chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Case number PHHY2014US051390, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, VAERS reference number: 518753) website on 24 Apr 2014. This report refers to a 5-year-old female patient. Past medical history included recurrent otitis media, requiring placement of tympanostomy tubes, asthma, leg pain and headache. She also had chronic splenomegaly, sickle cell anemia, low grade fever, urticarial response to fire and bites and allergies to dust, mold, mildew and cockroaches. Her vaccination history included administration of four doses of PREVNAR 7 (other manufacturer, batch number: unknown), one dose of PREVNAR 13 (batch number: unknown), hepatitis B vaccine (other manufacturer, batch number: unknown) and seasonal influenza vaccine (unknown manufacturer, batch number: unknown) and seasonal influenza vaccine (unknown manufacturer, batch number: unknown) (see case: PHHY2014US051803). She usually developed a low grade fever after receiving these vaccines. Two and a half years earlier she was vaccinated with PNEUMOVAX (other manufacturer, batch number: unknown) and six months prior she was vaccinated with one dose  of meningococcal vaccine (manufacturer and batch number unknown). On the same day she received again PNEUMOVAX in her right arm and meningococcal vaccine in her left arm. On the same day after vaccination, she experienced an unusual severe local reaction to PNEUMOVAX and her right arm was swollen, red and painful. She had experienced fever and nausea. In the morning of the next day, she experienced pain in her head and neck. Her body temperature was 102.9 degrees F. She administered ibuprofen. 10 h later body temperature was 101.3 degrees F. She went to the Hematology clinic where she received ketorolac for pain and ondansetron for nausea. Upon examination it was noted that the right arm was tender and swollen. She received one dose of IV ceftriaxone, but blood culture was subsequently negative. She was discharged from the clinic with ibuprofen and morphine. The swelling in the right arm resolved at home within 24 h. The final outcome of the events was complete recovery. The reporter stated that immune reactions she experienced after administering PNEUMOVAX were amplified by the meningococcal vaccine administered concurrently.
Age: 5.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Nausea, Neck pain, Pyrexia
Clinical narrative: Case number PHHY2014US051390, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, VAERS reference number: 518753) website on 24 Apr 2014. This report refers to a 5-year-old female patient. Past medical history included recurrent otitis media, requiring placement of tympanostomy tubes, asthma, leg pain and headache. She also had chronic splenomegaly, sickle cell anemia, low grade fever, urticarial response to fire and bites and allergies to dust, mold, mildew and cockroaches. Her vaccination history included administration of four doses of PREVNAR 7 (other manufacturer, batch number: unknown), one dose of PREVNAR 13 (batch number: unknown), hepatitis B vaccine (other manufacturer, batch number: unknown) and seasonal influenza vaccine (unknown manufacturer, batch number: unknown) and seasonal influenza vaccine (unknown manufacturer, batch number: unknown) (see case: PHHY2014US051803). She usually developed a low grade fever after receiving these vaccines. Two and a half years earlier she was vaccinated with PNEUMOVAX (other manufacturer, batch number: unknown) and six months prior she was vaccinated with one dose  of meningococcal vaccine (manufacturer and batch number unknown). On the same day she received again PNEUMOVAX in her right arm and meningococcal vaccine in her left arm. On the same day after vaccination, she experienced an unusual severe local reaction to PNEUMOVAX and her right arm was swollen, red and painful. She had experienced fever and nausea. In the morning of the next day, she experienced pain in her head and neck. Her body temperature was 102.9 degrees F. She administered ibuprofen. 10 h later body temperature was 101.3 degrees F. She went to the Hematology clinic where she received ketorolac for pain and ondansetron for nausea. Upon examination it was noted that the right arm was tender and swollen. She received one dose of IV ceftriaxone, but blood culture was subsequently negative. She was discharged from the clinic with ibuprofen and morphine. The swelling in the right arm resolved at home within 24 h. The final outcome of the events was complete recovery. The reporter stated that immune reactions she experienced after administering PNEUMOVAX were amplified by the meningococcal vaccine administered concurrently.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea, Vomiting
Clinical narrative: Case number PHHY2014US047078 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518946) website on 14 Apr 2014. This report refers to a 19-year-old male patient. His medical history included ADHD. Concomitant drugs included ibuprofen and STATTERA. He was vaccination with MENVEO (batch number: M12119) in the left arm on 06 Jan 2014. On 07 Jan 201, 24 hours after vaccination he experienced nausea, vomiting, and swelling, hot to touch and redness at site. The patient visited the emergency room. The final outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Discomfort, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Case number PHHY2014US029503 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 519114) on 06 Mar 2014. This report refers to an 11-year-old male patient. Past medical history and concomitant medication were not reported. His dad had a history of similar effect with Tetanus shot. He was vaccinated with MENVEO, (batch number: M13012) intramuscularly into left arm on 08 Jan 2014. On the same day, he was also vaccinated with FLUZONE, (batch number: UH907AD) intramuscularly into left arm and GARDASIL, (batch number: J012212) intramuscularly into right arm. On 09 Jan 2014, one day after vaccinations, he developed increasing erythema, edema and pain to (L) deltoid and went to emergency room (ER) for evaluation. Treatment with ibuprofen, ice and BENADRYL was recommended and was taken. On 10 Jan 2014 during follow-up visit in clinic, erythema, edema and discomfort increased. On 11 Jan 2014 during follow-up visit in clinic, edema and redness extended to (L) elbow. Treatment with KEFLEX thrice daily was started orally. He played a basketball game on 11 Jan 2014 and his mom reported on 13 Jan 2014 that it was much better. Final outcome of the events was recovered. Seriousness and causality of the events was not reported.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Case number PHHY2014US048750 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 519625) on 14 Apr 2014: This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M11051) intramuscularly in to the left arm along with HAVRIX (other manufacturer, batch number: YG4XA) intramuscularly in to right arm on 15 Jan 2014. On 16 Jan 2014, she experienced localized redness, swelling, itching and warmth at an unknown site. Treatment was rendered with cold compress, BENADRYL and MOTRIN. Outcome of the events was reported as complete recovery. Events were assessed as non-serious by the reporter. No further information about causality was reported.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Burning sensation, Pain in extremity, Rash generalised, Rash maculo-papular
Clinical narrative: Case number PHHY2014US046658 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 519693) web site on 14 Apr 2014. This report refers to an 11 year old male patient. His medical history included NAFLD and obesity. His concomitant medications included ibuprofen. He was vaccinated with MENVEO (batch number: A12100) and BOOSTRIX (other manufacturer, batch number: AC52B092FA) both vaccines administered in the left arm and GARDASIL (other manufacturer, batch number: J006236) in the right arm on 06 Jan 2014. On 07 Jan 2014, he had generalized maculopapular rash and pain/burning on the bottom of feet. He had no treatment and would have a follow up visit on 16 Jan 2014. The outcome was reported as complete recovery. The event was reported as non serious, however was internally assessed as medically significant by MAH. The causality was not reported.
Age: 25.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain upper, Anxiety, Pyrexia, Rash, Vomiting
Clinical narrative: Case number PHHY2014US049361 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 519844) on 14 Apr 2014: This report refers to a 25-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13051) intramuscularly in to the right arm on 17 Jan 2014. On 18 Jan 2014, she had rash on her right side of the body; she was vomiting and developed a fever and had stomach pains. She also had feeling of anxiety and freaked out about every little thing and she had never had a history of anxiety. No treatment was given till the time of reporting but she planned on seeing a doctor. Outcome of the events was reported as unknown. Events were assessed as non-serious by the reporter. No further information about causality was reported.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Case number PHHY2014US0470855 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 519871) website on 14 Apr 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: X13012) in the right arm on 16 Jan 2014. Concomitant on the same date, he also vaccinated with GARDASIL (batch number: J012212) in the left arm and BOOSTRIX (batch number: 93279) in the left arm on 16 Jan 2014. On 18 Jan 2014, he experienced 4 cm warm and pierchic red in the right arm (local reaction around injection site). The outcome of the events was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported. No additional information was available.
Age: 13.0
Sex: F
Vaccine: HPV2, MNQ
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Case number PHHY2014US043030 is an initial spontaneous report received from a nurse via the vaccine adverse event reporting system (VAERS reference number: 520605) web site on 08 Apr 2014 with a follow up report received from the VAERS on 13 Nov 2014. This report refers to a 13 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12128) intramuscularly into right arm and first dose of CERVARIX (other manufacturer, batch number: AHPVA174BJ) into left arm on 12 Jul 2013. On 13 Jul 2013, she felt really bad and had fever at a body temperature of 101.5 degrees Fahrenheit. She felt really bad and the issues have progressed over the weekend. On 14 July 2013 in the morning, she experienced fatigue, headache and myalgia. On 14 Jul 2013, she experienced premature onset of menstruation and sore throat. Reporter stated that the subject had a regular menses cycle of one week that ended on 4 Jul 2013 but began again on 14 Jul 2013. On an unknown date after vaccination, she experienced arthralgia, injection site pain, injection site redness and swelling injection site. On 15 Jul 2013, she visited a physician for medical support. The outcome of the event was reported as condition unchanged. The events were reported as non-serious. The causality was not reported. The nurse was considering whether the second and third injections of the series should be continued or not. Follow up report received from the VAERS on 13 Nov 2014: Added event and updated outcome.
Age: 13.0
Sex: F
Vaccine: HPV2, MNQ
Symptoms: Injection site swelling, Menstruation irregular, Myalgia
Clinical narrative: Case number PHHY2014US043030 is an initial spontaneous report received from a nurse via the vaccine adverse event reporting system (VAERS reference number: 520605) web site on 08 Apr 2014 with a follow up report received from the VAERS on 13 Nov 2014. This report refers to a 13 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12128) intramuscularly into right arm and first dose of CERVARIX (other manufacturer, batch number: AHPVA174BJ) into left arm on 12 Jul 2013. On 13 Jul 2013, she felt really bad and had fever at a body temperature of 101.5 degrees Fahrenheit. She felt really bad and the issues have progressed over the weekend. On 14 July 2013 in the morning, she experienced fatigue, headache and myalgia. On 14 Jul 2013, she experienced premature onset of menstruation and sore throat. Reporter stated that the subject had a regular menses cycle of one week that ended on 4 Jul 2013 but began again on 14 Jul 2013. On an unknown date after vaccination, she experienced arthralgia, injection site pain, injection site redness and swelling injection site. On 15 Jul 2013, she visited a physician for medical support. The outcome of the event was reported as condition unchanged. The events were reported as non-serious. The causality was not reported. The nurse was considering whether the second and third injections of the series should be continued or not. Follow up report received from the VAERS on 13 Nov 2014: Added event and updated outcome.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Abdominal pain upper, Activities of daily living impaired, Erythema, Headache, Pain in extremity
Clinical narrative: Case number PHHY2014US043686, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520708) website on 08 Apr 2014. This report refers to a 11-year-old female patient. Her medical history included allergy to sulfates, parabens and latex. She was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported, so conservatively coded as MENVEO INN) along with hepatitis A vaccine (other manufacturer, batch number: not reported)) on 22 Jan 2014. On the same date, she also received TDAP (other manufacturer, batch number: not reported) in the right arm. On the same date, after vaccination she experienced huge swollen lump on arm, about the size of a large baseball (width) which was purple, red, achy, sore and painful to touch. She also had fever, headache, tummy ache, possible diarrhea and had to leave school early the day after. The outcome, seriousness and causality of the events were not reported.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Pyrexia, Skin discolouration, Tenderness, Upper extremity mass
Clinical narrative: Case number PHHY2014US043686, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520708) website on 08 Apr 2014. This report refers to a 11-year-old female patient. Her medical history included allergy to sulfates, parabens and latex. She was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported, so conservatively coded as MENVEO INN) along with hepatitis A vaccine (other manufacturer, batch number: not reported)) on 22 Jan 2014. On the same date, she also received TDAP (other manufacturer, batch number: not reported) in the right arm. On the same date, after vaccination she experienced huge swollen lump on arm, about the size of a large baseball (width) which was purple, red, achy, sore and painful to touch. She also had fever, headache, tummy ache, possible diarrhea and had to leave school early the day after. The outcome, seriousness and causality of the events were not reported.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Bed rest, Dizziness, Headache, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2014US043587 is an initial spontaneous report received the Vaccine Adverse Event Reporting System (VAERS, reference number: 521055) website on 08 Apr 2014. This report refers to an 11-year-old male patient. He was vaccinated with meningococcal vaccine (unknown manufacturer, batch number: not reported, hence conservatively coded as MENVO INN) on 21 Jan 2014. On 23 Jan 2014, three days after vaccination, he experienced fever, headaches, vomiting and dizzy. He was treated mostly with bed rest, limited ibuprofen for headache. The events were reported as non-serious. Outcome of the events was reported as recovered. Causality of the events were not reported.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Rash papular
Clinical narrative: Case number PHHY2014US047190, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521806) website on 14 Apr 2014. This report refers to a 16 year old female patient. Her past medical history included asthma and eczema. Her concomitant medication included PEPCID. She was vaccinated with MENVEO (batch number: M12104) intramuscularly into her left arm on 29 Jan 2014. On the same day, she had itching of the arm where the vaccine was administered and at 04:00 PM, she had a fine popular rash up and down the arm. She visited the emergency room on an unspecified date. She was treated with BENADRYL. She completely recovered from the events on an unspecified date. The events were reported as non-serious and the causality of the events was not reported.
Age: 41.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Pain, Spinal pain
Clinical narrative: Case number PHHY2014US071025, is an initial spontaneous report from a consumer (patient mother) via Vaccine adverse event reporting website (VAERS id: 521832) received on 09 Jun 2014. This report refers to a 41 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: A11077) intramuscular on 28 Jan 2014. On 29 Jan 2014, she developed spine pain, chills and body pain after vaccination. Outcome of the events was recovered on 03 Feb 2014. The events were reported as non-serious. Causality of the events was not reported.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Pallor, Vomiting
Clinical narrative: Case number PHHY2014US051354 is an initial spontaneous report received from a physician via vaccine adverse event reporting system (VAERS ID: 521965) on 24 Apr 2014. This report refers to a 14-years-old male patient. He had no medical history and concomitant medications. He was vaccinated with meningococcal polysaccharide vaccine (manufacturer and batch number: not reported) and GARDASIL (other manufacturer, batch number: not reported) on an unknown date in 2014. On the same day after vaccination, he began to vomit and became lightheaded and pale. He sought medical attention in the office and no treatment was given for the adverse event. No lab diagnosis was performed. The event outcome was reported as complete recovery on the same day. The event was reported non-serious. The causality was not reported. The physician reported that the patient might not continue with the GARDASIL series. The physician also reported that the patient had not consumed an adequate amount of fluid before vaccination with GARDASIL.
Age: 17.0
Sex: F
Vaccine: HIBV, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHHY2014US056475 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522087) website on 06 May 2014. This report refers to a 17-year-old female patient. Her medical history was not reported and concomitant vaccination included ADACEL (other manufacturer, batch number: U4384AA) intramuscularly in the left arm on 05 Feb 2014. It was reported that on 05 Feb 2014, she was inadvertently given PEDVAX-HIB (other manufacturer, batch number: J008091) intramuscularly in the right arm instead of MENVEO (batch number: not reported). The event was reported as non-serious. No adverse events were reported following the maladministration.
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: Back pain, Cold sweat, Device colour issue, Dyspnoea, Hyperhidrosis
Clinical narrative: Case number PHHY2014US054726 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522617) web site on 06 May 2014. This report refers to a 39 year old male patient. His medical history included cerebral palsy. Concomitant medication was not reported. He was vaccinated with MENVEO (batch number: A13011) intramuscularly into left arm on 27 Jan 2014. On 07 Feb 2014, he experienced hot and cold sweats, fever on and off (not measured), neck and back pain, consistent weakness of all limbs especially left arm, stiff neck, some difficulty in breathing and shortness of breath, white of eyes changed to slight blue, excess thirst, tingling of joints and clammy feeling. She was taken to emergency room for medical support. The outcome and causality of the events were not reported. The events were reported as non-serious.
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: Muscular weakness, Musculoskeletal stiffness, Neck pain, Paraesthesia, Pyrexia
Clinical narrative: Case number PHHY2014US054726 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522617) web site on 06 May 2014. This report refers to a 39 year old male patient. His medical history included cerebral palsy. Concomitant medication was not reported. He was vaccinated with MENVEO (batch number: A13011) intramuscularly into left arm on 27 Jan 2014. On 07 Feb 2014, he experienced hot and cold sweats, fever on and off (not measured), neck and back pain, consistent weakness of all limbs especially left arm, stiff neck, some difficulty in breathing and shortness of breath, white of eyes changed to slight blue, excess thirst, tingling of joints and clammy feeling. She was taken to emergency room for medical support. The outcome and causality of the events were not reported. The events were reported as non-serious.
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: Thirst
Clinical narrative: Case number PHHY2014US054726 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522617) web site on 06 May 2014. This report refers to a 39 year old male patient. His medical history included cerebral palsy. Concomitant medication was not reported. He was vaccinated with MENVEO (batch number: A13011) intramuscularly into left arm on 27 Jan 2014. On 07 Feb 2014, he experienced hot and cold sweats, fever on and off (not measured), neck and back pain, consistent weakness of all limbs especially left arm, stiff neck, some difficulty in breathing and shortness of breath, white of eyes changed to slight blue, excess thirst, tingling of joints and clammy feeling. She was taken to emergency room for medical support. The outcome and causality of the events were not reported. The events were reported as non-serious.
Age: 24.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Erythema, Fatigue, Musculoskeletal stiffness, Nausea
Clinical narrative: Case number PHHY2014US055868, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524198) website on 06 May 2014. This report refers to a 24-year-old female patient. Past medical history was not reported. Concomitant medications included BENADRYL, TYLENOL and Cool compress. She was vaccinated with MENVEO (batch number: M12102), along with ADACEL (other manufacturer, batch number: C4497AA) intramuscularly into the right arm on 25 Feb 2014. On 26 Feb 2014, she experienced redness, soreness in arm, tired, dizzy, nausea and stiffness. The final outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 24.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US055868, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524198) website on 06 May 2014. This report refers to a 24-year-old female patient. Past medical history was not reported. Concomitant medications included BENADRYL, TYLENOL and Cool compress. She was vaccinated with MENVEO (batch number: M12102), along with ADACEL (other manufacturer, batch number: C4497AA) intramuscularly into the right arm on 25 Feb 2014. On 26 Feb 2014, she experienced redness, soreness in arm, tired, dizzy, nausea and stiffness. The final outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Dizziness, Hyporesponsive to stimuli, Unresponsive to stimuli
Clinical narrative: Case number PHHY2014US055873, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524205) website on 06 May 2014. This report refers to an 11-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with MENVEO, (batch number: 13012), along with FLUZONE, (batch number: UH949AB) intramuscularly into the left arm and GARDASIL, (batch number: J008423) intramuscularly into the right arm on 27 Feb 2014. On the same day about five to eight minutes after vaccination, he became lightheaded and was less verbally responsive. He was place din supine position, eyes closed not verbally responsive for one to two minutes. Gradually he felt better, verbally responsive and all symptoms resolved within 15 minutes. The final outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Lymphadenopathy, Upper respiratory tract infection
Clinical narrative: Case number PHHY2014US071262 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524450) website on 09 Jun 2014. This report refers to an 11-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A13050) intramuscularly in the right arm and BOOSTRIX (other manufacturer, batch number: 253B4) intramuscularly in the left arm on 11 Feb 2014. On 12 Feb 2014, she developed approximately a baseball area of redness of right arm after receiving vaccines. She also had increased body temperature of 99 degree F and swollen glands at the same time. She developed upper respiratory infection symptoms, 1-2 days later. She was not given any treatment. Her mother reported the physician on 27 Feb 2014 regarding the events. The event outcome was reported as complete recovery. The events were reported as non-serious and the causality was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site vesicles
Clinical narrative: Case number PHEH2014US105615 is an initial spontaneous report from the nurse received on 18 MAR 2014. This report refers to a 11-year-old male patient. He was vaccinated with MENVEO (batch number: not reported) intramuscularly on 04 MAR 2014. On the same date, after vaccination he experienced local reaction at the MENVEO injection site consisting of lesions and vesicles with complaints of itching, burning and swelling. The patient was treated with steroid cream and the reactions were completely healed at the time of the report. The seriousness and causality of the events were not reported. Non-significant follow up report received from physician on 11 APR 2014: Physician requested for patient information.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Local reaction, Skin lesion
Clinical narrative: Case number PHEH2014US105615 is an initial spontaneous report from the nurse received on 18 MAR 2014. This report refers to a 11-year-old male patient. He was vaccinated with MENVEO (batch number: not reported) intramuscularly on 04 MAR 2014. On the same date, after vaccination he experienced local reaction at the MENVEO injection site consisting of lesions and vesicles with complaints of itching, burning and swelling. The patient was treated with steroid cream and the reactions were completely healed at the time of the report. The seriousness and causality of the events were not reported. Non-significant follow up report received from physician on 11 APR 2014: Physician requested for patient information.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injection site discharge, Injection site swelling
Clinical narrative: Case number PHEH2014US105615 is an initial spontaneous report from the nurse received on 18 MAR 2014. This report refers to a 11-year-old male patient. He was vaccinated with MENVEO (batch number: not reported) intramuscularly on 04 MAR 2014. On the same date, after vaccination he experienced local reaction at the MENVEO injection site consisting of lesions and vesicles with complaints of itching, burning and swelling. The patient was treated with steroid cream and the reactions were completely healed at the time of the report. The seriousness and causality of the events were not reported. Non-significant follow up report received from physician on 11 APR 2014: Physician requested for patient information.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site vesicles
Clinical narrative: Case number PHHY2014US072136, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525309) website on 09 Jun 2014. This report refers to a 11-year-old male patient. His medical history included obesity and obstructive sleep apnea. His vaccination history included swollen arm due to BOOSTRIX (other manufacturer) on an unknown date (at age 10). He was vaccinated with MENVEO (batch number: M12092) intramuscularly in the left arm on 04 Mar 2014. On 06 Mar 2014, his left upper arm was swollen and it draining clear fluid. He was referred to allergist. He took BENADRYL and prednisone as treatment drugs. The outcome of the events was unknown. The events reported as non serious. The causality of the events was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Local reaction, Skin lesion
Clinical narrative: Case number PHHY2014US072136, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525309) website on 09 Jun 2014. This report refers to a 11-year-old male patient. His medical history included obesity and obstructive sleep apnea. His vaccination history included swollen arm due to BOOSTRIX (other manufacturer) on an unknown date (at age 10). He was vaccinated with MENVEO (batch number: M12092) intramuscularly in the left arm on 04 Mar 2014. On 06 Mar 2014, his left upper arm was swollen and it draining clear fluid. He was referred to allergist. He took BENADRYL and prednisone as treatment drugs. The outcome of the events was unknown. The events reported as non serious. The causality of the events was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injection site discharge, Injection site swelling
Clinical narrative: Case number PHHY2014US072136, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525309) website on 09 Jun 2014. This report refers to a 11-year-old male patient. His medical history included obesity and obstructive sleep apnea. His vaccination history included swollen arm due to BOOSTRIX (other manufacturer) on an unknown date (at age 10). He was vaccinated with MENVEO (batch number: M12092) intramuscularly in the left arm on 04 Mar 2014. On 06 Mar 2014, his left upper arm was swollen and it draining clear fluid. He was referred to allergist. He took BENADRYL and prednisone as treatment drugs. The outcome of the events was unknown. The events reported as non serious. The causality of the events was not reported.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US071911 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525563) website on 09 Jun 2014 with a follow up report received from PTC on 01 Aug 2014. This report refers to an 18 years old male patient. His medical history was not reported. Concomitant vaccination included HAVRIX (other manufacturer, batch number: AHAVB532AA) administered intramuscularly. He was vaccinated with MENVEO (batch number: not reported) intramuscularly on 26 Jan 2014. It was reported that patient received 1 mg dose instead of 0.5 ml dose. Upon follow up PTC has confirmed that the initially reported batch number did not belong to MENVEO. No adverse events were reported following the maladministration. Follow up report received from PTC on 01 Aug 2014: PTC confirmed that the batch number did not belong to MENVEO. Hence, the incorrectly reported batch number was removed.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Induration, Petechiae, Skin warm, Swelling
Clinical narrative: Case number PHHY2014US072681 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525943) website on 09 Jun 2014. This case refers to an 11-year-old male child. His medical history and concomitant medications were not reported. On 10 Mar 2014, he was vaccinated with MENVEO (batch number: A13014) along with ADACEL (other manufacturer, batch number: N435Z) intramuscularly in the left arm. Following the vaccinations, on 11 Mar 2014, his left arm was hot to touch and he had hardness and swelling over an area of 7 inches wide and 5 12/ inches long along with red spot. He had completely recovered from the events on an unknown date. The event was reported as non serious. The causality of the events was unknown.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood pressure abnormal, Bradycardia, Heart rate abnormal, Hypotension
Clinical narrative: Case number PHHY2014US070809 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 527221) website on 09 Jun 2014. This case refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. On 31 Mar 2014, she was vaccinated with MENVEO (batch number: A130155) in the left arm along with GARDASIL (other manufacturer batch number: J011272) in the right arm. Following the vaccinations, on the same date (31 Mar 2014), she experienced hypotension and bradycardia. She responded to p.o. fluid, but still experienced persisting unstable blood pressure and heart rate. She showed some response upon ambulation after an hour of monitoring. Due to the events she was transferred tot the local Emergency Department on an unknown date. The final outcome of the events was unknown. The causality of the events was not reported. The events were reported as non-serious.
Age: 13.0
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Case number PHHY2014US071728 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 527295) website on 09 Jun 2014. This report refers to a 13-year-old female patient. She was vaccinated with MENVEO (batch number: A13047) intramuscular into left arm on 28 Mar 2014. On the same day, post vaccination, she experienced left arm swelling (the size of a softball), tense, hot, red and tender at site. On the same day primary care physician was called, who assessed for anaphylaxis. No respiratory or gastrointestinal (GI) symptoms were noted. Three small nonpruritic blanching pinpoint erythematous lesions on ipsilateral trunk were reported. Advised likely large local reaction and instructed parents to ice area, give BENADRYL and ibuprofen until resolved and follow up of no improvement in 3 days or worsening at any point. She came in for reassessment 31 Mar 2014 and her arm was still slightly swollen, hot, and tender but vastly improved. The events were reported as non-serious. Final outcome of the events was reported as recovered. Causality of the events was not reported.
Age: 13.0
Sex: U
Vaccine: MNQ
Symptoms: Pallor, Rash erythematous, Tension
Clinical narrative: Case number PHHY2014US071728 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 527295) website on 09 Jun 2014. This report refers to a 13-year-old female patient. She was vaccinated with MENVEO (batch number: A13047) intramuscular into left arm on 28 Mar 2014. On the same day, post vaccination, she experienced left arm swelling (the size of a softball), tense, hot, red and tender at site. On the same day primary care physician was called, who assessed for anaphylaxis. No respiratory or gastrointestinal (GI) symptoms were noted. Three small nonpruritic blanching pinpoint erythematous lesions on ipsilateral trunk were reported. Advised likely large local reaction and instructed parents to ice area, give BENADRYL and ibuprofen until resolved and follow up of no improvement in 3 days or worsening at any point. She came in for reassessment 31 Mar 2014 and her arm was still slightly swollen, hot, and tender but vastly improved. The events were reported as non-serious. Final outcome of the events was reported as recovered. Causality of the events was not reported.
Age: 36.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHHY2014US081376 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 527961) website on 01 Jul 2014. This report refers to a 36-year-old male patient. On 05 Apr 2014, he was vaccinated with MENVEO (batch number: M12009 and expiry date: Feb 2014) intramuscularly into left arm which was expired. No adverse event was reported following this medication error. The event was reported as non-serious. No additional information was available.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Eye movement disorder, Tremor, Visual impairment
Clinical narrative: Case number PHHY2014US081386 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 527963) website on 01 Jul 2014. This report refers to a 17-year-old female patent. She was vaccinated with MENVEO (batch number: M12090) into left arm on 24 Mar 2014. Post MENVEO vaccination, she blinked/winced for pain and claimed that she was feeling weak and reported that there was nothing to eat that morning. Then she was given HAVRIX (other manufacturer and batch number: 5B23A) into left arm. Post vaccination with HAVRIX, her legs were shaking (impatient). Then she was given GARDASIL (other manufacturer and batch number: J011272) into right arm. Post GARDASIL vaccination, she claimed that she was seeing dark spots. She leaned her head against the wall (resting), held hands up (breast level) and her eyes slightly rolled back. Physician was called and order 2L or O2. She was given with a sweet (lollipop), sandwich and lie down for observation. After 30 mins, she was discharged in no distress; viral signs were checked and were within normal limit. These events were reported as non-serious. Outcome of the events was reported as recovered. Causality of the events was not reported.
Age: 54.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHHY2014US081577 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 527966) website on 01 Jul 2014. This report refers to a 54 year old male patient. He was vaccinated with an expired dose of MENVEO (batch number: M12009, expiry date: Feb 2014) intramuscularly into left arm on 05 Apr 2014. No adverse event was reported following this medication error.
Age: 34.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Erythema, Local swelling, Nausea, Pain
Clinical narrative: Case number PHHY2014US071239, is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 528082) web site received on 09 Jun 2014. This report refers to a 34-year-old female patient. Past medical history included no spleen. No concomitant medication was reported. Her vaccination history included administration of MENVEO (batch number: not reported) and Pneumococcal vaccine polyvalent (other manufacturer, batch number: not reported) seven days prior. She was vaccination with MENVEO (batch number: not reported) along with Pneumococcal vaccine polyvalent (other manufacturer, batch number: not reported) on 01 Mar 2014. On the same day 20 minutes after vaccination, she experienced nausea. On 02 Mar 2014, she developed large local swelling. Also she experienced redness and pain. The outcome of the events was completely recovery. The events were reported as non-serious. Causality was not reported.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US071777, is an initial spontaneous from Vaccine Adverse Event Reporting System (VAERS reference number: 528204) website received on 09 Jun 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: M12100) into the left arm along with GARDASIL )other manufacturer, batch number J012212), FLUMIST QUADRIVALENT (Other manufacturer, batch number: BJ2149) BOOSTRIX (other manufacturer, batch number: 932Z9) on 06 Mar 2014. It was reported that he was administered MENVEO that remained at temperature 19 in the refrigerator approximately for two hours. No adverse event was reported following this administration error.
Age: 11.0
Sex: M
Vaccine: FLUN4, HEP, HEPA, HPV4, IPV, MMRV, MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US081270, is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number: 528206) website received on 01 Jul 2014. This report refers to an 11-year-old male child. His medical history and concomitant medications were not reported. On 06 Mar 2014, he was vaccinated with MENVEO (batch number: M12100) in the right arm along with VAQTA (other manufacturer, batch number: J012768) in the left arm and ENGERIX-B (other manufacturer, batch number: AHBV190BA) in the left arm. On the same day, he was also vaccinated with GARDASIL (other manufacturer, batch number: J012212) in the right arm; FLUMIST (other manufacture, batch number 8I2149) intranasally, PROQUAD (other manufacturer, batch number: J007202) in the right arm subcutaneously, IPOL (other manufacture, batch number: J151611) in the right arm subcutaneously and BOOSTRIX (other manufacture, batch number: 932Z9) in the left arm. It was reported that the vaccine was stored in the refrigerator at a temperature below 1.9 for approximately two hours. No adverse event was reported following this administration error (inappropriate storage of drug).
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, Somnolence
Clinical narrative: Case number PHHY2014US079914, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 528879) website on 25 Jun 2014. This report refers to a male neonate of less than one year age (around 4 months). His concomitant medication included Vitamin D3 (cholecalciferol). He was vaccinated with MENVEO (manufacturer and batch number: not reported) intradermally in the arm on 25 Mar 2014. On the same date, after vaccination he experienced a brief episode of drowsiness. The patient recovered from the event. The event reported as non-serious. The causality of the event was not reported. Following an internal review, a significant correction was done for the information received on 25 Jun 2014: The product coding was changed from meningococcal general INN to meningococcal ACYW-135 vaccine.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Pallor
Clinical narrative: Case number PHHY2014US081492 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 528930) website on 01 Jul 2014. This report refers to a 13-year-old male patient. The patient was vaccinated with MENVEO (batch number: A13014) intramuscularly into right arm on 18 Apr 2013. On the same day, the patient was also vaccinated with HAVRIX (other manufacturer and batch number: A13014) and GARDASIL (other manufacturer and batch number: J012438) both intramuscularly into left arm. On the same day, post vaccinations, the patient was pale and felt light headed. The reporter laid patient on his back with his feet up and gave water and a lollipop. Patient laid on his back for 10-15 minutes. After patient feeling better, the reporter sat him up slowing and had his legs hang off the edge of the bed. Patient sat on edge of the bed for a few minutes and then the reporter asked him to stand. Patient stated he felt better. The reporter then asked the patient to sit in the lobby for a few more minutes. Patient left with no other signs or symptoms. These events were reported as non-serious. Outcome of the events was reported s recovered. Causality of the events was not reported.
Age: 10.0
Sex: U
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Headache, Pyrexia, Somnolence, Swelling, Vaccination site swelling
Clinical narrative: Case number PHHY2014US091014 is an initial spontaneous report received from a nurse via the Vaccine Adverse Event Reporting System (VAERS reference number: 529691) website on 22 Jul 2014. This report refers to a 10-year-old patient. The patient's medical history included allergy to penicillin (drug hypersensitivity) and concomitant medications were not reported. The patient was vaccinated with MENVEO (manufacturer and batch number: not reported) in the left arm deltoid on 21 Apr 2014. On the same day patient also received tetanus diphtheria acellular pertussis vaccine (manufacturer and batch number: not reported) in the left arm deltoid on 21 Apr 2014. On the same day patient also received tetanus diphtheria acellular pertussis vaccine (other manufacturer, batch number, batch number: not reported) on unknown site and VARIVAX (other manufacturer, batch number: not reported) at a dose of 0.5 ml subcutaneously in the left arm deltoid on 21 Apr 2014. On 21 Apr 2014, within 24 hours of receiving VARIVAX, the patient had high fever with a body temperature of 101.8 F, headache, vaccination site swelling. The patient was just lying around and sleeping and swelling spread under the arm. The patient sought medical attention and the physician directed to apply tea bags and ice to the area and to take BENADRYL. The event outcome was reported as condition improving. The final outcome of the events was reported as condition unchanged. The events were reported as non-serious. The causality of the event was not provided.