chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2013US116986. is an initial spontaneous report received from the Vaccine Adverse Event System (VAERS reference number: 487153) website on 15 Oct 2013, with the follow-up received on 20 Jan 2014. This report refers to a 12-year-old male patient. He was vaccinated with MENVEO (batch number: A12010) and GARDASIL (other manufacturer and batch number: 0101AE), on 15 Mar 2013. On the same day, after vaccination he had a horrible stomach ache, dizziness and headache. The following day, he had all the same symptoms plus fever and muscle aches. On the third day, he had fever up to 104, horrible headache, muscle aches and extreme fatigue. The patient visited the emergency room. The outcome of the events reported as not recovered as of 18 Mar 2013. The seriousness and causality of the events were not reported. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 487153) website on 20 Jan 2014: Suspect vaccines recoded from MENVEO INN to MENVEO, human papilloma vaccine to GARDASIL and updated both suspect vaccines batch numbers.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2013US056819 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 488039) website on 05 Jun 2013: This report refers to a 21-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A11078) intramuscularly into the left arm on 25 Mar 2013. On 27 Mar 2013, she experienced redness, swelling, pain and itchiness at the injection site that was warm to touch. She also reported experiencing increased thirst. She was advised to take ibuprofen/ ALEVE and BENADRYL and drinks lots of water. Outcome of the events was reported as condition unchanged at the time of reporting. No additional information about causality and seriousness was reported.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Thirst
Clinical narrative: Case number PHHY2013US056819 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 488039) website on 05 Jun 2013: This report refers to a 21-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A11078) intramuscularly into the left arm on 25 Mar 2013. On 27 Mar 2013, she experienced redness, swelling, pain and itchiness at the injection site that was warm to touch. She also reported experiencing increased thirst. She was advised to take ibuprofen/ ALEVE and BENADRYL and drinks lots of water. Outcome of the events was reported as condition unchanged at the time of reporting. No additional information about causality and seriousness was reported.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHHY2013US069256 is an initial spontaneous report from the Vaccine Adverse Reporting System (VAERS reference number: 489247) website on 03 Jul 2013. This report refers to a 21-year-old female patient. She was vaccinated with MENVEO (batch number: not reported) via subcutaneous route on 13 Dec 2012. The patient visited the emergency room and was advised to contact doctor if she had any pain or other symptoms. No adverse event was reported following this medication error. The seriousness and causality of the events were not reported.
Age: 27.0
Sex: F
Vaccine: MNQ
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Case number PHHY2013US069265 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 489248) website on 03 JUL 2013. This report refers to a 27-year-old female patient. She was vaccinated with MENVEO (batch number: A11087) via subcutaneous route on 13 DEC 2013. On 14 DEC 2012, one day after vaccination she experienced pain and swelling at the vaccination site. The patient visited the emergency room. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 23.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache, Injection site rash, Nausea, Neck pain
Clinical narrative: Case number PHHY2013US069438, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS Ref: 489524) web site on 03 Jul 2013: This report refers to a 23-year-old female patient. Her medical history was not reported. This poly medicated patient was vaccinated with MENVEO (batch number: A12023) intramuscularly into the left arm on 16 Apr 2013. On the same day after vaccination, she felt like she was going to pass out and threw up. She stated that her neck hurts, had a low grade fever and headache, and felt nauseous. She had a rash where the injection was given. The rash was itchy, swollen, and hot. Outcome of the event was reported as condition unchanged. Seriousness and causality assessment was not reported.
Age: 23.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia, Rash pruritic, Vomiting
Clinical narrative: Case number PHHY2013US069438, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS Ref: 489524) web site on 03 Jul 2013: This report refers to a 23-year-old female patient. Her medical history was not reported. This poly medicated patient was vaccinated with MENVEO (batch number: A12023) intramuscularly into the left arm on 16 Apr 2013. On the same day after vaccination, she felt like she was going to pass out and threw up. She stated that her neck hurts, had a low grade fever and headache, and felt nauseous. She had a rash where the injection was given. The rash was itchy, swollen, and hot. Outcome of the event was reported as condition unchanged. Seriousness and causality assessment was not reported.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Oedema, Pruritus, Skin warm
Clinical narrative: Case number PHHY2013US069447, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS Ref: 489599) web site on 03 Jul 2013: This report refers to 16-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: M1152) into right arm on 08 Apr 2013. On 10 Apr 2013, she experienced warm to touch and edematous (unknown site) 10/8 cm. No signs of abscess and cellulitis. She visited the emergency room. Treatment medication included BENADRYL at a dose of 50 mg per oral that helped somewhat of the itching. Outcome of the events was complete recovery. Seriousness and causality assessment was not reported.
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Vaccination site joint discomfort, Vaccination site pain
Clinical narrative: Case number PHHY2013US16778 is an initial report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 489788) on 15 OCT 2013. This report refers to a 13-year-old female patient. She was of good health but had diabetes mellitus type 1. Her concomitant medications were NOVOLOG and LANTUS. She was vaccinated with meningococcal vaccine (manufacturer and batch number not reported hence conservatively taken as Menveo INN), FLUMIST (other manufacturer and batch number: not reported) via intranasal route. GARDASIL (other manufacturer, batch number not reported), diphtheria tetanus acellular pertussis vaccine (other manufacturer, batch number: not reported) and an unknown vaccine 08 JAN 2013. On 09 JAN 2013, vaccination site started out with a bean size red mark and grew to a grape fruit size mark with pain and joint discomfort. She went emergency room. The outcome of the events was reported as complete recovery.
Sex: M
Vaccine: FLU3, MNQ, FLU3, MNQ
Symptoms: Injection site mass, Muscle twitching
Clinical narrative: Case number PHHY2013US069297 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 489862) website on 03 JUL 2013. This report refers to a 16-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with AFLURIA (other manufacturer, batch number P50608) intramuscularly into right arm and MENVEO (batch number: M11082) intramuscularly into left arm on 12 APR 2013. On 20 APR 2013, he developed a 2.5 inch lump on left arm at the site of meningitis vaccine. He also experienced muscle twitches for the 2 days prior to the lump developing. The outcome of the events was recovered as of unspecified date. Causality and seriousness of the events were not reported.
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site induration, Skin warm, Swelling
Clinical narrative: Case number PHHY2013US069322 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 490201) on 03 JUL 2013. This report refers to an 11 year old male patient.  His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A11077) intramuscularly in the left arm and BOOSTIX (other manufacturer, batch number: AC52B100BA) intramuscularly in the right arm on 23 AR 2013 at about 8:00 am, he noticed redness, swelling and it was warm to touch. He went to the clinic and the induration measured about 9x9 cm on left deltoid area. His mother was instructed by the physician's assistant to apply cold compresses and administer MOTRIN until the swelling and redness subside. The patient's mother was fine with the instructions. The patient was advised to re visit clinic if symptoms worsen. The final outcome was reported as condition unchanged.
Sex: F
Vaccine: IPV, MNQ, TDAP, TYP, YF
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Fatigue, Malaise
Clinical narrative: Case number PHHY2013US069321 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 490947) on 03 JUL 2013. This report refers to a 54-years-old female patient. She did not have any know drug allergies and her concomitant medications included Topamax for migraines as and when needed. She ws vaccinated with MENVEO (batch number: M12026) intramuscularly in the left arm, IPOL (other manufacturer, batch number: H16041) and ADACEL (other manufacturer, batch number: C4385AA) both vaccines administered intramuscularly in the right arm, YF-VAX (other manufacturer, batch number: UH58AA) subcutaneously in the left arm and VIVOTIF (other manufacturer, batch number: 3000326) via oral route on 30 APR 2013. IT was reported that on the same date, she also took a dose of Topamax at about 11:00 PM after typhoid vaccination. After vaccination she slept fine. On 01 May 2013, after her breakfast she had onset of illness. She reported 8 to 9 episodes of watery diarrhea over 3-5 hours with waves of abdominal pain reaching intensity of 8/10 on a 0-10 pain scale.  By 12 Noon, diarrhea had resolved and waves of abdominal pain were much less frequent and less intense about 4-6/10 on 0-10 pain scale. She denied any fever, chills, rash, itching, breathing changes, nausea or vomiting. She felt little weak and fatigued. She was recommended to contact PMD and to have rest and fluids (clear fluids). She was asked not to continue the second dose if any diarrhea continued next day or if the PMD recommended stopping the vaccination. She was followed up on 06 MAY 2013. She stated that as all symptoms had resolved and she felt normal, she took the second dose of VIVOTIF (other manufacturer, batch number: not reported) as scheduled. She had twice loose stools and mild cramping which resolved quickly. When she    had her third dose of VIVOTIF (other manufacturer, batch number: not reported) she had once mile loose  tool with mild cramping which resolved quickly. No diagnostic laboratory tests were done. It was stated that she had plans to take final dose as scheduled on evening of 06 MAY 2013. The final outcome was reported as complete recovery.
Sex: F
Vaccine: IPV, MNQ, TDAP, TYP, YF
Symptoms: Muscle spasms
Clinical narrative: Case number PHHY2013US069321 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 490947) on 03 JUL 2013. This report refers to a 54-years-old female patient. She did not have any know drug allergies and her concomitant medications included Topamax for migraines as and when needed. She ws vaccinated with MENVEO (batch number: M12026) intramuscularly in the left arm, IPOL (other manufacturer, batch number: H16041) and ADACEL (other manufacturer, batch number: C4385AA) both vaccines administered intramuscularly in the right arm, YF-VAX (other manufacturer, batch number: UH58AA) subcutaneously in the left arm and VIVOTIF (other manufacturer, batch number: 3000326) via oral route on 30 APR 2013. IT was reported that on the same date, she also took a dose of Topamax at about 11:00 PM after typhoid vaccination. After vaccination she slept fine. On 01 May 2013, after her breakfast she had onset of illness. She reported 8 to 9 episodes of watery diarrhea over 3-5 hours with waves of abdominal pain reaching intensity of 8/10 on a 0-10 pain scale.  By 12 Noon, diarrhea had resolved and waves of abdominal pain were much less frequent and less intense about 4-6/10 on 0-10 pain scale. She denied any fever, chills, rash, itching, breathing changes, nausea or vomiting. She felt little weak and fatigued. She was recommended to contact PMD and to have rest and fluids (clear fluids). She was asked not to continue the second dose if any diarrhea continued next day or if the PMD recommended stopping the vaccination. She was followed up on 06 MAY 2013. She stated that as all symptoms had resolved and she felt normal, she took the second dose of VIVOTIF (other manufacturer, batch number: not reported) as scheduled. She had twice loose stools and mild cramping which resolved quickly. When she    had her third dose of VIVOTIF (other manufacturer, batch number: not reported) she had once mile loose  tool with mild cramping which resolved quickly. No diagnostic laboratory tests were done. It was stated that she had plans to take final dose as scheduled on evening of 06 MAY 2013. The final outcome was reported as complete recovery.
Age: 34.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Injection site induration, Injection site pain
Clinical narrative: Case number PHHY2013US083971 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 491637) web site on 06 Aug 2013 This report refers to a 34-year-old male patient. His medcal history included sulfa allergy and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12027) at a dose of 0.5 cc intramuscularly in to left arm on 07 May 2013. On 07 May 2013, approximately 12 hours post left deltoid intramuscular administration of MENVEO, he reported flu like symptoms including fever with a body temperature of 102.2. The next night he had a body temperature of 100.5 with coils, sweats, pain in left deltoid with swelling. He reported enlarged and tender left axillary lymph nodes up to the size of an orange. Symptoms mostly resolved later. He went to emergency room and examination revealed left deltoid tenderness/firmness. The site was warm and skin was intact with a body temperature of 98.4F. The outcome of the event was reported as complete recovery.
Age: 34.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling, Injection site warmth, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Case number PHHY2013US083971 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 491637) web site on 06 Aug 2013 This report refers to a 34-year-old male patient. His medcal history included sulfa allergy and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12027) at a dose of 0.5 cc intramuscularly in to left arm on 07 May 2013. On 07 May 2013, approximately 12 hours post left deltoid intramuscular administration of MENVEO, he reported flu like symptoms including fever with a body temperature of 102.2. The next night he had a body temperature of 100.5 with coils, sweats, pain in left deltoid with swelling. He reported enlarged and tender left axillary lymph nodes up to the size of an orange. Symptoms mostly resolved later. He went to emergency room and examination revealed left deltoid tenderness/firmness. The site was warm and skin was intact with a body temperature of 98.4F. The outcome of the event was reported as complete recovery.
Age: 9.0
Sex: M
Vaccine: MNQ, PPV, TDAP
Symptoms: Agitation, Asthenia, Crying, Emotional disorder, Headache
Clinical narrative: Case number PHHY2013US117143 is an initial spontaneous report received the Vaccine Adverse Event Reporting System (VAERS, reference number: 491768) website on 15 Oct 2013. This report refers to a 09-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with meningococcal vaccine (manufacturer and batch number unknown hence conservatively coded as MENVEO INN) into left arm, pneumococcal vaccine (manufacturer and batch number unknown) into left leg and TDAP (manufacturer and batch number unknown) into right arm on 12 May 2013. On the same day, after vaccination, he experienced fever, lethargy, extreme headache, nausea, weakness, crying, emotional, and agitated. Outcome of the events was reported as not recovered as of 16 May 2013. No seriousness and causality of the events were reported.
Age: 9.0
Sex: M
Vaccine: MNQ, PPV, TDAP
Symptoms: Lethargy, Nausea, Pyrexia
Clinical narrative: Case number PHHY2013US117143 is an initial spontaneous report received the Vaccine Adverse Event Reporting System (VAERS, reference number: 491768) website on 15 Oct 2013. This report refers to a 09-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with meningococcal vaccine (manufacturer and batch number unknown hence conservatively coded as MENVEO INN) into left arm, pneumococcal vaccine (manufacturer and batch number unknown) into left leg and TDAP (manufacturer and batch number unknown) into right arm on 12 May 2013. On the same day, after vaccination, he experienced fever, lethargy, extreme headache, nausea, weakness, crying, emotional, and agitated. Outcome of the events was reported as not recovered as of 16 May 2013. No seriousness and causality of the events were reported.
Age: 9.0
Sex: F
Vaccine: MNQ, PPV, TDAP
Symptoms: Emotional disorder, Headache, Lethargy, Nausea, Peripheral swelling
Clinical narrative: Case number PHHY2013US117148 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 491769) website on 15 Oct 2013. This report refers to a 09-year-old female patient. Her medical history and concomitant medication were not reported. On 14 May 2013, she was vaccinated with meningococcal vaccine (manufacturer and batch number unknown, conservatively coded as MENVEO INN) into left leg. On the same day, she also received pneumococcal vaccine (manufacturer and batch number unknown) into left arm and TDAP vaccine (manufacturer and batch number unknown) into right arm. On the same day, after vaccination, she experienced fever of temperature 101-100.8, extreme lethargy, extreme headache, nausea, emotional and swollen arm. Outcome of the events was reported as not recovered as of 16 May 2013. No seriousness and causality was reported for the events.
Age: 9.0
Sex: F
Vaccine: MNQ, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2013US117148 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 491769) website on 15 Oct 2013. This report refers to a 09-year-old female patient. Her medical history and concomitant medication were not reported. On 14 May 2013, she was vaccinated with meningococcal vaccine (manufacturer and batch number unknown, conservatively coded as MENVEO INN) into left leg. On the same day, she also received pneumococcal vaccine (manufacturer and batch number unknown) into left arm and TDAP vaccine (manufacturer and batch number unknown) into right arm. On the same day, after vaccination, she experienced fever of temperature 101-100.8, extreme lethargy, extreme headache, nausea, emotional and swollen arm. Outcome of the events was reported as not recovered as of 16 May 2013. No seriousness and causality was reported for the events.
Age: 9.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Crying, Mobility decreased, Pain, Rash, Rash macular
Clinical narrative: Case number PHHY2013US084182 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 492288) website on 06 Aug 2013. This report refers to a 09-year-old male patient. His medical history included sinus infection. He was vaccinated with MENVEO (batch number: unknown) on 20 May 2013. On an unspecified date, after vaccination, he had extreme pain (site unspecified). He was also crying and was not able to lift the arm. On 22 May 2013, in the morning he had a quarter size rash, by 8:00 pm, the rash had grown to cover half of his arm with hot splotchy. He visited the emergency room. The outcome of the events was reported as not recovered as of 22 May 2013. No seriousness and causality were reported.
Age: 9.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Skin warm
Clinical narrative: Case number PHHY2013US084182 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 492288) website on 06 Aug 2013. This report refers to a 09-year-old male patient. His medical history included sinus infection. He was vaccinated with MENVEO (batch number: unknown) on 20 May 2013. On an unspecified date, after vaccination, he had extreme pain (site unspecified). He was also crying and was not able to lift the arm. On 22 May 2013, in the morning he had a quarter size rash, by 8:00 pm, the rash had grown to cover half of his arm with hot splotchy. He visited the emergency room. The outcome of the events was reported as not recovered as of 22 May 2013. No seriousness and causality were reported.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Arthralgia, Hallucination, Pyrexia
Clinical narrative: Case number PHHY2013US084185 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 492310) website on 06 Aug 2013: This report refers to a 12-year-old male patient. His medical history was not reported. His concomitant medication included Albuterol 0.083% nebulization. He was vaccinated with MENVEO (batch number: M11077) intramuscularly in to the right leg along with VAQTA (other manufacturer, batch number: 0628AE) intramuscularly in to the left leg and with ADACEL (batch number: U4106BA) intramuscularly in to the left leg on 16 May 2013. On 17 May 2013 he developed fever, arthralgia and probable hallucinations. He visited the emergency room (ER) on 17 May 2013 at 9:23 am and was discharged at 11:10 am. He was given 400 mg oral MOTRIN and 640 mg oral TYLENOL as treatment measures. He was stable and his condition improved at the time of discharge. Final outcome of the events was reported as complete recovery as 22 May 2013. No further information about causality and seriousness was reported.
Age: 27.0
Sex: F
Vaccine: MNQ
Symptoms: Petechiae
Clinical narrative: Case number PHHY2013US084186 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 492559) website on 06 Aug 2013: This report refers to a 27-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A11077) intramuscularly in to the left arm on 21 May 2013. On 23 May 2013, she experienced pin-point, red dots on stomach and legs. They appeared within days of immunization and were still present at the time of reporting but her condition was improving as on 27 May 2013. No other symptoms were reported. No further information about causality and seriousness was reported.
Age: 42.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia, Wheezing
Clinical narrative: Case number PHHY2013US117179 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 493005) on 15 Oct 2013: This report refers to a 42-year-old female patient. Medical history included diabetes and concomitant medication included PROZAC. She was vaccinated with a meningococcal vaccine (manufacturer and batch number: unknown, therefore conservatively taken as MENVEO INN) along with a pneumococcal vaccine (other manufacturer, batch number: unknown) on 30 May 2013. On 01 Jun 2013, she experienced wheezing in evening that was relieved with inhaler, chills and fever (onset approximately 11 p.m.). The reaction continued through to the next day with low fever, body aches, sweats and chills. The event outcome was condition unchanged as of 01 Jun 2013. No further information about seriousness and causality was reported.
Sex: M
Vaccine: HEPA, HPVX, MNQ, TDAP, VARCEL
Symptoms: Nodule
Clinical narrative: Case number PHHY2013US117183, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 493130) website on 15 OCT 2013. This report refers to a 12-year-old male patient. The patient was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported, so conservatively coded as MENVEO INN), hepatitis A (manufacturer and batch number: not reported), human papilloma virus vaccine (manufacturer and batch number, not reported) and varicella zoster virus vaccine (manufacturer and batch number: not reported) on 10 APR 2013. On the same date, after vaccinations he had a large, egg sized knot on right deltoid. IT was reported that the knot was almost there for 2 months after vaccination. The outcome of the event reported as not recovered. The seriousness and causality of the event were not reported.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema, Pruritus, Tenderness
Clinical narrative: Case number PHHY2013US097242, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 493157) website on 05 Sep 2013. This report refers to a 11-year-old male patient. He was vaccinated with MENVEO (batch number: A11081) via intramuscular route in the left arm and ADACEL (other manufacturer, batch number: 04421AA) via intramuscular route in the right arm on 20 May 2013. On 23 May 2013, the patient experienced redness, edema, itching and tenderness over an area of 4 cm (unspecified site). The outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUN3, HEPA, HPVX, MNQ
Symptoms: Abdominal pain, Cough, Decreased appetite, Dizziness, Headache
Clinical narrative: Case number PHHY2013US117185, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 493882) website on 15 OCT 2013. This report refers to a 12-year old female patient. Medical history included eczema throughout life. Her diet does not include eggs, dairy products and meats except poultry. Concomitant drugs included sulfamethoxazole which was given few weeks later with Probiotic. She was vaccinated with Meningococcal vaccine (manufacturer and batch number: not reported, so conservatively coded as Menveo INN), FLUMIST (batch number: not reported); Hepatitis A (manufacturer and batch number: not reported) and HPV (batch number: not reported) on 15 JAN 2013. On the same date, after vaccinations she experienced abdominal pain, headache, congestion, cough, runny nose, dizziness, loss of appetite and ringing in the ears. It was reported that the events continued with only two weeks of relief at times. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUN3, HEPA, HPVX, MNQ
Symptoms: Respiratory tract congestion, Rhinorrhoea, Tinnitus
Clinical narrative: Case number PHHY2013US117185, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 493882) website on 15 OCT 2013. This report refers to a 12-year old female patient. Medical history included eczema throughout life. Her diet does not include eggs, dairy products and meats except poultry. Concomitant drugs included sulfamethoxazole which was given few weeks later with Probiotic. She was vaccinated with Meningococcal vaccine (manufacturer and batch number: not reported, so conservatively coded as Menveo INN), FLUMIST (batch number: not reported); Hepatitis A (manufacturer and batch number: not reported) and HPV (batch number: not reported) on 15 JAN 2013. On the same date, after vaccinations she experienced abdominal pain, headache, congestion, cough, runny nose, dizziness, loss of appetite and ringing in the ears. It was reported that the events continued with only two weeks of relief at times. The seriousness and causality of the events were not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pain, Rash, Swelling
Clinical narrative: Case number PHHY2013US097158 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 493966) 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: A011081) in the left arm deltoid on 10 Jun 2013. On 11 Jun 2013, he had pain in his left deltoid. It was reported that while training for wrestling and boxing, he was on floor off and on. The rash started approximately at 12:30 pm. It was reported that he had swelling which was worse. He went to emergency room. He took ADVIL due to pain and was treated with ice pack. He was advised to take CLARITIN 10 mg once daily. The outcome was reported as condition unchanged. The seriousness and causality of the events was not assessed.
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Case number PHHY2013US083966, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS Ref: 494001) web site on 06 Aug 2013: This report refers to 10-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO and BOOSTRIX (batch number: AC52B071AA) both intramuscularly into left arm on 10 Jun 2013. On 11 Jun 2013, she developed red, swollen, itchy arm. Redness and swelling wrapping around the arm. Outcome of the event was complete recovery. Seriousness and causality assessment was not reported.
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Insomnia, Neck pain
Clinical narrative: Case number PHHY2013US117190, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 494272) website on 15 Oct 2013. On 16 Jun 2013, she had pain in elbow joints, severe pain in neck and inability to sleep. Her pain was worse when lying down. She took ADVIL. The outcome of the events reported as not recovered. The seriousness and causality of the events were not reported.
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2013US117192, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 494310) website on 15 OCT 2013. This report refers to a 11-year-old patient. He was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported, so conservatively coded as MENVEO INN) in the right arm and GARDASIL (batch number: not reported, other manufacturer) in the left arm, intramuscularly on 24 MAR 2013. It was reported that both the vaccines were exposed to temperature of 26 Fahrenheit for a total of 135 hours. No adverse effects reported. It was reported that the patient did not seek any medical attention.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Case number PHHY2013US097399, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 494824) website on 05 SEP 2013. This report refers to a 14-year-old female patient. She was vaccinated with MENVEO (batch number: A11081) in the left arm on 19 JUN 2013. On 20 JUN 2013, she experienced localized mild erythema and hive-like swelling. She had no fever or pain. The outcome of the events reported as not recovered. The seriousness and causality of the events were not reported.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHHY2013YS097414, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 494851) website on 05 SEP 2013. This report refers to a 18-year-old male patient. His medical history was not reported. On an unknown date, the patient was accidentally vaccinated with only MenCYW-135 liquid component of MENVEO (batch number: X11041) and did not receive Men A lyophilized conjugate. It was reported that the patient did not experience any adverse event after the maladministration. No other information was available.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Lymph gland infection, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2013US117196 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 494865) website on 15 Oct 2013. This report refers to a 12-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with meningococcal vaccine (manufacturer and batch number unknown, hence conservatively coded with MENVEO INN) and TDAP (manufacturer and batch number unknown) on 19 Jun 2013. On the same day, he experienced pain in the arm, swelling under the arm and weakness. He was diagnosed with infection with lymph nodes after visiting emergency room. Outcome of the events was reported as not recovered as of 23 Jun 2013. No seriousness and causality was reported for the events.
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Muscle twitching
Clinical narrative: Case number PHHY2013US110855 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 495216) website on 04 Oct 2013. This report refers to an 18-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M1107Z) intramuscularly on 19 Jun 2013. On 20 Jun 2013, he experienced swelling, tenderness, redness of muscle site where he received the vaccine. His muscle also felt like it was twitching but his mother could not see anything. He received ibuprofen and symptoms were resolved as of 24 Jun 2013. He had no fever. No causality and seriousness of the events were reported.
Age: 16.0
Sex: M
Vaccine: HPVX, MNQ
Symptoms: Asthenia, Chills, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Case number PHHY2013US117199 is an initial report received via vaccine adverse event reporting system (VAERS reference number: 495453) on 15 Oct 2013. This report refers to a 16-year-old male patient. His medical history was not reported and concomitant medications included BACTRIM. He was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported hence conservatively taken as MENVEO INN) and human papilloma virus vaccine (other manufacturer, batch number: not reported) on 19 Jun 2013. On 20 Jun 2013, he had fever with a body temperature of 102.3, chills, sweats, nausea, dizziness and weakness. The outcome of the events was reported as complete recovery.
Age: 16.0
Sex: M
Vaccine: HPVX, MNQ
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2013US117199 is an initial report received via vaccine adverse event reporting system (VAERS reference number: 495453) on 15 Oct 2013. This report refers to a 16-year-old male patient. His medical history was not reported and concomitant medications included BACTRIM. He was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported hence conservatively taken as MENVEO INN) and human papilloma virus vaccine (other manufacturer, batch number: not reported) on 19 Jun 2013. On 20 Jun 2013, he had fever with a body temperature of 102.3, chills, sweats, nausea, dizziness and weakness. The outcome of the events was reported as complete recovery.
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: Case number PHHY2013US110739 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 495600) website received on 04 Oct 2013. This report refers to a 12-year-old male patient. The patient had no known allergies in the past. The patient was vaccinated with MENVEO (batch number: M12113) in the right arm on 19 Jun 2013. On 20 Jun 2013, after vaccination he experienced redness, pain/warm to touch and 9 x 10 cm of induration. The patient visited the emergency room. The outcome of the events reported as recovered on an unknown date. The seriousness and causality of the events were not reported.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Case number PHHY2013US110745 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 495815) website on 04 OCT 2013. This report refers to 22-year-old male patient. The patient was vaccinated with MENVEO (batch number: M11032) intramuscularly in the left arm on 28 JUN 2013. On 30 JUN 2013, he noticed hives on his upper body and arms, it was also reported that he was out of town over the weekend and said he had spent time in the hotel's pool. He was recommended BENADRYL 25 mg QID. The patient has not taken anything for hives. The outcome of the event reported as recovered on an unknown date. The seriousness and causality of the events were not reported.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Ear pain, Headache, Limb discomfort, Oropharyngeal pain, Pain in jaw
Clinical narrative: Case number PHHY2013US110752 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 495905) website on 04 Oct 2013. This report refers to an 18-year-old female patient. Her medical history included seasonal allergies. The patient was vaccinated with MENVEO, (batch number: A12025) and VARIVAX, (batch number: H019521) in the left arm on 01 Jul 2013. She also received HAVRIX in the right arm on the same date. On the same date, after vaccinations she felt her left arm like dead weight. She developed a sore throat with shooting pain on left side of jaw and had left ear pain. She also developed headache. She visited the emergency room. It was reported that the arm symptoms resolved in 24 hours and outcome of other events reported as condition unchanged as of 05 Jul 2013. The seriousness and causality of the events were not reported.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Eyelid disorder, Headache, Hypoaesthesia, Vision blurred, Vomiting
Clinical narrative: Case number PHHY2013US110785 is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 496059) website on 04 Oct 2013. This report refers to a 22-year-old female patient . She was vaccinated with MENVEO (batch number: 094534) on 02 Jul 2013. On the same date, after vaccination the patient had headache and vomiting. On an unknown date, after vaccination she experienced numbness that started in her left side of face then moved to her right side, also had blurred vision and trouble blinking. The patient visited the emergency room. The outcome of the events reported as not recovered as of 06 Jul 2013. The seriousness and causality were not reported.
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Nodule, Tenderness
Clinical narrative: Case number PHHY2013US110813 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496381) website on 04 OCT 2013. This report refers to a 15-year-old female patient. On 21 JUN 2013, she was vaccinated with MENVEO (ACYW-135, batch number: M12026) intramuscularly in the right arm. GARDASIL (batch number: H021608) intramuscularly in the right arm, VAQTA (batch number H019104) intramuscularly in the left arm and BOOSTRIX (batch number AC52B09FA) intramuscularly in the left arm. On the same date in the evening, after vaccinations she experienced tenderness in right arm pit area which progressed to a nodule (3mm solitary node) in right axilla. The patient visited the emergency room. She was prescribed with antibiotics on 26-JUN-2013. The outcome of the events reported as recovered as 09-JUL-2013.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Heart rate increased, Hypoaesthesia
Clinical narrative: Case number PHHY2013US110790 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 497075) website on 04 Oct 2013. This report refers to a 20-year-old male patient. He was vaccinated with MENVEO (batch number: M12095) intramuscularly into left arm on 27 Jul 2013. On the same day, after vaccination, he had numbness to left arm, headaches, and fast pulse. His mother took him to the emergency room and was told to apply some cool compresses and take pain medications. His mother was advised to take the patient to the physician if he had any concerns. Outcome of the events was reported as not recovered as of 17 Jul 2013. No causality and seriousness were reported.
Age: 13.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHHY2013US110844 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 497458) website on 04 Oct 2013. This report refers to a 13-year-old male patient. He had requested for MENVEO (batch number: M11042) and VARIVAX (other manufacturer, batch number: H016715) vaccines, but instead he was provided MMR II. On 22 Jul 2013, he was vaccinated with MMR II (other manufacturer, batch number: 0496AE) subcutaneously in the left arm. No adverse event was reported following this administration error.
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dyskinesia, Gait disturbance
Clinical narrative: Case number PHHY2013US110749, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 497839) website on 04 OCT 2013. This report refers to 11-year-old male patient. His medical history included asthma and his concomitant medications included antibiotics and medications for treatment of asthma. He was vaccinated with MENVEO (batch number: M11051) intramuscularly into left arm, ADACEL (batch number: C4247AA) intramuscularly in the left arm and GARDASIL (batch number: H020002) intramuscularly in the right arm on 17 JUL 2013. One minute post vaccination, his injected arms were jerking and had some legs limping. He was lowered to floor and cool cloth was put on the forehead. After awaking, he did not recall the incident and he left the ambulatory with mom. He was alert and oriented twenty minutes post activity. The event outcome was reported completely recovered. The seriousness and causality was not reported.
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Case number PHHY2013US110751 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 497842) website on 04 OCT 2013. The report refers to 11-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: A12083) in the right arm and BOOSTRIX (batch number: AC52B092DA) in the left arm on 22 JUL 2013. On the same day of vaccination , he experienced swelling (unspecified site), erythema and pruritus. It was reported that there was no pain or fever. He visited the emergency room. The event outcome was reported as completely recovered. The seriousness and causality was not reported. No additional information was available.
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Hyperhidrosis, Malaise, Pallor, Vomiting
Clinical narrative: Case number PHHY2013US110762, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 498159) website on 04 OCT 2013. This report refers to a 12-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M11052) and GARDASIL (other manufacturer, batch number: 0555AE) both intramuscularly in the left arm and HAVRIX (other manufacturer, batch number: AHAVB692AA) and ADACEL (other manufacturer,  batch number: U4383AA) both intramuscularly in the right arm and VARIVAX (other manufacturer, batch number: H014193) subcutaneously in the right arm on 31 JUL 2013. Shortly after vaccination with GARDASIL, she reported that she was not feeling well and her skin color was pale. She was slightly coherent, perspiring and vomiting. The nurse helped her to sit back in the chair and cold wet cloth was applied on back of her neck. As per her mother, she vomited all milk that had consumed. The nurse requested mother to giver her a well-balanced meal with plenty of fluids before next appointment. Mother stated all of her sisters do the same thing when getting vaccination. The patient recovered on same day. The seriousness and causality were not reported. No additional information was available.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Chest X-ray normal, Dyspnoea, Electrocardiogram normal, Respiratory tract congestion
Clinical narrative: Case number PHHY2013US127746 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 498278) website on 11 Nov 2013. This report refers to a 17-year-old male patient. His medical history and concomitant medication were not reported. He was previously vaccinated with MENVEO on 09 Jul 2007. He was vaccinated with MENVEO (batch number: A12131) intramusuclarly into left arm on 29 Jul 2013. On the same day, after vaccination, he developed chest congestion and shortness of breath in the evening. At 5 pm, he worked out with lifting and ate only soup that evening. On 30 Jul 2013, he had chest X-ray which was negative and electrocardiogram which was within normal limits. Outcome of the events was reported as recovered as of 01 Aug 2013. No seriousness and causality was reported for the events.
Age: 1.5
Sex: F
Vaccine: FLUX, HIBV, IPV, MNQ
Symptoms: Irritability, Rhinorrhoea, Somnolence
Clinical narrative: Case number PHHY2013YS110764 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System website (reference number: 498285) on 04 OCT 2013. This report refers to a 1.5 year-old female infant. Her medical history was not reported. Her concomitant medication included TYLENOL 3.75 ml. She was vaccinated with   MENVEO (batch number unknown) along with hemophilus influenza B (manufacturer and batch number unknown) and with inactivated polio virus (manufacturer and batch number unknown) on 01 AUG 2013. All the vaccines were administered in the leg. On the same day after vaccinations, the child took a prolonged nap which was more than normal for her. She woke up very irritable and cranky. She had continued fussiness and runny nose. Final outcome of the events was reported as condition unchanged as on 01 AUG 2013. No further information about seriousness and causality was provided.