chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Crying, Injection site pain, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2014US071824 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525457) website on 09 Jun 2014. This report refers to a 15-year-old male patient. He was handicapped and could not speak. His medical history included asthma, cerebral palsy, G-tube dependence, microcephaly, constipation, developmental delay, encephalopathy, gastroesophageal reflux, closed hip dislocation, viral meningitis, Methicillin resistant Staphylococcus aureus infection, osteopenia, otitis media, pneumonia, seizures, closed tibial fracture and toxic shock syndrome. His current conditions included cough, congestion and moaning. His concomitant medication were antibiotics, albuterol sulfate, amoxicillin-potassium clavulanate, baclofen, ergocalciferol, fluticasone nasal spray, MIRALAX, Multivitamin with fluoride, NYSTOP, PHENERGAN-Codeine, SANTYL, SUDAFED, TOPAMAX and valproic acid. He was vaccinated with MENVEO (batch number: A13014), BOOSTRIX (other manufacturer, batch number: 42B4N) and VARIVAX (other manufacturer, batch number: J007951), all vaccines administered in the right arm on 28 Feb 2014. On an unknown date after vaccination, his vaccination site was raised, red and warm to touch. He also had pain in the site and was crying constantly due to the pain. He had oral intake of liquids. He went to emergency room for evaluation. There were no other symptoms. He denied vomiting, fever and diarrhea. The event outcome was reported as unknown. The events were reported as non-serious and the causality was not reported.
Age: 12.0
Sex: M
Vaccine: MNQ, TYP
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Case number PHHY2014US070947 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525502) web site on 09 Jun 2014. This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: V13051) intramuscularly in the right arm on 05 Mar 2014. He also concomitantly received VIVOTIF (other manufacturer, batch number: 3000691) via oral route on the same day. It was reported that on 07 May 2014, she had large, red swollen area of 15 cm x 11 cm at the site of vaccination. The event outcome was reported as complete recovery. The event was reported as non-serious and the causality was not reported.
Age: 36.0
Sex: M
Vaccine: FLU3, HEP, MMR, MNQ, TDAP, TYP
Symptoms: Rash erythematous
Clinical narrative: Case number PHHY2014US055203 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 525620) website on 06 May 2014. This report refers to 36 year old male patient. His medical history lactose intolerance. He was vaccinated with MENVEO (batch number: M13051) intramuscular (IM) into left arm on 11 Mar 2014. On the same day he also received ENGERIX-B (batch number: Y9RX5, other manufacturer) IM into right arm, FLUZONE (batch number: U4792AA, other manufacturer) into left arm, MMR II (batch number: J006994, other manufacturer) subcutaneous into left arm, ADACEL (batch number: C4506AC, other manufacturer) IM into right arm and VIVOTIF (batch number: 3000690, other manufacturer) per oral. The patient reported that he was not taking any medications within two weeks of receiving vaccines. On 21 Mar 2014, he reported that he had a rash that started on his abdomen and back. Within 1-2 hours spread to include some of his chest, possibly some on his inner arm bicep area (these later resolved) and also on his feet, ankles and up to his mid-calf area on both feet and legs. He did not have any signs of fever, chills, itching, pain, discomfort. He feel ok. Rash was described as small red dots that look like "hair follicles" but are not raised. He was encouraged him to take some BENADRYL and monitor closely. If the symptoms worsen or rash spreads more, he should consult the physician as soon as possible. If he continues to feel okay and symptoms do not worse they will monitor closely until he will have a physician appointment. Outcome of the event and causality assessment was not reported. The event was reported as non-serious.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Vaccination site discolouration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2014US071288 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525698) web site on 09 Jun 2014. This report refers to an 11-year-old female patient. Her medical history included penicillin allergy and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M12024) and HAVRIX (other manufacturer, batch number: 7973G); both vaccines administered intramuscularly in the left arm on 10 Mar 2014. On 11 Mar 2014, her vaccination site was swollen, warm to touch and was red and purple in colour. The event outcome was reported as condition unchanged. The events were reported as non-serious and the causality was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US056435, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525732) website on 06 May 2014. This report refers to an 11-year-old male patient. Past medical history included attention deficit/hyperactivity disorder (ADHD). No concomitant medication was reported. His vaccination history included administration of MMR II (other manufacturer, batch number: not reported) and he experienced fever. He was vaccinated with MENVEO (batch number: not reported) intramuscularly into the left arm on 09 Mar 2014. On 10 Mar 2014, he experienced redness, swelling, heat at injection site of 11 cm. His left arm circumference was three cm larger than the right arm and the swelling increased 12 percent in the vaccinated arm. The final outcome of the events was unknown. The event was reported as non-serious. Causality was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injected limb mobility decreased, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Case number PHHY2014US056486, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525814) web site on 06 May 2014. This report refers to an 11-year-old male patient. Past medical history included bee stings allergy. No concomitant medication was reported. Prior receiving the vaccination he was well. He was vaccinated with MENVEO (batch number: A13012) intravenously into the left arm on 20 Feb 2014. On 22 Feb 2014, he experienced pain in the vaccinated area and it was firm, erythematous. Also he was unable to move the vaccinated arm. Treatment for the events was rendered with AUGMENTIN. The final outcome of the events was complete recovery after two days. The events were reported as non-serious. Causality was not reported.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Eye pruritus, Eye swelling, Eyelid rash, Injection site erythema
Clinical narrative: Case number PHHY2014US070832, is an initial spontaneous report from Vaccine adverse event reporting website (VAERS id: 526150) received on 09 Jun 2014. This report refers to a 13 year old female patient. Her medical history included psoriasis. Concomitant medication was not reported. She was vaccinated with MENVEO (batch number: A13016) intramuscular into left arm on 04 Feb 2014. On the same day she received HAVRIX (batch number: K555K, other manufacturer) intradermal into left arm and GARDASIL (batch number: J00272, other manufacturer) intramuscular into right arm. On 04 Feb 2014, she reported that her eyes were red with swelling and itching. She also developed rash on eyelids, mildly dizzy and injection site mildly red and swollen. Causality of the events and final outcome was not reported. The event was reported as non-serious.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Injection site swelling, Ocular hyperaemia
Clinical narrative: Case number PHHY2014US070832, is an initial spontaneous report from Vaccine adverse event reporting website (VAERS id: 526150) received on 09 Jun 2014. This report refers to a 13 year old female patient. Her medical history included psoriasis. Concomitant medication was not reported. She was vaccinated with MENVEO (batch number: A13016) intramuscular into left arm on 04 Feb 2014. On the same day she received HAVRIX (batch number: K555K, other manufacturer) intradermal into left arm and GARDASIL (batch number: J00272, other manufacturer) intramuscular into right arm. On 04 Feb 2014, she reported that her eyes were red with swelling and itching. She also developed rash on eyelids, mildly dizzy and injection site mildly red and swollen. Causality of the events and final outcome was not reported. The event was reported as non-serious.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2014US071882 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 526400) web site on 09 Jun 2014. This report refers to an 11 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A13011) intramuscularly, BOOSTRIX (other manufacturer, batch number: JP44F) intramuscularly and VARIVAIX (other manufacturer, batch number: J007952) subcutaneously, all in the right deltoid on 19 Mar 2014. On 20 Mar 2014, he developed a knot of 03 inches in diameter at right deltoid. The right deltoid was tender, hard and hot to touch. The outcome was not reported. The event was reported as non serious and causality was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2014US071505 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 526468) web site on 09 Jun 2014. This case refers to an 11-year-old female patient. Her medical history included celiac disease and allergy to gluten. Her concomitant medications were not reported. On 21 Mar 2014, she was vaccinated intramuscularly with MENVEO (batch number: 13015) in the deltoid muscle of right arm along with BOOSTRIX (other manufacturer, batch number: 4P724) in the left arm, intramuscularly. Following the vaccinations, few hours later on the same day (21 Mar 2014), she had erythema, swelling and tenderness over an area of 3 inches x 3 inches in the right deltoid. She was rendered treatment with azithromycin. The final outcome of the events was reported as complete recovery. The causality of the events was not reported. The events were reported as non-serious.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2014US071069 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 526872) web site on 09 Jun 2014. This case refers to an 11-year-old female patient. Her medical history included penicillin allergy. Her concomitant medications were not reported. On 18 Mar 2014, she was vaccinated with MENVEO (batch number: A13014) in the deltoid muscle of right arm along with BOOSTRIX (other manufacturer, batch number: 7GH57) in the left arm. Following the vaccinations, two days later on 20 mar 2014, she had redness and swelling over an area of 2.5 inches x 2.5 inches in the right deltoid. The final outcome of the events was reported as complete recovery. The causality of the events was not reported. The events were reported as non-serious.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US066792 is an initial spontaneous report from vaccine adverse event reporting system web site (VAERS reference number: 527517) on 28 May 2014. This case refers to an 11 year old male patient. His past medical history included Turner's syndrome, asthma and anaphylaxis. His current conditions included an ear infection. His concomitant medications included sodium fluoride, CLARITIN, fluticasone, somatropin and SINGULAIR. On 01 Apr 2014, he was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported) into this left arm and HPV vaccine (other manufacturer, batch number not reported) into his right arm. On the same day after vaccination, he had a circle the size of quarter around the injection site that was hot. His whole upper arm was swollen with a red circle the size of a baseball. He went to emergency room. On 03 Apr 2014, the physician measured the redness at a size of 6 centimeters. The outcome of the events was not reported. The events were reported as non serious and the causality of the events was not reported. Following an internal review performed on 06 Jun 2014 of the data received on 28 May 2014, it was identified that the event verbatim 'whole upper arm was swollen with a red circle the size of a baseball' was erroneously coded to vaccination site swelling and hence, if was no recoded as extensive swelling of vaccinated limb.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache
Clinical narrative: Case number PHHY2014US079042 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 527688) website on 25 Jun 2014. This report refers to an 11 year old female child. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M13051) intramuscularly in right arm along with BOOSTRIX (other manufacturer, batch number: 253B4) intramuscularly into left arm on 02 Apr 2014. On the same day, 05 minutes after vaccination, she experienced frontal headache. She was observed for 20 minutes; not other reactions occurred. The outcome was reported as complete recovery. The event was reported as non serious and causality was not reported.
Age: 17.0
Sex: F
Vaccine: HPV2, HPV2, MNQ
Symptoms: Activities of daily living impaired, Blood test, Fatigue, Headache, Mononucleosis heterophile test negative
Clinical narrative: Case number PHHY2014US081289 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 527794) website on 01 Jul 2014. This report refers to a 17-year-old female patient. Her medical history included cough, cold, allergy due to guaifenesin and hives. She was vaccinated with MENVEO (batch number: A13017) intramuscularly into right arm on 04 Nov 2013. On the same day, she was also vaccinated with CERVARIX (other manufacturer and batch number: PH43F) intramuscularly into left arm. On 31 Jan 2014, 88 days after vaccinations, she experienced dizziness, vertigo, headaches and fatigue. She had a visit to emergency room and was seen by primary care physician and a neurologist. Laboratory tests performed included mono, Lyme testing, CBC (complete blood picture), CMV (cytomegalovirus), ESR (red blood cell sedimentation rate), thyroid and urine cultures which were all found to be normal. These events were reported as non-serious. Outcome of the events was reported as condition unchanged as of 07 Apr 2014. Causality of the events was not reported.
Age: 17.0
Sex: F
Vaccine: HPV2, HPV2, MNQ
Symptoms: Nuclear magnetic resonance imaging, Vertigo
Clinical narrative: Case number PHHY2014US081289 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 527794) website on 01 Jul 2014. This report refers to a 17-year-old female patient. Her medical history included cough, cold, allergy due to guaifenesin and hives. She was vaccinated with MENVEO (batch number: A13017) intramuscularly into right arm on 04 Nov 2013. On the same day, she was also vaccinated with CERVARIX (other manufacturer and batch number: PH43F) intramuscularly into left arm. On 31 Jan 2014, 88 days after vaccinations, she experienced dizziness, vertigo, headaches and fatigue. She had a visit to emergency room and was seen by primary care physician and a neurologist. Laboratory tests performed included mono, Lyme testing, CBC (complete blood picture), CMV (cytomegalovirus), ESR (red blood cell sedimentation rate), thyroid and urine cultures which were all found to be normal. These events were reported as non-serious. Outcome of the events was reported as condition unchanged as of 07 Apr 2014. Causality of the events was not reported.
Age: 17.0
Sex: F
Vaccine: HPV2, HPV2, MNQ
Symptoms: Borrelia test negative, Culture urine negative, Cytomegalovirus test negative, Dizziness, Fatigue
Clinical narrative: Case number PHHY2014US081289 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 527794) website on 01 Jul 2014. This report refers to a 17-year-old female patient. Her medical history included cough, cold, allergy due to guaifenesin and hives. She was vaccinated with MENVEO (batch number: A13017) intramuscularly into right arm on 04 Nov 2013. On the same day, she was also vaccinated with CERVARIX (other manufacturer and batch number: PH43F) intramuscularly into left arm. On 31 Jan 2014, 88 days after vaccinations, she experienced dizziness, vertigo, headaches and fatigue. She had a visit to emergency room and was seen by primary care physician and a neurologist. Laboratory tests performed included mono, Lyme testing, CBC (complete blood picture), CMV (cytomegalovirus), ESR (red blood cell sedimentation rate), thyroid and urine cultures which were all found to be normal. These events were reported as non-serious. Outcome of the events was reported as condition unchanged as of 07 Apr 2014. Causality of the events was not reported.
Age: 17.0
Sex: F
Vaccine: HPV2, HPV2, MNQ
Symptoms: Full blood count normal, Headache, Mononucleosis heterophile test negative, Red blood cell sedimentation rate normal, Thyroid function test normal
Clinical narrative: Case number PHHY2014US081289 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 527794) website on 01 Jul 2014. This report refers to a 17-year-old female patient. Her medical history included cough, cold, allergy due to guaifenesin and hives. She was vaccinated with MENVEO (batch number: A13017) intramuscularly into right arm on 04 Nov 2013. On the same day, she was also vaccinated with CERVARIX (other manufacturer and batch number: PH43F) intramuscularly into left arm. On 31 Jan 2014, 88 days after vaccinations, she experienced dizziness, vertigo, headaches and fatigue. She had a visit to emergency room and was seen by primary care physician and a neurologist. Laboratory tests performed included mono, Lyme testing, CBC (complete blood picture), CMV (cytomegalovirus), ESR (red blood cell sedimentation rate), thyroid and urine cultures which were all found to be normal. These events were reported as non-serious. Outcome of the events was reported as condition unchanged as of 07 Apr 2014. Causality of the events was not reported.
Age: 17.0
Sex: F
Vaccine: HPV2, HPV2, MNQ
Symptoms: Vertigo
Clinical narrative: Case number PHHY2014US081289 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 527794) website on 01 Jul 2014. This report refers to a 17-year-old female patient. Her medical history included cough, cold, allergy due to guaifenesin and hives. She was vaccinated with MENVEO (batch number: A13017) intramuscularly into right arm on 04 Nov 2013. On the same day, she was also vaccinated with CERVARIX (other manufacturer and batch number: PH43F) intramuscularly into left arm. On 31 Jan 2014, 88 days after vaccinations, she experienced dizziness, vertigo, headaches and fatigue. She had a visit to emergency room and was seen by primary care physician and a neurologist. Laboratory tests performed included mono, Lyme testing, CBC (complete blood picture), CMV (cytomegalovirus), ESR (red blood cell sedimentation rate), thyroid and urine cultures which were all found to be normal. These events were reported as non-serious. Outcome of the events was reported as condition unchanged as of 07 Apr 2014. Causality of the events was not reported.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2014US081850 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 528156) website on 01 Jul 2014. This report refers to a 15 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with a dose of MENVEO (batch number: M13014) into right arm, BOOSTRIC (other manufacturer, batch number: EA2GE) into left arm and VARIVAX (other manufacturer, batch number: J003707) into left arm on 08 Apr 2014. On 10 Apr 2014, his right arm was swollen, red, hard and warm to touch. He took ADVIL and BENADRYL as treatment medication. On 11 Apr 2014 in the morning, his symptoms improved. The final outcome was reported as complete recovery. The event was reported as non serious. Causality was not reported.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Case number PHHY2014US081374, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 528248) website on 01 Jul 2014. This report refers to a 11-year-old male patient. His medical history included oppositional defiant disorder, obesity, attention deficit/hyperactivity disorder and asthma. He was vaccinated with MENVEO (batch number: A13014) in the right arm along with HAVRIX (other manufacturer, batch number: 5B23A) in the left arm, both intramuscularly on 07 Apr 2014. On the same date at night after vaccination, his arm became red and swollen and his arm was sore and itchy. His left upper arm had 8 cm ring of erythema, swelling and mild tenderness. He visited the emergency room. He was treated with cetirizine and mometasone cream. The final outcome of the events was unknown. The causality of the events was not reported. The events reported as non-serious; however the case was internally upgraded as medically significant by the agency.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Case number PHHY2014US081374, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 528248) website on 01 Jul 2014. This report refers to a 11-year-old male patient. His medical history included oppositional defiant disorder, obesity, attention deficit/hyperactivity disorder and asthma. He was vaccinated with MENVEO (batch number: A13014) in the right arm along with HAVRIX (other manufacturer, batch number: 5B23A) in the left arm, both intramuscularly on 07 Apr 2014. On the same date at night after vaccination, his arm became red and swollen and his arm was sore and itchy. His left upper arm had 8 cm ring of erythema, swelling and mild tenderness. He visited the emergency room. He was treated with cetirizine and mometasone cream. The final outcome of the events was unknown. The causality of the events was not reported. The events reported as non-serious; however the case was internally upgraded as medically significant by the agency.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Case number PHHY2014US081470, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 528445) website on 01 Jul 2014. This report refers to a 11-year-old female patient. On 03 Apr 2014, she was vaccinated with MENVEO (batch number: M13015) in the right arm along with HAVRIX (other manufacturer, batch number: 3535C) and ADACEL (other manufacturer, batch number: U4667AA) in the left arm, intramuscularly. On the same date in the afternoon after vaccination, her right arm became increasingly red and swollen. On 10 Apr 2014, her entire upper arm (unspecified side) swelled, painful and warm to touch. She visited the emergency room. On 11 Apr 2014, her swelling increased, extending beyond previously marked borders. She was given antibiotics. The final outcome of the events reported as recovered. The events reported as non serious. The causality of the events was not reported.
Age: 2.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2014US081368, is an initial spontaneous report from Vaccine adverse event reporting website (VAERS id: 528950) received on 01 Jul 2014. This report refers to a 2 year old female patient. Her medical history included allergic rhinitis. Concomitant medication included CLARITIN. She was vaccinated with MENVEO (batch number: A12100) into left arm on 16 Apr 2014. On the same day she also received HAVRIX (batch number: 7C47T) into right arm; GARDASIL (batch number: J011272, other manufacturer) into right arm and BOOSTRIX (batch number: AC52B099CA, other manufacturer) into left arm. The next morning, on 17 Apr 2014, her mother noticed that the area was red and it hurt to touch the area. The redness continued to spread and she was taken to the clinic on 18 Apr 2014. She had a 7/7 cm area of erythema, warmth, induration of left arm in the deltoid region at the injection site and also had mild pain with palpation. She was told to return to the clinic if the symptoms got worse or did not improve. Outcome of the events was unknown. Causality assessment was not reported. The events were reported as non-serious.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2014US081399, is an initial spontaneous report from Vaccine adverse event reporting web site (VAERS id: 529072) received on 01 Jul 2014. This report refers to an 11 year old male patient. His medical history included allergic rhinitis and tic disorder. Concomitant medication was not reported. He was vaccinated with MENVEO (batch number: A12128) intramuscular into left arm on 16 Apr 2014. On the same day he also received BOOSTRIX (batch number: 4327T, other manufacturer) intramuscular into left arm. On 17 Apr 2014, he developed large local swelling and redness at injection site measuring 14 cm round. He was recommended to take BENADRYL, ibuprofen and cool compress. Outcome of the events was unknown. Causality assessment was not reported. The events were reported as non-serious.
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Blood glucose, Dizziness, Nausea, Vomiting
Clinical narrative: Case number PHHY2014US081466, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 529644) website on 01 Jul 2014. This report refers to an 11-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: X13017) into the left arm, along with GARDASIL (other manufacturer, batch number: H020901) into the right arm on 28 Apr 2014. On the same day after vaccination at 12:05 PM, he felt dizzy and nauseous. He was instructed to lie down. At 12:06 PM, he was given apple juice. At 12:10 PM, he vomited. At 12:10 PM blood pressure was checked (result not reported). At 12:11 PM blood glucose was checked (result not reported). At 12:26 PM symptoms resolved without intervention. The final outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US081512, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 529861) web site on 01 Jul 2014. This report refers to an 11-year-old male patient. Past medical history included attention deficit hyperactivity disorder (ADHD). Concomitant medication included CONCERTA. He was vaccinated with MENVEO (batch number: X13015), along with BOOSTRIX (other manufacturer, batch number: N4C77) intramuscularly on 24 Apr 2014. On 25 Apr 2014, he experienced swelling, erythema, tenderness and mild warmth at injection site. The swelling and erythema were 10 into 12. The final outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 55.0
Sex: F
Vaccine: HEP, MNQ, YF
Symptoms: Nausea, Vomiting
Clinical narrative: Case number PHHY2014US081555, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 529918) website on 01 Jul 2014. This report refers to a 55-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with MENVEO (batch number: M13014), along with ENGERIX-B (other manufacturer, batch number: X3EL3) intramuscularly and YF-VAX (other manufacturer, batch number: UH669AA) subcutaneously on 30 Apr 2014. On the same day after vaccination, she experienced nausea and vomiting. The final outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Case number PHHY2014US081766, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 530214) website on 01 Jul 2014. This report refers to an 11-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: M13017), along with GARDASIL (batch number: J011272) intramuscularly into the right arm and FLUARIX (other manufacturer, batch number: H25EX) and ADACEL (other manufacturer, batch number: U4646AA) intramuscularly into the left arm on 02 May 2014. On 05 May 2014, he experienced redness, swelling and eight into eight cm induration in the right arm at site of injection. Also he experienced three into four cm induration in the left arm injection site. The final outcome of the events was unknown. The events were reported as non-serious. Causality was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema
Clinical narrative: Case number PHHY2014US081740 is an initial spontaneous report received via vaccine adverse event reporting system website (VAERS reference number: 530532) on 01 Jul 2014. This report refers to a 11 year old male patient. His past medical history and concomitant medications were not reported. On 07 May 2014, he was vaccinated with MENVEO (batch number: not reported) and BOOSTRIX (other manufacturer, batch number: not reported). On 08 May 2014, he developed localised erythema on his entire upper arm. He completely recovered from the event on an unspecified date. The event was assessed as non-serious by the reporter and the causality of the event was not reported.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Case number PHHY2014US078739, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 530996) website on 25 Jun 2014. This report refers to 11-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with Meningococcal vaccine INN (manufacturer and batch number unknown) into left arm on 13 May 2014. On the same day he also received DTaP (manufacturer and batch number unknown) into right arm. On the same day he developed redness, warmth and swelling. Warmth remained, swelling and redness increased to approximately 4 cm diameter between shoulder and elbow. The outcome of the events and causality assessment was not reported. The events were reported as non-serious.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2014US097944 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 531128) web site on 04 Aug 2014. This report refers to a 21 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A13064) intramuscularly on 14 May 2014. On 16 May 2014, she experienced injection site swelling (orange sized), pain, redness, hardness and itching. Final outcome was reported as condition unchanged. The events were reported as non-serious. The causality was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Case number PHHY2014US097706, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 531240) website on 08 Aug 2014. This case refers to an 11-year-old female patient. She was vaccinated with MENVEO (batch number: M12130) and BOOSTRIX (batch number: 338G5, other manufacturer) both intramuscularly into right deltoid on 16 May 2014. Post vaccination, after an unspecified period of time, she experienced swelling and tenderness in right armpit. These events were reported as non-serious. Outcome and causality of the events were not reported. Following an internal review on 12 Aug 2014 of the data received on 08 Aug 2014, following correction has been performed. The events were wrongly coded previously hence now corrected to local swelling and tenderness. Narrative was updated accordingly.
Sex: M
Vaccine: MNQ
Symptoms: Skin warm, Swelling
Clinical narrative: Case number PHHY2014US099503, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 531501) website on 08 Aug 2014. This report refers to a male patient of an unspecified age. His past medical history and concomitant medications were not reported. On 19 May 2014, he was vaccinated with MENVEO (batch number: A12132) into his right arm. On an unspecified date after the vaccination, the patient developed swelling and his skin was warm to touch. The outcome of the events was not reported. The events were assessed as non serious and the causality of the events was not reported.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US100402 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 531525) on 08 Aug 2014. This report refers to a 10 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12100) intramuscularly in the left arm on 06 Feb 2014. It was reported that the vaccine administered to her experienced temperature excursion. No adverse event was reported following the maladministration.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US100422 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 531543) on 08 Aug 2014. This report refers to a 16 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M13017) intramuscularly in the right arm on 05 Mar 2014. It was reported that the vaccine administered to him experienced temperature excursion. No adverse event was reported following the maladministration.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US0100431 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 531546) on 08 Aug 2014. This report refers to a 16 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12100) intramuscularly in the left arm on 10 Feb 2014. It was reported that the vaccine administered to him experienced temperature excursion. No adverse event was reported following the maladministration.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US100571 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 5315447) on 08 Aug 2014. 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: M12100) intramuscularly in the right arm on 14 Feb 2014. It was reported that the vaccine administered to her experienced temperature excursion. No adverse event was reported following the maladministration.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US100582 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 531549) on 08 Aug 2014. 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: M12100) intramuscularly in the left arm on 20 Feb 2014. It was reported that the vaccine administered to him experienced temperature excursion. No adverse event was reported following the maladministration.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US100611 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531550) on 08 Aug 2014. This report refers to a 16 years old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M12100) intramuscularly in the left arm on 03 Feb 2014. It was reported that the vaccine administered to him experienced temperature excursion. No adverse event was reported following the medication error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099338 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 531559) website on 08 Aug 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (Batch number: M12100) intramuscularly into left arm on 03 Feb 2014. It was reported that there was a temperature excursions of vaccine. Before administration it was not stored in recommended temperature range. No adverse event was reported following this medication error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099836, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 531565) website on 08 Aug 2014. This report refers to an 11 year old male patient. His past medical history and concomitant medications were not reported. On 31 Jan 2014, he was vaccinated with MENVEO (batch number: M12102) which had a temperature excursion while in storage intramuscularly into his right arm. No adverse events were reported following this medication error (incorrect storage of drug).
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US100166, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 531573) website on  08 Aug 2014. This report refers to an 18 year old female patient. Her past medical history and concomitant medications were not reported. On 11 Feb 2014, she was vaccinated with MENVEO (batch number: M12100) which had a temperature excursion while in storage intramuscularly into her left arm. No adverse events were reported following this maladministration.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2014US102680 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531588) website on 08 Aug 2014. This report refers to an 11 year old male patient. His medical history included possible allergy to bee sting. He was vaccinated with MENVEO (batch number: A130146) intramuscularly into right arm along with BOOSTRIX (other manufacturer, batch number: N3BE2) intramuscularly into left arm, both on 19 May 2014. On the same day after vaccination, he experienced severe headache. On 20 May 2014 (day 1), he had fever and vomiting. He was taken to emergency room for medical support. The outcome was reported as complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US100637 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531619) on 08 Aug 2014. This report refers to an 11 years old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M13017) intramuscularly in the left arm on 11 Mar 2014. It was reported that the vaccine administered to him experienced temperature excursion. No adverse event was reported following this medication error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US100638 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531621) on 08 Aug 2014. This report refers to an 11 years old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M12100) intramuscularly in the left arm on 14 Jan 2014. It was reported that the vaccine administered to her experienced temperature excursion. No adverse event was reported following the medication error.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Decreased appetite, Discomfort, Erythema, Headache, Nausea
Clinical narrative: Case number PHHY2014US104394 is an initial spontaneous report received from the vaccine adverse event reporting system (reference number: 531801) website on 08 Aug 2014. This report refers to an 11 year old male patient. His current condition included headache prior to vaccination. He was vaccinated with MENVEO (batch number:  M13015) into right arm, HAVRIX (other manufacturer, batch number 3535C) into left arm, GARDASIL (other manufacturer, batch number H020901) into right arm and BOOSTRIX (other manufacturer, batch number:  4P724) into left arm, all intramuscularly on 21 May 2014.  On the same day after vaccination, the severity of headache increased. He had mild nausea, fever and was unable to eat dinner. He might have received over the counter pain reliever medicine on the same day. He was asked to take rest. On 22 May 2014, after awakening in the morning, he felt warm to the touch and was unable to eat. Severe headache still continued. Treatment was rendered with 200 mg ibuprofen.  On 22 May 2014, he stayed home from school. On 23 May 2014, he still complaining of headache but of lesser intensity; fever has subsided; be missed a second day of school. It was not reported whether appetite returned or not. He also developed vaccination site swelling, redness, blotchy appearance and warm to touch (04 inch diameter) at right arm. Left arm had mild discomfort if touched. He had not sought other medical attention at this point. Final outcome was reported as complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Pyrexia, Rash macular, Skin warm, Vaccination site swelling
Clinical narrative: Case number PHHY2014US104394 is an initial spontaneous report received from the vaccine adverse event reporting system (reference number: 531801) website on 08 Aug 2014. This report refers to an 11 year old male patient. His current condition included headache prior to vaccination. He was vaccinated with MENVEO (batch number:  M13015) into right arm, HAVRIX (other manufacturer, batch number 3535C) into left arm, GARDASIL (other manufacturer, batch number H020901) into right arm and BOOSTRIX (other manufacturer, batch number:  4P724) into left arm, all intramuscularly on 21 May 2014.  On the same day after vaccination, the severity of headache increased. He had mild nausea, fever and was unable to eat dinner. He might have received over the counter pain reliever medicine on the same day. He was asked to take rest. On 22 May 2014, after awakening in the morning, he felt warm to the touch and was unable to eat. Severe headache still continued. Treatment was rendered with 200 mg ibuprofen.  On 22 May 2014, he stayed home from school. On 23 May 2014, he still complaining of headache but of lesser intensity; fever has subsided; be missed a second day of school. It was not reported whether appetite returned or not. He also developed vaccination site swelling, redness, blotchy appearance and warm to touch (04 inch diameter) at right arm. Left arm had mild discomfort if touched. He had not sought other medical attention at this point. Final outcome was reported as complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099913 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number:  531808) on 08 Aug 2014. 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: M12100) intramuscularly in the right arm on 03 Feb 2014. It was reported that the vaccine administered to him experienced temperature excursion. No adverse event was reported following the medication error.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099923 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531809) on 08 AUG 2014. This report refers to a 17 years old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M12100) intramuscularly in the left arm on 31 JAN 2014. It was reported that the vaccine administered to him experienced temperature excursion. No adverse event was reported following the medication error (incorrect storage of drug).
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099924 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531814) on 08 Aug 2014. This report refers to a 12 years old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M12102) intramuscularly in the left arm on 31 Jan 2014. It was reported that the vaccine administered to him experienced temperature excursion. No adverse event was reported following this medication error.