chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2012US110845 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System website (VAERS reference number: 466026) on 04 Dec 2012: This report refers to an 11-year-old female patient. Her concomitant medications included CLARITIN and Albuterol inhaler. She was vaccinated with MENVEO (batch number: M10126A) intramuscularly along with ADACEL (other manufacturer, batch number: U3486DA) intramuscularly into the left arm and with GARDASIL (batch number: 1745AA) intramuscularly into the right arm on 20 Sep 2012. On 21 Sep 2012 she experienced red, swollen and warm to touch left deltoid which was also firm. Ibuprofen 300mg was given at 9:20am and ice was applied to the site. Erythema and firmness was on anterior upper arm extending over half the upper arm. There was no reaction posteriorly. The final outcome was reported as condition unchanged as on 21 Sep 2012. No further information about seriousness and causality was reported.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pain
Clinical narrative: Case number PHHY2012US111482 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 466669) web site on 04 Dec 2012. This report refers to a 12-year-old male patient. His medical history included seasonal allergies, asthma and eczema and concomitant medications were SINGULAIR, FLONASE and ZYRTEC. He was vaccinated with MENVEO (batch number: M10129) on to left arm and ADACEL (batch number: C3941AA, other manufacturer) on to right arm on 25 Sep 2012. On 26 Sep 2012, he experienced red swelling and hardness at the site of injection (left deltoid). He also had pain. He was instructed to keep ice pack and BENADRYL and TYLENOL for pain. The final outcome of the events was reported as condition unchanged as of 27 Sep 2012.
Age: 12.0
Sex: M
Vaccine: FLU3, HEPA, IPV, MNQ
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Case number PHHY2012US111289 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 467040) website on 04 DEC 2012. This report refers to a 12-year-old male patient. His medical history included juvenile rheumatoid arthritis. The child was well at the time of vaccination. He ws vaccinated with MENVEO (batch  number: M11082) intramuscularly in to the right arm along with HAVRIX (other manufacturer, batch number: AHAV13667CB) in to the right leg and with IPOL (other manufacturer, batch number: H1305) subcutaneously in to the left arm and FLUZONE (other manufacturer, batch number: UH715AA) in to the left leg on 28 SEP 2012. On 29 SEP 2012 there were marked erythema and edema (about 5x5 cm) starting 24 hours after injection extending down right arm. He started on Clindamycin for 10 days taken orally. He was afebrile. Outcome was reported as complete recovery. No further information about seriousness and causality was reported.
Age: 18.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Incorrect product formulation administered
Clinical narrative: Case number PHHY2012US111350 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 467181) on 04 DEC 2012. This report refers to 18-year-old female patient. She was vaccinated with MENVEO (batch number: A11052) intramuscularly in left arm, FLUZONE (batch number: U4431CD, manufacturer: Sanofi) intramuscularly in right arm, ADACEL (batch number: C3976AA, manufacturer Sanofi) intramuscularly in right am on 11 SEP 2012. She was only given liquid portion of MENVEO because there was only one bottle in the box. The bin was labeled "it take two" but she thought that was referring to the number of doses a child had to get and not the number of bottles used for a single injection. The patient has no reaction. No other information was reported.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Asthenia, Headache, Peripheral coldness
Clinical narrative: Case number PHHY2012US111362 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 467310) on 04 Dec 2012. This report refers to 18-year-old male patient. He was vaccinated with MENVEO (batch number: A11052) in left arm and VAQTA (batch number: 1005AA, manufacturer: Merck) in right arm on 29 Sep 2012. On 30 Sep 2012, after the vaccination, the patient felt weak and headache. His feet were cold. The final outcome of events was reported as complete recovery as of 01 Oct 2012.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2012US111367 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS Reference number: 467327) website on 04 Dec 2012. 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: M11047) on to right arm on 24 Sep 2012. On 25 Sep 2012, his vaccination site was red, swollen and was giving off heat. He went to emergency room. The final outcome of the events was reported as condition unchanged as of 25 Sep 2012.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2013US000465, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 468488) web site on 02 Jan 2013. This report refers to 11-year-old male patient. His medical history was not reported. Concomitant medication included CLARITIN, Fluticasone, CONCERTA. He was vaccinated with MENVEO (batch number: M12013) intramuscular into the left deltoid and BOOSTRIX (batch number: AC52B099AA) IM into the right deltoid on 04 Oct 2012. On 05 Nov 2012, the patient developed 3/3.5 cm area of erythema in the right deltoid and 8/5 cm area of erythema in left deltoid. Left arm was warm and swollen. Data states 5% have erythema and 2% had shown to have induration. The final outcome of the events was recovered. The seriousness and causality assessment was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2013US000467, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 468489) web site on 02 Jan 2013. This report refers to 11-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: M12013) intramuscular into the left deltoid and BOOSTRIX (batch number: AC52B099AA) IM into the right arm on 04 Oct 2012. On 05 Nov 2012, the patient developed erythema, warm to touch and swelling in the area of left deltoid. Data states 5% have erythema and 2% had shown to have induration. The final outcome of the events was recovered. The seriousness and causality assessment was not reported.
Age: 49.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Pruritus generalised
Clinical narrative: Case number PHHY2013US000470, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 468640) website on 02 Jan 2013. This report refers to 49-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: A11078) IM into left arm on 13 Sep 2012. On 16 Sep 2012, 3 days after vaccination patient experienced itchiness all over the body. Patient also had redness on groin area. Patient used Vaseline to relieve symptoms. He was still experiencing these symptoms. The final outcome of the events was condition unchanged. The seriousness and causality assessment was not reported.
Age: 40.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pruritus generalised, Rash
Clinical narrative: Case number PHHY2013US000478 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 468641) website on 02 Jan 2013. This report refers to a 40-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A 11078) intramuscularly on to left arm on 13 Sep 2012. On 16 Sep 2012, she experienced itchiness all over the body. She also had redness and rash on groin area. She used VASELINE (paraffin soft) to relieve symptoms. It was reported that she still experienced the symptoms. The final outcome was reported as condition unchanged as of 09 Oct 2012.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Case number PHHY2013US000479 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 468816) website on 02 Jan 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: A11082) and GARDASIL (other manufacturer, batch number: H010123); both vaccines intramuscularly on to left arm on 27 Sep 2012. On 28 Sep 2012, she experienced swelling in left arm which was mildly tender on palpation. It was reported that the reaction was localized. She went to emergency room. The final outcome was reported as complete recovery as of 02 Oct 2012.
Age: 11.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Pain, Peripheral swelling, Rash
Clinical narrative: Case number PHHY2013US000483 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 469458) web site on 02 JAN 2013. This report refers to an 11-year-old male patient. It was reported that he did not have any known allergies. His concomitant medication included mebendazole. He was vaccinated with MENVEO (batch number: M11052) and GARDASIL (other manufacturer, batch number: H010123) intramuscularly on to left arm, FLUMIST (other manufacturer, batch number: AJ2108) via intranasal route and ADACEL (other manufacturer, batch number: C4247AA) intramuscularly on to right arm on 12 OCT 2012. On 13 OCT 2012, he complained of pain and swollen arms with a large rash. He went to emergency room. He was given antibiotics, steroid cream and Benadryl on 14 OCT 2012. The final outcome was reported as complete recovery as of 15 OCT 2012.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Case number PHHY2013US000792 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 469860) web site on 02 Jan 2013. This report refers to a 18-year-old male patient. He was vaccinated MENVEO (batch number: M11082) intramuscularly in the left arm on 09 Oct 2012. On the same date, about 2 hours after vaccination the patient experienced hives on legs (bilateral). It was reported that the patient contacted MD and was instructed to take BENADRYL. The outcome of the event was reported as recovered. The seriousness and causality of the event were not reported.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2013US000827 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 469903) website on 03 JAN 2013. This report refers to a 176-year-old fejale patient. Her medical history and concomitant medicaitons were not reported. Sh ewsa vaccinated with MENVO (btch number: A12013) and FLUZONE (batch number: UH731AB), both vaccines intramuscularly on to left arm and GARDASIL (batch number: H012973 intramuscularly on to right arm on 03 OCT 2012. On 05 OCT 2012, she experienced redness and swelling in left arm. The outcome of the events was reported as condition unchanged as of 05 OCT 2012.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Case number PHHY2013US000576 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 470178) website on 02 Jan 2013: This report refers to a 12-year-old male patient. His medical history included mild persistent asthma and concomitant medication was VENTOLIN. He was vaccinated with MENVEO (batch number: M12013) and HAVRIX (other manufacture, batch number: AHAVB646BA) both vaccines on to right arm on 08 Oct 2012. 12 hours after vaccination, on 09 Oct 2012, he experienced red, swelling, warm area about 5x5 which slowly increased in size. It was reported that he was accidentally given a third hepatitis A vaccine. Patient had an emergency visit. The outcome of the events was reported as complete recovery. Seriousness and causality were not reported.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: case number PHHY2013US000604 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 470185) on 03 JAN 2013. THis case refers to an 11-year-old female patient. She was vaccinated with MENVEO (batch number: A10057) in her right arm on 03 OCT 2012. On the same day she was also vaccinated with FLUMIST (other manufacturer, bartch number: AJ2106) intranasally, GARDASIL (other manufacturer, batch number: 0101AE) in her right arm and ADACEL (other manufacturer, batch number: C39476A) in her left arm. On 04 OCT 2012 her mother noticed localized reactions of redness, warmth and minor tenderness to touch in the right deltoid. It measured around 4x3 inches on 05 OCT 2012 at 16:00. She had recovered completely on an unspecified date. Seriousness and causality of the events were not reported. No other information was available.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Case number PHHY2013US000690 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 470285) on 01 Nov 2012. This report refers to a 11-year-old male patient. His medical history included lot of skin problems. He was vaccinated with MENVEO (batch number: M11046) intramuscularly in right arm, ADACEL (batch number: U438AA) intramuscularly in left arm and VARIVAX (batch number: H009841) subcutaneously in left arm on 15 Oct 2012, after the vaccination, the patient's arm was red and was warm which continued to get bigger. The outcome of events was reported as condition unchanged as of 18 Oct 2012.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: case number PHHY2013US000485 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 470687) website on 02 JAN 2013. This report refers to an 11-year-old male patient. His medical history included obesity and heart murmur and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M11051 and GARDASIL (other manufacturer, batch number: H010123) intramuscularly on to right arm and FLUARIX (other manufacturer, batch number: AFLUA688AA) and BOOSTRIX (other manufacturer, batch number: AC52B088AA) intramuscularly on to left arm on 15 OCT 2012. On the same day he experienced redness and swelling at the right arm deltoid (at the vaccination site) which measured 4 inch in length and 4.75 inches in width. The event was reported on 18 OCT 2012. The final outcome was reported as condition unchanged.
Age: 32.0
Sex: F
Vaccine: IPV, MNQ, TYP, YF
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2013US000559 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 470809) on 02 Jan 2013. This report refers to a 32-year-old female patient. The patient was vaccinated on 20 Oct 2012 with following vaccines: MENVEO (batch number: A11041) intramuscularly on left arm, IPOL (batch number: G10831) intramuscularly on right arm, TYPHIM VI (batch number: G15421) intramuscularly on right arm and YF-VAX (batch number: UH296AB) subcutaneously on left arm. On 21 Oct 2012, the patient experienced swelling at the deltoid region. The patient reported swelling had increased on 22 Oct 2012 and was accompanied by warmth and induration. Outcome of the events were reported as condition unchanged as of 22 Oct 2012. Seriousness and causality of the events were not reported.
Age: 18.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Urticaria
Clinical narrative: Case number PHHY2013US000887 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471286) on 02 JAN 2013. This report refers to a 13-year-old female patient. The patient was vaccinated with MENVEO (batch number: A11071) and FLUZONE (batch number: UH733AA) both on 23 OCT 2012. On 24 OCT 2012, the patient experienced hives. Outcome of the event was reported as condition unchanged as of 24 OCT 2012. Seriousness and causality of the events were not reported. No further information was available.
Age: 45.0
Sex: M
Vaccine: FLU3, MNQ, PPV
Symptoms: Headache, Injection site pain, Malaise, Rash
Clinical narrative: Adverse Event Reporting System (VAERS reference number: 471308) on 01 NOV 2012. This report refers to a 45-year-old male patient. Concomitant medications included Singulair, Clarinex, Axiron, and Finasteride. He was vaccinated with MENVEO (batch number: not reported), FLUZONE (batch number: not reported) and PNEUMOVAX (batch number: not reported) on 08 OCT 2012. On 08 OCT 2012, after the vaccination, he experienced pain at injection site. On 09 OCT 2012, he was not feeling well and had headache. On 10 OCT 2012, he developed rash. The outcome of the events was reported as condition unchanged as of 24 OCT 2012. The seriousness and causality of the event was not reported.
Age: 30.0
Sex: M
Vaccine: HEP, IPV, MNQ
Symptoms: Pyrexia, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Case number PHHY2013US000443 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 471399) on 02 Jan 2013. This case refers to a 30-year-old male patient. It was reported that he had mild reactions (myalgias, fatigue) to vaccines (not specified) in the past. He was vaccinated with MENVEO (batch number: A11065) intramuscularly into his left arm on 22 Aug 2012. On the same day he was also vaccinated with RECOMBIVAX HB (other manufacturer, batch number: 13301) subcutaneously in left arm. On 24 Aug 2012 he developed red, blotchy, mildly itchy rash on his upper and lower extremities. Then on 02 Sep 2012 he developed fever of 102.9 which persisted for four days. He had recovered completely on an unspecified date. The seriousness and causality were not reported.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2013US012379 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 471482) on 08 Feb 2013: This report refers to an 11-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: M11082) intramuscularly in to the left arm along with HAVRIX (batch number: AHAVB523AA) intramuscularly in to the right arm on 16 Oct 2012. On 17 Oct 2012, 14 hours after vaccination, her left upper arm was swollen, red and warm, that lasted till the pharmacy visit which was made 24 hour after injection. She visited Emergency Room (ER) following these events. Final outcome was reported as condition unchanged as on 17 Oct 2012. No further information about causality and seriousness was provided.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2013US000676 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471550) on 02 Jan 2013. This report refers to a 11-years-old female patient. The patient's preexisting conditions included eczema and tension headaches. Concomitant medications included KEFLEX 250/5 ml and ibuprofen 100 mg/5 ml. The patient was vaccinated with following vaccinations intramuscularly on left arm on 15 Oct 2012: MENVEO (batch number: M11052), GARDASIL (batch number: H011350) and ADACEL (batch number: C4009AA). On the same day, the patient experienced pain, swelling, redness, warm to touch at injection site and itching. Outcome of the events were reported as recovered. Seriousness and causality of the events were not reported. No further information was available.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Case number PHHY2013US000700 is an initial spontaneous report received from vaccine adverse vent reporting system (VAERS reference number: 471561) on 01 Nov 2012. This report refers to a 11-year-old male patient. He was vaccinated with Menveo meningococcal A, C, W, and Y conjugate vaccine, batch number: A11050) intramuscularly in left arm on 15 Oct 2012, after the vaccination the patient experienced an area of large redness and was warm to touch. The outcome of events was reported as complete recovery as of 18 Oct 2012. The seriousness and causality of the events was not reported.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Vaccination site swelling
Clinical narrative: Case number PHHY2013US000777, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471626) website on 02 Jan 2013. This report refers to a 16-year-old female patient. Her medical history was not reported. Her concomitant medications included DEPO-PROVERA 150mg/ml administered in the left arm. She was vaccinated with MENVEO (batch number: M11046) intramuscularly in the right arm on 23 Oct 2012 and VAQTA (other manufacturer, batch number: 0628AE) intramuscularly in the left arm on 23 Oct 2012. On 24 Oct 2012, the site of vaccination started as red, raised area about 3 cm. On 25 Oct 2012, it was increased to about 3 diameter. The area of injection site was hot to touch and tender without red streaks. She remained afebrile. The event outcome was reported as complete recovered as of 26 Oct 2012. The seriousness and causality of the events was not reported.
Age: 66.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2013US000919 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471813) website on 02 Jan 2013: This report refers to a 66-year-old male patient. His current condition included diabetes and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: A11046) on to left arm and BOOSTRIX (batch number: AC52B081BA) on to right arm on 24 Oct 2012. He was administered MENVEO outside of age guidelines.  No adverse event was reported. No further information was provided.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Case number PHHY2013US000935 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471879) web site on 02 Jan 2013: This report refers to a 14-year-old male patient whose medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M11052) on to left arm and ADACEL (batch number: U4106BA) on to right arm on 17 Oct 2012. On an unspecified date after vaccination, he experienced headache. He also experienced swelling and redness at injection site and mild nausea. He visited emergency room. Outcome of the event was reported as condition unchanged. Seriousness and causality were not reported.
Age: 42.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Nodule, Pain, Pain in extremity, Skin warm
Clinical narrative: Case number PHHY2013US012389 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 472269) website on 08 Feb 2013. This report refers to a 42-year-old female patient. Her medical history was not reported and concomitant medications included pharmacy. She was vaccinated with MENVEO (batch number: not reported) and BOOSTRIX (other manufacturer, batch number: not reported); both vaccines administered on to left arm on 14 Oct 2012. On 15 Oct 2012, she had 'pain in left arm like a knot'. It was reported that the knot was swollen red. It was like there was 'fever on the knot' and it hurt when touched. The outcome of the events was reported as condition unchanged.
Age: 53.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Case number PHHY2013US012390 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 472276) on 08 Feb 2013: This report refers to a 53-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: unknown) along with BOOSTRIX (other manufacturer, batch number: unknown) on 14 Oct 2012. On 15 Oct 2012 he experienced soreness in shoulder, neck and arms. Final outcome was reported as condition unchanged at the time of reporting. No further information about causality and seriousness was provided.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Antinuclear antibody, Blood creatine phosphokinase, C-reactive protein, Epstein-Barr virus test, Full blood count
Clinical narrative: Case number PHHY2013US000527 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number: 473217) website on 02 JAN 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: M10057) intramuscularly in her left arm, FLUMIST (other manufacturer, batch number: 501113P) GARDASIL (other manufacturer, batch number 0476AA) intramuscularly in her left arm and ADACEL (other manufacturer, batch number U3874BA) intramuscularly in her right arm on 24 OCT 2011. On 04 NOV 2012 she went to her pediatrician with severe leg pain and muscle aches. Her lab data included C-reactive protein (CRP), creatinine kinase, sedimentation rate, rheumatoid factor, X-ray of hip and femur, Epstein-Barr virus test, complete blood count (CBC), urinalysis (UA) and antinuclear antibody test for which results were not reported. The outcome of the events was reported as recovered as of 24 OCT 2012. The seriousness and causality assessment of the events was not reported.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Myalgia, Pain in extremity, Red blood cell sedimentation rate, Rheumatoid factor, Urine analysis
Clinical narrative: Case number PHHY2013US000527 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number: 473217) website on 02 JAN 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: M10057) intramuscularly in her left arm, FLUMIST (other manufacturer, batch number: 501113P) GARDASIL (other manufacturer, batch number 0476AA) intramuscularly in her left arm and ADACEL (other manufacturer, batch number U3874BA) intramuscularly in her right arm on 24 OCT 2011. On 04 NOV 2012 she went to her pediatrician with severe leg pain and muscle aches. Her lab data included C-reactive protein (CRP), creatinine kinase, sedimentation rate, rheumatoid factor, X-ray of hip and femur, Epstein-Barr virus test, complete blood count (CBC), urinalysis (UA) and antinuclear antibody test for which results were not reported. The outcome of the events was reported as recovered as of 24 OCT 2012. The seriousness and causality assessment of the events was not reported.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: X-ray limb, X-ray of pelvis and hip
Clinical narrative: Case number PHHY2013US000527 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number: 473217) website on 02 JAN 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: M10057) intramuscularly in her left arm, FLUMIST (other manufacturer, batch number: 501113P) GARDASIL (other manufacturer, batch number 0476AA) intramuscularly in her left arm and ADACEL (other manufacturer, batch number U3874BA) intramuscularly in her right arm on 24 OCT 2011. On 04 NOV 2012 she went to her pediatrician with severe leg pain and muscle aches. Her lab data included C-reactive protein (CRP), creatinine kinase, sedimentation rate, rheumatoid factor, X-ray of hip and femur, Epstein-Barr virus test, complete blood count (CBC), urinalysis (UA) and antinuclear antibody test for which results were not reported. The outcome of the events was reported as recovered as of 24 OCT 2012. The seriousness and causality assessment of the events was not reported.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong technique in product usage process
Clinical narrative: Case number PHHY2013US012399 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 473386) on 08 Feb 2013: This report refers to a 13-year-old female patient. Her medical history and concomitant medication was not reported. She was given only the MenA powder component of Menveo vaccine, (batch number A10057) reconstituted with a sterile diluent instead of MenCYW on 20 Jul 2012. No other adverse reaction was reported. No further information about causality and seriousness was provided.
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) web site 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), intramuscularly in the right arm, HAVRIX (other manufacturer, batch number: AHAVB646BA) in the right arm intramuscularly, GARDASIL (other manufacturer, batch number H010123) intramuscularly in the left arm and VARIVAX vaccine (other manufacturer, batch number: H013638) subcutaneously 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.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Limb discomfort, Paraesthesia, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2013US011971 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 474414) on 08 Feb 2013. This case refers to a 21-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M11082) intramuscularly in his left deltoid on 15 Nov 2012. On 16 Nov 2012, he developed 4x5 inches swelling in left arm which was red and warm to touch, with discomfort (6 on scale 1-10). He also experienced tingling in his left hand. He had an emergency doctor visit due to these events. The final outcome was reported as condition unchanged. The seriousness and causality were not reported.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2013US012145, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 474595) website on 08 Feb 2013. This report refers to 11 year old male patient. His medical history and concomitant medication was not reported. He was MENVEO (batch number: AX0146) into right arm, BOOSTRIX (batch number: AC52B093DA) into left arm and FLUZONE (batch number: UH717AC) into right arm on 12 Nov 2012. On 13 Nov 2012, the patient developed right arm red, swollen and hot to touch. Outcome of the event was complete recovery. Seriousness and causality of the event was not reported.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Dizziness, Headache, Nausea, Visual impairment
Clinical narrative: Case number PHHY2013US012501 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 476296) on 08 FEB 2013. This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2012/2013 (batch number: 1206101) intramuscularly in to the left arm along with MENVEO (batch number: A11081) intramuscularly in to the right arm. ADACEL (other manufacturer, batch number: U4393BA) intramuscularly in to the right arm and VARIVAX (other manufacturer, batch number: U4393BA) intramuscularly in to the right arm and VARIVAX (other manufacturer, batch number: H016057) subcutaneously in to the left arm on 28 NOV 2012. On the same day after vaccination, he experienced weakness, was seeing spots, had headache, nausea, dizziness and was lightheaded. Finale outcome was reported as complete recovery of the patient. No further information about causality and seriousness was reported.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: C-reactive protein, Full blood count, Musculoskeletal pain, Red blood cell sedimentation rate, Tenderness
Clinical narrative: Case number PHHY2013US012478, is an initial report received from Vaccine Adverse Event Reporting System (VAERS reference number: 476392) website on 08 Feb 2013. This report refers to a 17-year-old female patient. Her medical history was not reported and concomitant medication included Amoxicillin. She was vaccinated with MENVEO vaccine (batch number: M11041), intramuscularly in the left arm on 15 Nov 2012. On the same day after vaccination, she experienced superficial shoulder pain and tenderness. The patient was visited to the emergency room or physician. She underwent complete blood count (CBC), erythrocyte sedimentation rate (ESR)and C-reactive protein (CRP) but results were not reported. The outcome of the event was reported as condition unchanged as of 05 Dec 2012. The causality and seriousness of the events was not reported.
Age: 23.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: Case number PHHY2013US012236 is an initial spontaneous report received from vaccine adverse event reporting system web site (VAERS reference number: 476739) on 08 Feb 2013. This case refers to a 23-year-old female patient. She had no allergies in the past. She was vaccinated with MENVEO (batch number: A11078) intramuscularly in her left arm on 07 Nov 2012. On 08 Nov 2012 she experienced runny nose, sneezing, sore throat and headache. She was suggested treatment with CLARITIN and TYLENOL. The final outcome was reported as condition unchanged. The seriousness and causality were not reported.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2013US012305 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 477141) on 08 Feb 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: M11066) intramuscularly in to the right arm along with HAVRIX (other manufacturer, batch number: AHAVB605CA) intramuscularly in to the left arm, BOOSTRIX (other manufacturer, batch number: AC52B085AA) intramuscularly in to the left arm and VARIVAX (other manufacturer, batch number: H013640) subcutaneously in to the right arm on 14 Nov 2012. On the same day after vaccination, both arms were sore and swollen by the time he got home. Swelling continued and his mother sought medical treatment on 16 Nov 2012 from primary doctor. He visited the emergency room (ER) following these events. It was reported that both arms were swollen and red from shoulder to elbows. He was given oral prednisone and he completely recovered on an unknown date. No further information about causality and seriousness was provided.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHHY2013US012252 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 477336) on 08 Feb 2013: This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with two doses of MENVEO on 21 Aug 2012 and 23 Oct 2012, respectively. Second dose (batch number: X11042) was administered intramuscularly in to the left arm. She was concomitantly vaccinated with BOOSTRIX (other manufacturer, batch number: U4383AA) intramuscularly in to the left arm on 23 Oct 2012. No adverse event was reported following this administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Case number PHHY2013US012258 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 477362) on 08 Feb 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: M11033) intramuscularly in to the left arm on 19 Nov 2012. On the same day after vaccination, he experienced sore arm which was slightly red. After lunch on 20 Nov 2012, the redness increased and he also experienced swelling that increased in area. He visited the emergency room (ER) following these events. Final outcome was reported as complete recovery. No further information about causality and seriousness was provided.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Case number PHHY2013US012291 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 477415) web site on 08 Feb 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: M11047), GARDASIL (batch number: H010649) and BOOSTRIX (batch number: AC52B073CA) on to left arm and HAVRIX (batch number: AHAVB646BA) on to right arm on 12 Nov 2012. On 13 Nov 2012, she experienced swelling, redness and tenderness on both arms, but was more significant on right arm. She went to emergency room. The outcome of the events was reported as condition unchanged.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2013US012301 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 477463) on 08 Feb 2013: This report refers to an 11-year-old male patient. His medical history had no ADHD and his concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12081) intramuscularly in to the left arm along with BOOSTRIX (other manufacturer, batch number: AC52B094AE) intramuscularly in to the right arm and GARDASIL (other manufacturer, batch number: 0636AE) intramuscularly in to the right arm on an unspecified date. After vaccinations, he experienced swelling, redness (8 cm on left arm and 17 cm on right arm) and warmth at both the injection sites. He also experienced mild tenderness at touch to the vaccinated sites. Final outcome was reported as complete recovery. No further information about causality and seriousness was provided.
Age: 39.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2013US012279 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 477575) website on 08 Feb 2013: This report refers to a 39-year-old female patient. Her concomitant medication include Vitamin D 5000 IU and AZURETTE. She was vaccinated with MENVEO (batch number: X11042) intramuscularly to left arm on 10 Nov 2012. On 11 Nov 2012 patient found swelling, red, hard and hot at site of injection. On 12 Nov 2012, site was same if not slightly worse. Patient was being presented to another pharmacy location and was advised to call and report the reaction. Patient was not alarmed and declined coming into show. Outcome of the events were reported as condition unchanged as of 15 Nov 2012. Seriousness and causality were not reported.
Age: 1.0
Sex: M
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Asterixis, Autism spectrum disorder, Communication disorder, Constipation, Crying
Clinical narrative: Involuntary movements: flapping of arms, stiffening and rigidity of body, fractal grimacing, screaming and crying, sick, constipation, lack of communication, went backwards in ability to do previous milestones.
Age: 1.0
Sex: M
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Dyskinesia, Grimacing, Malaise, Muscle rigidity, Musculoskeletal stiffness
Clinical narrative: Involuntary movements: flapping of arms, stiffening and rigidity of body, fractal grimacing, screaming and crying, sick, constipation, lack of communication, went backwards in ability to do previous milestones.
Age: 1.0
Sex: M
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Screaming
Clinical narrative: Involuntary movements: flapping of arms, stiffening and rigidity of body, fractal grimacing, screaming and crying, sick, constipation, lack of communication, went backwards in ability to do previous milestones.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: 10/2/5 Received flu shot. 10/16/15 Legs and hand went completely numb. 10/21/15 - 10/23/15 Hosp. 10/23/15 - started getting some feeling in legs. 1/13/16 - got about 1/2 feeling in legs and hand. 3/14/16 - Saw neurologist. Guillain-Barre.
Age: 27.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Induration, Pain, Pruritus
Clinical narrative: VARIVAX vaccine administered 6/8/16. 6/10/16 area redness, swelling evident Solumedrol 125mg IM given.
Age: 27.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: VARIVAX vaccine administered 6/8/16. 6/10/16 area redness, swelling evident Solumedrol 125mg IM given.
Age: 20.0
Sex: M
Vaccine: RUB
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: Patient stated it started with a small, red cluster on the right upper arm and then proceeded to spread to left arm. Rash like appearance on bilateral arms.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Rash pruritic
Clinical narrative: The patient stated with a rash a week later after reciving the small pox vaccine on the 3rd of June 2016. Clobetasol and Atarax were prescribed by PCM. Pruritic rash continued to spread on the patients arms and legs. The PCM prescribed Prednisone and a follow up within 48 hours.
Age: 16.0
Sex: M
Vaccine: HPVX
Symptoms: Dyskinesia, Electroencephalogram normal, Facial paralysis, Hemiparesis, Hypersomnia
Clinical narrative: This literature marketed report has been received from the authors of a published article concerning a 16 year old male patient. The patient's concurrent condition included sleep apnoea. On an unknown date, the patient was vaccinated with a second dose of HPV (manufacturer unknown) or HPV 9 (manufacturer unknown) (dose, route, lot# and expiration date were not reported). Concomitant therapy was not reported. The patient presented to the sleep clinic for evaluation of hypersomnia. This was sudden in onset and started on an unknown date after he received the second dose of the HPV (manufacturer unknown) or HPV 9 (manufacturer unknown). He had an excessive day time sleepiness with an Epworth score of 24. He had multiple sleep attacks during the day, naps were slightly refreshing and he was sleeping more than 15 hours in a 24-hour period. He had no hallucinations or rapid eye movements (REM) behavior disorders. He did have one episode of sleep paralysis. He also developed abnormal right-sided limb movements followed by weakness. These were also associated with facial drooping on the same side. These episodes were triggered by emotions such as excitement or anger and lasted about 10-15 seconds and at times occurred in clusters. He underwent a brain nuclear magnetic resonance imaging (MRI) and electroencephalogram (EEG), which were both negative for any pathology. These episodes could represent an atypical presentation of cataplexy. He underwent an in-lab sleep study followed by an Multiple Sleep Latency Test (MSLT). The sleep study ruled out sleep apnea as a cause of hypersomnia. The MSLT was consistent with a diagnosis of narcolepsy with a mean sleep latency of 0.6 seconds and five out of five naps with sleep -onset REM periods. The outcome of narcolepsy was unknown. The authors considered narcolepsy to be related to the HPV vaccination. Upon internal review, the event of narcolepsy was considered to be medically significant. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPVX
Symptoms: Narcolepsy, Nuclear magnetic resonance imaging brain normal, Sleep attacks, Sleep paralysis, Sleep study
Clinical narrative: This literature marketed report has been received from the authors of a published article concerning a 16 year old male patient. The patient's concurrent condition included sleep apnoea. On an unknown date, the patient was vaccinated with a second dose of HPV (manufacturer unknown) or HPV 9 (manufacturer unknown) (dose, route, lot# and expiration date were not reported). Concomitant therapy was not reported. The patient presented to the sleep clinic for evaluation of hypersomnia. This was sudden in onset and started on an unknown date after he received the second dose of the HPV (manufacturer unknown) or HPV 9 (manufacturer unknown). He had an excessive day time sleepiness with an Epworth score of 24. He had multiple sleep attacks during the day, naps were slightly refreshing and he was sleeping more than 15 hours in a 24-hour period. He had no hallucinations or rapid eye movements (REM) behavior disorders. He did have one episode of sleep paralysis. He also developed abnormal right-sided limb movements followed by weakness. These were also associated with facial drooping on the same side. These episodes were triggered by emotions such as excitement or anger and lasted about 10-15 seconds and at times occurred in clusters. He underwent a brain nuclear magnetic resonance imaging (MRI) and electroencephalogram (EEG), which were both negative for any pathology. These episodes could represent an atypical presentation of cataplexy. He underwent an in-lab sleep study followed by an Multiple Sleep Latency Test (MSLT). The sleep study ruled out sleep apnea as a cause of hypersomnia. The MSLT was consistent with a diagnosis of narcolepsy with a mean sleep latency of 0.6 seconds and five out of five naps with sleep -onset REM periods. The outcome of narcolepsy was unknown. The authors considered narcolepsy to be related to the HPV vaccination. Upon internal review, the event of narcolepsy was considered to be medically significant. Additional information has been requested.