chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: FLU3, HEPA, IPV, MNQ, TDAP, TYP, YF
Symptoms: Urticaria
Clinical narrative: Case number PHHY2013US069354 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 488660) website on 03 Jul 2013. This report refers to 23-year-old male patient. His medical history and concomitant medication were not reported. On 20 Mar 2013, he was vaccinated with FLUZONE (other manufacturer, batch number: UH718AB) subcutaneously left arm, HAVRIX (other manufacturer, batch number: AHAVB597AA) intramuscularly into right arm, IPOL (other manufacturer, batch number: H145) subcutaneously into right arm, MENVEO (batch number: unknown) intramuscularly into right arm, BOOSTRIX (other manufacturer, batch number: AC52B103BA) into left arm, TYPHIM II (other manufacturer, batch number: G1542) and YF-VAX (other manufacturer, batch number: UH3597AA) into left arm. On 27 Mar 2013, a week after, he broke out into hives on his arms, chest, and neck. He did not consult the physician but received BENADRYL. His hives were healing but he was advised to contact primary care physician immediately. The final outcome of the event was reported as not recovered as of 05 Apr 2013. The seriousness and outcome of the event were not reported.
Age: 44.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Injection site erythema, Injection site urticaria, Pyrexia, Urticaria
Clinical narrative: Case number PHHY2013US116751 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 488679) website on 15 Oct 2013. This report refers to a 44-year-old female patient. Her medical history included allergic to Penicillin and Vanco, and she was vaccinated with meningococcal vaccine (manufacturer and batch number unknown hence conservatively coded as MENVEO INN) and yellow fever (manufacturer and batch number unknown), both vaccines were given into right arm on 06 Apr 2013. On the same day, after vaccination, she had swollen and red half dollar size welts on deltoid of right arm. She also had welts in back of right arm. She went to emergency room due to these events. Outcome of the events was reported as not recovered as of 08 Apr 2013. No seriousness and causality was reported for the events.
Age: 28.0
Sex: F
Vaccine: HEPAB, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Case number PHHY2013US069355, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 488767) website on 03 JUL 2013. This report refers to a 28-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M11053), intramuscularly in the left arm and ADACEL (other manufacturer, batch number: U4567AA) intramuscularly in the left arm on 26 MAR 2013 respectively. Concomitantly, she was also vaccinated with TWINRIX (other manufacturer, batch number: AHABB231BA) intramuscularly in the right arm on 26 MAR 2013. On 01 APR 2013, she experienced injection site redness, induration and itching to left arm. The event outcome was reported as completely recovered as of 03 APR 2013. The seriousness and causality of the events was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2013US069362, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 489083) website on 03 JUL 2013. This report refers to an 11-year-old-female patient. Her current illness included abdominal pain and ovarian cyst and concomitant medication included Lortab and Zofran. She was vaccinated with MENVEO (batch number 11072), intramuscularly in the right arm and ADACEL (other manufacturer, batch number: U4567AA) intramuscularly in the right arm on 02 APR 2013 respectively. On 04 APR 2013, she experienced right upper arm red and warm to touch with pain. She was consulted to emergency room or doctor. The event outcome was reported as completely recovered as of 04 APR 2014. The seriousness and causality of the events was not reported.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Case number PHHY2013US069423 is an initial report from the Vaccine Adverse Event Reporting System (VAERS reference number: 489496) website on 03 JUL 2013. This report refers to a 10-year-old male patient. He was vaccinated with MENVEO (batch number: A11082) in the right arm and BOOSTRIX (batch number: AC52B074AA, other manufacturer) in the left arm, both via intramuscular route on 16 APR 2013. On 17 APR 2013, he presented with local adverse reaction at the site of immunization, reported as area was hot, with erythema, pain, itching and induration 9.0 cm x 9.0 cm on the right deltoid. He felt sleepy. Ice applied to the patient. It was reported that he have verbalized relief. The final outcome was reported as recovered. The seriousness and causality of the events were not reported.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Local reaction, Somnolence
Clinical narrative: Case number PHHY2013US069423 is an initial report from the Vaccine Adverse Event Reporting System (VAERS reference number: 489496) website on 03 JUL 2013. This report refers to a 10-year-old male patient. He was vaccinated with MENVEO (batch number: A11082) in the right arm and BOOSTRIX (batch number: AC52B074AA, other manufacturer) in the left arm, both via intramuscular route on 16 APR 2013. On 17 APR 2013, he presented with local adverse reaction at the site of immunization, reported as area was hot, with erythema, pain, itching and induration 9.0 cm x 9.0 cm on the right deltoid. He felt sleepy. Ice applied to the patient. It was reported that he have verbalized relief. The final outcome was reported as recovered. The seriousness and causality of the events were not reported.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Macule, Pruritus, Rash generalised
Clinical narrative: Case number PHHY2013US069442 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 489575) website on 03 JUL 2013. This report refers to a 22-year-old male patient. He had no known drug allergies and vaccination history included meningitis vaccine in 2008 without any adverse reaction. It was reported that he was not on any batch number: X12027) via intramuscular route in the left arm on 16 APR 2013. On 17 APR 2013, he developed itching and later that day he noticed a rash on hip flexors, under arms and then above ankles. It was reported that later rash spread to chest and thighs. On examination, the patient had pruritic macules on chest, back, and inner thighs. The event rash has improved after treatment with BENADRYL and oatmeal bath. The final outcome of the events was reported as completely recovered on an unspecified date. The seriousness and causality of the events were not reported.
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Case number PHHY2013US069283, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 489697) website on 03 JUL 2013. This report refers to an 11-year-old male patient. His medical history included asthma and allergic rhinitis. Concomitant medication included Allegra, Nasonex, and Ventolin. He was vaccinated with MENVEO (batch number: M12024), in the left arm on 15 APR 2013. On 16 APR 2013, he experienced redness and pain at site. The event outcome was reported as completely recovered. The seriousness and causality of the events was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Case number PHHY2013US069502, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 490253) website on 03 JUL 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M12011), in the right arm on 24 APR 2013. Concomitantly, he was also vaccinated with BOOSTRIX (other manufacturer, batch number: AC52B100AA) in the left arm on 24 APR 2013. On the same day after vaccination, he experienced erythematous and warm area (R) deltoid measuring 8x10 cm. The event outcome was reported as completely recovered as of 26 APR 2013. The seriousness and causality of the events was not reported.
Age: 50.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Case number PHHY2013US069503 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 490256) on 03 JUL 2013. This report refers to a 50-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number A11046) in the left arm on 23 APR 2013. On the same date, eight hours after vaccination, he experienced chills, headache, and pyrexia. The outcome of the event was reported as complete recovery.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Case number PHHY2013US083987 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 490752) website on 06 AUG 2013. This report refers to a 13-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: X12024) intramuscularly into left arm on 26 APR 2013. On 28 APR 2013, he experienced large local reaction at the injection site which described as swelling (from shoulder to elbow) and warmth. The outcome of the events was reported  as recovered. No seriousness and causality of the events were reported.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Peripheral swelling, Urticaria, Varicella virus test
Clinical narrative: Case number PHHY2013US084167, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 490939) website on 06 AUG 2013. This report refers to a 17-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number M12027) in the left arm and VARIVAX (batch number H018454, other manufacturer) in the right arm on 13 APR 2013. On 26 APR 2013, she woke up with hives all over body and her right arm was swollen and red. She applied ice at the vaccination site and visited emergency room. She underwent varicella virus test (results were not reported). The outcome of the events was reported as condition unchanged as of 29 APR 2013. The causality and seriousness of the events were not reported.
Age: 27.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Injection site warmth, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Case number PHHY2013US084161, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 491051) website on 06 AUG 2013. This report refers to 27-year-old male patient. He was vaccinated with MENVEO (batch number: A12029) in the right arm and ENERGIX-B (batch number AHBVC064CA) in the left arm, both via intramuscular route on 30 APR 2013. On 05 MAR 2013, he presented with swelling and pain in right arm. It was reported that the area of the injection was warm to touch. He noticed that his arm was hurting after someone else  touched the area. There was no pain or swelling in left arm. The outcome of the events reported as condition unchanged as of 06 MAY 2013. The causality and seriousness of the events were not reported.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Immediate post-injection reaction, Pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2013US117465 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number 491052) on 15 OCT 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with meningococcal vaccine (manufacturer and batch number not reported, hence conservatively taken as MENVEO INN and diphtheria tetanus acellular pertussis vaccine (other manufacturer, batch number: not reported) on 28 MAR 2013. On the same date, immediately after injection to upper arm, he complained of pain with movement. His vaccination site had severe swelling and was very warm to touch. The outcome was reported as complete recovery.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: Case number PHHY2013US084092, is an initial spontaneous report received from the consumer (patient's mother) via Vaccine Adverse Event Reporting System (reference number: 491104) website on 06 AUG 2013. This report refers to 11-year-old male patient. He was vaccinated with MENVEO (batch number: A11078) in the right arm on 16 APR 2013. On the same date after vaccination, the site of vaccination was red and hot. On the next night (date unspecified), he had a raised rash that just extended to about elbow at the vaccination site. The patient visited the emergency room. His mother gave BENADRYL as a treatment. The outcome of the events reported as recovered. No other information was available.
Age: 15.0
Sex: F
Vaccine: DTAP, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: Case number PHHY2013US084072, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 491130) website on 06 Aug 2013. This report refers to a 15-year-old female patient. Her medical history was not reported. No concomitant medications. She was vaccinated with MENVEO, (batch number: not reported), VARIVAX, (batch number: 0410AA), BOOSTRIX, (batch number: not reported) and DTAP, (batch number: not reported) on 12 Sep 2011. On the same date, her urine pregnancy test was performed and results showed that her human chorionic gonadotropin was positive and she was pregnant (5 weeks of gestation). Her last menstrual date was on 03 Aug 2011 and her estimated delivery date was on 09 May 2012. The patient did not seek medical attention and at the time of the report, no adverse effects were seen. The nurse stated that the health department had no information regarding the patient or her pregnancy outcome at the time of the report. Follow up information received on 06 Aug 2013: This case is lost to follow up because the reporter was anonymous.
Age: 1.0
Sex: M
Vaccine: MMR, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth, Pyrexia
Clinical narrative: Case number PHHY2013US116822 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 491401) website on 15 OCT 2013. This report refers to a 01-year-old male patient.  His medical history was not reported. His historical treatment included lidocaine ointment (numbing cream) prior to vaccinations. He was vaccinated with meningococcal vaccine (manufacturer and batch number unknown, hence conservatively coded as MENVEO INN) into leg on 07 MAY 2013. On the same day, he also received MMR (manufacturer and batch number unknown) and varicella vaccine (manufacturer and batch number unknown) into leg. On 07 MAY 2013, after vaccinations, he experienced hot, hard red lump at the injection site. He also had low fever and received Tylenol. Outcome of the events was reported as not recovered as of 10 MAY 2013. No seriousness and causality was reported.
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Case number PHHY2013US083969 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 491447) website on 06 AUG 2013. This report refers to an 11-year-old male patient. His medical history included allergic rhinitis and current condition included vomiting. His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A11076) and BOOSTRIX (other manufacturer, batch number: AC52B093BA) both vaccines administered intramuscularly in to the left arm and GARDASIL (other manufacturer, batch number: H014645) intramuscularly in the right arm on 08 MAY 2013, he experienced swelling , pain and redness over left deltoid which was the inoculation site. He also had an episode of tactile fever that resolved. It was reported that urticaria developed on left leg and arm lasting one night that resolved without medications. He continued to have dermal oedema on left deltoid. He went to emergency room. The final outcome was reported as condition unchanged.
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Case number PHHY2013US083969 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 491447) website on 06 AUG 2013. This report refers to an 11-year-old male patient. His medical history included allergic rhinitis and current condition included vomiting. His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A11076) and BOOSTRIX (other manufacturer, batch number: AC52B093BA) both vaccines administered intramuscularly in to the left arm and GARDASIL (other manufacturer, batch number: H014645) intramuscularly in the right arm on 08 MAY 2013, he experienced swelling , pain and redness over left deltoid which was the inoculation site. He also had an episode of tactile fever that resolved. It was reported that urticaria developed on left leg and arm lasting one night that resolved without medications. He continued to have dermal oedema on left deltoid. He went to emergency room. The final outcome was reported as condition unchanged.
Age: 23.0
Sex: F
Vaccine: MNQ, TDAP, TYP, YF
Symptoms: Urticaria
Clinical narrative: Case number PHHY2013US084007 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 491984 web site on 06 AUG 2013. This report refers to a 23-year-old female patient. Her medical history was not reported and concomitant medications included Imitrex and Loestrin Fe. She was vaccinated with MENVEO (batch number: M12006) intramuscularly in to left arm. ADACEL (other manufacturer,  batch number: C4365AA) intradermally in the left arm and VIVOTIF (other manufacturer, batch number: 3000283) via oral route on 10 MAY 2013. She also received YF-VAX (other manufacturer, batch number: 3000283) via oral  route on 10 MAY 2013, she had three patches of hives for which  she self-medicated with Benadryl. On the second day she had two patches of hives and on the third day one patch for which she again self-medicated with Benadryl. The outcome of the event was reported as complete  recovery.
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Case number PHHY2013US117471 is an initial spontaneous report received from a physician via Vaccine Adverse Event Reporting System (VAERS reference number: 492353) on 15 OCT 2013. This report refers to an 11-year or 12 -year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported), hence conservatively taken as MENVEO INN), GARDASIL (other manufacturer, batch number: not re ported) in the upper deltoid of arm and diphtheria tetanus acellular pertussis vaccine (other manufacturer, batch number not reported) on an unknown date. On an unspecified date, after receiving GARDASIL she fell faint and dizzy. The outcome of the event was reported as complete recovery.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2013US084189 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 492629) website on 06 Aug 2013. This report refers to a 12-year-old female patient. her concomitant condition included mild concussion after bus accident. Her concomitant medication included MOTRIN and TYLENOL. She was vaccinated with MENVEO, batch number: M11072 intramuscularly into left arm (deltoid), BOOSTRIX (batch number: AC54B079BA) intramuscularly into left arm and VARIVAX (batch number: H018014) on 20 May 2013. On 22 may 2013, she presented to the emergency room with pain, redness and swelling in the left deltoid. The outcome of the events was reported as recovered. No seriousness and causality were reported.
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2013US084192 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 492792) website on 06 AUG 2013. This report refers to a 16-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12093) intramuscular in to the right arm along with VARIVAX (varicella vaccine, other manufacturer, batch number: H011962) subcutaneously into the left arm on 28 MAY 2013. On 30 MAY 2013, he presented with red and swollen area the size of baseball at the injection site. Final outcome of the events was reported as complete recovery on an undetermined date. No further information about causality and seriousness was reported.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Rash erythematous, Skin warm
Clinical narrative: Case number PHHY2013US084020, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 493020) website on 06 Aug 2013. This report refers to 16-year-old male patient. His preexisting condition included varicella which was medically confirmed. He was vaccinated with MENVEO (batch number: M12004) in the right arm and GARDASIL (batch number: H021346) in the left arm in 23 May 2013. On 24 may 2013, he experienced large, red area on upper right arm, which was in a size of one and half softball. It was reported the area was edematous and raised. he also had red rash on torso and his right arm was warm to touch. he took ibuprofen and BENADRYL as treatment drugs. The event redness was almost gone by 26 may 2013 in the morning. The outcome of the events was reported as completely recovered on an unspecified date. The causality and seriousness of the events were not reported.
Age: 24.0
Sex: M
Vaccine: MNQ
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2013US097195, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 493108) website on 05 SEP 2013. This report refers to a 24-year-old male patient. The patient did not mention about his medical history. He was vaccinated with MENVEO (batch number: M12009) via intramuscular route in the left arm on 11 APR 2013. On 14 MAY 2013, one month after vaccination he experienced pain in his hand. He was advised to take Tylenol  as a treatment. He had no other systems and was advised to visit the doctor, but the patient refused. The outcome of the event reported as not recovered. The seriousness and causality of the event were not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Case number PHHY2013US097156 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 493828) website on 05 SEP 2013. This report refers to an 11-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12114) intramuscularly in the right arm and ADACEL (other manufacturer, batch number: C4328AA) in the left arm on an unknown date. On an unspecified date, her right upper arm was 4 1/2 x 3 x 1/4 inches firm red area which was warm. The outcome was reported as complete recovery. The seriousness and causality of the events was not assessed.
Age: 12.0
Sex: F
Vaccine: HPV2, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Case number PHHY2013US083962, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS Ref: 493883) web site on 06 Aug 2013: The report refers to 12-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: A12013) IM into right arm, ADCEL (batch number: C4034AA) IM into left arm and CERVARIX (batch number: AHPVA174BJ) ID into right arm on 29 May 2013. On the same day she experienced dizziness. Outcome of the event was complete recovery. Seriousness and causality assessment was not reported.
Sex: F
Vaccine: HPV2, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Case number PHHY2013US083964, is an initial spontaneous report received from a  health care professional via Vaccine Adverse Event Reporting System (VAERS Ref: 493885) website on 06 AUG 2013: This report refers to 12-year-old female patient. Her medical history and concomitant medication was not reported. She as vaccinated with MENVEO (batch number X12013) IM into right arm. ADACEL (batch number: C4034AA) IM into right arm and CERVARIX (batch number AHPVA174BJ) IM into right arm on 11 JUN 2013. On the same day she experienced dizziness. Event was treated with ammonia. Outcome of the event was complete recovery. Seriousness and causality assessment was not reported.
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2013US097168 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number 494225) website on 05 SEP 2013. This report refers to an 11-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12027) and GARDASIL (other manufacturer, batch number: H017698), both vaccines administered intramuscularly in the right arm and ADACEL (other manufacturer,batch   number: U4421AA) intramuscular in the left arm on 12 JUN 2013. ON 13 JUN 2013, she had redness, swelling, pain and  warmth in right upper arm deltoid. She saw primary care provider. The outcome was reported as complete recovery. The seriousness and causality of the events was not assessed.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Case number PHHY2013US097174 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 494316) on 05 SEP 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 numberA12028) intramuscularly in to the right arm along with BOOSTRIX (other manufacturer, batch number: AC52B100BA) intramuscularly in to the left arm on 11 JUN 2013. On 12 JUN 2013, he experienced 2 x 3 inches warm, indurated area at the left deltoid and 6 x 7 inches red, warm, indurated area at the right upper arm. Following these events he had to visit the emergency room (ER). He was recommended to recheck if  he had fever, increased pain or decreased use of arm. It was advised that the condition should improve without treatment over the following 2-4 days. Final outcome of the event was reported as complete recovery of the patient on an undetermined date. No additional information about causality and seriousness was reported.
Sex: F
Vaccine: HPV2, MNQ
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Case number PHHY2013US097182 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 494442) website on 05 SEP 2013. This report refers to a 13-years-old female patient. Her medical history included attention deficit hyperactivity disorder (ADHD) and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12027) in the right arm and CERVARIX (other manufacturer, batch number: AHPVAS174BJ) in the left arm on 17  JUN 2013. On the same date, she had severe headaches, dizziness and nausea which occurred 2 hours after the shot. She was administered baby aspirin at home around 6:00 PM. The outcome was reported as complete recovery. The seriousness and causality of the events was not assessed.
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Local reaction, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Case number PHHY2013US097210 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 494516) on 05 SEP 2013. This report refers to a 10-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12115) in to the right arm along with BOOSTRIX (other manufacturer, batch number: 35559) in to the left arm on 10 JUN 2013. On 11 JUN 2013, he experienced local reaction with swelling and erythema of entire upper arm where vaccine was administered. Final outcome of the event was reported as complete recovery of the patient on an undetermined date. No additional information about causality and seriousness was reported.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Case number PHHY2013US097384 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 494801) on 05 Sep 2013: This report refers to a 10-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12115) in to the right arm along with BOOSTRIX (other manufacturer, batch number: 35559) in to the right arm on 14 Jun 2013. On 16 Jun 2013, she experienced severe local reaction that was described as severe swelling and erythema. Final outcome of the event was reported as complete recovery of the patient on an undetermined date. No additional information about causality and seriousness was reported.
Sex: M
Vaccine: HEP, HEPA, HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Case number PHHY2014US013391 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 494884) website on 03 FEB 2014. This report refers to a 14-year-old male patient. His medical history included Amoxicillin allergy. His concomitant medication was not reported. He was vaccinated with MENVEO (batch number: X12123) in to the left arm along with ENGERIX B (other manufacturer, batch number: AHBVC253AA) in to the left arm, with HAVRIX  (other manufacturer, batch number: AHAVB690CA) in to the right arm and with GARDASIL (other manufacturer, batch number: J003727) in to the right arm on 19 JUN 2013. ON 20 JUN 2013, swelling to upper left arm was noticed by patient. He was brought to the pharmacy and his mother saw the reaction first at 48 hours. The site was red. His left upper arm with two puncture site of vaccines in deltoid had irregular splotchy, red, firm, rash inferior to sites and posteriorly the red rash had spread from finger to elbow. Margins were marked and Keflex was recommend only if the reaction got worse. BENADRYL 50 mg and cool compresses were applied as treatment measures. Final outcome of the events was reported as condition unchanged as on 21 JUN 2013. No further information about seriousness and causality was reported,
Sex: M
Vaccine: HEP, HEPA, HPV4, MNQ
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Case number PHHY2014US013391 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 494884) website on 03 FEB 2014. This report refers to a 14-year-old male patient. His medical history included Amoxicillin allergy. His concomitant medication was not reported. He was vaccinated with MENVEO (batch number: X12123) in to the left arm along with ENGERIX B (other manufacturer, batch number: AHBVC253AA) in to the left arm, with HAVRIX  (other manufacturer, batch number: AHAVB690CA) in to the right arm and with GARDASIL (other manufacturer, batch number: J003727) in to the right arm on 19 JUN 2013. ON 20 JUN 2013, swelling to upper left arm was noticed by patient. He was brought to the pharmacy and his mother saw the reaction first at 48 hours. The site was red. His left upper arm with two puncture site of vaccines in deltoid had irregular splotchy, red, firm, rash inferior to sites and posteriorly the red rash had spread from finger to elbow. Margins were marked and Keflex was recommend only if the reaction got worse. BENADRYL 50 mg and cool compresses were applied as treatment measures. Final outcome of the events was reported as condition unchanged as on 21 JUN 2013. No further information about seriousness and causality was reported,
Age: 47.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2013US097425, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 494888) website on 05 Sep 2013. This report refers to a 47-year-old male patient. He was vaccinated with MENVEO batch number: X110771) via intramuscular route in the left arm on 19 Jun 2013. On 20 Jun 2013, 24 hours after vaccination the patient developed red raised erythematous patch on arm inferior to injection site/at area of injection. He had no fever or pain, but his left arm had a patch of raised skin. His primary MD instructed the patient to seek further medical attention, if the area becomes more swollen or his temperature raised. The outcome of the events reported as not recovered. The seriousness and causality of the events were not reported.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Case number PHHY2013US097322, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 495126) website on 05 Sep 2013. This report refers to 10-year-old female patient. Her medical history was not reported. Concomitant drugs included SINGULAIR, ZYRTEC, FLONASE and Albuterol. She was vaccinated with MENVEO (batch number: A12027) in the left arm on 07 Jun 2013. On the same date, she received BOOSTRIX (batch number: AC52B094EA) in the right arm and VARIVAX (batch number: H018784) in the left arm. On 08 Jun 2013, she developed "a golf ball size knot, redness and warm to touch in the left arm at injection site". The outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Case number PHHY2013US110858 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 495266) website on 04 Oct 2013. This report refers to an 11-year-old female patient. She was vaccinated with MENVEO (batch number: A12002) into right arm and ADACEL (batch number: C4137AA) into left arm on 15 Jun 2013. On 26 Jun 2013, she had a swollen hot itchy right arm which was erythematous (measuring 6 1/2 inches wide to the left and to the right, 10 1/2 inches circumference and 7 inches long down and up). Outcome of the events was reported as recovered. No causality and seriousness of the events were reported.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Case number PHHY2013US111738 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 495268) website on 04 Oct 2013. This report refers to a 17-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M12096) intramuscularly into arm (unspecified) and VARIVAX (other manufacturer, batch number: H019520) subcutaneously into arm (unspecified) on 24 Jun 2013. On 25 Jun 2013, the injection arm was painful, swelling and warm. She went to emergency room on 26 Jun 2013 with painful, red, swelling, and warm arm (injected arm) about 3.5 inches wide and 2.5 inches long. She had no fever. She was prescribed with prednisone and amoxicillin and she was asked to receive this medication if she develop fever. Outcome of the events was reported as recovered. No seriousness and causality of the events was reported.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Skin warm
Clinical narrative: Case number PHHY2013US097642 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 495297) website on 05 SEP 2013. This report refers to a 10-years old female patient. Her medical history included allergy to an unspecified antibiotic and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12094) and GARDASIL (other manufacturer, batch number: 0636AA) both vaccines administered intramuscularly in the right arm on 25 JUN 2013, her right arm was very hot to touch with a red area around where the injection was given. Her parents reported that it grew about 1/2 more in diameter on an unknown date. IT was about the size of a baseball and was very hot and had a hard spot in middle which measured about 100mm x 80 mm. She stated that the event was not painful and did not hurt her. She had applied cold gel pack and warm compresses. The outcome was reported as condition unchanged. The seriousness and causality of the events was not assessed.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2013US110873 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 495426) website on 04 Oct 2013. This report refers to an 11-year-old female patient. She was vaccinated with MENVEO (batch number: A11077) into left arm on 20 Jun 2013. On 21 Jun 2013, she experienced erythema and induration at injection site approximately seven centimeters in circumference. She also had warmth, tenderness and anesthesia in the injected area, which was improved after 48 hours after receiving BENADRYL. She visited emergency room for these events. Outcome of the events was reported as recovered. No causality and seriousness of the events were reported.
Age: 10.0
Sex: U
Vaccine: MNQ
Symptoms: Peripheral swelling, Skin induration, Skin warm
Clinical narrative: Case number PHHY2013US110874 is an initial spontaneous report received the Vaccine Adverse Event Reporting System (VAERS reference number: 495433) website on 04 Oct 2013. This report refers to a 10-year-old male patient. His medical history included allergic to ibuprofen. He was vaccinated with MENVEO (batch number: A12011) into left arm on 03 Jun 2013. On 05 Jun 2013, his arm was swollen, hard and hot. He visited the emergency room due to these events. Outcome of the events was reported as recovered. No causality and seriousness of the events were reported.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Case number PHHY2013US110875 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 495546) website on 04 Oct 2013: This report refers to a 12-year-old male patient. His medical history included Reactive attachment disorder (RAD), allergic rhinitis and eczema. He was vaccinated with MENVEO (batch number: M12120) intramuscularly into left arm on 20 Jun 2013. On the same day, after vaccination, he had painful left deltoid which was treated with ice and MOTRIN orally. On 22 Jun 2013, he had left deltoid swelling from elbow to shoulder. His left deltoid was slight red and itchy. He was taken to urgent care and described this reaction as a local vaccine reaction. He was prescribed with prednisone for five day and NAPROSYN. He was completely recovered on 26 Jun 2013. No causality and seriousness of the events were reported.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Headache, Injection site pain, Injection site swelling, Pain
Clinical narrative: Case number PHEH213US015651 is an initial spontaneous report received from a nurse on 18 Jul 2013, and with a follow up report received from a nurse on 24 Jul 2013 with a follow up information received from vaccine adverse event reporting system (VAERS ID: 495700) on 05 Sep 2013: This report refers to a 17-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12124) at 0.5 ml intramuscularly in the left arm on 28 Jun 2013. On the same day after vaccination, she experienced swelling and soreness at the injection site, headache, body ache and low grade temperature. The outcome of the event was reported as complete recovery. The seriousness and causality was reported. Follow up report received from nurse on 24 Jul 2013: Updated batch number. Follow up information received from vaccine adverse event reporting system on 05 Sep 2013: Site of vaccination and events outcome updated.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2013US097655 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 495882) web site on 05 Sep 2013. This report refers to an 11-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12125) intramuscularly in the right arm on 01 Jul 2013. On the same date, he had swelling and redness of the forearm where vaccine was adminsitered. He was seen by physician on 03 Jul 2013 as swelling was increasing. He was treated with MOTRIN and was given was compresses and antibiotics as precaution. The outcome was reported as condition unchanged. The seriousness and causality of the events was not assessed.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: Case number PHHY2013US110760 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 495915) website on 04 OCT 2013. This report refers to a 16-year-old female patient. Medical history included seasonal and environmental allergies. Concomitant drug included  Allegra. The patient was vaccinated with MENVEO (batch number: 12114) in the right arm on 01 JUL 2013. On 02 JUL 2013, 24 hours after vaccination she experienced swelling in her         right arm. The outcome of the event reported as not recovered. The seriousness and causality of the event were not reported.
Age: 9.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Case number PHHy2013US110789 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496063) website on 04 Oct 2013. This report refers to a 09-year-old male patient. His medical history included asthma, peanut allergy and allergic rhinitis. Concomitant drugs included EPIPEN and Albuterol HFA. The patient was vaccinated with MENVEO (batch number: M12027) intramuscularly in the left arm on 01 Jul 2013. On 03 Jul 2013, his left deltoid became erythematous, warm and was mildly edematous. The outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site induration
Clinical narrative: Case number PHHY2013US110801 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 496099) website on 04 OCT 2013. This report refers to 17-years-old female patient . Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number X12024) intramuscularly in the left arm on 01 JUL 2013. On 02 JUL 2013, she developed 5x5 cm of induration in her left deltoid. The outcome of the event was reported as condition unchanged. The causality and seriousness of the event were not reported.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2013US117200 is an initial report received via vaccine adverse event reporting system (VAERS reference number: 496145) on 15 Oct 2013. This report refers to a 18-year-old female patient. Her medical history was not reported and concomitant medications included birth control pills (BCP). She was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported hence conservatively taken as MENVEO INN) intramuscular in the left arm on 05 Jul 2013. On 06 Jul 2013, she experienced swelling, redness and soreness at the site of vaccination. The outcome of the events was reported as complete recovery.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2013US110805 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496267) website on 04 Oct 2013. This report refers to 12-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A12094) and ADACEL (batch number: U4170AA), both intramuscularly in the right arm on 08 Jul 2013. On the same date after vaccination, she developed 85 x 90 mm of swelling and redness at right deltoid which was hot to touch. The outcome of the events reported as recovered. The causality and seriousness of the events were not reported.
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2013US110817 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 496776) website on 04 OCT 2013. This report refers to 21-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A12097) intramuscularly in the right arm on 12 JUL 2013. On 15 JUL 2013, she developed swelling and redness in the injection area, her arm was hurting all the way to wrist and she felt warm at her injection area. The outcome of the events was reported as condition unchanged. The causality and seriousness of the events were not reported.