chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2013US140134 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 502237) on 03 Dec 2013. This report refers to an 11-years-old female patient. Her medical history asthma and peanuts and sea food allergy and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12008) intramuscularly in the left arm on 27 Aug 2013. She also received BOOSTRIX (other manufacturer, batch number: AC52B73CA) intramuscularly in the right arm and GARDASIL (other manufacturer, batch number: 1229AA) intramuscularly in the left arm on 27 Aug 2013. On 28 Aug 2013, she had swelling, redness, warmth and pain in the left arm. She went to emergency room. The outcome of the event was reported as complete recovery.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2013US127759 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502480) website on 11 Nov 2013. This report refers to a 12-year-old male patient. His medical history was not reported. His concomitant medication included ADDERALL XR. He was vaccinated with MENVEO (batch number: M 12013) intramuscularly into right arm (deltoid) and HAVRIX (batch number: JR737) intramuscularly into left arm on 10 Sep 2013. On 11 Sep 2013, his right deltoid was red, raised, and warm touch and itching therefore applied anti-itch cream and ice packs and received ibuprofen after emergency visit. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Activities of daily living impaired, Dizziness, Fatigue, Nausea
Clinical narrative: Case number PHHY2013US139981 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503764) website on 03 DEC 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M13012) intramuscularly into the right arm, along with GARDASIL (other manufacturer, batch number: J007354) intramuscularly into the left arm, with FLUZONE (other manufacturer, batch number UA900AA) intramuscularly in to the right arm and with BOOSTRIX (other manufacturer, batch number: YJ475) intramuscularly in to the left arm on 23 Sep 2013. On the same day after vaccination, he walked out and within 10 minutes he felt nauseated, lightheaded and fatigued. He was unable to return to school. All symptoms cleared in about three hours. No previous similar history was reported. He had eaten his breakfast. The final outcome of the events was complete recovery. The seriousness and causality of the events were not reported. No additional information was available.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2013US139986 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 503849) website on 03 Dec 2013: This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A2128) in to the left arm on 20 Aug 2013. On 21 Aug 2013, he experienced warmth, redness and swollen left arm. He visited the emergency room following these events. Final outcome of the events was reported as complete recovery on an undetermined date. No further information about causality and seriousness was reported.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: Case number PHHY2013US140056 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 503909) on 03 Dec 2013. This report refers to a 12-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12128) intramuscularly in the right arm and BOOSTRIX (other manufacturer, batch number: AC52B092FA) intramuscularly and VARIVAX (other manufacturer, batch number: AC52B092FA) subcutaneously; both vaccines given in the left arm on 19 Sep 2013. On the same day after receiving all the three vaccines, patient felt dizzy. She was applied cool compresses and sucker was given. She waited for 15 minutes and left without any problem. The outcome of the event was reported as complete recovery.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2013US140058 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 503927) on 03 DEC 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12128) and GARDASIL (other manufacturer, batch number: H017698), both vaccines given intramuscularly in the right arm and BOOSTRIX (other manufacturer, batch number: AC52B092FA) intramuscularly in the left arm and FLUMIST (other manufacturer, batch number BH2090) via intranasal route on 15 SEP 2013. On 20 SEP 2013, he had redness and swelling on right arm and his other contacted the clinic. It was reported that the event was in a large area on right arm and there were no other symptoms. He came to the clinic. He was applying the ice pack. The outcome of the event was reported as complete recovery.
Age: 12.0
Sex: M
Vaccine: HEP, MNQ, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: Case number PHHY2013US140090 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 503950) website on 03 Dec 2013: This report refers to a 12-year-old male child. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12128) intramuscularly in to the right arm along with ENGERIX-B (other manufacturer, batch number: AHBVC188BA) intramuscularly in to the right arm, with BOOSTRIX (other manufacturer, batch number: AC52B092FA) intramuscularly in to the left arm and with VARIVAX (other manufacturer, batch number: J003540) subcutaneously in to the left arm, on 19 Sep 2013. On the same day after vaccinations, he felt dizzy. Cold compress was applied and sucker was given. He recovered 15 minutes later and then left. No further information about causality and seriousness was reported.
Age: 16.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Blood ketone body absent, Blood test normal, Exposure during pregnancy, Ultrasound antenatal screen normal, Vomiting
Clinical narrative: Case number PHHY2013US135690 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 504053) website on 25 NOV 2013. This report refers to a 16-year-old pregnant female patient. Her medical history was not reported. Her concomitant medication include PYRIDOXINE. on 04 OCT 2012, she was vaccinated with a meningococcal vaccine (manufacturer and batch number: unknown) therefore conservatively taken as MENVEO INN, FLUMIST (other manufacturer, batch number: unknown) given intranasal and with a second dose of GARDASIL (other manufacturer, batch number: not reported). Approximately on 10 OCT 2012 th3e patient found out that she was pregnant. On 10 OCT 2012, gestational age was 7 weeks 2 days, blood pressure was 127/75, leukocyte was negative, blood test was negative and ketones were negative. Her last menstrual period (LMP) was on 23 AUG 2012 with an estimated delivery date (EDD) of 30 MAY 2013. Patient was scheduled for an ultrasound on 13 NOV 2012. The patient received first and second doses of GARDASIL at physician's office. No treatment was given. Patient sought medical attention. She denied contractions (CTX), vaginal birth (VB) or range of motion (ROM). She experienced vomiting but was able to keep some liquid and solids down. She discussed maternal fetal medicine (MFM) for vaccinations with live viruses in early pregnancy. Ultrasound on 13 NOV 2012 (week 11) was normal. Ultrasound on 08 JAN 2013 (week 19) was normal. Pregnancy was ongoing as on 14 FEB 2013. No further information about causality and seriousness was reported.   Follow up information received on 25 NOV 2013. This case is considered lost to follow up because the reporter was anonymous.
Age: 16.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ
Symptoms: White blood cell count normal
Clinical narrative: Case number PHHY2013US135690 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 504053) website on 25 NOV 2013. This report refers to a 16-year-old pregnant female patient. Her medical history was not reported. Her concomitant medication include PYRIDOXINE. on 04 OCT 2012, she was vaccinated with a meningococcal vaccine (manufacturer and batch number: unknown) therefore conservatively taken as MENVEO INN, FLUMIST (other manufacturer, batch number: unknown) given intranasal and with a second dose of GARDASIL (other manufacturer, batch number: not reported). Approximately on 10 OCT 2012 th3e patient found out that she was pregnant. On 10 OCT 2012, gestational age was 7 weeks 2 days, blood pressure was 127/75, leukocyte was negative, blood test was negative and ketones were negative. Her last menstrual period (LMP) was on 23 AUG 2012 with an estimated delivery date (EDD) of 30 MAY 2013. Patient was scheduled for an ultrasound on 13 NOV 2012. The patient received first and second doses of GARDASIL at physician's office. No treatment was given. Patient sought medical attention. She denied contractions (CTX), vaginal birth (VB) or range of motion (ROM). She experienced vomiting but was able to keep some liquid and solids down. She discussed maternal fetal medicine (MFM) for vaccinations with live viruses in early pregnancy. Ultrasound on 13 NOV 2012 (week 11) was normal. Ultrasound on 08 JAN 2013 (week 19) was normal. Pregnancy was ongoing as on 14 FEB 2013. No further information about causality and seriousness was reported.   Follow up information received on 25 NOV 2013. This case is considered lost to follow up because the reporter was anonymous.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Amenorrhoea, Maternal exposure before pregnancy, Pregnancy test urine positive
Clinical narrative: Case number PHHY2013US140189 is an initial report received from a nurse via Vaccine Adverse Event Reporting System (VAERS reference number: 504213) website on 03 Dec 2013. This report refers to a 13-years-old female patient. Her medical history included myopia, attention deficit hyperactivity disorder and allergy to sulfa drugs. She had no prior pregnancies. Her concomitant medications were not reported. Her last menstrual period (LMP) was 26 Jan 2012. She was vaccinated with MENVEO (batch number: not reported), FLUMIST (batch number: not reported), GARDASIL (other manufacturer, batch number: 671006/1291AA, expiry date: 12 Apr 2014) intramuscularly and BOOSTRIX (other manufacturer, batch number: not reported) on 27 Feb 2012. On 27 Apr 2012, she went to emergency room for amenorrhea. Urine pregnancy test was performed on 27 Apr 2012 it was determined at this time that she was pregnant. Her estimated delivery date was 01 Nov 2012. She sought medical attention by hospital visit. She delivered a healthy male infant on 09 Oct 2012 (at week 41 from LMP) without complications. His weight was 7 pounds (lb) and 12 ounces (oz) and length was 21. Apgar score was 7 and 8. No further information was provided.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Case number PHHY2013US0140196 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 504248) website on 03 Dec 2013. This report refers to a 12-year-old male patient. He did not have any known drug allergies. His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12121) intramuscularly in the left arm and GARDASIL (other manufacturer, batch number: H021608) intramuscularly in the right arm on 11 Sep 2013. On 11 Sep 2013, he had fever which continued for 3 days and his left arm was swollen. On 14 Sep 2013, he went to emergency room with swollen left arm and he didn't  have fever on that day. The outcome of the event was reported as complete recovery.
Age: 29.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen normal
Clinical narrative: Case number PHHY2013US147153, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 504411) website on 16 Dec 2013. This report refers to 29-year-old female patient. Her medical history included salpingo plasty, fallopian tube obstruction and drug hypersensitivity for ULTRAM and CELEXA. Her current condition included WELLBUTRIN and SEROQUEL. Her last menstrual period was on 26 Jul 2013. She was vaccinated with meningococcal vaccine (unknown strain and manufacturer, batch number: not reported, so conservatively coded as MENVEO INN) and VARIVAX (batch number: not reported) on 26 Aug 2013. On 27 Aug 2013, she received a positive pregnancy test. Ultrasound scan was performed on 05 Sep 2013, which revealed uterine pregnancy and gestational age was determined to be 4 weeks and three days on 27 Aug 2013. Her estimated date of delivery was 02 May 2014. No adverse event was reported.
Sex: M
Vaccine: DTAP, HEP, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site reaction, Injection site warmth
Clinical narrative: Case number PHHY2013US136974, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 504413) website on 25 Nov 2013. This report refers to a male patient of an unknown age. On 15 Aug 2013, he was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported, so conservatively taken as MENVEO INN) GARDASIL (other manufacturer and batch number: not reported), VARIVAX (other manufacturer and batch number: not reported), RECOMBIVAX HB (other manufacturer and batch number: not reported), DTP vaccine (other manufacturer and batch number: not reported) and tetanus toxoid (other manufacturer and batch number: not reported). On 16 Aug 2013, the patient experienced severe local injection reaction, a large, hard lump that was red and hot to touch. A treatment was given for the events, CLARITIN or BENADRYL and supportive care (unspecified). It was reported that all symptoms resolved within one week time. The seriousness and causality of the events were not reported.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2013US140204 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 504749) website on 03 Dec 2013. This report refers to a 13-year-old male patient. His medical history included allergic rhinitis, seasonal allergies, allergic to shellfish and pollen allergy. His concomitant medications included prescribed naproxen from Aug 2013 and CLARITIN 10 mg once daily from 21 Sep 2013. He was vaccinated with MENVEO (batch number: M12130) intramuscularly in to the right arm along with HAVRIX (batch number: AHAVB641AA) intramuscularly in to the right arm, with GARDASIL (other manufacturer, batch number: H017698) intramuscularly in to the left arm, with ADACEL (other manufacturer, batch number: C4152AA) intramuscularly in to the left arm and with Varicella (other manufacturer, batch number: J003219) subcutaneously in to the left arm on 24 Sep 2013. On the same day after vaccination, he complained of redness, swelling and itching at the right deltoid that started in the evening. He also complained of headache and lightheadedness. He denied nausea and vomiting. He was afebrile. He visited the emergency room (ER) following these events. The outcome of the event was reported as condition unchanged as of 25 Sep 2013. The causality and seriousness of the event were not reported.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Erythema
Clinical narrative: Case number PHHY2013US139937, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 505333) website on 03 DEC 2013. This report refers to a an 11-year-old male patient. His concurrent conditions included asthma (stable). No concomitant medication was reported. He was vaccinated with MENVEO (batch number X12094) intramuscularly into the right arm and GARDASIL (other manufacturer, batch number: H020901) intramuscularly into the right arm on 30 SEP 2013. Concomitantly he was also vaccinated with FLUZONE (other manufacturer, batch number UH899AD) intramuscularly into the left arm on 30 SEP 2013. On 01 OCT 2013, he developed redness on the right arm which was 12 cm. He was treated with BENADRYL. The final outcome of the event was reported as complete recovery. The seriousness and causality of the event were not reported. No additional information was available.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Case number PHHY2013US13997, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 505439) website on 03 Dec 2013. This report refers to a 12-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: X11072) intramuscularly into the right arm, along with GARDASIL (other manufacturer, batch number: H020002) intramuscularly into the left arm and with ADACEL (other manufacturer, batch number: U4421AA) intramuscularly into the right arm, on 25 Jul 2013. On 26 Jul 2013, she experienced redness, warmth and induration at the injection site. The final outcome of the events was complete recovery. The seriousness and causality of the events were not reported. No additional information was available.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Antinuclear antibody, Borrelia test, Chills, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: Case number PHHY2013US140013 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 505601) on 03 Dec 2013. This report refers to an 18-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12004) intramuscularly in the left arm on 22 Aug 2013. On 24 Aug 2013, it was reported that she was feeling chills, ache and her arm hurt after shot. She went to emergency room. She had done Lyme's test, antinuclear antibody (ANA), erythrocyte sedimentation rate (ESR) and thyroid function tests (TFT) and the results were not reported. The outcome of the event was reported as complete recovery.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Thyroid function test
Clinical narrative: Case number PHHY2013US140013 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 505601) on 03 Dec 2013. This report refers to an 18-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12004) intramuscularly in the left arm on 22 Aug 2013. On 24 Aug 2013, it was reported that she was feeling chills, ache and her arm hurt after shot. She went to emergency room. She had done Lyme's test, antinuclear antibody (ANA), erythrocyte sedimentation rate (ESR) and thyroid function tests (TFT) and the results were not reported. The outcome of the event was reported as complete recovery.
Age: 7.0
Sex: M
Vaccine: FLU3, MNQ, TYP, YF
Symptoms: Erythema, Feeling hot, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2013US136843 is an initial spontaneous report received from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 505757) website on 25 NOV 2013. This case refers to a 7-year-old male patient. The patient was vaccinated with FLUZONE (other manufacturer, batch number: UH904AA) intramuscularly in left arm. MENVEO (batch number: A13014) intramuscularly in right arm, TYPHIM VI (other manufacturer, batch number: J12011) intramuscularly in left arm and YF-VAX (other manufacturer, batch number: UH3671AA) subcutaneous in left arm on 02 OCT 2013. On 03 OCT 2013, after the vaccination, the patient developed mild pain in right arm that increased. He developed swelling of right arm from shoulder to forearm, and erythema and warmth over the next 1.5 days. The patient went to emergency room for the events. The outcome of events was reported as condition unchanged. The seriousness and causality of events was not reported.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Inflammation
Clinical narrative: Case number PHHY2014US000776, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 506023) website on 06 Jan 2014. This report refers to a 12-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M13012) intramuscularly in the left arm and GARDASIL (other manufacture, batch number: J008423) intramuscularly in the right arm on 02 Oct 2013. On 03 Oct 2013, he experienced inflammation surrounds surface about 5.5 inches x 5.5 inches left deltoid where MENVEO vaccine given. Advised warm compress to affected area with BENADRYL used as directed. The outcome of the events was reported as condition unchanged as of 07 Oct 2013. The seriousness and causality of the events were not reported. No additional information was available.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Neck pain, Pain
Clinical narrative: Case number PHHY2014US000779, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 506138) website on 06 Jan 2014. This report refers to a 11-year-old female patient. She was vaccinated with MENVEO (batch number: M12009) in the right arm and ADACEL (batch number: C4432AB) in the left arm on 30 Sep 2013 (3:20 pm). On 01 Oct 2013, she experienced shooting pain from right deltoid into her neck. It was reported that the pain comes and goes. The final outcome of the events reported as not recovered.
Sex: U
Vaccine: MNQ, PPV
Symptoms: Body temperature increased
Clinical narrative: Case number PHHY2014US006293 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference ID: 506344) website on 20 Jan 2014: This report refers to a patient of unknown age and gender. This patient's medical history and concomitant medications were not reported. This patient was vaccinated with a meningococcal vaccine (manufacturer and batch number: unknown, therefore conservatively considered as MENVEO INN) along with PNEUMOVAX (other manufacturer, batch number: unknown) on an undetermined date in 2010. On an unspecified date in 2010, this patient developed temperature of 104 degrees Fahrenheit. The outcome of the event was unknown. The relatedness between the event and vaccines was not reported. Additional information was not available.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema
Clinical narrative: Case number PHHY2014US000788, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 506730) website on 06 Jan 2014. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12102) intramuscularly in the left arm on 08 Oct 2013. On the same day after vaccination, he experienced redness in left arm at vaccination site of MENVEO with 5 ccm long and 3 cm wide. He was treated with antibiotics (unspecified) and he did warm compress. The outcome of the events was reported as complete recovered on of 09 Oct 2013. The seriousness and causality of the events were not reported. No additional information was available.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Case number PHHY2014US001018 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 508174) website on 06 Jan 2014: This report refers to a 13-year-old male patient. His medical history included no known drug allergies. His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12132) along with GARDASIL (other manufacturer, batch number: J007354) on 07 Oct 2013. Both the vaccines were administered intramuscularly in to the left arm. On 08 Oct 2013, he experienced three and a half inches into three inches non-tender, firm, blanchable area of erythema at the injection site. On 09 Oct 2013, the reaction grew to six inches into eight inches non-tender, firm, blanchable erythematous are at injection. He visited the emergency room (ER) following these events. Final outcome of the events was reported as complete recovery. No further information about seriousness and causality was provided.
Age: 59.0
Sex: F
Vaccine: HIBV, MNQ, PPV
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US006303 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference ID: 509374) website on 20 Jan 2014: This report refers to a 59-year-old female patient. Her medical history included soft tissue sarcoma, pancreatitis, thyroid cancer and fibromyalgia. This polymedicated patient was vaccinated with a meningococcal vaccine (manufacturer and batch number: unknown) and with PNEUMOVAX (other manufacturer, batch number: unknown) on 08 Oct 2013. On 09 Oct 2013, she experienced extreme pain in the arm of vaccine that lasted for two weeks. An ultrasound was performed; however results for this examination were not reported. She applied moist heat, ice and used TYLENOL every three hours to treat the condition. She visited the emergency room (ER) following these events. The outcome of events was reported as condition unchanged as on 21 Oct 2013. No further information about causality and seriousness was reported.
Age: 35.0
Sex: F
Vaccine: IPV, MNQ, TYP, YF
Symptoms: Contusion, Injection site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Case number PHHY2014US001089, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509390) website on 06 Jan 2014. This report refers to a 35-year-old female patient. Her historical drug included LEVAQUIN. Concomitant drugs included oral contraceptive pills, herbal drugs, SINGULAIR and ZYRTEC. On 16 Oct 2013, she was vaccinated with MENVEO (batch number: M13011) intramuscularly in the left arm. On the same date, she also received IPOL (other manufacturer, batch number: J1406) intramuscularly in the left arm, VOVOTIF (other manufacture, batch number: 3000429) orally and YF-Vax (other manufacturer, batch number: UH672AA) subcutaneously in the right arm. On 16 Oct 2013, she experienced 5 cm x 7 cm red and raised patch at yellow fever vaccination site in the right arm. These events resolved in 10 days, but bruising remained and vaccination site pain if touched. On 17 Oct 2013, at MENVEO site of vaccination she experienced 3 cm x 5 cm red, raised and pruritic patch at left arm. The outcome of the events reported as not recovered. The seriousness and causality of the events were not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2014US001126, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509459) website on 06 Jan 2014. This report refers to a 11-year-old female patient. On 08 Oct 2013, she was vaccinated with MENVEO (batch number: A12124) and BOOSTRIX (other manufacturer, batch number: E5957) in the left arm. On the same date, after vaccination she experienced redness and swelling to the left arm. Her mother was concerned and took her to emergency room. The patient was prescribed with an antibiotic. The final outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Injection site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2014US001263, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509666) website on 06 JAN 2014. This report refers to an 11-year-old female patient. Her medical history included obesity and concomitant medication was reported. She was vaccinated with MENVEO (batch number: A12100) intramuscularly into the left arm and GARDASIL (other manufacturer, batch number: H021608) intramuscularly into the right arm and FLUMIST (other manufacturer, batch number: BH2090) on 15 OCT 2013. On the same day after vaccination, she experienced redness, swelling, pruritus and hot in area where vaccine was given. She was visited to the emergency room or physician. The final outcome of the events was reported as complete recovery. The seriousness and causality of the events were not reported. No additional information was available.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2014US000719 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 509980) on 06 Jan 2014. This report refers to an 18 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: 796H5) intramuscularly in the left arm on 18 Oct 2013. On 19 Oct 2013, he developed body aches, and had left shoulder pain the morning after receiving vaccine. He also complained of dizziness, nausea, 'point' aches and headache for the next 2 days. He also had some redness, warmth and pain in the area of injection for 3 days. The outcome of the event was reported as complete recovery. The seriousness and causality of the events were not reported.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Nausea, Pain
Clinical narrative: Case number PHHY2014US000719 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 509980) on 06 Jan 2014. This report refers to an 18 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: 796H5) intramuscularly in the left arm on 18 Oct 2013. On 19 Oct 2013, he developed body aches, and had left shoulder pain the morning after receiving vaccine. He also complained of dizziness, nausea, 'point' aches and headache for the next 2 days. He also had some redness, warmth and pain in the area of injection for 3 days. The outcome of the event was reported as complete recovery. The seriousness and causality of the events were not reported.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Peripheral swelling
Clinical narrative: Case number PHHY2014US000950 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 510405) website on 06 Jan 2014: This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12014/X13014) intramuscularly in to the left arm 29 Oct 2013. On the same day after vaccination, his entire vaccinated arm from clavicle to wrist was red, swollen, and itchy. Final outcome of the events was reported as condition unchanged as on 30 Oct 2013. No further information about seriousness and causality was provided.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Pruritus
Clinical narrative: Case number PHHY2014US000950 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 510405) website on 06 Jan 2014: This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12014/X13014) intramuscularly in to the left arm 29 Oct 2013. On the same day after vaccination, his entire vaccinated arm from clavicle to wrist was red, swollen, and itchy. Final outcome of the events was reported as condition unchanged as on 30 Oct 2013. No further information about seriousness and causality was provided.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Case number PHHY2014US006318 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (Vaers Reference ID: 510703) website on 20 Jan 2014: This report refers to an 11-year-old female child. her medical history and concomitant medications were not reported. She was vaccinated with a meningococcal vaccine (manufacturer and batch number: unknown, therefore conservatively considered as MENVEO INN intramuscularly in to the right arm along with tetanus, diphtheria and acellular pertussis vaccine (other manufacturer, batch number: unknown) intramuscularly in to the left arm on 29 Oct 2013. On 31 Oct 2013, she experienced red area below the injection site which was warm to touch along with soreness in her left arm. The outcome of events was reported as condition unchanged as on 31 Oct 2013. No further information about causality and seriousness was reported.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Limb discomfort, Local reaction
Clinical narrative: Case number PHHY2014US013338 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 511708) on 03 Feb 2014. This report refers to a 16-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M13014) and HAVRIX (other manufacturer, batch number: 494G5), both vaccines administered intramuscularly in the left arm and GARDASIL (other manufacturer, batch number: J011272) intramuscularly in the right arm on 31 Oct 2013. On 01 Nov 2013, he experienced large local reaction in the left posterior arm which was further described as indurated, erythematous, warm arm from shoulder down to almost elbow and there was significant discomfort in the arm. No systemic symptoms were reported. He went to emergency room and started prednisone course per oral. The outcome was reported as complete recovery. The seriousness and causality of the event were not reported.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US000882, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 511768) website on 06 JAN 2014. This report refers to a 11-year-old female patient. On 04 NOV 2013, she was vaccinated with MENVEO (batch number: M13011) and FLUZONE batch number: UH905AB) in the left arm and GARDASIL (batch number: J007354) in the right arm. On 05 NOV 2013, she experienced pain and swelling in left upper arm. On 06 NOV 2013, her arm was slightly warm to touch and pink in left upper arm 4" x 2 3/4" . She took BENADRYL and cool compress. The outcome of the events reported as not recovered. The seriousness and causality of the events were not reported.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2014US013236, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 511948) website on 03 Feb 2014. This report refers to a 16-year-old female patient. Her medical history and concomitant medication were reported. She was vaccinated with MENVEO (batch number: M12124) intramuscularly into the left arm on 21 Oct 2013. On 22 Oct 2013, she experienced redness, swelling and pain around site of injection. Her mother stated that, events started on 22 Oct 2013 and she thought it would improve. Her mother contacted the clinic on 24 Oct 2013 and she had no fever noted (temperature was 97.6 in the clinic). The final outcome of the events was reported as complete recovery. The seriousness and causality of the events were reported. No additional information was available.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Erythema, Local swelling, Pain in extremity, Pruritus
Clinical narrative: Case number PHHY2014US013377 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 512573) on 03 Feb 2014. This report refers to an 11-years-old female patient. Her medical history included allergy to penicillins and her concomitant medications were not reported. On 08 Nov 2013, she was vaccinated with MENVEO (batch number: M1213) and ADACEL (other manufacturer, batch number: C4152AA); both vaccines administered in the left arm and HAVRIX (other manufacturer, batch number: 5J5HT) and GARDASIL (other manufacturer, batch number: 1359AA); both vaccines administered in the right arm. On 10 Nov 2013, she experienced local swelling reaction, redness and pain in the left upper arm. She also had itching on an unknown date in Nov 2013 and her father used over the counter (OTC) cream. She was seen by the health care provider on 11 Nov 2013 and was prescribed ibuprofen, BENADRYL and cold compress. The event outcome was reported as complete recovery. The seriousness and causality of the event were not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Pain in extremity, Vaccination site papule
Clinical narrative: Case number PHHY2014USA013417 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 512776) on 03 Feb 2014. This report refers to an 11-year-old female patient. Her medical history included varicella disease and iritis and her concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13012) in the right arm and ADACEL (other manufacturer, batch number: U4655AA) in the left arm on 07 Nov 2013. On 08 Nov 2013, she developed soreness in both arms. She also had redness and a cluster of small papule like bumps at and surrounding sites of vaccination. The symptoms decreased in the right arm, but got worse in the left arm. She was asked to see a doctor for the events. The event outcome was reported as condition unchanged. The seriousness and causality of the event were not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2014US014562 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 514687) on 03 Feb 2014. This report refers to an 11-yers-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12092) in the left arm on 21 Nov 2013. Concomitantly she was also vaccinated with ADACEL (other manufacturer, batch number: C403AA) in right arm on 21 Nov 2013. On the same day after vaccination, she experienced left arm swollen and redness. Outcome of the events was reported as complete recovery as of 25 Nov 2013. The seriousness and causality of the events were not reported. No additional information was available.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2014US014505, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514752) website on 03 Feb 2014. This report refers to a 11-year-old male patient. On 18 Nov 2013, he was vaccinated with MENVEO (batch number: M13012), BOOSTRIX (other manufacturer, batch number: 22C9R) in the right arm and GARDASIL (other manufacturer, batch number: J006236) in the left arm, intramuscularly. On 20 Nov 2013, he experienced redness and swelling in right arm it was warm to touch. The patient was taken to the emergency room. The final outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Inflammation, Injection site erythema
Clinical narrative: Case number PHHY2014US014564, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514789) website on 03 Feb 2014. This report refers to a 18-year-old female. Her medical history included boils, a month before vaccination. She was vaccinated with MENVEO (batch number: M13011) intramuscularly in the left arm at deltoid muscle on 05 Nov 2013. On 06 Nov 2013, she experienced redness at injection site, at a size of half dollar. It was reported that the ice was applied at the circled area and she took ibuprofen. She was advised to apply ise on and off every 15 min for a couple of hours and to take ibuprofen every 4 hours for inflammation. Following day (event though patient did not apply ice), redness reduced to area of original reaction in a small C shape. The final outcome of the events reported as recovered. The seriousness and causality of the events were not reported. Following an internal review, a significant correction done for the information received on 03 Feb 2014. The event vaccination site erythema linked as a symptom to vaccination site inflammation.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Skin lesion
Clinical narrative: Case number PHHY2014US014564, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514789) website on 03 Feb 2014. This report refers to a 18-year-old female. Her medical history included boils, a month before vaccination. She was vaccinated with MENVEO (batch number: M13011) intramuscularly in the left arm at deltoid muscle on 05 Nov 2013. On 06 Nov 2013, she experienced redness at injection site, at a size of half dollar. It was reported that the ice was applied at the circled area and she took ibuprofen. She was advised to apply ise on and off every 15 min for a couple of hours and to take ibuprofen every 4 hours for inflammation. Following day (event though patient did not apply ice), redness reduced to area of original reaction in a small C shape. The final outcome of the events reported as recovered. The seriousness and causality of the events were not reported. Following an internal review, a significant correction done for the information received on 03 Feb 2014. The event vaccination site erythema linked as a symptom to vaccination site inflammation.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Case number PHHY2014US015265, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516140) website on 03 FEB 2014. This report refers to an 11-year-old male patient. On 09 DEC 2013, he was vaccinated with MENVEO (batch number: M13014), FLUZONE (batch number: UH898AC, other manufacturer) in the left arm, HAVRIX (batch number: K555K, other manufacturer) and BOOSTRIXC (batch number: 74AP3, other manufacturer) in the right arm, intramuscularly. On the same date, after vaccinations he experienced rash at upper chest. He had no hives or swelling of ears or lips and no difficulty breathing. The final outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Case number PHEH2014US002354 is an initial spontaneous report from the medical assistant received on 31 Jan 2014. This report refers to a 10-year-old male patient. He was vaccinated with MENVEO (batch number: M13051, expiry date: May 2015) at a dose of 0.5 ml intramuscularly on 27 Jan 2014. On 28 Jan 2014, he experienced 12 x 12 cm of red welt near the injection site. The outcome of the event reported as not recovered. The events reported as non serious. The causality of the events was not reported.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2012US019489 is an initial spontaneous report received from a nurse on 28 Sep 2012 with a follow up information on 28 Sep 2012, and with a follow up received on 12 Nov 2012. This case refers to an 18-year-old pregnant female patient. Date of last menstrual period was 01 August 2012. The patient had no medical problem. This pregnant patient was inadvertently vaccinated with MENVEO, (batch number: A11051, expiry date: Apr 2013) intramuscularly on 13 Sep 2012. No adverse event was reported since vaccination. No other information was available. Folow up information received on 28 Sep 2012: Expiry date of vaccine updated. Follow up report received on 12 Nov 2012. Updated patient demographics. LMP date. Follow up information received on 13 Aug 2013: Multiple attempts were made to obtain outcome of event without success. This case is considered lost to follow up.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of vomiting in a 25-year-ol female patient who received ENGERIX adult (batch number F2LR7, expiry date unknown). On 24th November 2014, the patient received ENGERIX B adult. On 24th November 2014, 20 min after receiving ENGERIX B adult, the patient experienced vomiting. On 24th November 2014, the outcome of the vomiting was recovered/resolved. It was unknown if the reporter considered the vomiting to be related to ENGERIX B adult. Additional information received: Reporter was told 20 mins after the injection the patient needed to go to the restroom. The patient began to vomit in the bathroom.
Age: 0.99
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Diet refusal, Erythema, Eye swelling
Clinical narrative: Approximately 8 to 12 hours after receiving the Hep B Vaccine, patient's body began to swell and with red hives and dark purple spots.  We took him to the ER.  He was kept for observation over night.  He was very sick, weak, would not nurse, his tongue, face lips, eyes were severely swollen. His body was covered in red welts and purpura spots.
Age: 0.99
Sex: M
Vaccine: HEP
Symptoms: Food allergy, Lip swelling, Malaise, Purpura, Skin discolouration
Clinical narrative: Approximately 8 to 12 hours after receiving the Hep B Vaccine, patient's body began to swell and with red hives and dark purple spots.  We took him to the ER.  He was kept for observation over night.  He was very sick, weak, would not nurse, his tongue, face lips, eyes were severely swollen. His body was covered in red welts and purpura spots.
Age: 0.99
Sex: M
Vaccine: HEP
Symptoms: Stress, Swelling, Swelling face, Swollen tongue, Tic
Clinical narrative: Approximately 8 to 12 hours after receiving the Hep B Vaccine, patient's body began to swell and with red hives and dark purple spots.  We took him to the ER.  He was kept for observation over night.  He was very sick, weak, would not nurse, his tongue, face lips, eyes were severely swollen. His body was covered in red welts and purpura spots.
Age: 0.99
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Approximately 8 to 12 hours after receiving the Hep B Vaccine, patient's body began to swell and with red hives and dark purple spots.  We took him to the ER.  He was kept for observation over night.  He was very sick, weak, would not nurse, his tongue, face lips, eyes were severely swollen. His body was covered in red welts and purpura spots.