chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Blepharospasm, Blood glucose normal, Dizziness, Heart rate decreased, Pallor
Clinical narrative: Case number PHHY2013US012223 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 477297) website on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 215601) on 24 Jun 2014: This report refers to a 24-year-old male patient. Family history included valve problem. He was vaccinated with FLUVIRIN (batch number: 1206401 and expiry date: 30 Jun 2013) intramuscularly to left arm on 08 Dec 2012. At the end of administration of Flu vaccine, patient felt fainting. Patient was pale, eyes fluttered slightly, had mild tremor in both hands and pulse rate was 46 to 48 and 59 after 15 minutes. Blood pressure was 104/74 and after sometime it was 102/80. Glucose level was 77. There was no loss of consciousness and it was near syncopal episode. Reported 3 similar episodes in last year. Consultant physician commented that it could be a probable vasovagal response. Outcome of the events were reported as complete recovery. Seriousness and causality were not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1206401) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 215601) on 24 Jun 2014: Updated batch review report.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Presyncope, Tremor
Clinical narrative: Case number PHHY2013US012223 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 477297) website on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 215601) on 24 Jun 2014: This report refers to a 24-year-old male patient. Family history included valve problem. He was vaccinated with FLUVIRIN (batch number: 1206401 and expiry date: 30 Jun 2013) intramuscularly to left arm on 08 Dec 2012. At the end of administration of Flu vaccine, patient felt fainting. Patient was pale, eyes fluttered slightly, had mild tremor in both hands and pulse rate was 46 to 48 and 59 after 15 minutes. Blood pressure was 104/74 and after sometime it was 102/80. Glucose level was 77. There was no loss of consciousness and it was near syncopal episode. Reported 3 similar episodes in last year. Consultant physician commented that it could be a probable vasovagal response. Outcome of the events were reported as complete recovery. Seriousness and causality were not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1206401) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 215601) on 24 Jun 2014: Updated batch review report.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2013US032645 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS ID 481969) received on 04 Apr 2013, with a follow-up information received from Quality Assurance Department (reference number: 220612) on 23 Jun 2014: This report refers to a 19-year-old male patient. He was vaccinated with FLUVIRIN (batch number 1206101 and expiry date: Jun 2013) intramuscularly into unspecified location on 20 Jan 2013. On the same day 30 to 40 minutes later he fainted. He was taken to emergency room. The outcome of the event was reported as condition unchanged as of 21 Jan 2013. The seriousness and causality assessment of the event was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1206101) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 220612) on 23 Jun 2014: Updated batch review report.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Dyspnoea
Clinical narrative: Case number PHHY2013US032604 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 482047) on 04 Apr 2013, with a follow-up information received from Quality Assurance Department (reference number: 220621) on 23 Jun 2014: This report refers to a 22-year-old female patient. The patient's medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1205101 and expiry date: 30 Jun 2013) intramuscularly on 18 Jan 2013. On the same day, after the vaccination, the patient developed facial cyanosis and difficulty breathing. The patient had to go to emergency room due to the events. The seriousness of the events was reported as life threatening. The outcome of events was reported as complete recovery. The causality of events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1205101) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 220621) on 23 Jun 2014: Updated batch review report.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Blister, Burning sensation, Skin disorder, Stevens-Johnson syndrome
Clinical narrative: Case number PHHY2013US032656 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS reference number: 482275) on 04 Apr 2013, with a follow-up information received from Quality Assurance Department (reference number: 222944) on 24 Jun 2014: This report refers to a 67-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1204301 and expiry date: 31 May 2013) intramuscularly, along with ZOSTAVAX (other manufacturer, batch number: 1566AE) subcutaneously in to the right arm on 10 Sep 2012. On 21 Sep 2012, he felt his body was on fire and he went to the emergency room. Two hours later, he had blisters all over the arms, crotch and legs. He was admitted in isolation because the doctors thought it was Steven Johnson Syndrome. He suffered from blisters for three weeks and at the time of reporting on 22 Jan 2013, he still had unspecified skin issue. Final outcome was reported as condition unchanged as on 22 Jan 2013. No further information about causality and seriousness was reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1204301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Following an internal review of the data received on 04 Apr 2013, it was identified that verbatim 'Steven Johnson syndrome' was erroneously not captured as an event in this case. Therefore, Stevens Johnson syndrome was coded as an additional event in the case. Follow up information received from the Quality Assurance Department (reference number: 222944) on 24 Jun 2014: Updated batch review report.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Dysphagia, Dyspnoea, Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US117497, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 495763) web site on 15 Oct 2013 with a follow-up received on 25 Nov 2013, and with a follow up report received from QA department (reference number: 302065) on 24 Jun 2014. This report refers to a 46-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1205001, expiry date: 30 Jun 2013) intramuscularly in to the left arm on 02 Nov 2012. On an unknown date in Dec 2012 (reported as approximately 4 days prior to admission in hospital), she had back and neck pain, generalized weakness, numbness, shortness of breath and difficulty in swallowing. She was admitted to hospital on 20 Dec 2012 and was diagnosed with Guillain Barre syndrome. It was reported that she had respiratory failure requiring mechanical ventilation and tracheostomy. It was reported that she had a prolonged rehabilitation. The outcome of the events was reported as condition unchanged. Based on the document review, it was stated that the FLUVIRIN, batch number 1205001 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 495763) website on 25 Nov 2013: Updated information about trade name, batch number, date, site and route of administration of influenza vaccine. Non-significant follow up report received from Quality Assurance Department on 27 May 2014: Updated QA reference number only (reference number: 302065). Follow up report received from a QA department (reference number: 302065) on 30 May 2014. Updated batch review report and expiry date of vaccine.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mechanical ventilation, Neck pain, Respiratory failure, Tracheostomy
Clinical narrative: Case number PHHY2013US117497, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 495763) web site on 15 Oct 2013 with a follow-up received on 25 Nov 2013, and with a follow up report received from QA department (reference number: 302065) on 24 Jun 2014. This report refers to a 46-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1205001, expiry date: 30 Jun 2013) intramuscularly in to the left arm on 02 Nov 2012. On an unknown date in Dec 2012 (reported as approximately 4 days prior to admission in hospital), she had back and neck pain, generalized weakness, numbness, shortness of breath and difficulty in swallowing. She was admitted to hospital on 20 Dec 2012 and was diagnosed with Guillain Barre syndrome. It was reported that she had respiratory failure requiring mechanical ventilation and tracheostomy. It was reported that she had a prolonged rehabilitation. The outcome of the events was reported as condition unchanged. Based on the document review, it was stated that the FLUVIRIN, batch number 1205001 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 495763) website on 25 Nov 2013: Updated information about trade name, batch number, date, site and route of administration of influenza vaccine. Non-significant follow up report received from Quality Assurance Department on 27 May 2014: Updated QA reference number only (reference number: 302065). Follow up report received from a QA department (reference number: 302065) on 30 May 2014. Updated batch review report and expiry date of vaccine.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Asthenia, Cardiac pacemaker insertion, Dysstasia, Hip fracture, Hypoaesthesia
Clinical narrative: Case number PHHY2014US019235 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 518160) web site on 17 Feb 2014 with a follow-up received on 24 Apr 2014, with a follow-up information received from Quality Assurance Department (reference number: 302079) on 24 Jun 2014. This report refers to a 49-year-old male patient. His medical history included chronic pain and high blood pressure and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 122105) intramuscularly along with PNEUMOVAX (other manufacturer, batch number: H014282) intramuscularly on 23 Nov 2012. On 24 Nov 2012, his legs became numb and he lost feeling. He had loss of strength in legs, hands and arms. He could not stand up as his legs did not hold him. He went to emergency room. It was reported that he had blood treatments (not further specified) and he suffered 5 or 6 heart attacks. He had a pace maker inserted on an unknown date. On an unspecified date, he became paralyzed from the neck down and he had broken hip. He was hospitalized for 22 days following these events. He had lots of unspecified tests and lab work but the details were not reported. The outcome of the events was reported as condition unchanged as of 22 Dec 2013. The reporter assessed the event as life-threatening and permanent disability. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 122105) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from the vaccine adverse event reporting system (VAERS reference number: 518160) web site on 24 Apr 2014: Updated trade names, batch numbers and route of administration of the suspect vaccines and information on hospitalization. Non significant follow up information received from the Quality Assurance Department (reference number: 302079) on 27 May 2014: QA number updated. Follow up information received from the Quality Assurance Department (reference number: 302079) on 24 Jun 2014: Updated batch review report.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Laboratory test, Muscular weakness, Myocardial infarction, Paralysis, Paraplegia
Clinical narrative: Case number PHHY2014US019235 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 518160) web site on 17 Feb 2014 with a follow-up received on 24 Apr 2014, with a follow-up information received from Quality Assurance Department (reference number: 302079) on 24 Jun 2014. This report refers to a 49-year-old male patient. His medical history included chronic pain and high blood pressure and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 122105) intramuscularly along with PNEUMOVAX (other manufacturer, batch number: H014282) intramuscularly on 23 Nov 2012. On 24 Nov 2012, his legs became numb and he lost feeling. He had loss of strength in legs, hands and arms. He could not stand up as his legs did not hold him. He went to emergency room. It was reported that he had blood treatments (not further specified) and he suffered 5 or 6 heart attacks. He had a pace maker inserted on an unknown date. On an unspecified date, he became paralyzed from the neck down and he had broken hip. He was hospitalized for 22 days following these events. He had lots of unspecified tests and lab work but the details were not reported. The outcome of the events was reported as condition unchanged as of 22 Dec 2013. The reporter assessed the event as life-threatening and permanent disability. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 122105) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from the vaccine adverse event reporting system (VAERS reference number: 518160) web site on 24 Apr 2014: Updated trade names, batch numbers and route of administration of the suspect vaccines and information on hospitalization. Non significant follow up information received from the Quality Assurance Department (reference number: 302079) on 27 May 2014: QA number updated. Follow up information received from the Quality Assurance Department (reference number: 302079) on 24 Jun 2014: Updated batch review report.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Sensory loss
Clinical narrative: Case number PHHY2014US019235 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 518160) web site on 17 Feb 2014 with a follow-up received on 24 Apr 2014, with a follow-up information received from Quality Assurance Department (reference number: 302079) on 24 Jun 2014. This report refers to a 49-year-old male patient. His medical history included chronic pain and high blood pressure and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 122105) intramuscularly along with PNEUMOVAX (other manufacturer, batch number: H014282) intramuscularly on 23 Nov 2012. On 24 Nov 2012, his legs became numb and he lost feeling. He had loss of strength in legs, hands and arms. He could not stand up as his legs did not hold him. He went to emergency room. It was reported that he had blood treatments (not further specified) and he suffered 5 or 6 heart attacks. He had a pace maker inserted on an unknown date. On an unspecified date, he became paralyzed from the neck down and he had broken hip. He was hospitalized for 22 days following these events. He had lots of unspecified tests and lab work but the details were not reported. The outcome of the events was reported as condition unchanged as of 22 Dec 2013. The reporter assessed the event as life-threatening and permanent disability. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 122105) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from the vaccine adverse event reporting system (VAERS reference number: 518160) web site on 24 Apr 2014: Updated trade names, batch numbers and route of administration of the suspect vaccines and information on hospitalization. Non significant follow up information received from the Quality Assurance Department (reference number: 302079) on 27 May 2014: QA number updated. Follow up information received from the Quality Assurance Department (reference number: 302079) on 24 Jun 2014: Updated batch review report.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Myocardial infarction, Paralysis, Sensory loss, Therapeutic procedure
Clinical narrative: Case number PHHY2014US019235 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 518160) web site on 17 Feb 2014 with a follow-up received on 24 Apr 2014, with a follow-up information received from Quality Assurance Department (reference number: 302079) on 24 Jun 2014. This report refers to a 49-year-old male patient. His medical history included chronic pain and high blood pressure and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 122105) intramuscularly along with PNEUMOVAX (other manufacturer, batch number: H014282) intramuscularly on 23 Nov 2012. On 24 Nov 2012, his legs became numb and he lost feeling. He had loss of strength in legs, hands and arms. He could not stand up as his legs did not hold him. He went to emergency room. It was reported that he had blood treatments (not further specified) and he suffered 5 or 6 heart attacks. He had a pace maker inserted on an unknown date. On an unspecified date, he became paralyzed from the neck down and he had broken hip. He was hospitalized for 22 days following these events. He had lots of unspecified tests and lab work but the details were not reported. The outcome of the events was reported as condition unchanged as of 22 Dec 2013. The reporter assessed the event as life-threatening and permanent disability. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 122105) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from the vaccine adverse event reporting system (VAERS reference number: 518160) web site on 24 Apr 2014: Updated trade names, batch numbers and route of administration of the suspect vaccines and information on hospitalization. Non significant follow up information received from the Quality Assurance Department (reference number: 302079) on 27 May 2014: QA number updated. Follow up information received from the Quality Assurance Department (reference number: 302079) on 24 Jun 2014: Updated batch review report.
Sex: M
Vaccine: FLU3, PPV, VARZOS, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: Case number PHHY2014US046159 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 518203) web site on 14 Apr 2014, with a follow-up information received from Quality Assurance Department (reference number: 295605) on 24 Jun 2014. This report refers to a male patient of unknown age. The patient's current condition included neuropathy. The patient was vaccinated with a dose of FLUVIRIN (batch number: 1310101) via intramuscular route into left arm, PNEUMOVAX (other manufacturer, batch number: H012972) via intramuscular route into right arm and ZOSTAVAX (other manufacturer, batch number: J010447) via subcutaneous route into left arm on 19 Dec 2013. On the same day after vaccination, the patient experienced left arm neuropathy radiating to neck. The treatment was rendered with tramadol at a dose of 50 mg at an interval of every 6 hours and diazepam at a dose of 5 mg twice a day. The outcome of the events was reported as condition unchanged. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1310101) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 295605) on 24 Jun 2014: Updated batch review report.
Sex: M
Vaccine: FLU3, PPV, VARZOS, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Facial pain, Injection site reaction, Insomnia, Pain, Pain in extremity
Clinical narrative: Case number PHHY2014US046159 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 518203) web site on 14 Apr 2014, with a follow-up information received from Quality Assurance Department (reference number: 295605) on 24 Jun 2014. This report refers to a male patient of unknown age. The patient's current condition included neuropathy. The patient was vaccinated with a dose of FLUVIRIN (batch number: 1310101) via intramuscular route into left arm, PNEUMOVAX (other manufacturer, batch number: H012972) via intramuscular route into right arm and ZOSTAVAX (other manufacturer, batch number: J010447) via subcutaneous route into left arm on 19 Dec 2013. On the same day after vaccination, the patient experienced left arm neuropathy radiating to neck. The treatment was rendered with tramadol at a dose of 50 mg at an interval of every 6 hours and diazepam at a dose of 5 mg twice a day. The outcome of the events was reported as condition unchanged. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1310101) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 295605) on 24 Jun 2014: Updated batch review report.
Sex: M
Vaccine: FLU3, PPV, VARZOS, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Paraesthesia
Clinical narrative: Case number PHHY2014US046159 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 518203) web site on 14 Apr 2014, with a follow-up information received from Quality Assurance Department (reference number: 295605) on 24 Jun 2014. This report refers to a male patient of unknown age. The patient's current condition included neuropathy. The patient was vaccinated with a dose of FLUVIRIN (batch number: 1310101) via intramuscular route into left arm, PNEUMOVAX (other manufacturer, batch number: H012972) via intramuscular route into right arm and ZOSTAVAX (other manufacturer, batch number: J010447) via subcutaneous route into left arm on 19 Dec 2013. On the same day after vaccination, the patient experienced left arm neuropathy radiating to neck. The treatment was rendered with tramadol at a dose of 50 mg at an interval of every 6 hours and diazepam at a dose of 5 mg twice a day. The outcome of the events was reported as condition unchanged. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1310101) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 295605) on 24 Jun 2014: Updated batch review report.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyskinesia, Injection site mass, Tremor
Clinical narrative: Case number PHHY2014US049820 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 523348) website on 24 Apr 2014, and with a follow up report received from VAERS on 28 May 2014, and a follow-up received from Quality Assurance Department (QA, reference number: 302787) on 30 May 2014, and with a follow up report received from a QA department (reference number: 302787) on 24 Jun 2014. This report refers to a 64-year-old female patient. Her medical history included Degenerative Disc S in lower back. Her concomitant medications included DOXEPIN. She was vaccinated with FLUVIRIN (batch number: 1308301, expiry date: 31 Mar 2014) on 23 Sep 2013. On 25 Sep 2013, she developed large egg shaped bump where injection was administered. Upon standing up, her legs shook and trembled 'jerkingly' and she felt like they were 'going to give way'; her arms trembled and shook uncontrollably. This lasted about two weeks then stopped. Outcome of the events was reported as complete recovery. The reporter assessed the seriousness of the case as non-serious; however, the case was upgraded to medically significant by the agency. No further information about causality was reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1308301 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from VAERS on 28 May 2014. Updated the product from Influenza vaccine INN to FLUVIRIN and batch number reported. Non-significant follow-up received from Quality Assurance Department (QA, reference number: 302787) on 30 May 2014: Updated QA reference number only. Follow up report received from a QA department (reference number: 302787) on 24 Jun 2014. Updated batch review report and expiry date of vaccine.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyskinesia, Injection site swelling, Tremor
Clinical narrative: Case number PHHY2014US049820 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 523348) website on 24 Apr 2014, and with a follow up report received from VAERS on 28 May 2014, and a follow-up received from Quality Assurance Department (QA, reference number: 302787) on 30 May 2014, and with a follow up report received from a QA department (reference number: 302787) on 24 Jun 2014. This report refers to a 64-year-old female patient. Her medical history included Degenerative Disc S in lower back. Her concomitant medications included DOXEPIN. She was vaccinated with FLUVIRIN (batch number: 1308301, expiry date: 31 Mar 2014) on 23 Sep 2013. On 25 Sep 2013, she developed large egg shaped bump where injection was administered. Upon standing up, her legs shook and trembled 'jerkingly' and she felt like they were 'going to give way'; her arms trembled and shook uncontrollably. This lasted about two weeks then stopped. Outcome of the events was reported as complete recovery. The reporter assessed the seriousness of the case as non-serious; however, the case was upgraded to medically significant by the agency. No further information about causality was reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1308301 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from VAERS on 28 May 2014. Updated the product from Influenza vaccine INN to FLUVIRIN and batch number reported. Non-significant follow-up received from Quality Assurance Department (QA, reference number: 302787) on 30 May 2014: Updated QA reference number only. Follow up report received from a QA department (reference number: 302787) on 24 Jun 2014. Updated batch review report and expiry date of vaccine.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Bacterial infection, Injection site cellulitis, Injection site infection, Rash papular, Rash pruritic
Clinical narrative: Initial case received on 16 June 2014 via a third party query tool search on the VAERS database, under reference number 524428. A 19-year-old male patient had received a percutaneous injection of ACAM2000 in the left arm on 21 February 2014 (lot number not reported). On 03 March 2014, approximately 10 days post vaccination, the patient experienced mildly pruritic rash on the torso. The rash was papular in nature. Secondary bacterial infection, cellulitis, was developed at the injection site. Lab data, other medications and prior vaccinations were not reported. The patient had no known current illnesses or medical history. The patient went for an emergency visit. Final outcome was not reported. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of patient's vaccination. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Bacterial infection, Injection site cellulitis, Rash papular, Rash pruritic
Clinical narrative: Initial case received on 16 June 2014 via a third party query tool search on the VAERS database, under reference number 524428. A 19-year-old male patient had received a percutaneous injection of ACAM2000 in the left arm on 21 February 2014 (lot number not reported). On 03 March 2014, approximately 10 days post vaccination, the patient experienced mildly pruritic rash on the torso. The rash was papular in nature. Secondary bacterial infection, cellulitis, was developed at the injection site. Lab data, other medications and prior vaccinations were not reported. The patient had no known current illnesses or medical history. The patient went for an emergency visit. Final outcome was not reported. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of patient's vaccination. Documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Dermatitis contact, Injection site cellulitis, Injection site rash, Rash generalised
Clinical narrative: Initial case received on 16 June 2014 via a third party query tool search on the VAERs database, under reference number 525080. A 20-year-old male patient had received a percutaneous injection of ACAM2000 (manufacturer Sanofi Pasteur, lot number VV04003A) in the left arm as well as an intramuscular injection of BIOTHRAX (other manufacturer, lot number FAV349A) in the right arm on 10 February 2014. On 18 February 2014, 8 days post vaccination, rash was noticed around smallpox vaccination site in the ER. Onset date of the events was reported to be 13 February 2014, i.e. 3 days post vaccination. Diagnosis of cellulitis was established. The patient was treated with SEPTRA 800/160 1 tablet twice a day for 10 days. On 24 February 2014, rash had spread to hands. Patient was seen at ER, diagnosis of contact dermatitis was made. The patient was treated with MYCOLOG TID and ATARAX 1 tablet QD. On 04 March 2014, rash had spread to bilateral arms, hands, chest, face and neck. The patient was treated with prednisone 20 mg 1 tablet 3 times a day for 10 days. Patient stated that he has now a history of unknown rash but marked no on smallpox form. Lab data and prior vaccinations were not reported. The patient had no known previous medical history. At the time of the report, the patient was not recovered. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date field. Documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Cellulitis, Dermatitis contact, Rash, Vaccination site rash
Clinical narrative: Initial case received on 16 June 2014 via a third party query tool search on the VAERs database, under reference number 525080. A 20-year-old male patient had received a percutaneous injection of ACAM2000 (manufacturer Sanofi Pasteur, lot number VV04003A) in the left arm as well as an intramuscular injection of BIOTHRAX (other manufacturer, lot number FAV349A) in the right arm on 10 February 2014. On 18 February 2014, 8 days post vaccination, rash was noticed around smallpox vaccination site in the ER. Onset date of the events was reported to be 13 February 2014, i.e. 3 days post vaccination. Diagnosis of cellulitis was established. The patient was treated with SEPTRA 800/160 1 tablet twice a day for 10 days. On 24 February 2014, rash had spread to hands. Patient was seen at ER, diagnosis of contact dermatitis was made. The patient was treated with MYCOLOG TID and ATARAX 1 tablet QD. On 04 March 2014, rash had spread to bilateral arms, hands, chest, face and neck. The patient was treated with prednisone 20 mg 1 tablet 3 times a day for 10 days. Patient stated that he has now a history of unknown rash but marked no on smallpox form. Lab data and prior vaccinations were not reported. The patient had no known previous medical history. At the time of the report, the patient was not recovered. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date field. Documents held by sender: none.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Fluid retention, Headache, Hypertension, Hypertensive crisis
Clinical narrative: Case number PHHY2014US070876 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525522) website on 09 Jun 2014, with a follow-up received from Quality Assurance Department (QA, reference number: 305203) on 24 Jun 2014. This report refers to an adult female patient. Her medical history included allergies to penicillin, BETADINE, DEMEROL, SUDAFED, codeine and contrast dye. Her concomitant medication included CELEXA and ibuprofen. She was vaccinated with FLUVIRIN (batch number: 1204301) in the left arm on 07 Oct 2012. It was reported that after vaccination, on an unknown date in 2012, she had hypertensive crisis, headache and neck pain. She was hospitalized for 2 weeks with the same effects. All or most of the laboratory tests and invasive procedures were within normal limits. The effect wore off within two and a half months. The final outcome of the event was reported as unknown. The events were reported as serious and the causality was not reported. She was further vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and experienced hypertensive crisis (see related case number: PHHY2014US071011). Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1204301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from Quality Assurance Department (reference number: 305203) on 11 Jun 2014: Updated QA reference number only. Follow-up received from Quality Assurance Department (QA, reference number: 305203) on 24 Jun 2014: Updated batch review report.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Laboratory test normal, Malaise, Neck pain, Oedema
Clinical narrative: Case number PHHY2014US070876 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525522) website on 09 Jun 2014, with a follow-up received from Quality Assurance Department (QA, reference number: 305203) on 24 Jun 2014. This report refers to an adult female patient. Her medical history included allergies to penicillin, BETADINE, DEMEROL, SUDAFED, codeine and contrast dye. Her concomitant medication included CELEXA and ibuprofen. She was vaccinated with FLUVIRIN (batch number: 1204301) in the left arm on 07 Oct 2012. It was reported that after vaccination, on an unknown date in 2012, she had hypertensive crisis, headache and neck pain. She was hospitalized for 2 weeks with the same effects. All or most of the laboratory tests and invasive procedures were within normal limits. The effect wore off within two and a half months. The final outcome of the event was reported as unknown. The events were reported as serious and the causality was not reported. She was further vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and experienced hypertensive crisis (see related case number: PHHY2014US071011). Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1204301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from Quality Assurance Department (reference number: 305203) on 11 Jun 2014: Updated QA reference number only. Follow-up received from Quality Assurance Department (QA, reference number: 305203) on 24 Jun 2014: Updated batch review report.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Hypertensive crisis, Neck pain
Clinical narrative: Case number PHHY2014US070876 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525522) website on 09 Jun 2014, with a follow-up received from Quality Assurance Department (QA, reference number: 305203) on 24 Jun 2014. This report refers to an adult female patient. Her medical history included allergies to penicillin, BETADINE, DEMEROL, SUDAFED, codeine and contrast dye. Her concomitant medication included CELEXA and ibuprofen. She was vaccinated with FLUVIRIN (batch number: 1204301) in the left arm on 07 Oct 2012. It was reported that after vaccination, on an unknown date in 2012, she had hypertensive crisis, headache and neck pain. She was hospitalized for 2 weeks with the same effects. All or most of the laboratory tests and invasive procedures were within normal limits. The effect wore off within two and a half months. The final outcome of the event was reported as unknown. The events were reported as serious and the causality was not reported. She was further vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and experienced hypertensive crisis (see related case number: PHHY2014US071011). Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1204301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from Quality Assurance Department (reference number: 305203) on 11 Jun 2014: Updated QA reference number only. Follow-up received from Quality Assurance Department (QA, reference number: 305203) on 24 Jun 2014: Updated batch review report.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Muscular weakness, Musculoskeletal pain, Neuralgic amyotrophy
Clinical narrative: Case number PHHY2014US070836, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 526645) website on 09 Jun 2014, with a follow-up received from Quality Assurance Department (QA, reference number: 305205) on 24 Jun 2014. This report refers to a 41-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1310101) into the arm on 08 Nov 2013. On 13 Nov 2013, she experienced onset of pain in right shoulder followed by weakness. She had pain for one month followed by lessening of pain for two months with accompanied weakness in right arm and shoulder. In Mar 2014, she was given a diagnosis of Parsonage-Turner Syndrome. The outcome of the events was condition unchanged. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Causality was not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1310101) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from Quality Assurance Department (reference number: 305205) on 11 Jun 2014: Updated QA reference number only. Follow-up received from Quality Assurance Department (QA, reference number: 305205) on 24 Jun 2014: Updated batch review report.
Age: 54.0
Sex: U
Vaccine: ANTH, FLUX, HEP, HEPA, IPV, MMR, SMALL, TYP, VARCEL, YF, ANTH, FLUX, HEP, HEPA, IPV, MMR, SMALL, TYP, VARCEL, YF
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Bursitis, Cervical spinal stenosis
Clinical narrative: This case was received on 16 June 2014 via a third party query tool search on the VAERS database, under reference number 526956. A 54-year-old patient (gender not reported) had received on an unspecified date a percutaneous injection of SPV. The patient had also received on unspecified date(s) the following vaccines: IPV, MMR, YELLOW FEVER VACCINE, VARICELLA VACCINE (LIVE) (manufactured by Merck), ANTHRAX VACCINE, HEP B, HEP A, TYPHOID VI POLYSACCHARIDE VACCINE AND INFLUENZA VACCINE. For all these vaccines (except Varicella vaccine), manufacturer were unknown. Lot number, route and site of administration were also unknown for all these products. On unspecified date(s), the patient experienced the following symptoms: abdominal discomfort, arthralgia, back pain, bursitis, cervical spinal stenosis, musculoskeletal pain, myalgia, pain in extremity, tendon injury, and tendonitis. It was also reported: "muscles pain, back pains, legs, shoulder, fingers, upset stomach, joints hurt so much". Current illnesses, medical history, prior vaccinations and corrective treatment received were not reported. The patient had received "PPD" as other medications. For lab data, the following was reported: "Tendon broken (5); Bursitis; Tendinitis; Cervicals clogging spinal cord". At the time of the report, the patient was not recovered. Documents held by sender: none.
Age: 54.0
Sex: U
Vaccine: ANTH, FLUX, HEP, HEPA, IPV, MMR, SMALL, TYP, VARCEL, YF, ANTH, FLUX, HEP, HEPA, IPV, MMR, SMALL, TYP, VARCEL, YF
Symptoms: Musculoskeletal pain, Myalgia, Pain in extremity, Tendon injury, Tendonitis
Clinical narrative: This case was received on 16 June 2014 via a third party query tool search on the VAERS database, under reference number 526956. A 54-year-old patient (gender not reported) had received on an unspecified date a percutaneous injection of SPV. The patient had also received on unspecified date(s) the following vaccines: IPV, MMR, YELLOW FEVER VACCINE, VARICELLA VACCINE (LIVE) (manufactured by Merck), ANTHRAX VACCINE, HEP B, HEP A, TYPHOID VI POLYSACCHARIDE VACCINE AND INFLUENZA VACCINE. For all these vaccines (except Varicella vaccine), manufacturer were unknown. Lot number, route and site of administration were also unknown for all these products. On unspecified date(s), the patient experienced the following symptoms: abdominal discomfort, arthralgia, back pain, bursitis, cervical spinal stenosis, musculoskeletal pain, myalgia, pain in extremity, tendon injury, and tendonitis. It was also reported: "muscles pain, back pains, legs, shoulder, fingers, upset stomach, joints hurt so much". Current illnesses, medical history, prior vaccinations and corrective treatment received were not reported. The patient had received "PPD" as other medications. For lab data, the following was reported: "Tendon broken (5); Bursitis; Tendinitis; Cervicals clogging spinal cord". At the time of the report, the patient was not recovered. Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure increased, Eyelid oedema, Renal impairment, Renal injury
Clinical narrative: I have already sent the information that you have asked for concerning my flu shot. I don't understand why I have received another form requesting the same information in more detail. I have already had over a dozen trips to my doctor or his Physician Assistant because of the affects of the flu shot. I have suffered severe facial swelling, blurred vision, kidney problems, severe headaches, nausea, and myriad of typical flu symptoms. I took the shot at 3:30 PM. Within 30 minutes of taking the shot I had a bad headache. By 7:30 PM I had a sore throat and sinus pain and swelling. My eyelids and facial tissue also began swelling to the point that I could barely open my eyes. At approximately 8:00 PM, my husband took me to the Emergency Room. I visited my Optometrist. He examined my eyes and read through the data sheets of the flu serum, provided by pharmacy. Dr suggested that the potential cause of the problem, is the mercury based preservative. The same preservative had been used previously in contact lens materials and had caused allergic reactions in some patients. It is no longer used in contact lens solutions. This was my first ever flu shot. The only reason that I took the shot was because it was suggested that it would protect my sister when I went to visit her. My sister is suffering from 4th stage cancer and her immune system is compromised. I will never recommend getting a flu shot to anyone after the ongoing heath problems I have suffered since January 2014.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Eyelid oedema, Headache, Influenza, Nausea
Clinical narrative: I have already sent the information that you have asked for concerning my flu shot. I don't understand why I have received another form requesting the same information in more detail. I have already had over a dozen trips to my doctor or his Physician Assistant because of the affects of the flu shot. I have suffered severe facial swelling, blurred vision, kidney problems, severe headaches, nausea, and myriad of typical flu symptoms. I took the shot at 3:30 PM. Within 30 minutes of taking the shot I had a bad headache. By 7:30 PM I had a sore throat and sinus pain and swelling. My eyelids and facial tissue also began swelling to the point that I could barely open my eyes. At approximately 8:00 PM, my husband took me to the Emergency Room. I visited my Optometrist. He examined my eyes and read through the data sheets of the flu serum, provided by pharmacy. Dr suggested that the potential cause of the problem, is the mercury based preservative. The same preservative had been used previously in contact lens materials and had caused allergic reactions in some patients. It is no longer used in contact lens solutions. This was my first ever flu shot. The only reason that I took the shot was because it was suggested that it would protect my sister when I went to visit her. My sister is suffering from 4th stage cancer and her immune system is compromised. I will never recommend getting a flu shot to anyone after the ongoing heath problems I have suffered since January 2014.