chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received on 09-Dec-2013 from a health care professional. A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of PENTACEL (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient received underdose of PENTACEL. As of 09-Dec-2013 patient did not have any adverse events. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received on 05 December 2013 from a health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of PENTACEL (lot number, route and site of vaccination was not reported) on an unspecified date. The nurse reported that they gave only ACTHIB portion diluted with sterile water. As of 05 December 2013, patient did not have any adverse events. List of documents held by sender: none.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 09 December 2013. A 4-month-old patient (unknown gender) had received PENTACEL and the nurse gave the PENTACEL vaccine reconstituted with sterile water gave it to patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Underdose
Clinical narrative: Initial misuse report received on 11-Dec-2013 from a health care professional. A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of PENTACEL (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient received underdose of PENTACEL vaccine. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a reporter on 03 December 2013. The patient had received the DTap/IPV alone from PENTACEL. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: Initial report received from healthcare professional on 13 December 2013. A patient (age and gender unknown) whose medical history and concomitant medications were not reported received PENTACEL (lot number and expiration date were not reported) (site, route and dose number not reported) on an unknown date. On 06 October 2013. The nurse reported that PENTACEL powder was mixed with sterile water and DTaP/IPV not given. Sterile water for injection No clinical data on the use of other diluents than what is licensed with the vaccine. It is the opinion of our Medical Director that use of sterile water or 0.9% NS might lead to dissociation of the protein-polysaccharide conjugate. In the absence of clinical data showing that normal immunogenicity is retained using these diluents, we cannot support this practice. Discard DTaP/IPV and give a properly reconstituted dose of PENTACEL. Chart lot numbers appropriately. Laboratory investigation and corrective treatment were not reported. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial report received from a healthcare professional on 13 December 2013. A child patient received PENTACEL and received HIB portion reconstituted with sterile water. (No information was provided regarding the patient). No adverse event was reported.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 06 February 2014. This case is invalid as no patient information is available. An unknown patient had received only dtap ipv portion of PENTACEL on an unspecified date. No adverse event was reported. List of documents held by sender: None.
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Initial misuse report received from a healthcare professional on 11 February 2014. It was reported that the patient (in child age group) (no information was provided regarding the patient) had received only DTAP/IPV portion of PENTACEL on an unspecified date. No adverse event was reported. Documents held by sender: none.
Age: 0.2
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 06 February 2014. It was reported that a 2-month-old patient received PENTACEL and ACTHIB on the same day on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional (pharmacist) on 06 February 2014. A patient whose demographics were not reported had received only the DTAP-IPV portion of PENTACEL. No adverse event was reported. List of documents held by sender: none.
Age: 0.2
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 10 January 2014. A 02-month-old patient had received a dose of PENTACEL on an unspecified date. It was reported that the patient was given a dose possible without the DTAP/IPV and may have been mixed with sterile water. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 06 February 2014. A patient had received a dose of PENTACEL on an unspecified date. A medical assistant took the ActHIB portion from PENTACEL and reconstituted it with Merck diluent and administered the vaccine. The Dtap-IPV was not administered. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 14 February 2014. A patient had received a dose of PENTACEL on an unspecified date. It was reported that the product way was too long in transit and the MA's recorded and unpacked it. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 05 February 2014. This case is invalid as individual patient identifiable were not reported. Gave only DTaP-IPV from PENTACEL to a patient (No information was provided regarding the patient) on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 13 February 2014. A 4-months-old patient (gender was not reported) had received a dose of PENTACEL and a dose of ACTHIB in 2 separate injections on the same day. No adverse event was reported. Documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying
Clinical narrative: Initial report received from a healthcare professional on 15 April 2014. A male patient, whose age, medical history and concomitant medications were not reported, had received a dose of PENTACEL, (batch number C4574AA, dose number, route and site of vaccination not reported) on an unspecified date. On an unspecified date, the patient experienced excessive crying. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Rash macular
Clinical narrative: This is a literature case in which a 5-month-old girl who was referred for a skin rash after vaccination, which we determined to be due to haemophilus b antigen, as well as a logical methodology for evaluating such reactions. A 5-month-old girl experiencing a blotchy skin rash 5 minutes after receiving two vaccines, which resolved after 20 minutes without treatment. There was no associated shortness of breath or wheeze. The patient was advised not to perform skin testing due to the mild nature of the reaction and the desire to avoid excessive skin tests in this very young patient. The vaccine antigens were individually administered each at the next recommended dosing interval, in challenge doses. The selected alternative preparations were administered based on subsequent reactions and components of the individual vaccines, using the CDC's vaccine Excipient and Media Summary which lists all component of commercially available vaccines. Haemophilus b antigen was determined to be the causative agent.  Identifying the causative agent in a patient with a vaccine reaction is critical to minimize the chance of reaction recurrence which, if IgE-mediated, could be life-threatening upon reexposure. Concurrently, the necessity of immunization cannot be overstated. Many reactions are often attributed to vaccine excipients. In this case, careful evaluation demonstrated that the rash was in response to the hemophilus b antigen itself. The logical methodology was presented to ascertain the causative agent(s) following a minor vaccine reaction, so that they may be avoided when possible, while allowing for safe administration of the necessary immunizations. A 5-month-old female patient (date of birth not reported), whose medical history and concomitant medication were not reported, had received a dose of PENTACEL vaccine (batch number, dose number, route and site of administration were not reported) on unspecified date. On an unspecified date, with in 5 minutes of vaccine administration the patient experienced blotchy rash. The patient was advised not to perform skin testing due to the mild nature of the reaction and the desire to avoid excessive skin tests in this very young patient. Complimentary investigation and corrective treatment were not reported. The patient was recovered on an unspecified date after 20 minutes of onset. Documents held by sender: None.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Rash, Urticaria
Clinical narrative: Initial report received from healthcare professional on 29 April 2014. A 04-month-old male patient, whose medical history and concomitant medications were not reported, had received second dose of PENTACEL, batch number: C4483AA (route and anatomical site of administration were not reported) on 28 February 2014. It was reported that on 28 February 2014, same day after receiving PENTACEL, the patient experienced facial rash that was "hive like". The corrective treatments and laboratory investigations were not reported. At the time of this report the outcome was recovered. Documents held by sender: none.
Age: 0.12
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 07 January 2014. This case is linked to case number 2014SA010023 (for 5 year old patient, same reporter and same vaccine). A 06-week-old patient had received a dose of PENTACEL instead of DTAP and IPOL vaccine on an unspecified date in August 2013. No adverse event was reported. Documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional (Doctor) on 21-Aug-2013. A 4-year-old patient (no other information ws provided regarding patient) had received the dose of PENTAEL. They got an xtra dose of ACTHIB. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 06 January 2014. A patient has received a dose of PENTACEL on 3 January 2013 reporter said that they found the ActHib on the counter and don't know how long it was there. The patient was received DTap-IPV was not received ActHib component of PENTACEL. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Underdose
Clinical narrative: Initial information was received from other healthcare professional on 14 January 2014. This patient of unknown age and gender whose medical history and concomitant medication was not reported had received PENTACEL (dose, route, form and anatomical site of administration not reported) of incorrect reconstitution. The hib portion with sterile water was reconstituted and have not given the dtap/ipv. Hib portion was not counted as valid. It was advised to administer a PENTACEL.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: A patient (no other information was provided regarding patient) had received the dose of PENTACEL gave it reconstituted with sterile water. i.e. wrong solution used in drug reconstitution. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 08 January 2014. A patient (gender and date of birth was not reported) had received ActHib component of PENTACEL vaccine inadvertently reconstituted with sterile water and DTap/IPV was not administered. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: DTAP, DTAPIPVHIB, FLU3, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 25 February 2014. The cases were received at GPV on 21 March 2014.   A patient (no information was provided regarding the patient) had received dose of FLUZONE, ACTHIB; DAPTACEL; PENTACEL; MENACTRA, ADACEL 30 F multiple times daily for 20 minutes each time since 2/7 on an unspecified date, i.e. incorrect product storage. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 14 January 2014. A patient had received a dose of PENTACEL which was administered dtap/ipv part without the hib. It's an underdose. This is invalid case as the individual patient identifiers missing. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 14 January 2014. A child patient (demographics unknown) had received PENTACEL. The patient received only the DtaP/IPV component. Although not licensed, DTaP-IPV is immunogenic when administered without first reconstituting the ActHib component. Because the child was not given the ActHib component of PENTACEL, he/she needs to be given a separate injection of ActHib reconstituted with saline diluent. Since not administered together, chart lot numbers and vaccine name/component appropriately. No adverse event was reported. List of documents held by sender: none
Age: 5.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 07 January 2014. This case is linked to case number 2014SA010491 (for 6 week old patient, same reporter and same vaccine). A 5-year-old patient had received a dose of PENTACEL instead of DTaP and IPOL vaccine on an unspecified date in August 2013. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 24 September 2013. The cases were received on 21 March 2014. A patient had received a dose of PENTACEL on an unspecified date. It was reported that the patient received only the Dtap/IPV and did not give the ActHib powder. No adverse events were reported. List of documents held by sender: none
Sex: U
Vaccine: DTAPIPVHIB, IPV
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: The case were received on 21 March 2014 at the agency. Initial misuse report received from a healthcare professional on 23 August 2013. A patient had received PENTACEL and IPOL on the same visit instead of DAPTACEL. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 26 September 2013. The case was received on 21 March 2014 at agency. A child had received fifth dose of PENTACEL in the DTaP series. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23 September 2013. The cases were received on 21 March 2014 at agency. An expired PENTACEL was administered (exp. date 17 September 2013) on unspecified date. It was an expired vaccine used. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 26 September 2013. The cases were received on 21 March 2014 at agency. A patient had received a dose of PENTACEL on an unspecified date. It was reported that the patient received DTaP/IPV without first reconstituting the ACTHIB component. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Underdose, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional (nurse) on 17 September 2013 and the case was received on 21 March 2014 at agency. A patient (gender and date of birth was not reported) had administered only the ACTHIB portion of PENTACEL vaccine with sterile water and DTaP-IPV portion was not administered on 16 September 2013. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 04 March 2014. A patient (gender and date of birth was not reported) had administered only the DTaP-IPV portion of PENTACEL vaccine without first reconstituting the ACTHIB component. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered
Clinical narrative: Initial case was received from a healthcare professional on 12 March 2014. A patient of unknown demographics whose medical history and concomitant medications were not reported had received the ACTHIB component that was reconstituted by the sterile water and not the DTaP/IPV component of PENTACEL vaccine (batch number, dose, route and anatomical site of administration not reported) on an unknown date. List of documents held by sender: None.
Age: 0.8
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional (Nurse) on 12 March 2014. A 9-month-old patient has received only DTaP IPV portion of PENTACEL on unspecified date. It was an underdose. No adverse event was reported. List of documents held by sender: none.
Age: 0.4
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 14 February 2014. A 5-month-old patient received PENTACEL on an unspecified date. It was reported there the patient had received the ACTHIB and used sterile water to reconstitute and given to a 5 month as the second dose in the series. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Underdose, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 12 February 2014. A patient had received only the DTaP/IPV component of PENTACEL. Vaccine underdose was administered to the patient. No adverse event was reported. List of documents held by sender: None.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional (nurse) on 28 October 2013 and the case was received on 21 March 2014 at the agency. A patient (gender and date of birth was not reported) had administered only the ACTHIB portion of PENTACEL with sterile water and DTAP-IPB portion was not administered on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 1.3
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a helathcare professional (nurse) on 24 October 2013 and the case was received on 21 March 2014. A 15.month-old patient (gender was not reported) has received only the DTap-IPV portion of PENTACEL (batch number, route and site of administration was not reported), however the ActHIB component was not administered on an unspecified date. No adverse event was reproted. List of documents held by sender: none
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 28 October 2013. The cases were received on 21 March 2014 at GPV. A patient had received a dose of PENTACEL on an unspecified date. It was reported that the patient received DTaP/IPV without the HIB. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 28 October 2013. The case were received on 21 March 2014 at the agency. A patient had received a dose of PENTACEL on an unspecified date. It was reported that the patient received DTAP/IPV only. The Acthib was not given. No adverse event was reported. List of documents held by sender: none.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 16 October 2013. The cases were received on 21 March 2014. A 4-month-old patient had received only ACTHIB powder with a sterile water diluent from PENTACEL. It's was vaccine underdose. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 19 August 2013. A patient (no other information was provided regarding patient) had received the dose of PENTACEL gave it reconstituted with sterile water i.e. wrong solution used in drug reconstitution. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 27-Aug-2013. The case was received on 21-Mar-2014 at the agency. This is an invalid case as individual patient identifiers are not reported. The patient had received unstable PENTACEL on an unknown date. The reporter stated that the nursing staff gave only the DTAP/IPV part of PENTACEL. No adverse event was reported. (No information was provided regarding the patients). List of documents held by sender; none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 30-Aug-2014. A patient (no other information was provided regarding the patient) had received only the DTAP-IPV. Should give Acthib with correct diluent ASAP. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 29-Aug-2013. A patient (no other information was provided regarding patient) had received  only the ACTHIB component reconstituted with sterile water still has the DTAP/IPV component As per CDC, any dose of ACTHIB reconstituted with a diluent other than DTAP-IPV or the specific ACTHIB diluent should not be counted as valid and must be repeated. Although not licensed, DTAP-IPV is immunogenic when administered without first reconstituting the ACTHIB component. For this situation pt. can be administered the DTAP/IPV component and a separate ACTHIB vaccine. if don't have separate ACTHIB vaccine, need to discard that extra DTAP/IPV component of PENTACEL and administer an appropriately reconstituted PENTACEL dose. No adverse event was reported. List of documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHHY2012US038229, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 449169) website on 07 May 2012. This report refers to a 19-years-old female patient. She was vaccinated with MENVEO (batch number: M10123), intramuscularly in the left arm on 10 Jan 2012. After careful screening for last normal menstrual period (LNMP), on 19 Dec 2011 she stated that, there no chance of pregnancy, however she stated now that, she was pregnant at time of vaccination. Her prenatal care started on 10 Feb 2012 and without complaint at this time. No adverse event was reported. Follow-up received on 17 Jun 2013: No further follow-up will be pursued because the reporter was anonymous. This case is considered lost to follow-up.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHHY2013US012426, is an initial report received from Vaccine Adverse Event Reporting System (VAERS reference number: 474288) website on 08 Feb 2013. This report refers to a 17-year-old female pregnant patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO vaccine (batch number: M11081), intramuscular in the right arm, HAVRIX (batch number: AHAVB646BA) in the right arm intramuscularly, GARDASIL (batch number H010123) intramuscularly in the left arm and VARIVAX vaccine (batch number: H013638) subcutaneous in the left arm 14 Nov 2012. No signs or symptoms of an adverse event were noted. The vaccines were given per mother's request. After administration the patient informed us that she was pregnant. No more information was available. Follow-up information received on 17 Jun 2013: Reporter was anonymous, this case is considered lost to follow-up.
Age: 12.0
Sex: M
Vaccine: FLU3, HEPA, HPV2, MNQ, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2013US012474 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 476427) on 08 FEB 2013. This report refers to a 12-year old male patient. He was vaccinated with MENVEO (batch number M11050) and VARIVAX (batch number: H009635) intramuscularly on right arm on 06 NOV 2012. He was also vaccinated with FLUARIX (batch number: AFLUA695CA) HAVRIX (batch number; AHAZB646AA) and CERVARIX (batch number: AHPVA174RT) intramuscularly on left arm on 06 NOV 2012. On 07 NOV 2012, he experienced 10 x 10 cm circular area of significant swelling and warmth around injection site. He also experienced pain around injection site. Differential diagnosis of possible cellulitis vs allergic reaction was suspected. He had a visit to emergency room. Outcome of the events were reported as condition unchanged. Seriousness and causality of the events was not reported. No further information was available.   Following an internal review on 13 MAR 2013 of the date received on 08 FEB 2013, it was found that the event of cellulitis and allergic reaction was wrongly captured as events. Hence it was removed and the case was downgraded.
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2013US032516 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS reference number: 481158) on 04 Apr 2013. This case refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A10065) intramuscularly in his left arm on 07 Jan 2013. On the same day he was also vaccinated with GARDASIL (other manufacturer, batch number: 1262AA) intramuscularly and FLUARIX (other manufacturer, batch number: AFLUA7433BA) intramuscularly in his left arm. On 07 Jan 2013 the same day of vaccination, he experienced left arm swelling and redness. The final outcome was not reported. The seriousness and causality were not reported. No other information was available.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site erythema, Injection site pain, Skin warm, Tenderness
Clinical narrative: Case number PHHY2013US032535 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 481190) on 04 Apr 2013. This case refers to a 22-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12024) intramuscularly in her left arm on 13 Dec 2012. Two days after vaccination her left arm began to feel warm; became pink and painful to touch. On 18 Dec 2012 she came back to the clinic, her arm was still pink from armpit to just above elbow. In the outer aspect she had small area 2 inches x 1.5 inches below site which was more pink and tender to touch. The final outcome was reported as completely recovered on an unspecified date. The seriousness and causality were not reported. No other information was available.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2013US032495, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 481844) website on 04 Apr 2013. This report refers to an 11-years-old male patient. His current illness included viral illness and sore throat and historical condition included allergic to Penicillin, allergic rhinitis, oppositional defiant disorder (ODD) and esophoria. Concomitant medication was not reported. He was vaccinated with MENVEO (batch number: X12010) intramuscularly in the right arm and BOOSTRIX vaccine (batch number: AC52B081BA), intramuscularly in the right arm on 16 Jan 2013. Concomitantly he was also vaccinated with GARDASIL (batch number: H013831) intramuscularly in the left arm on 16 Jan 2013. On 17 Jan 2013, he experienced increased redness, pain and swelling of the right arm where immunizations given. He was seen at our office on 18 Jan 2013 by nurse and she suggested symptomatic care of cool compresses, ibuprofen and TYLENOL. Nurse rechecked of symptoms were persisting or increase in severity. The outcome of the events was reported as condition unchanged as of 18 Jan 2013. The causality of the events was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Local reaction, Vaccination site swelling
Clinical narrative: Case number PHHY2013US032527 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS reference number: 482834) on 04 Apr 2013: This report refers to an 11-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: A12013) in to the right arm along with BOOSTRIX (batch number: AC52B094AA) in to the left arm on 23 Jan 2013. On 25 Jan 2013, he experienced local reaction described as areas of redness and swelling at both the vaccination sites and was advised to take BENADRYL and apply cool packs to each site. On 28 Jan 2013, the local had gotten smaller and the child attended school that day. Final outcome was reported as complete recovery of the patient on an unknown date. No further information about causality and seriousness was reported.
Age: 46.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Case number PHHY2013US044396 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 483453) website on 06 may 2013. This report refers to a 46-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M12013) intramuscularly into left arm on 31 Jan 2013. On the same day, she experienced lightheadedness within 15 minutes of receiving vaccine and resolved within approximately 3 hours. The outcome of the event was resolved. The seriousness and causality of the event were not reported.
Age: 42.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2013US044398 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 483467) website on 06 May 2013. This report refers to a 42-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: unknown) on an unspecified date. On an unspecified date, after vaccination with MENVEO, injection site on left arm was swollen (of fist size) red, hard and painful (throbbing). The outcome of the events was reported as not recovered. The seriousness and causality of the events were not reported.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Case number PHHY2013US032576 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 483779) website on 04 Apr 2013. This report refers to 10-year-old female patient. Her medical history was not reported. She was not taking any other medications during the time of vaccination. On 05 Feb 2012, she was vaccinated with MENVEO (batch number: A10126) intramuscularly into left arm. On 06 Feb 2013, her left arm really became hot, red and started to swell and had a lot of itching. The size of that area was reported as "6.0 x 4.5". She had no increase in temperature and she was prescribed with BENADRYL for every six hours, for five days. The outcome of the events was reported as not recovered as of 07 Feb 2013. The seriousness and causality of the events were not reported.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHHY2013US032598 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS reference number: 483821) on 04 Apr 2013: This report refers to an 11-year-old male patient. His medical history and concomitant medication was not reported. He was given only MenCYW lyophilized conjugate component of MENVEO (batch number: M10130) intramuscularly in to the right arm on 08 Feb 2013 without being reconstituted with MenA. Concomitantly he was vaccinated with GARDASIL (other manufacturer, batch number: H01293 intramuscularly in to the left arm and with ADACEL (other manufacturer, batch number: U4383AA) intramuscularly in to the left arm on 08 Feb 2013. No adverse event was reported following this administration error.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Case number PHHY2013US116911 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 484261) website on 15 Oct 2013. This report refers to an 11-year-old male patient. His medical history included chronic hives. His concomitant medication included ZYRTEC. He was vaccinated with meningococcal vaccine (manufacturer and batch number unknown, hence conservatively coded with MENVEO INN) and TDAP (manufacturer and batch number unknown) into left arm on 28 Jan 2013. On 29 Jan 2013, he experienced soreness at injection site, red/raised bumps at injection site, fever and severe headaches. He went to emergency room due to these events. Outcome of the events was reported as not recovered. No seriousness and causality was reported for the event.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2013US116911 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 484261) website on 15 Oct 2013. This report refers to an 11-year-old male patient. His medical history included chronic hives. His concomitant medication included ZYRTEC. He was vaccinated with meningococcal vaccine (manufacturer and batch number unknown, hence conservatively coded with MENVEO INN) and TDAP (manufacturer and batch number unknown) into left arm on 28 Jan 2013. On 29 Jan 2013, he experienced soreness at injection site, red/raised bumps at injection site, fever and severe headaches. He went to emergency room due to these events. Outcome of the events was reported as not recovered. No seriousness and causality was reported for the event.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Case number PHHY2013US044382, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 484841) website on 06 May 2013. This report refers to a 10-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: M11082) intramuscularly in the right arm on 13 Feb 2013. On 15 Feb 2013, she experienced redness, warmth, pain at injection site 8 x 13 cm (right deltoid only) and fever. She was consulted to emergency room or doctor. On 16 Feb 2013, she was treated with cephadroxil. The event outcome was reported as condition unchanged as of 16 Feb 2013. The seriousness and causality of the events was not reported.
Age: 62.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Urticaria, Vaccination site pain, Vaccination site reaction
Clinical narrative: Case number PHHY2013US044432 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 484943) web site on 06 May 2013. This report refers to a 62-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: X11082) intramuscularly on to left arm on 11 Feb 2013. On 17 Feb 2013, she experienced a very large welt at vaccination site and it was red, painful and itchy. She was treated with prednisone and hydrocortisone cream which were helping. The outcome of the event was reported as complete recovery.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Case number PHHY2013US044429 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 485301) web site on 06 May 2013. This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12024) on to left arm on 18 Feb 2013. On 21 Feb 2013, she experienced redness and rash at injection site. The outcome of the event was reported as complete recovery.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: Case number PHHY2013US044400 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS Ref: 485794) web site on 06 May 2013: This report refers to 11 year old female patient. The patient's medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: M11051) into left arm, GARDASIL (batch number: H010123) into left arm and BOOSTRIX (batch number: AC52B081AA) on 25 Feb 2013. On 26 Feb 2013, she experienced warm induration reaction of 16/10 cm on left upper arm. Event was treated with MOTRIN. He had to go to the emergency on 27 Feb 2013. The patient's father refused to take oral anti-inflammatory drug ATB. The outcome of the events was completely recovered. Seriousness and causality assessment was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2013US056717 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number:486091) website on 05 Jun 2013. This report refers to an 11-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M12005) into right arm on 27 Feb 2013. On an unknown date, after vaccination she developed swelling of right deltoid area (vaccination area) of 5 cm x 5 cm with itching and erythema but no induration. The outcome of the events was not recovered at the time of report. The seriousness and causality of the events were not reported.
Age: 25.0
Sex: F
Vaccine: IPV, MNQ, TYP
Symptoms: Headache
Clinical narrative: Case number PHHY2013USA056724 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 486689) website on 05 Jun 2013. This report refers to a 25-year-old female patient. Her medical history included pretreatment with NUVARING and MUCINEX. Her concomitant medication included mefloquine as antimalarial and ZITHROMAX for anti-diarrhea. She was vaccinated with IPOL (other manufacturer, batch number: H1452) subcutaneously into right arm, MENVEO (batch number: X12011) into left arm and VIVOTIF (other manufacturer, batch number: 3000220) orally on 23 Jan 2013. On 24 Jan 2013, she woke up with headache and no other symptoms were present. It was reported that headache was due to fluids which she drank at noon. The outcome of the event was recovered. The seriousness and causality of the event were not reported.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2013US056787 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 487426) received on 05 June 2013. This report refers to 11-year-old female patient. Her medical history and concomitant were not reported. She was vaccinated with MENVEO (batch number: M11081) and GARDASIL (other manufacturer, batch number: H016238) into right arm and VAQTA (batch number: H010437) and BOOSTRIX (other manufacturer, batch number: AC52B088AA) into left arm; all vaccines administered on 12 Mar 2013. On 13 Mar 2013, she developed enlarged area of swelling, redness and warmth which was measuring 5 inch by 4 inch size and located at right upper arm and it was without discharge or streaking. The outcome of the events was reported as complete recovery. The causality and seriousness of the events were not reported.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2013US056801 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number:487538) web site on 05 Jun 2013. This report refers to 11-year-old male patient. His current condition included asthma and allergic rhinitis. His concomitant medications included of FLONASE, VENTOLINE and FLOVENT. He was vaccinated with MENVEO (batch number: M12008) intramuscularly into left arm and ADACEL (other manufacturer, batch number: U4421AA) intramuscularly left deltoid, GARDASIL (other manufacturer, batch number: H016238) intramuscularly into right arm, VARIVAX (other manufacturer, batch number: H018526) subcutaneously into right arm; all vaccines administered on 19 Mar 2013. On the same day night, he developed some redness in deltoid area where immunization was given. Later, the redness got bigger. On 21 Mar 2013, he visited emergency room of the clinic for evaluation. His left deltoid area was warm to touch with induration and measuring 10.5 cm across and 11 cm up and down. The movement was normal and tender to touch. He was treated with ibuprofen. The outcome of the events was reported as condition unchanged. The causality and seriousness of the events were not reported.
Age: 18.0
Sex: M
Vaccine: HEPA, IPV, MMR, MNQ
Symptoms: Pyrexia, Rash
Clinical narrative: Case number PHHY2013US116724 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 487628) website on 15 Oct 2013. This report refers to a 18-year-old male patient. His medical history and concomitant medication were not reported. On 08 Mar 2013, he was vaccinated with meningococcal vaccine (manufacturer and batch number unknown, hence conservatively coded as MENVEO INN into arm. On the same day, he also received hepatitis A/hepatitis B vaccine (manufacturer and batch number unknown), polio virus inactivated (manufacturer and batch number unknown), MMR vaccine (manufacturer and batch number unknown) and TDAP (batch number unknown) into arm. On 19 Mar 2013, he experienced fever and also rash appeared the next day as well. Fever lasted for three days but rash was still present as of 23 Mar 2013. No seriousness and causality was reported for these events.
Age: 16.0
Sex: M
Vaccine: MMR, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Case number PHHY2013US069352 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 488209) website on 03 Jul 2013. This report refers to 16-year-old male patient. His medical history included gastritis, pharyngitis, sinusitis, ADHD, asthma and constipation. His concomitant medication included ALLEGRA. He was vaccinated with MMR II (other manufacturer, batch number: 1885AA) subcutaneously into left arm, MENVEO (batch number: M11047) intramuscularly into left arm and VARIVAX (other manufacturer, batch number: H011912) subcutaneously into right arm on 25 Mar 2013. On the same day, he developed redness at the administration site (unspecified arm). On 26 Mar 2013, he went to emergency room with swelling of right arm around site and nausea. Patient received BENADRYL and ranitidine as a treatment. The outcome of the events was reported as recovered. The seriousness and outcome of the events were not reported.