chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Tremor
Clinical narrative: Case number PHHY2013US012148 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 475134) web site on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 211584) on 22 Jun 2014. This report refers to a 45-year-old female patient. Her medical history was not reported and concomitant medications included SYNTHROID, gabapentin and VIVELLE DOT. She was vaccinated with FLUVIRIN (batch number: 1205301 and expiry date: Jun 2013) intramuscularly on to right limb on 26 Oct 2012. On the same day, approximately 2 hours after the shot, she began to get very dizzy. She was unable to walk. She was lying down with her eyes closed as she was feeling dizzy. She was taken to her family doctor where they checked her. While she was there, she began having severe tremors or what they called rigors. It was reported that her blood pressure was measured as 96/60 (units unspecified) by a nurse initially. It was reported that her blood pressure and body temperature were usually quite low. Later at the doctor's office, her heart rate went up to 140 (normal values and units not reported). Her temperature was initially measured as 97 degrees and after the rigors it was 100 degrees. She had a blood test done and her complete blood count was normal. She was watched for a while and by the time she left, her blood pressure and temperature became normal. It was reported that the dizziness continued for the rest of the day, but everything else stopped. She became normal the next day. The final outcome of the events was reported as complete recovery. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1205301) 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: 211584) on 22 Jun 2014: Updated batch review report.
Age: 65.0
Sex: M
Vaccine: FLU3, HEP, HEPA, PPV
Symptoms: Abnormal dreams, Amnesia, Asthenia, Burning sensation, Chills
Clinical narrative: Case number PHHY2013US012105 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 475229) on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 210532) on 22 Jun 2014. This case refers to a 65-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1206401 and expiry date: 30 Jun 2013) intramuscularly in his left arm on 09 Nov 2012. On the same day he was also vaccinated with ENGERIX-B (other manufacturer, batch number: AVBVC111AA) intramuscularly in right arm, HAVRIX (other manufacturer, batch number: AVAVB532AA) intramuscularly in right arm, PNEUMOVAX (other manufacturer, batch number: H009826) intramuscularly in left arm and BOOSTRIX (other manufacturer, batch number: AC52B097CA) intramuscularly in left arm. On 10 Nov 2012, the patient reported that he had burning sensation due to one of the vaccine administered in left arm. He also had convulsions on 10 Nov 2012 (night), while on a trip and did not remember much of the trip due to high fever. On 11 Nov 2012 he was not able to sleep through the night; woke up every 40 minutes and had weird dreams. On 12 Nov 2012 he still had fever and chills (continuous shaking) and took TYLENOL, ibuprofen and BENADRYL. The patient and his wife called on 13 Nov 2012 to complain of symptoms and were advised to see MD right away. Due to the situation the patient was in, patient was unable to see an MD at that time. On 14 Nov 2012 he felt better, but still had little bit of fever, and 5 inch diameter of redness of the left arm (injection site). He was weak and had no strength. There was also a hard lump (was the size of a softball) in the area, getting softer as the days passed on. The patient was advised again to see MD as soon as possible to find out what type of reaction he might have received from the vaccination. The final outcome was reported as condition unchanged as of 14 Nov 2012. The seriousness and causality were not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (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: 210532) on 22 Jun 2014: Updated batch review report.
Age: 65.0
Sex: M
Vaccine: FLU3, HEP, HEPA, PPV
Symptoms: Convulsion, Induration, Injection site erythema, Mass, Middle insomnia
Clinical narrative: Case number PHHY2013US012105 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 475229) on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 210532) on 22 Jun 2014. This case refers to a 65-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1206401 and expiry date: 30 Jun 2013) intramuscularly in his left arm on 09 Nov 2012. On the same day he was also vaccinated with ENGERIX-B (other manufacturer, batch number: AVBVC111AA) intramuscularly in right arm, HAVRIX (other manufacturer, batch number: AVAVB532AA) intramuscularly in right arm, PNEUMOVAX (other manufacturer, batch number: H009826) intramuscularly in left arm and BOOSTRIX (other manufacturer, batch number: AC52B097CA) intramuscularly in left arm. On 10 Nov 2012, the patient reported that he had burning sensation due to one of the vaccine administered in left arm. He also had convulsions on 10 Nov 2012 (night), while on a trip and did not remember much of the trip due to high fever. On 11 Nov 2012 he was not able to sleep through the night; woke up every 40 minutes and had weird dreams. On 12 Nov 2012 he still had fever and chills (continuous shaking) and took TYLENOL, ibuprofen and BENADRYL. The patient and his wife called on 13 Nov 2012 to complain of symptoms and were advised to see MD right away. Due to the situation the patient was in, patient was unable to see an MD at that time. On 14 Nov 2012 he felt better, but still had little bit of fever, and 5 inch diameter of redness of the left arm (injection site). He was weak and had no strength. There was also a hard lump (was the size of a softball) in the area, getting softer as the days passed on. The patient was advised again to see MD as soon as possible to find out what type of reaction he might have received from the vaccination. The final outcome was reported as condition unchanged as of 14 Nov 2012. The seriousness and causality were not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (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: 210532) on 22 Jun 2014: Updated batch review report.
Age: 65.0
Sex: M
Vaccine: FLU3, HEP, HEPA, PPV
Symptoms: Poor quality sleep, Pyrexia, Sleep disorder, Tremor
Clinical narrative: Case number PHHY2013US012105 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 475229) on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 210532) on 22 Jun 2014. This case refers to a 65-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1206401 and expiry date: 30 Jun 2013) intramuscularly in his left arm on 09 Nov 2012. On the same day he was also vaccinated with ENGERIX-B (other manufacturer, batch number: AVBVC111AA) intramuscularly in right arm, HAVRIX (other manufacturer, batch number: AVAVB532AA) intramuscularly in right arm, PNEUMOVAX (other manufacturer, batch number: H009826) intramuscularly in left arm and BOOSTRIX (other manufacturer, batch number: AC52B097CA) intramuscularly in left arm. On 10 Nov 2012, the patient reported that he had burning sensation due to one of the vaccine administered in left arm. He also had convulsions on 10 Nov 2012 (night), while on a trip and did not remember much of the trip due to high fever. On 11 Nov 2012 he was not able to sleep through the night; woke up every 40 minutes and had weird dreams. On 12 Nov 2012 he still had fever and chills (continuous shaking) and took TYLENOL, ibuprofen and BENADRYL. The patient and his wife called on 13 Nov 2012 to complain of symptoms and were advised to see MD right away. Due to the situation the patient was in, patient was unable to see an MD at that time. On 14 Nov 2012 he felt better, but still had little bit of fever, and 5 inch diameter of redness of the left arm (injection site). He was weak and had no strength. There was also a hard lump (was the size of a softball) in the area, getting softer as the days passed on. The patient was advised again to see MD as soon as possible to find out what type of reaction he might have received from the vaccination. The final outcome was reported as condition unchanged as of 14 Nov 2012. The seriousness and causality were not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (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: 210532) on 22 Jun 2014: Updated batch review report.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Altered visual depth perception, Arrhythmia, Chest pain, Computerised tomogram, Disorientation
Clinical narrative: Case number PHHY2013US012283 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 477397) on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 210528) on 22 Jun 2014. This case refers to a 55-year-old female patient. She is a traumatic spinal cord survivor with multiple neurological issues. Her vaccination history included reactions to different vaccinations in the past (not specified). She was vaccinated with FLUVIRIN (batch number: 122204 and expiry date: 31 May 2013) intramuscularly in her left arm on 28 Nov 2012. She experienced severe chest pain within 10 minutes after vaccination. Twenty four hours later she had reduced sensation of entire left side (arm, leg and head). Thirty six hours later, she lost fine motor coordination, disoriented, short of breath with cardiac arrhythmias. She also had hand tremors, sensitivity to sound and lights and reduced visual perception. She had an emergency doctor visit due to these events. It was reported that there was no means to diagnose vaccine reactions. She underwent routine lab work and CT scan. The results were not reported. The seriousness was reported as life threatening. The final outcome was reported as condition unchanged. The causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 122204) 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: 210528) on 22 Jun 2014: Updated batch review report.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hyperacusis, Laboratory test, Motor dysfunction, Photophobia
Clinical narrative: Case number PHHY2013US012283 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 477397) on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 210528) on 22 Jun 2014. This case refers to a 55-year-old female patient. She is a traumatic spinal cord survivor with multiple neurological issues. Her vaccination history included reactions to different vaccinations in the past (not specified). She was vaccinated with FLUVIRIN (batch number: 122204 and expiry date: 31 May 2013) intramuscularly in her left arm on 28 Nov 2012. She experienced severe chest pain within 10 minutes after vaccination. Twenty four hours later she had reduced sensation of entire left side (arm, leg and head). Thirty six hours later, she lost fine motor coordination, disoriented, short of breath with cardiac arrhythmias. She also had hand tremors, sensitivity to sound and lights and reduced visual perception. She had an emergency doctor visit due to these events. It was reported that there was no means to diagnose vaccine reactions. She underwent routine lab work and CT scan. The results were not reported. The seriousness was reported as life threatening. The final outcome was reported as condition unchanged. The causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 122204) 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: 210528) on 22 Jun 2014: Updated batch review report.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Sensory disturbance, Tremor
Clinical narrative: Case number PHHY2013US012283 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 477397) on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 210528) on 22 Jun 2014. This case refers to a 55-year-old female patient. She is a traumatic spinal cord survivor with multiple neurological issues. Her vaccination history included reactions to different vaccinations in the past (not specified). She was vaccinated with FLUVIRIN (batch number: 122204 and expiry date: 31 May 2013) intramuscularly in her left arm on 28 Nov 2012. She experienced severe chest pain within 10 minutes after vaccination. Twenty four hours later she had reduced sensation of entire left side (arm, leg and head). Thirty six hours later, she lost fine motor coordination, disoriented, short of breath with cardiac arrhythmias. She also had hand tremors, sensitivity to sound and lights and reduced visual perception. She had an emergency doctor visit due to these events. It was reported that there was no means to diagnose vaccine reactions. She underwent routine lab work and CT scan. The results were not reported. The seriousness was reported as life threatening. The final outcome was reported as condition unchanged. The causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 122204) 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: 210528) on 22 Jun 2014: Updated batch review report.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Axillary pain, Drug administered at inappropriate site, Impaired driving ability, Mobility decreased
Clinical narrative: Case number PHHY2013US069600, is initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 478268) website on 03 Jul 2013 with a follow up information received from the quality assurance department (QA reference number: 239765) on 23 Jun 2014. This report refers to a 59 year-old female patient. Her medical history included diabetes and Dressler Syndrome. Her concomitant medications included LANTUS and metoprolol. She was vaccinated with FLUVIRIN (batch number: 1206401, expiry date: 30 Jun 2013) intramuscularly in the right arm on 16 Nov 2012. It was reported that she was vaccinated in the "joint" (inappropriate site). On the same day of vaccination, she experienced difficulty in moving arm (unspecified) greater than 45 degree angle. She had pain under armpit and cannot lie on the side. She experienced difficulty in dressing and driving. The pain slowly got worse on the same day. She visited the emergency room. She was prescribed TYLENOL and ibuprofen, but they were ineffective. The event outcome was condition unchanged as of 14 Dec 2012. The seriousness and causality were not reported. Upon follow up information received from the quality assurance department (QA reference number: 239765) on 23 Jun 2014 it was reported that based on the document review, it was concluded that FLUVIRIN batch number 1206401 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No other information was available. Follow up information received from the quality assurance department on 23 Jun 2014: Batch summary and expiry date updated.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Case number PHHY2013US044411 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 485171) web site on 06 May 2013 with follow up information received from the quality assurance department (QA reference number: 227446) on 23 Jun 2014. This report refers to a 48-year-old male patient. His medical history was not reported and concomitant medications included atenolol, simvastatin, lisinopril and SINGULAIR. He was vaccinated with FLUVIRIN, (batch number: 1206101, expiry date: Jun 2013) in left deltoid on 14 Jan 2013. On 04 Feb 2013, he experienced shingles outbreak in dermatome that correlated with where vaccine was administered. The shingles broke out in left shoulder and pectoral area. He went to emergency room. The outcome of the event was reported as condition unchanged. Upon follow up information received from the quality assurance department (QA reference number: 227446) on 23 Jun 2014 it was reported that based on the document review, it was concluded that FLUVIRIN batch number 1206101 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No other information was available. Follow up information received from the quality assurance department on 23 Jun 2014: Batch summary and expiry date updated.
Age: 28.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Adverse reaction, Disorientation, Dizziness, Loss of consciousness, Pallor
Clinical narrative: Case number PHHY2014US046480 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 519981) on 14 Apr 2014, with a follow-up information received from Quality Assurance Department (reference number: 295245) on 13 Jun 2014: This report refers to a 28-year-old male patient. His medical history included minor egg allergy and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: 004021A) intramuscularly in to the left arm on 21 Jan 2014. On the same day after vaccination, he started to feel faint. He started to turn pale white and stated that he thought he was having a reaction. He then blacked our and was unaware of his surroundings for a just a minute before. Outcome of the events was reported as complete recovery. Events were assessed as non-serious by the reporter; however the case was internally upgraded to serious by company. No further information about causality was reported. Based on the investigation performed, the QA department stated that, FLUCELVAX (batch number: 004021A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 295245) on 22 Apr 2014: Updated QA reference number only. Follow up information received from the Quality Assurance Department (reference number: 295245) on 13 Jun 2014: Updated batch review report.
Age: 28.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Disorientation, Dizziness, Loss of consciousness, Pallor
Clinical narrative: Case number PHHY2014US046480 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 519981) on 14 Apr 2014, with a follow-up information received from Quality Assurance Department (reference number: 295245) on 13 Jun 2014: This report refers to a 28-year-old male patient. His medical history included minor egg allergy and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: 004021A) intramuscularly in to the left arm on 21 Jan 2014. On the same day after vaccination, he started to feel faint. He started to turn pale white and stated that he thought he was having a reaction. He then blacked our and was unaware of his surroundings for a just a minute before. Outcome of the events was reported as complete recovery. Events were assessed as non-serious by the reporter; however the case was internally upgraded to serious by company. No further information about causality was reported. Based on the investigation performed, the QA department stated that, FLUCELVAX (batch number: 004021A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 295245) on 22 Apr 2014: Updated QA reference number only. Follow up information received from the Quality Assurance Department (reference number: 295245) on 13 Jun 2014: Updated batch review report.
Age: 23.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Case number PHHY2014US046521, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520028) website on 14 Apr 2014, with a follow-up information received from Quality Assurance Department (reference number: 295268) on 12 Jun 2014. This report refers to a 23-year-old male patient. He was vaccinated with FLUCELVAX (batch number: 010021A) intramuscularly in the right arm on 11 Jan 2014. On the same date, immediately after vaccination he fainted. The final outcome of the event reported as recovered. The event was reported as non-serious; however the case was internally upgraded as medically significant by the MAH. The causality of the event was not reported. Based on the investigation performed, the QA department stated that, FLUCELVAX (batch number: 010021A) 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: 295268) on 12 Jun 2014: Updated batch review report.
Age: 49.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Computerised tomogram, Dysphagia, Dyspnoea, Fatigue, Full blood count
Clinical narrative: Case number PHHY2014US046412 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521542) web site on 14 Apr 2014, with a follow-up information received from Quality Assurance Department (reference number: 295238) on 13 Jun 2014. This report refers to a 49 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: 004011A) intramuscularly in the left arm on 12 Jan 2014. On 12 Jan 2014, he experienced tinnitus immediately following vaccination. He also experienced tachycardia, fatigue, dyspnea and dysphagia which were treated for 2 weeks. He also had tingling nerve of extremities. He was hospitalized for 3 days. Complete blood Count (CBC), Chem 7, Magnetic Resonance Imaging (MRI), spinal tap and Computerised Tomogram (CT) scan were done and the results were not reported. He was treated with prednisone, Albuterol and acetazolamide. The events were reported as ongoing. The event was reported as serious due to hospitalization. The causality was not reported. Based on the investigation performed, the QA department stated that, FLUCELVAX vaccine (batch number: 004011A) 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: 295238) on 13 Jun 2014: Updated batch review report.
Age: 49.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Immediate post-injection reaction, Laboratory test, Lumbar puncture, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Case number PHHY2014US046412 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521542) web site on 14 Apr 2014, with a follow-up information received from Quality Assurance Department (reference number: 295238) on 13 Jun 2014. This report refers to a 49 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: 004011A) intramuscularly in the left arm on 12 Jan 2014. On 12 Jan 2014, he experienced tinnitus immediately following vaccination. He also experienced tachycardia, fatigue, dyspnea and dysphagia which were treated for 2 weeks. He also had tingling nerve of extremities. He was hospitalized for 3 days. Complete blood Count (CBC), Chem 7, Magnetic Resonance Imaging (MRI), spinal tap and Computerised Tomogram (CT) scan were done and the results were not reported. He was treated with prednisone, Albuterol and acetazolamide. The events were reported as ongoing. The event was reported as serious due to hospitalization. The causality was not reported. Based on the investigation performed, the QA department stated that, FLUCELVAX vaccine (batch number: 004011A) 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: 295238) on 13 Jun 2014: Updated batch review report.
Age: 49.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Tachycardia, Tinnitus
Clinical narrative: Case number PHHY2014US046412 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521542) web site on 14 Apr 2014, with a follow-up information received from Quality Assurance Department (reference number: 295238) on 13 Jun 2014. This report refers to a 49 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: 004011A) intramuscularly in the left arm on 12 Jan 2014. On 12 Jan 2014, he experienced tinnitus immediately following vaccination. He also experienced tachycardia, fatigue, dyspnea and dysphagia which were treated for 2 weeks. He also had tingling nerve of extremities. He was hospitalized for 3 days. Complete blood Count (CBC), Chem 7, Magnetic Resonance Imaging (MRI), spinal tap and Computerised Tomogram (CT) scan were done and the results were not reported. He was treated with prednisone, Albuterol and acetazolamide. The events were reported as ongoing. The event was reported as serious due to hospitalization. The causality was not reported. Based on the investigation performed, the QA department stated that, FLUCELVAX vaccine (batch number: 004011A) 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: 295238) on 13 Jun 2014: Updated batch review report.
Age: 18.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Syncope
Clinical narrative: Case number PHHY2014US047237, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521814) website on 14 Apr 2014, with a follow-up information received from Quality Assurance Department (reference number: 295517) on 13 Jun 2014. This report refers to an 18 year old male patient. His past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: 004031A) intramuscularly into his left arm on 31 Jan 2014. On the same day, he developed syncope. He completely recovered from syncope. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUCELVAX (batch number: 004031A) 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: 295517) on 13 Jun 2014: Updated batch review report.
Age: 63.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Abasia, Blood test abnormal, Joint swelling, Mobility decreased, Pain
Clinical narrative: Case number PHHY2014US054877 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522825) web site on 06 May 2014, with a follow-up information received from Quality Assurance Department (reference number: 298546) on 13 Jun 2014. This report refers to a 63 year old male patient. His current condition included atrial fibrillation and his concomitant medications included Pradaxa at a dose of 150 mg and losartan at a dose of 25 mg. He was vaccinated with FLUCELVAX (batch number: 010021A) on 23 Nov 2013. On 30 Nov 2013, his left knee became so swollen that he could not see his kneecap. Over a period of few weeks the symptoms became worse to such an extent that he could not walk or lift his arms. He also developed low grade fever and pain continued till the date of reporting. He was taken to emergency room for medical support. 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. Based on the investigation performed, the QA department stated that, FLUCELVAX (batch number: 010021A) 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: 298546) on 13 Jun 2014: Updated batch review report.
Age: 63.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2014US054877 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522825) web site on 06 May 2014, with a follow-up information received from Quality Assurance Department (reference number: 298546) on 13 Jun 2014. This report refers to a 63 year old male patient. His current condition included atrial fibrillation and his concomitant medications included Pradaxa at a dose of 150 mg and losartan at a dose of 25 mg. He was vaccinated with FLUCELVAX (batch number: 010021A) on 23 Nov 2013. On 30 Nov 2013, his left knee became so swollen that he could not see his kneecap. Over a period of few weeks the symptoms became worse to such an extent that he could not walk or lift his arms. He also developed low grade fever and pain continued till the date of reporting. He was taken to emergency room for medical support. 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. Based on the investigation performed, the QA department stated that, FLUCELVAX (batch number: 010021A) 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: 298546) on 13 Jun 2014: Updated batch review report.
Age: 63.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Abasia, Joint swelling, Mobility decreased, Pain, Pyrexia
Clinical narrative: Case number PHHY2014US054877 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522825) web site on 06 May 2014, with a follow-up information received from Quality Assurance Department (reference number: 298546) on 13 Jun 2014. This report refers to a 63 year old male patient. His current condition included atrial fibrillation and his concomitant medications included Pradaxa at a dose of 150 mg and losartan at a dose of 25 mg. He was vaccinated with FLUCELVAX (batch number: 010021A) on 23 Nov 2013. On 30 Nov 2013, his left knee became so swollen that he could not see his kneecap. Over a period of few weeks the symptoms became worse to such an extent that he could not walk or lift his arms. He also developed low grade fever and pain continued till the date of reporting. He was taken to emergency room for medical support. 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. Based on the investigation performed, the QA department stated that, FLUCELVAX (batch number: 010021A) 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: 298546) on 13 Jun 2014: Updated batch review report.
Age: 37.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Activities of daily living impaired, Blood copper increased, Malaise, Myalgia, Nausea
Clinical narrative: Case number PHHY2014US054731 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 523861) website on 06 May 2014, with a follow-up information received from Quality Assurance Department (reference number: 298424) on 13 Jun 2014. This report refers to a 37-year-old female patient. Her medical history included gluten allergy. She was vaccinated with FLUCELVAX (batch number: 009021A) intramuscularly into left arm on 11 Jan 2014. On 13 Jan 2014, two days after vaccination, she became ill and missed work; symptoms included muscle ache, nausea and vomiting. She claims her lab indicate high level of copper. The case was reported as serious (Life-threatening). Outcome of the events was reported as recovered. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUCELVAX (batch number: 009021A) 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: 298424) on 13 Jun 2014: Updated batch review report.
Age: 37.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Vomiting
Clinical narrative: Case number PHHY2014US054731 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 523861) website on 06 May 2014, with a follow-up information received from Quality Assurance Department (reference number: 298424) on 13 Jun 2014. This report refers to a 37-year-old female patient. Her medical history included gluten allergy. She was vaccinated with FLUCELVAX (batch number: 009021A) intramuscularly into left arm on 11 Jan 2014. On 13 Jan 2014, two days after vaccination, she became ill and missed work; symptoms included muscle ache, nausea and vomiting. She claims her lab indicate high level of copper. The case was reported as serious (Life-threatening). Outcome of the events was reported as recovered. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUCELVAX (batch number: 009021A) 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: 298424) on 13 Jun 2014: Updated batch review report.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: CSF protein increased, Caesarean section, Exposure during pregnancy, Fall, Guillain-Barre syndrome
Clinical narrative: Case number PHHY2014US054782 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 524893) website on 06 May 2014, and with a follow up report received on 18 Jun 2014. This report refers to a 40-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13392P) in the left arm on 24 Sep 2013 when she was pregnant. On 01 Dec 2013, she had Guillain Barre syndrome. She was admitted prior to delivery for 5 days intravenous immunoglobulin (IVIG) treatment. It was reported that her cerebrospinal fluid (CSF) protein increased and she had sensory involvement leading to falls on unknown dates. There was no respiratory involvement. She was admitted to hospital on 03 Feb 2014 for C-section. The outcome of pregnancy was not reported. The final outcome of the event was reported as unknown. The event was reported as serious. The causality of the event was not reported. The case was considered as lost to follow up. Follow up report received on 18 Jun 2014. This case was considered lost to follow up.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immunoglobulin therapy, Sensory disturbance
Clinical narrative: Case number PHHY2014US054782 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 524893) website on 06 May 2014, and with a follow up report received on 18 Jun 2014. This report refers to a 40-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13392P) in the left arm on 24 Sep 2013 when she was pregnant. On 01 Dec 2013, she had Guillain Barre syndrome. She was admitted prior to delivery for 5 days intravenous immunoglobulin (IVIG) treatment. It was reported that her cerebrospinal fluid (CSF) protein increased and she had sensory involvement leading to falls on unknown dates. There was no respiratory involvement. She was admitted to hospital on 03 Feb 2014 for C-section. The outcome of pregnancy was not reported. The final outcome of the event was reported as unknown. The event was reported as serious. The causality of the event was not reported. The case was considered as lost to follow up. Follow up report received on 18 Jun 2014. This case was considered lost to follow up.
Age: 51.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Asthenia, Dizziness, Impaired work ability, Pain in extremity, Tremor
Clinical narrative: Case number PHHY2014US071663, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 528431) website on 09 Jun 2014 with a follow up report received from the Quality Assurance department (QA reference number: 305636) on 12 Jun 2014. This report refers to a 51 year old female patient. Past medical history included latex, NEOSPORIN and sulfa allergy. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1308901) intramuscularly into the right arm, along with TDAP (other manufacturer, batch number: U4837AA) intramuscularly into the left arm on 20 Mar 2014. On 21 Mar 2014, she became faint, weak and trembled. She had extreme pain in left arm and was unable to work. She was sent to emergency room twice. 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. The previously reported batch number '1308907' was found to be an invalid batch number by the Quality Assurance department and the most likely batch number would be '1308901' for which the investigation would be performed. Follow up report was received from the Quality Assurance department (QA reference number: 305636) on 12 Jun 2014: The batch number and the QA reference number were updated.
Age: 1.8
Sex: M
Vaccine: HEP, PNC13
Symptoms: Bronchitis, Cough, Otitis media acute, Pyrexia, Rhinorrhoea
Clinical narrative: Fever (temperature up to 102), nasal discharge, cough.  Seen in office for bilateral acute otitis media and bronchitis.  Treated with a course of Augmentin-ES antibiotic.
Age: 1.58
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Irritability, Malaise, Rash generalised, Vomiting
Clinical narrative: Emesis for three days with diarrhea and a rash over the body.  Irritability.  Seen in the office for two visits while ill.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an unspecified number of patients (reported as "a couple of patients") of unknown age and gender. On an unknown date the patients were vaccinated with a dose of GARDASIL (dose, route and lot number not reported). On an unknown date the patients passed out after receipt of GARDASIL. The outcome of the event and relatedness between the event and GARDASIL were not reported. Upon internal review the event of passing out was determined to be medically significant. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site discolouration, Injection site oedema, Injection site swelling, Local swelling
Clinical narrative: Around 7pm patient noticed Left arm itchy and red. Next morning 5-1-14 woke up with arm swollen and more redness. used Benadryl and applied ice. Providers exam; Left arm from shoulder to distal elbow with violaceous discoloration, bulky edema and 1cm enlargement compare to other arm. Erythema and color extend to left upper superior aspect of breast. Patient prescribed Medrol 4mg dose pack. Patient reported sx going away the day after began Medrol.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: Around 7pm patient noticed Left arm itchy and red. Next morning 5-1-14 woke up with arm swollen and more redness. used Benadryl and applied ice. Providers exam; Left arm from shoulder to distal elbow with violaceous discoloration, bulky edema and 1cm enlargement compare to other arm. Erythema and color extend to left upper superior aspect of breast. Patient prescribed Medrol 4mg dose pack. Patient reported sx going away the day after began Medrol.
Age: 51.0
Sex: F
Vaccine: PPV, TD
Symptoms: Cellulitis, Chills, Headache, Hypersensitivity, Induration
Clinical narrative: Injection Site of Pneumonia Vaccine was hot and swollen, chills, nausea, vomiting, headache, muscle pain, fever rose to 104 but was 102 plus in doctor''s office on 6/19/2014, prescribed Bactrim for 10 days for Celllutis, returned to Dr on 06/20/2014 and was sent to ER because redness, swelling around injection site had spread, ER on Friday eve, 06/20/2014, where given an antibiotic injection (of?) and prescribed a 2d oral antibiotic, Keflex to be taken in conjunction with first prescribed antibiotic, returned to Dr on 06/24/2014, red, swollen area has receded, still hard hot lump about the size of a golf ball, was instructed to finish both courses of antibiotics, Dr said I had symptoms of both an allergic reaction and cellulitis
Age: 51.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Mass, Myalgia
Clinical narrative: Injection Site of Pneumonia Vaccine was hot and swollen, chills, nausea, vomiting, headache, muscle pain, fever rose to 104 but was 102 plus in doctor''s office on 6/19/2014, prescribed Bactrim for 10 days for Celllutis, returned to Dr on 06/20/2014 and was sent to ER because redness, swelling around injection site had spread, ER on Friday eve, 06/20/2014, where given an antibiotic injection (of?) and prescribed a 2d oral antibiotic, Keflex to be taken in conjunction with first prescribed antibiotic, returned to Dr on 06/24/2014, red, swollen area has receded, still hard hot lump about the size of a golf ball, was instructed to finish both courses of antibiotics, Dr said I had symptoms of both an allergic reaction and cellulitis
Age: 51.0
Sex: F
Vaccine: PPV, TD
Symptoms: Nausea, Pyrexia, Skin warm, Vomiting
Clinical narrative: Injection Site of Pneumonia Vaccine was hot and swollen, chills, nausea, vomiting, headache, muscle pain, fever rose to 104 but was 102 plus in doctor''s office on 6/19/2014, prescribed Bactrim for 10 days for Celllutis, returned to Dr on 06/20/2014 and was sent to ER because redness, swelling around injection site had spread, ER on Friday eve, 06/20/2014, where given an antibiotic injection (of?) and prescribed a 2d oral antibiotic, Keflex to be taken in conjunction with first prescribed antibiotic, returned to Dr on 06/24/2014, red, swollen area has receded, still hard hot lump about the size of a golf ball, was instructed to finish both courses of antibiotics, Dr said I had symptoms of both an allergic reaction and cellulitis
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Erythema, Lip swelling, Mammogram, Pruritus
Clinical narrative: Lower lip became red and swollen as well as itchy; Red area appeared around nipple of left breast; round 50 cent piece size red area also appeared on left chest -patient went to urgent care the next day to be seen- MD was ruling out cellulitis vs. breast issue- prescribed antibiotics (doxycycline BID for 10 days) and sent for diagnostic ultrasound and mammogram of left breast
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound scan
Clinical narrative: Lower lip became red and swollen as well as itchy; Red area appeared around nipple of left breast; round 50 cent piece size red area also appeared on left chest -patient went to urgent care the next day to be seen- MD was ruling out cellulitis vs. breast issue- prescribed antibiotics (doxycycline BID for 10 days) and sent for diagnostic ultrasound and mammogram of left breast
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Severe swelling of entire inside of upper arm; severe redness; itching; very hardened area at injection site; very sore, painful and burning. Redness and itching keeps spreading; now past elbow on inside of arm 3 days later.  Still able to function but painful even to use arm and especially if anything, even clothing, comes in contact with it.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Tenderness
Clinical narrative: Severe swelling of entire inside of upper arm; severe redness; itching; very hardened area at injection site; very sore, painful and burning. Redness and itching keeps spreading; now past elbow on inside of arm 3 days later.  Still able to function but painful even to use arm and especially if anything, even clothing, comes in contact with it.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Cellulitis, Chills, Injection site erythema, Injection site pain
Clinical narrative: Started with extreme pain at the injection site. That same night I developed fever and chills. Next day I realized my entire upper arm was swollen and red and not just the inject site. I could even lift my arm. Saw a doctor the next day and he advised that it was cellulitis and prescribed my keflex 500 qid and ibuprofen 600 tid. Its been 4 days since I received the vaccine, I still have some swelling and redness. There is some swelling around my forearm now as well but its still minor. I had to call in sick for a day as well due to this.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Local swelling, Pyrexia
Clinical narrative: Started with extreme pain at the injection site. That same night I developed fever and chills. Next day I realized my entire upper arm was swollen and red and not just the inject site. I could even lift my arm. Saw a doctor the next day and he advised that it was cellulitis and prescribed my keflex 500 qid and ibuprofen 600 tid. Its been 4 days since I received the vaccine, I still have some swelling and redness. There is some swelling around my forearm now as well but its still minor. I had to call in sick for a day as well due to this.