". The rash had then started to fade. The patient had not received any corrective treatments and laboratory investigations were not reported. At the time of this report, the patient had not recovered from the event. Documents held by sender: none. Follow up information received from a healthcare professional on 29 July 2013. The patient had medical history of hypertension and hyperlipidemia. The patient had no other illness at time of vaccination. The patient concomitant medication included; FLONASE, Hydrochlorothiazide (25 mg), Losartan (50 mg) and Simvastatin (20 mg). The patient had received second dose of YF vaccine on 05 June 2013 at 8:15 AM. The same day, the patient had also received a dose of TYPHIM VI vaccine (batch number: H7481) intramuscularly in left deltoid. The event of red rash started from right side where YF vaccine was given. No laboratory investigations were done. The patient had recovered from the event on 09 June 2013.
Age: 16.0
Sex: F
Vaccine: YF
Symptoms: Injection site swelling, Nasopharyngitis, Oropharyngeal pain, Pharyngeal erythema
Clinical narrative: Initial report received from healthcare professional on 12 June 2013. A 17-year-old female patient, received first dose of YF-VAX (lot number: UH597AA, route and site of administration was not reported) on 04 June 2013. The patient's medical history included heart raced to ZYRTEC administration and had stomach cramping with chicken and eggs. The patient had no illness at time of vaccination and had not received any vaccines within 4 weeks of 04 June 2013. Concomitant drugs were not reported. On 10 June 2013, 6 days after vaccination, the patient had developed cold symptoms, sore throat and redness 2 cm, slightly raised area at the injections site. Laboratory investigations/ details and corrective treatments were not reported. On an unspecified date, the patient had recovered from events. List of documents held by sender: none.
Sex: F
Vaccine: YF
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 29 May 2013. It was reported that a female patient had received YF vaccine 21 days after receiving varicella vaccine. No adverse event was reported. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: YF, YF
Symptoms: Acne, Hypersensitivity, Rash
Clinical narrative: Initial report received from healthcare professional on 21 November 2013. A 40-year-old female patient whose medical history and concomitant medications were not reported, received YF Vax (lot number UH671AA, expiration date 11-Feb-2013 and site of administration subcutaneous) at left arm (dose number not reported) on 16 October 2013. On 16 October 2013, the patient developed small bumps on various areas of her body resembling a pimple began day of vaccination. Reporter stated on initial evaluation on 21-Oct-2013 the bumps that appeared to be bigger than a mosquito bite, did not have a head like a pimple but would pop and ooze liquid of unknown description. Patient was evaluated by cardiovascular employee physician on 04-Nov-2013 and it the physician diagnosed skin condition as an allergic reaction. Laboratory investigation unknown and corrective treatment included BENADRYL, cortisone creme and OTC oatmeal baths. As of this report, outcome of the events was unknown. Documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: YF, YF
Symptoms: Acne, Laboratory test
Clinical narrative: Initial report received from healthcare professional on 21 November 2013. A 40-year-old female patient whose medical history and concomitant medications were not reported, received YF Vax (lot number UH671AA, expiration date 11-Feb-2013 and site of administration subcutaneous) at left arm (dose number not reported) on 16 October 2013. On 16 October 2013, the patient developed small bumps on various areas of her body resembling a pimple began day of vaccination. Reporter stated on initial evaluation on 21-Oct-2013 the bumps that appeared to be bigger than a mosquito bite, did not have a head like a pimple but would pop and ooze liquid of unknown description. Patient was evaluated by cardiovascular employee physician on 04-Nov-2013 and it the physician diagnosed skin condition as an allergic reaction. Laboratory investigation unknown and corrective treatment included BENADRYL, cortisone creme and OTC oatmeal baths. As of this report, outcome of the events was unknown. Documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: YF, YF
Symptoms: Acne, Hypersensitivity, Rash
Clinical narrative: Initial information received on 23 October 2013 from a health care professional: A 40-year-old female patient whose medical history and concomitant medication were not reported, received in yellow fever vaccine (lot number UH671AA, Expiry date unknown) on 16 October 2013. It was reported by the patient those 4-5 pimples a day or 2 after vaccine which then spread all over the body. She described them as pimples or mosquito bites that were red. She did not know if they were hives. Administration site reaction was not reported. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: YF, YF
Symptoms: Acne, Laboratory test
Clinical narrative: Initial information received on 23 October 2013 from a health care professional: A 40-year-old female patient whose medical history and concomitant medication were not reported, received in yellow fever vaccine (lot number UH671AA, Expiry date unknown) on 16 October 2013. It was reported by the patient those 4-5 pimples a day or 2 after vaccine which then spread all over the body. She described them as pimples or mosquito bites that were red. She did not know if they were hives. Administration site reaction was not reported. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial medication error report received from a healthcare professional on 04-Oct-2013. The patient had received yellow fever - inadvertently administered IM (intramuscular). (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 9.0
Sex: U
Vaccine: YF
Symptoms: Extra dose administered
Clinical narrative: Initial medication error report received on 04 September 2013 from a pharmacist. A 9 years unknown patient whose gender, medical history and concomitant medications were not reported, received a dose of YF (lot number, route and site of vaccination was not reported) on an unspecified date. Patient received 2nd dose of YF within a month. Most patients do not experience any material increased in local or systemic adverse events, but some might. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Initial report received from a non-healthcare professional on 12 September 2013. The patient had administered YF-VAX 5 doses, multidose vial, powder vial reconstituted with the single dose diluent of 0.6 ml. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 9.0
Sex: U
Vaccine: YF
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 03-Sep-2013. A 9-year-old patient of unknown gender was given YF-VAX intramuscular rather than subcutaneous route. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: YF
Symptoms: Pain, Pyrexia, Upper respiratory tract infection
Clinical narrative: Initial report received from a healthcare professional on 27 August 2013. A female patient whose date of birth and age at the time of event was not reported, had received a dose of YF VAX vaccine (lot number, dose in series, route and site of administration was not reported) on 25 June 2013. The patient had medical history of asthma and concomitant medications were not reported. On 27 June 2013, the patient developed URI (upper respiratory infections) symptoms and body ache. It was reported that the patient had low grade temperature. Laboratory investigations and corrective treatments were not reported. At the time of this report the outcome of the event was unknown. Documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: Injury associated with device, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 28 June 2013. It was reported that reconstituted YF-VAX, lot no. UH666AA, drew up into syringe, and while recapping needle stuck self with needle. No information was provided regarding the patients. No adverse event was reported. Documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: TDAP, YF
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: Initial report received from a consumer on 18 June 2013. A 35 year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of YV VAX (lot number, route and anatomical site of vaccination was not reported) and received ADACEL (lot number, route and anatomical site of vaccination was not reported) both on 18 April 2013. The patient reported that on an unspecified date she experienced injection site reaction of a dime sized welt and that was mildly sore. The patient was not sure that which one cause the reaction, she believed "it to be the yellow fever just because the welt correlated with where that vaccine was injected." It approximately took 10 days for welt to completely fade. As of 18 June 2013, the outcome was recovered. List of documents held by the sender: None.
Sex: F
Vaccine: YF
Symptoms: Injection site hypoaesthesia, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Initial case was received from a non-healthcare professional on 09 April 2014. A patient of unknown demographics whose medical history and concomitant medications were not reported had received a YELLOW FEVER VACCINE (dose, route, batch number and anatomical site of administration not reported) on an unknown date. On an unknown date, the patient developed intense pain at the injection a few days later that lead to inflammation. The patient described the reaction as waves of heat and numbing and the event went on for 4 months in some manner. No laboratory details or corrective treatment was reported. The outcome of the event was unknown. The list of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 07 March 2014. A patient (No information was provided regarding the patient) had received a dose of YF VAX (Lot number, expiration date, site of administration was not reported) to patient intramuscularly on an unspecified date. i.e. inappropriate route of administration. This case is of medication error. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 06 Mar 2014. A patient whose demographic details, medical history and concomitant medication were not reported received a dose of YF VAX vaccine on an unspecified date. (Route, dose, site and batch number not reported). It was reported that on an unspecified date patient received vaccine reconstituted with sterile water and administered. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 07 March 2014. A patient (No information was provided regarding the patient) had received a dose of YF VAX (Lot number, expiration date, route and site of administration were not reported) and the patient had received half dose due to vaccine spraying out at the needle/syringe connection on an unspecified date. i.e. vaccine underdose. This case is of medication error. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 05 March 2014. A patient had received a dose of YF Vax on an unspecified date. It was reported that the patient was given just the diluent. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 10 February 2014. This case is invalid as no patient information is available. An unknown patient had received YFVAX reconstituted with sterile water on unspecified date. No adverse event was reported. List of documents held by sender: None.
Sex: U
Vaccine: YF
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 03 January 2014. It was reported that the patient had received YF-vaccine inadvertently. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: YF
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Initial report received from a healthcare professional on 14 January 2014. A female patient had received a dose of YF-Vax (batch number, dose number, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced hives and shortness of breath. Laboratory tests and corrective treatment were not reported. On an unspecified date, the patient had recovered. Documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: YF
Symptoms: Neutrophil count decreased, Platelet count decreased, White blood cell count decreased
Clinical narrative: Initial report received from a health care professional on 04 December 2013. A female patient had received a 0.5 ml dose of YF-VAX (Lot number UH660AA, subcutaneously in the left arm on 27 November 2013. The patient had asthma as medical history. It was reported that the neutrophils count of the patient was decreased. On 27 February 2013 the WBC of the patient was 3400/mcl and neutrophil was 1500/mcl, on 24 April 2013 the WBC of the patient was 3900/mcl and neutrophil was 1600/mcl, on 19 June 2013 the WBC of the patient was 4600/mcl and neutrophil was 1700/mcl, on 14 August 2013 the WBC of the patient was 4700/mcl and neutrophil was 2100/mcl, on 9 October 2013the WBC of the patient was 4500/mcl and neutrophil was 2100/mcl. and on 4 December 2013 the WBC of the patient was 2900/mcl and neutrophil was 600/mcl.  Corrective treatment was not reported. At the time of this report the outcome of the events were not reported. Documents held by sender: none. Additional information received on 19-Dec-2013: Platelets decreased: Onset date, 04-Dec-2013. On 04-Dec-2013, white blood cell (neutrophils) and platelets decreased. On 10-Dec-2013, bone marrow examination was performed. On 18-Dec-2013, blood test showed improving tendency. Outcome of the events was reported to be unknown as of an unspecified date.
Age: 18.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Headache, Pyrexia
Clinical narrative: Initial report received from non-healthcare professional (patient parent) on 10 January 2014. An 18-year-old male patient, who is allergic to tree nuts with no illness at the time of vaccination, had received 1st dose of YF VAX (batch number and route of administration were not reported) in right arm on 11 January 2014 and Hepatitis A vaccine of other manufacturer (batch number, dose number, route and anatomical site af administration were not reported) on 17 January 2014. It was reported that on 12 January 2014, after receiving YF vaccine, the patient experienced fever of 101F and headache. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: YF
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Initial report received from a Health care professional on 28 April 2014. A 35 years old female patient had received subcutaneously a third dose of Yellow fever vaccine (Lot number UH673AA) in the left arm on 21 April 2014 at 9 AM. The patient had seasonal allergy and hypertension as medical history and the patient had received the first 2 doses of Yellow fever vaccine- lot number, route and site of vaccination in 2004 on an unspecified dates. On 26 April 2014 at 12.00 PM developed with red raised warm and thick area on left arm of the size of a tennis ball 7cmX 4cm. The patient had also received HCTZ 25 mg TOD, NORVASC 10mg TOD and Centrum daily. The patient had denied providing the illness at the time of vaccination. The laboratory details and corrective treatment were unknown. At the time of this report the patient was recovered. Documents held by sender: none.
Age: 26.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Initial report received from a health care professional on 20 December 2013. A female patient, whose age was not reported, had received a dose of YF vaccine (Lot number, dose number, route and site of vaccination was not reported) on 13 December 2013. Concomitant medication and medical history of the patient was not reported. Pre-existing physician diagnosed allergies, birth defects and medical conditions of the patient was unknown. Illness at the time of vaccination was unknown. It was reported that on 14 December 2013, the patient had experienced warmth and redness at the injection site and now it has increased to 3 inches x 2 inches. At the time of this report the outcome of the adverse event was not reported. Documents held by sender: none. Follow up information received on 03 February 2014. The patient had not received any other vaccine. The patient had recovered from the events on an unspecified date.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received on 12 December 2013 from a health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a YF VAX (lot number and site of vaccination was not reported, route intramuscularly) on 10 December 2013. Vaccine was given intramuscular at travel clinic on 10 December 2013 and it was given IM. As of 12 December 2013. Patient did not have any adverse events. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received on 09 December 2013 from a health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a YF VAX (lot number, route and site of vaccination was not reported) on an unspecified date. Vaccine was reconstituted with sterile water from MMR. As of 09 December 2013. Patient did not have any adverse events. List of documents held by sender: none.
Sex: U
Vaccine: TDAP, YF
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received on 03 December 2013 from a health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of ADCEL and YF VAX (lot number and site of vaccination was not reported, route intramuscularly) on an unspecified date. The primary care doctor mixed YF and ADACEL in the same syringe and gave it IM . As of 03 December 2013. Patient did not have any adverse events. List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: YF
Symptoms: Blister, Dermatitis bullous, Drug eruption, Haemorrhage, Injection site erythema
Clinical narrative: Initial report was received from literature on 10 May 2014. A 56-year-old female patient, whose concomitant medications were not reported, he received a dose of YELLOW FEVER VACCINE (batch number, dose number, route and anatomical site of administration were not reported) of unknown manufacturer on an unspecified date. The patient had no known allergies to medications, eggs, or vaccines, and denied a history of herpes or changes to her medication regimen. She reported no insect bites, trauma, or burns to the area. It was reported that on an unspecified date, after receiving Yellow Fever vaccine, the patient experienced an injection site reaction followed by a localized bullous fixed drug eruption. Hours after receiving the vaccine, a painful edematous plaque developed at the injection site. Four days later, she reported development of large, asymptomatic bullae localized to her nose. The lesions increased in size and eventually ruptured with minimal crust. She presented to clinic 10 days after receiving the vaccine. On exam, there was 1.2-cm erythematous, circular, superficial erosion with desquamative scale overlying the left nasal ala with scant hemorrhagic and serous crust. Superficial erosions were also appreciated on the columella. An erythematous patch surrounded the injection site on the upper right arm. Biopsy, culture, and direct immunofluorescence were deferred given the benign exam. Because the lesions were healing, no specific treatment was indicated. The eruption was cleared 2 days later without scarring or dyspigmentation. But at the time of this report, the outcome of other events was unknown. Documents held by sender: figure of Bullous fixed drug eruption.
Age: 56.0
Sex: F
Vaccine: YF
Symptoms: Injection site oedema, Injection site pain, Injection site plaque, Injection site reaction, Scab
Clinical narrative: Initial report was received from literature on 10 May 2014. A 56-year-old female patient, whose concomitant medications were not reported, he received a dose of YELLOW FEVER VACCINE (batch number, dose number, route and anatomical site of administration were not reported) of unknown manufacturer on an unspecified date. The patient had no known allergies to medications, eggs, or vaccines, and denied a history of herpes or changes to her medication regimen. She reported no insect bites, trauma, or burns to the area. It was reported that on an unspecified date, after receiving Yellow Fever vaccine, the patient experienced an injection site reaction followed by a localized bullous fixed drug eruption. Hours after receiving the vaccine, a painful edematous plaque developed at the injection site. Four days later, she reported development of large, asymptomatic bullae localized to her nose. The lesions increased in size and eventually ruptured with minimal crust. She presented to clinic 10 days after receiving the vaccine. On exam, there was 1.2-cm erythematous, circular, superficial erosion with desquamative scale overlying the left nasal ala with scant hemorrhagic and serous crust. Superficial erosions were also appreciated on the columella. An erythematous patch surrounded the injection site on the upper right arm. Biopsy, culture, and direct immunofluorescence were deferred given the benign exam. Because the lesions were healing, no specific treatment was indicated. The eruption was cleared 2 days later without scarring or dyspigmentation. But at the time of this report, the outcome of other events was unknown. Documents held by sender: figure of Bullous fixed drug eruption.
Age: 56.0
Sex: F
Vaccine: YF
Symptoms: Skin erosion
Clinical narrative: Initial report was received from literature on 10 May 2014. A 56-year-old female patient, whose concomitant medications were not reported, he received a dose of YELLOW FEVER VACCINE (batch number, dose number, route and anatomical site of administration were not reported) of unknown manufacturer on an unspecified date. The patient had no known allergies to medications, eggs, or vaccines, and denied a history of herpes or changes to her medication regimen. She reported no insect bites, trauma, or burns to the area. It was reported that on an unspecified date, after receiving Yellow Fever vaccine, the patient experienced an injection site reaction followed by a localized bullous fixed drug eruption. Hours after receiving the vaccine, a painful edematous plaque developed at the injection site. Four days later, she reported development of large, asymptomatic bullae localized to her nose. The lesions increased in size and eventually ruptured with minimal crust. She presented to clinic 10 days after receiving the vaccine. On exam, there was 1.2-cm erythematous, circular, superficial erosion with desquamative scale overlying the left nasal ala with scant hemorrhagic and serous crust. Superficial erosions were also appreciated on the columella. An erythematous patch surrounded the injection site on the upper right arm. Biopsy, culture, and direct immunofluorescence were deferred given the benign exam. Because the lesions were healing, no specific treatment was indicated. The eruption was cleared 2 days later without scarring or dyspigmentation. But at the time of this report, the outcome of other events was unknown. Documents held by sender: figure of Bullous fixed drug eruption.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional (nurse) on 22 November 2013 and the case was received on 21 March 2014 at GPV. A patient (no information of patient's were provided) had received a dose of YF-VAX) (batch number, route and site of administration were not reported) on an unspecified date. The vaccine was reconstituted with reconstituted with sterile water. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: YF
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 14 April 2014. It was reported that the kid pulled away and the child did not get the full dose of YF. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 16 April 2014. A dose of YF was administered intramuscularly instead of subcutaneously (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 24 April 2014. A dose of YF-VAX was reconstituted with sterile water instead of supplied diluent (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23 April 2014. YF-VAX was administered which was reconstituted with sterile water instead of supplied diluent. It was a wrong solution used in drug reconstitution. No adverse event was reported. List of documents held by sender: None.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 18 March 2014. YF-VAX was inadvertently reconstituted with sterile water instead of the YF-Vax Diluent. It was a wrong solution used in drug reconstitution. No adverse event was reported. List of documents held by sender: None.
Sex: U
Vaccine: YF
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional (nurse) on 22 April 2014. A patient (no information regarding patient was reported) had received a dose of YF VAX (batch number, route, site and dose in series was not reported) on an unspecified date. It was reported that the YF VAX was reconstituted with sterile water and administered. No adverse event was reported. List of documents held by sender: none