chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: U
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Fatigue, Headache, Injection site swelling, Pyrexia
Clinical narrative: Case number PHHY2014US092303 is an initial spontaneous report received from a nurse via vaccine adverse event reporting system (VAERS reference number: 529700) website on 22 Jul 2014. This report refers to a 10-year-old patient of an unknown gender. The patient was vaccinated with meningococcal vaccine INN (manufacturer and batch number unknown), VARIVAX (other manufacturer, batch number: unknown) subcutaneously into left arm and DTAP (other manufacturer, batch number: unknown) on 21 Apr 2014. On the same day, post vaccination, the patient experienced high fevers, headaches, injection site swelling and just lying around and sleeping. The patient sought medical attention and was seen by primary care physician and directed to apply tea bags and ice to area and take BENADRYL. The outcome of the events was not reported as recovering. The events were reported as non-serious. Causality of the events was not reported.
Age: 31.0
Sex: F
Vaccine: IPV, MNQ, PPV, TYP
Symptoms: Abdominal pain, Arthralgia, Chills, Dizziness, Fatigue
Clinical narrative: Case number PHHY2014US093025 is an initial spontaneous report received from via Vaccine Adverse Event Reporting System (VAERS reference number: 531121) web site on 22 Jul 2014. This report refers to a 31-year-old female patient. Her medical history included psoriasis, psoriatic arthritis and celiac disease. Her concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported), pneumococcal vaccine (other manufacturer, batch number: not reported), inactivated polio virus vaccine (other manufacturer, batch number: not reported) and typhoid VI polysaccharide vaccine (other manufacturer, batch number: not reported) on 16 May 2014. On the same day after vaccination, she had soreness in the vaccination site. By late evening, she experienced fatigue, swollen and sore joints, chills, low grade fever, headache, dizziness, nausea and abdominal pain. The vaccination site on the right arm developed redness and swelling on Saturday morning (date not reported) which worsened through the next day. Nausea and decreased appetite increased in the Sunday night. The final outcome of the event was reported as complete recovery. The events were reported as non-serious. The causality of the event was not reported.
Age: 31.0
Sex: F
Vaccine: IPV, MNQ, PPV, TYP
Symptoms: Headache, Injection site erythema, Injection site swelling, Joint swelling, Nausea
Clinical narrative: Case number PHHY2014US093025 is an initial spontaneous report received from via Vaccine Adverse Event Reporting System (VAERS reference number: 531121) web site on 22 Jul 2014. This report refers to a 31-year-old female patient. Her medical history included psoriasis, psoriatic arthritis and celiac disease. Her concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported), pneumococcal vaccine (other manufacturer, batch number: not reported), inactivated polio virus vaccine (other manufacturer, batch number: not reported) and typhoid VI polysaccharide vaccine (other manufacturer, batch number: not reported) on 16 May 2014. On the same day after vaccination, she had soreness in the vaccination site. By late evening, she experienced fatigue, swollen and sore joints, chills, low grade fever, headache, dizziness, nausea and abdominal pain. The vaccination site on the right arm developed redness and swelling on Saturday morning (date not reported) which worsened through the next day. Nausea and decreased appetite increased in the Sunday night. The final outcome of the event was reported as complete recovery. The events were reported as non-serious. The causality of the event was not reported.
Age: 31.0
Sex: F
Vaccine: IPV, MNQ, PPV, TYP
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Case number PHHY2014US093025 is an initial spontaneous report received from via Vaccine Adverse Event Reporting System (VAERS reference number: 531121) web site on 22 Jul 2014. This report refers to a 31-year-old female patient. Her medical history included psoriasis, psoriatic arthritis and celiac disease. Her concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported), pneumococcal vaccine (other manufacturer, batch number: not reported), inactivated polio virus vaccine (other manufacturer, batch number: not reported) and typhoid VI polysaccharide vaccine (other manufacturer, batch number: not reported) on 16 May 2014. On the same day after vaccination, she had soreness in the vaccination site. By late evening, she experienced fatigue, swollen and sore joints, chills, low grade fever, headache, dizziness, nausea and abdominal pain. The vaccination site on the right arm developed redness and swelling on Saturday morning (date not reported) which worsened through the next day. Nausea and decreased appetite increased in the Sunday night. The final outcome of the event was reported as complete recovery. The events were reported as non-serious. The causality of the event was not reported.
Age: 19.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dyskinesia, Eye movement disorder, Feeling abnormal
Clinical narrative: Case number PHHY2014US099201, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 531234) website on 08 Aug 2014. This case refers to a 19-year-old male patient. Past medical history included attention deficit-hyperactivity disorder (ADHD). He was vaccinated with MENVEO (batch number: A13064) intramuscularly into right arm on 17 May 2014. On the same day, he was also vaccinated with GARDASIL (batch number: J013324, other manufacturer) intramuscularly into left arm and HAVRIX (batch number: 9K22GD, other manufacturer) intramuscularly into right arm. Post vaccination, the patient reported that he does not feel so good. His eyes rolled back a little nit he slumped over. His arms and legs jerked once and were fine in a matter of minutes. These events were reported as non-serious. Outcome of the events was reported as recovered. Causality of the events was mot reported.
Age: 39.0
Sex: F
Vaccine: MMR, MNQ, VARCEL
Symptoms: Blister, Erythema, Injection site erythema, Papule, Pruritus
Clinical narrative: Case number PHHY2014US099750 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 531551) website on 08 Aug 2014. This report refers to a 39 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M13051) intramuscularly into left arm, MMR II (other manufacturer, batch number: J008782) subcutaneously into right arm and VARIVAX (other manufacturer, batch number: J012151) subcutaneously into left arm on 21 Apr 2014. On 23 Apr 2014, she developed five small red papules on her back with small vesicles on most of them. She experienced itching. On an unknown date, 10 days after vaccination, she had a large red area at left arm where MENVEO and VARIVAX were administered. Final outcome was reported as complete recovery after 03 to 04 days of onset. The events were reported as non-serious. Causality was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099342 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531562) website on 08 Aug 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: M12102) intramuscularly into left arm on 28 Jan 2014. It was reported that there was a temperature excursions of vaccine. Before administration it was not stored in recommended temperature range. No adverse event was reported following this medication error (incorrect storage of drug).
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099064, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 531598) website on 08 Aug 2014. This report refers to an 11-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M12102) intramuscularly into right arm on 22 Jan 2014, that had a temperature excursions. No adverse event was reported following this medication error.
Age: 12.0
Sex: F
Vaccine: IPV, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099086, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 531600) website on 08 Aug 2014. This report refers to a 12-year-old female patient. Concomitant vaccination included IPOL (batch number: J13821, other manufacturer). She was vaccinated with MENVEO (batch number: M12100) intramuscularly into right arm on 15 Jan 2014, that had a temperature excursions. No adverse event was reported following this medication error (incorrect storage of drug).
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099087, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 531605) website on 08 Aug 2014. This report refers to an 11-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO, (batch number: M13017) intramuscularly into right arm on 17 Mar 2014, that had a temperature excursions. No adverse event was reported following this medication error (incorrect storage of drug).
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099645 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 531628) on 08 Aug 2014. This report refers to a 12 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12102) intramuscularly in the right arm on 29 Jan 2014. It was reported that the vaccine administered to her experienced temperature excursion. No adverse event was reported following the maladministration.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099656 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 531648) on 08 Aug 2014. This report refers to a 17 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12100) intramuscularly in the left arm on 19 Feb 2014. It was reported that the vaccine administered to him experienced temperature excursion. No adverse event was reported following the maladministration.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099677 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 531658) on 08 Aug 2014. This report refers to a 12 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12102) intramuscularly in the right arm on 23 Jan 2014. It was reported that the vaccine administered to her experienced temperature excursion. No adverse event was reported following the maladministration.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099694 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 531664) on 08 Aug 2014. This report refers to a 15 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12100) intramuscularly in the left arm on 10 Feb 2014. It was reported that the vaccine administered to him experienced temperature excursion. No adverse event was reported following the maladministration.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099706 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 531668) on 08 Aug 2014. This report refers to an 11 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12100) intramuscularly in the right arm on 03 Feb 2014. It was reported that the vaccine administered to her experienced temperature excursion. No adverse event was reported following the maladministration.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099715 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 531684) on 08 Aug 2014. This report refers to a 13 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M13017) intramuscularly in the left arm on 13 Mar 2014. It was reported that the vaccine administered to him experienced temperature excursion. No adverse event was reported following the maladministration.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099721 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 531690) on 08 Aug 2014. This report refers to a 17 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12102) intramuscularly in the right arm on 24 Jan 2014. It was reported that the vaccine administered to him experienced temperature excursion. No adverse event was reported following the maladministration.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099730 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 531702) on 08 Aug 2014. This report refers to a 16 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12102) intramuscularly in the left arm on 27 Jan 2014. It was reported that the vaccine administered to him experienced temperature excursion. No adverse event was reported following the maladministration.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099626, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531708) website on 08 Aug 2014. This report refers to a 11-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with MENVEO (batch number: M12102) intramuscularly into the right arm on 24 Jan 2014. It was reported that there was a temperature excursion of MENVEO which was administered to the patient. No adverse event was reported following this medication error (incorrect storage of drug).
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099649, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531709) website on 08 Aug 2014. This report refers to a 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with MENVEO (batch number: M12100) intramuscularly into the left arm on 20 Feb 2014. It was reported that there was a temperature excursions of MENVEO vaccine which was administered to the patient. No adverse event was reported following this medication error. The case was reported as non-serious.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099662 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531711) website on 08 Aug 2014. This report refers to a 16-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: M12100) intramuscularly into the right arm on 03 Feb 2014. It was reported that there was a temperature excursion of MENVEO vaccine which was administered to the patient. No adverse event was reporting following this medication error. The case was reported as non-serious.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099680 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531713) website on 08 Aug 2014. This report refers to a 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with MENVEO (batch number: M12102) intramuscularly into the left arm on 31 Jan 2014. It was reported that there was a temperature excursions on MENVEO vaccine which was administered to the patient. No adverse event was reported following this medication error. The case was reported as non-serious.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099702, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531733) website on 08 Aug 2014. This report refers to a 12-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: M12102) intramuscularly into the left arm on 28 Jan 2014. It was reported that there was a temperature excursion of MENVEO which was administered to the patient. No adverse event was reported following this medication error (incorrect storage of drug). The case was reported as non-serious.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099717, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531735) website on 08 Aug 2014. This report refers to a 12-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: M12100) intramuscularly into the right arm on 19 Feb 2014. It was reported that there was a temperature excursion of MENVEO vaccine which was administered to the patient. No adverse event was reported following this medication error. The case was reported as non-serious.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099729 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531737) website on 08 Aug 2014. This report refers to a 12-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: M12100) intramuscularly into the right arm on 19 Feb 2014. It was reported that there was a temperature excursion of MENVEO which was administered to the patient. No adverse event was reported following this medication error (incorrect storage of drug). The case was reported as non-serious.
Age: 14.0
Sex: F
Vaccine: IPV, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099746, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531738) website on 08 Aug 2014. This report refers to a 14-year-old female patient. Historical conditions were not reported. Concomitant vaccine included IPOL (other manufacturer, batch number: J13821) subcutaneously in the left arm. She was vaccinated with MENVEO (batch number: M12100) intramuscularly into the right arm on 18 Feb 2014. It was reported that there was a temperature excursions of MENVEO which was administered to the patient. No adverse event was reported following this medication error (incorrect storage of drug). The case was reported as non-serious.
Age: 46.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Measles antibody positive, Mumps antibody test positive, No adverse event, Rubella antibody positive, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US009491 is an initial spontaneous report received from a nurse on 07 May 2014 with a follow up report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531764) on 08 Aug 2014 and with another follow up information received from the nurse on 02 Sep 2014. This report refers to a 46 year old female patient. Her medical history included acquired deformity which further described as unusual leg length (right leg shorter than left leg), anxiety, chronic post-traumatic stress disorder, depression, poorly controlled diabetes mellitus, essential hypertension, primary hypercoagulable state lupus anticoagulant, lupus anticoagulation sensitive, sleep disturbances, vitamin D deficiency. It was also reported that she had a medical history of allergies to ACE inhibitors (throat swelling), cefuroxime axetil (palpitations), DEMEROL (hallucinosis), MICARDIS (shock and unconsciousness), prednisone (chest tightness). She was on poly-medication. She was vaccinated with MENVEO (batch number: A12024, expiry date: Dec 2014) intramuscularly at a dose of 0.5 ml in the left deltoid on 07 May 2014 at 1.15 PM. She was also vaccinated with MMR II (other manufacturer, batch number: H018945, expiry date: 18 Oct 2014) intramuscularly in left deltoid at a dose of 0.5 ml on 07 May 2014. It was reported that vaccines were given in error as both were drawn up in same syringe and given together intramuscularly in left arm. On 07 May 2014, her vitals were taken and no results were provided. On 20 Aug 2014 she was tested for rubella IgG antibodies which showed a positive result of greater than 500.0 . On 22 Aug 2014, she was tested for mumps IgG antibodies which showed a positive result of 300.0, she was also tested for rubeola IgG antibodies which showed a positive result of 184.0. No adverse event was reported following this administration error (wrong technique in drug usage process). Follow up report received from VAERS on 08 Aug 2014: Changed co-suspect name (MMR to MMR II), added co-suspect vaccine details (batch number and expiry date) and vaccination site. Follow up information received from the nurse on 02 Sep 2014: Updated patient height and weight, medical history, concomitant medications. Updated batch number and expiry date of both vaccines, site of vaccination, lab data.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099512, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531911) website on 08 Aug 2014. This report refers to a 14-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: M12102) intramuscularly into the left arm on 23 Jan 2014. It was reported that there was a temperature excursions of MENVEO. No adverse event was reported following this medication error (incorrect storage of drug).
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099548, is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 531923) website on 08 Aug 2014. This report refers to a 15-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with MENVEO (batch number M12100) intramuscularly into the left arm on 1 Feb 2014. It was reported that there was a temperature excursions of MENVEO. vaccine. No adverse event was reported following this medication error.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099568, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531925) website on 08 Aug 2014. This report refers to a 12-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with MENVEO (batch number: M12102) intramuscularly into the right arm on 30 Jan 2014. It was reported that there was a temperature excursions of MENVEO. No adverse event was reported following this medication error (incorrect storage of drug).
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099616, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531930) website on 08 Aug 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) intramuscularly into the left arm on 03 Feb 2014. It was reported that there was a temperature excursions of MENVEO. No adverse event was reported following this medication error (incorrect storage of drug).
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099628, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531933) website on 08 Aug 2014. This report refers to a 10-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with MENVEO (batch number: M12100) intramuscularly into the left arm on 03 Feb 2014. It was reported that there was a temperature excursions of MENVEO. No adverse event was reported following this medication error (incorrect storage of drug).
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099674, is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 531934) website on 08 Aug 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) intramuscularly into the left arm on 13 Jan 2014. It was reported that there was a temperature excursions of MENVEO vaccine. No adverse event was reported following this medication error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099534, is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 531952) website on 08 Aug 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M12100) intramuscular into left arm on 03 Feb 2014. It was reported that the there was a temperature excursions of vaccine. Before administration it was not stored in recommended temperature range. No adverse event was reported following this medication error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099535, is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 531954) website on 08 Aug 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: M12100) intramuscularly into right arm on 03 Feb 2014. It was reported that there was a temperature excursions of vaccine. Before administration it was not stored in recommended temperature range. No adverse event was reported following this medication error.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099536, is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 531956) website on 08 Aug 2014. This report refers to a 12 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M12100) intramuscularly into right arm on 03 Feb 2014. It was reported that there was a temperature excursions of vaccine. Before administration it was not stored in recommended temperature range. No adverse event was reported following this medication error.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099537, is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 532039) website on 08 Aug 2014. This report refers to a 16 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M13017) intramuscularly into right arm on 11 Mar 2014. It was reported that there was a temperature excursions of vaccine. Before administration it was not stored in recommended temperature range. No adverse event was reported following this medication error.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099538, is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 532053) website on 08 Aug 2014. This report refers to a 13 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M13017) intramuscularly into right arm on 07 Mar 2014. It was reported that the there was a temperature excursions of vaccine. Before administration it was not stored in recommended temperature range. No adverse event was reported following this medication error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHHY2014US099539, is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 532054) website on 08 Aug 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 M12100) intramuscularly into right arm on 03 Feb 2014. It was reported that there was a temperature excursions of vaccine. Before administration it was not stored in recommended temperature range. No adverse event was reported following this medication error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099540, is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 532058) website on 08 Aug 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: M12100) intramuscularly into left arm on 03 Feb 2014. It was reported that the there was a temperature excursions of vaccine. Before administration it was not stored in recommended temperature range. No adverse event was reported following this medication error.
Age: 53.0
Sex: F
Vaccine: MNQ, TDAP, TYP
Symptoms: Disorientation, Dizziness, Erythema, Headache, Pain in extremity
Clinical narrative: Case number# PHHY2014US093045, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 533185) website on 22 Jul 2014. This report refers to a 53-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with meningococcal polysaccharide vaccine (unknown manufacturer, batch number: not reported) along with Tdap (other manufacturer, batch number: not reported) and typhoid VI vaccine polysaccharide (other manufacturer, batch number: not reported) intramuscularly on 05 Jun 2014. On the same day after vaccination she was disoriented and experienced swelling of arms, patches of redness on arms, pain in arms, headache, dizziness and fever (103.7). The outcome of the events swelling of arms, patches of redness on arms and pain in arms was not recovered; outcome of other events was recovered. The events were reported as non-serious. Causality was not reported.
Age: 53.0
Sex: F
Vaccine: MNQ, TDAP, TYP
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Case number# PHHY2014US093045, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 533185) website on 22 Jul 2014. This report refers to a 53-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with meningococcal polysaccharide vaccine (unknown manufacturer, batch number: not reported) along with Tdap (other manufacturer, batch number: not reported) and typhoid VI vaccine polysaccharide (other manufacturer, batch number: not reported) intramuscularly on 05 Jun 2014. On the same day after vaccination she was disoriented and experienced swelling of arms, patches of redness on arms, pain in arms, headache, dizziness and fever (103.7). The outcome of the events swelling of arms, patches of redness on arms and pain in arms was not recovered; outcome of other events was recovered. The events were reported as non-serious. Causality was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Rash
Clinical narrative: Case number# PHEH2014US012757, is a spontaneous report from a nurse received on 23 Jun 2014, with a follow up received from nurse on 22 Jul 2014. This report refers to a 11-year-old female patient. Historical conditions were not reported. She received TUBERSOL (batch number: 717235) intradermally at a dose of 0.1 ml into the left forearm on 19 Jun 2014. Her vaccination history included administration of MENACTRA (tolerated). She was vaccinated with MENVEO (batch number: A14022) intramuscularly at a dose of 0.5 ml in to the right deltoid on 19 Jun 2014 at 10:00 AM. On the same day at 10:30 AM, 30 minutes after vaccination, she returned to the pharmacy with rash on her arms, legs, and trunk. She was given BENADRYL 50mg and she was taken to the urgent care clinic. No further treatment was provided. She was instructed to consult an allergist but it was unknown at the time of reporting, whether the patient visited one or not. The outcome of the event was complete recovery. Seriousness and causality was not reported. Follow up received from nurse on 22 Jul 2014: Updated vaccination history, dose, route and site of vaccination of MENVEO and outcome of the event.
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Rash, Tuberculin test
Clinical narrative: Case number# PHEH2014US012757, is a spontaneous report from a nurse received on 23 Jun 2014, with a follow up received from nurse on 22 Jul 2014. This report refers to a 11-year-old female patient. Historical conditions were not reported. She received TUBERSOL (batch number: 717235) intradermally at a dose of 0.1 ml into the left forearm on 19 Jun 2014. Her vaccination history included administration of MENACTRA (tolerated). She was vaccinated with MENVEO (batch number: A14022) intramuscularly at a dose of 0.5 ml in to the right deltoid on 19 Jun 2014 at 10:00 AM. On the same day at 10:30 AM, 30 minutes after vaccination, she returned to the pharmacy with rash on her arms, legs, and trunk. She was given BENADRYL 50mg and she was taken to the urgent care clinic. No further treatment was provided. She was instructed to consult an allergist but it was unknown at the time of reporting, whether the patient visited one or not. The outcome of the event was complete recovery. Seriousness and causality was not reported. Follow up received from nurse on 22 Jul 2014: Updated vaccination history, dose, route and site of vaccination of MENVEO and outcome of the event.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Rash, Urticaria
Clinical narrative: Case number PHEH2014US015857 is an initial spontaneous report received from a physician on 06 AUG 2014. This report refers to an 18 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M14025) intramuscularly on 01 AUG 2014. On 02 AUG 2014, he developed hives and rash on right arm, neck and face. Treatment was rendered with oral antihistamine. He was under observation. He still has hives and rash but it did not worsen. The seriousness and causality were not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2014US016822, is an initial spontaneous report from a nurse received on 20 Aug 2014 with a follow up information received from a nurse on 23 Sep 2014. This report refers to an 11-year-old male patient. Past medical history included arm swelling at injection site. No concomitant medication was reported. He was vaccinated with an initial dose of MENVEO (batch number: M13057) at a dose of 0.5 ml intramuscularly in the left arm on 18 Aug 2014 at 8:18 am. On 19 Aug 2014, a day post vaccination (less than 24 hours after vaccination), arm swelling started at injection site. He developed large area of redness on an unknown date in Aug 2014. It was growing in size and the area was larger than baseball. The site was hot to touch and he also complained of itching at the site on an unknown date. He was started on KEFLEX for 10 days. The outcome of the events was complete recovery. Seriousness and causality was not reported. Follow up information received from a nurse on 23 Sep 2014: Patient demographics (height), dose, site and time of vaccination, event (vaccination site warmth, vaccination site pruritus) and outcome updated.
Age: 36.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Headache, Malaise, Musculoskeletal stiffness, Pyrexia, Rash
Clinical narrative: Case number PHEH2014US017247, is an initial spontaneous report received from the nurse on 26 Aug 2014 with a follow-up received from the nurse on 29 Sep 2014 with a follow up information received from Vaccine Adverse Event Reporting System (VAERS ID: 543282) on 29 Dec 2014. This report refers to a 36-year-old female patient. She did not have history of severe allergic reaction to any vaccination in the past. Her concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12102) at a dose of 0.5 ml intramuscularly in the arm on 22 Aug 2014 at 2 pm. On 23 Aug 2014, she woke up with severe headache, fever of 101 degrees Fahrenheit, stiff neck and general malaise. On 25 Aug 2014, she developed mild rash on face and neck. She visited emergency room with a nurse student and received care for the rash. It was reported that the rash persisted for 5 days. She went to emergency room. 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. Follow-up received from a nurse on 29 Sep 2014: Time of vaccination (2 pm), dosage of vaccination (0.5 ml), patient demographics (date of birth and age), temperature reading (101 degrees Fahrenheit), event verbatim (rash on face and neck) and onset of date of events was updated. Follow up information received from Vaccine Adverse Event Reporting System on 29 Dec 2014: Updated reporter information, site of vaccination, reported seriousness and outcome.
Age: 36.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Malaise, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Case number PHEH2014US017247, is an initial spontaneous report received from the nurse on 26 Aug 2014 with a follow-up received from the nurse on 29 Sep 2014 with a follow up information received from Vaccine Adverse Event Reporting System (VAERS ID: 543282) on 29 Dec 2014. This report refers to a 36-year-old female patient. She did not have history of severe allergic reaction to any vaccination in the past. Her concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12102) at a dose of 0.5 ml intramuscularly in the arm on 22 Aug 2014 at 2 pm. On 23 Aug 2014, she woke up with severe headache, fever of 101 degrees Fahrenheit, stiff neck and general malaise. On 25 Aug 2014, she developed mild rash on face and neck. She visited emergency room with a nurse student and received care for the rash. It was reported that the rash persisted for 5 days. She went to emergency room. 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. Follow-up received from a nurse on 29 Sep 2014: Time of vaccination (2 pm), dosage of vaccination (0.5 ml), patient demographics (date of birth and age), temperature reading (101 degrees Fahrenheit), event verbatim (rash on face and neck) and onset of date of events was updated. Follow up information received from Vaccine Adverse Event Reporting System on 29 Dec 2014: Updated reporter information, site of vaccination, reported seriousness and outcome.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Activities of daily living impaired, Headache, Peripheral swelling, Vaccination site nodule, Vaccination site swelling
Clinical narrative: Case number PHEH2014US020939 is an initial spontaneous report received from a medical assistant on 16 OCT 2014. This report refers to an 11 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M14024) intramuscularly in an arm on 20 AUG 2014. He also received tetanus diphtheria acellular pertussis vaccine (other manufacturer, batch number: not reported) in the other arm on the same day. It was reported that he had  headache, swollen arm, raised area at the vaccination site and had knots under his skin at the MENVEO vaccination site on the same day evening. It was reported that headache worsened on 21 AUG 2014 with increased severity causing him to barely lift his head up and he did not go to school. The headache persisted on 22 AUG 2014, but reduced in severity. The headache resolved on 23 AUG 2014. As per his other, knots persisted under the skin for one week after MENVEO administration. At the time of adverse events the patient did not seek medical attention. The patient completely recovered on 27 AUG 2014 and was doing well. The seriousness and causality of the events were not reported.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Eschar
Clinical narrative: This unsolicited case was received on 08-Mar-2016 via a third party query tool search on the VAERS database, under reference number 612771. This case involves a 22-years old female patient who received the following vaccinations on 12-Sep-2015: a dose of ACAM2000 (lot number- VV04003A, manufacturer: SANOFI PASTEUR) in the unknown site via intradermal route. Patient had no current illness. Information regarding prior vaccination, medical history and concomitant medications were not reported. On an unspecified date (reported as 30 November 2015), post vaccination; patient had experienced eschar. Laboratory investigations and corrective treatment were not reported. The outcome of the events was reported as unknown (reported as Recovery Unknown) (reported as "On 11/27/2015 she still had eschar -- decreasing in size from the previous week. Otherwise normal take and asymptomatic after 2 weeks post vaccine.") List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Erythema, Fatigue, Hypersomnia, Pain
Clinical narrative: 10x5 cm area of swelling, redness, warmth, welt, took 4 days of pain, could not lie on that side, had cough, fatigue, slept for 24 hours, no fever.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling, Urticaria
Clinical narrative: 10x5 cm area of swelling, redness, warmth, welt, took 4 days of pain, could not lie on that side, had cough, fatigue, slept for 24 hours, no fever.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure decreased, Dizziness, Immediate post-injection reaction
Clinical narrative: Immediately after the nurse administered the vaccine, I felt like I was going to faint. I felt the blood drain from my face and got dizzy. I have fainted in the past and know what it feels like, and I believe if I had stood or even remained sitting upright I would likely have fainted. The nurse had me lie down and checked my blood pressure, which she said was low. (It was normal earlier that day.) I felt this feeling come and go for the next 20 minutes or so before I was finally OK to sit up -- then probably 15 more minutes before I felt normal enough to stand.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Raised red site, hard & painful at site....next day I could barely move my arm & one month later still occasional nerve [?] pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Raised red site, hard & painful at site....next day I could barely move my arm & one month later still occasional nerve [?] pain.
Age: 23.0
Sex: M
Vaccine: YF
Symptoms: Arthralgia, Musculoskeletal discomfort, Rash, Rash papular
Clinical narrative: Initial unsolicited report received from a physician on 13-May-2016. This case involves a 23-year-old male patients who was vaccinated with a first dose of YF-VAX (batch number UI268AA, expiry date: 08-Sep-2017) by subcutaneous route in the left arm on 03-May-2016. Patient's illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions included: no known allergies. Concomitant medications were not reported. On 07-May-2016, four days following the vaccination, the patient experienced bilateral "hip discomfort" or joint pain. On 12-May-2016, nine days post vaccination, the patient developed a pink, papular rash over trunk and arms. Patient did not report any fever. Laboratory investigations and corrective treatment were not reported. The outcome of the events was reported as not recovered. It was reported that the patient's primary care physician had pronounced him "okay for now". List of documents held by sender: none.
Sex: F
Vaccine: HPV4
Symptoms: Impaired driving ability, Seizure
Clinical narrative: This spontaneous report as received from a physician assistant via a company representative refers to a non-pregnant female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, frequency, route of administration, lot# and expiry date were not reported). On an unknown date, the patient had several seizures. The patient was still seizure-prone at the time of the report. The patient was not able to obtain a driver's license or drive a car. The patient did not seek medical attention. The outcome of the event was reported as not recovered. The causality between the event and GARDASIL was not reported. Upon internal review, the event of seizure was considered to be medically significant. Additional information has been requested.