chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Autoimmune disorder, Condition aggravated, Herpes zoster, Injection site swelling
Clinical narrative: Case number PHHY2013US000818 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 469897) on 02 Jan 2013, and with a follow up report received from QA department (QA reference number: 208860) on 14 May 2014. This report refers to a 55-year-old female patient. The patient's preexisting conditions included allergies and asthma and auto-immune disorder (unspecified). Concomitant medications included SINGULAIR, Omega 3, Vitamin D3, MSM, L-LYSINE and COQ10. The patient was vaccinated with FLUVIRIN (batch number: 12252P) intramuscularly on left arm on 24 Sep 2012. On the same day, the patient experienced swelling and pain in left arm from shoulder down to hand; shot triggered autoimmune response that lasted for one week. The patient had an allergy shot (unspecified) on 04 Oct 2012. During doctor's visit on 15 Oct 2012, visual examination was done, the patient was diagnosed with an outbreak of shingles with onset approximately on the evening of 05 Oct 2012 or morning of 06 Oct 2012. Outcome of the events was reported as condition unchanged as of 16 Oct 2012. Seriousness and causality of the events was not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 12252P 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 QA department (QA reference number: 208860) on 14 May 2014. Updated batch review report.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Case number PHHY2013US000818 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 469897) on 02 Jan 2013, and with a follow up report received from QA department (QA reference number: 208860) on 14 May 2014. This report refers to a 55-year-old female patient. The patient's preexisting conditions included allergies and asthma and auto-immune disorder (unspecified). Concomitant medications included SINGULAIR, Omega 3, Vitamin D3, MSM, L-LYSINE and COQ10. The patient was vaccinated with FLUVIRIN (batch number: 12252P) intramuscularly on left arm on 24 Sep 2012. On the same day, the patient experienced swelling and pain in left arm from shoulder down to hand; shot triggered autoimmune response that lasted for one week. The patient had an allergy shot (unspecified) on 04 Oct 2012. During doctor's visit on 15 Oct 2012, visual examination was done, the patient was diagnosed with an outbreak of shingles with onset approximately on the evening of 05 Oct 2012 or morning of 06 Oct 2012. Outcome of the events was reported as condition unchanged as of 16 Oct 2012. Seriousness and causality of the events was not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 12252P 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 QA department (QA reference number: 208860) on 14 May 2014. Updated batch review report.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood creatine phosphokinase increased, Full blood count, Metabolic function test, Myalgia
Clinical narrative: Case number PHHY2013US000854, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 469915) web site on 02 Jan 2013 with a follow-up was received from Quality Assurance Department (reference number: 208867) on 14 May 2014. This report refers to a 40-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 12245P) into left arm on 03 Oct 2012. On 06 Oct 2012, 3 days after vaccination, he experienced severe incapacitating myalgia and weakness. He was diagnosed with rhabdomyolysis. No treatment was provided. Blood work was monitored. CPK (creatine phosphokinase) was 1000 (unknown units). CMP (complete metabolic panel), CBC (complete blood count) was done and results not reported. The outcome of the event was condition unchanged. Batch review report concluded that, based on the document review, it was stated that, the concerned with FLUVIRIN (batch number: 12245P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. The seriousness and causality of the events were not reported. Follow up report received from quality assurance department on 14 May 2014: Updated batch review report.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Rhabdomyolysis
Clinical narrative: Case number PHHY2013US000854, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 469915) web site on 02 Jan 2013 with a follow-up was received from Quality Assurance Department (reference number: 208867) on 14 May 2014. This report refers to a 40-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 12245P) into left arm on 03 Oct 2012. On 06 Oct 2012, 3 days after vaccination, he experienced severe incapacitating myalgia and weakness. He was diagnosed with rhabdomyolysis. No treatment was provided. Blood work was monitored. CPK (creatine phosphokinase) was 1000 (unknown units). CMP (complete metabolic panel), CBC (complete blood count) was done and results not reported. The outcome of the event was condition unchanged. Batch review report concluded that, based on the document review, it was stated that, the concerned with FLUVIRIN (batch number: 12245P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. The seriousness and causality of the events were not reported. Follow up report received from quality assurance department on 14 May 2014: Updated batch review report.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Injection site erythema, Injection site warmth, Local swelling, Oedema peripheral
Clinical narrative: Case number PHHY2013US000859 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 469918) website on 02 Jan 2013 with a follow-up was received from Quality Assurance Department (reference number: 209055) on 14 May 2014. This report refers to a 71-year-old female patient. Her medical history included allergy to sulfa drugs. Concomitant medication included CRESTOR. She was vaccinated with FLUVIRIN (batch number: 1205201) intramuscularly on 13 Oct 2012. On the same date, she was also vaccinated with PNEUMOVAX (batch number: 0813AA and manufacturer: Merck and Co) intramuscularly. On 14 Oct 2012, after vaccination the patient experienced localized redness, hot circle at injection site which was 4 inches at 24 hours and 6 inches at 48 hours, fluid held at inner arm large, puffed in moon shaped area about 1/4 inches high and "slight fever of 108". Her arm at 48 hours dropped to normal. The patient received NSAIDs (nonsteroidal anti inflammatory drugs) that helped with endured discomfort. The outcome of the events was reported as condition unchanged as of 15 Oct 2012. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN (batch number: 1205201) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. The seriousness and causality of the events were not reported. Follow up report received from quality assurance department on 14 May 2014: Updated batch review report.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2013US000859 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 469918) website on 02 Jan 2013 with a follow-up was received from Quality Assurance Department (reference number: 209055) on 14 May 2014. This report refers to a 71-year-old female patient. Her medical history included allergy to sulfa drugs. Concomitant medication included CRESTOR. She was vaccinated with FLUVIRIN (batch number: 1205201) intramuscularly on 13 Oct 2012. On the same date, she was also vaccinated with PNEUMOVAX (batch number: 0813AA and manufacturer: Merck and Co) intramuscularly. On 14 Oct 2012, after vaccination the patient experienced localized redness, hot circle at injection site which was 4 inches at 24 hours and 6 inches at 48 hours, fluid held at inner arm large, puffed in moon shaped area about 1/4 inches high and "slight fever of 108". Her arm at 48 hours dropped to normal. The patient received NSAIDs (nonsteroidal anti inflammatory drugs) that helped with endured discomfort. The outcome of the events was reported as condition unchanged as of 15 Oct 2012. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN (batch number: 1205201) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. The seriousness and causality of the events were not reported. Follow up report received from quality assurance department on 14 May 2014: Updated batch review report.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Staring
Clinical narrative: Case number PHHY2013US000867 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number 470520) received on 02 Jan 2013 with a follow up report received from Quality Assurance Department (QA reference number: 209091) on 14 May 2014. This report refers to a 65-year-old male patient. His medical history included seizure disorder, cerebral palsy and hypertension. He was vaccinated with FLUVIRIN (batch number 1203901, expiry date: 31 May 2013) intramuscularly in his left arm on 10 Oct 2012. On 10 Oct 2012 after vaccination he had "multiple seizures post immunization (5)" and staring spells. The patient was witnessed with known controlled seizure. The outcome of the events was reported as recovered as of 17 Oct 2012. The seriousness and causality assessment of the events was unknown. Based on the batch review performed, it was concluded that FLUVIRIN batch number 1203901 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received from QA department on 14 May 2014: Updated expiry date and batch review report.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Haematoma, Injection site pain, Tenderness
Clinical narrative: Case number PHHY2013US000874 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number 470526) received on 02 Jan 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 208879) on 14 May 2014. This report refers to a 36-year-old female patient. She was vaccinated with FLUVIRIN (batch number 12235P) intramuscularly in her right arm, PNEUMOVAX (other manufacturer, batch number H010515) intramuscularly in her right arm and ADACEL (other manufacturer, batch number U4335AA) intramuscularly in her left arm on 13 Oct 2012. On 15 Oct 2012 after the vaccination she complained of severe pain in posterior upper right arm. She went to physician who did not see anything. She had palpitated tenderness in arm. She was sent to emergency room and was diagnosed with hematoma. She still had pain. The outcome of the events was reported as condition unchanged. The seriousness and causality assessment of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 12235P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 208879) on 14 May 2014: Updated batch review report.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dry mouth, Fungal infection, Fungal test positive, Lip swelling
Clinical narrative: Case number PHHY2013US000897 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number 470570) received on 02 Jan 2013 with a follow-up was received from Quality Assurance Department (reference number: 209062) on 14 May 2014. This report refers to a 42-year-old female patient. Her medical history included asthma and allergies. Concomitant medications included SINGULAIR, Albuterol, PRILOSEC and CLARITIN. She was vaccinated with FLUVIRIN (batch number 1205001) intramuscularly in her right arm on 09 Oct 2012. On 09 Oct 2012 after vaccination, she felt lightheaded and nauseated. On 10 Oct 2012, she again felt lightheaded and nauseated. On 11 Oct 2012, she felt lightheaded and nauseated and her tongue developed rash and had a dry mouth. On 12 Oct 2012, she had blisters around the mouth, fever and her lips began swelling. On 14 Oct 2012, she began taking BENADRYL for swelling. On 15 Oct 2012, she went to a private physician. Urinalysis was completed which revealed yeast growing rapidly which became viral. The physician diagnosed as adverse reaction to flu vaccine. The outcome of the events was reported as recovered as of 19 Oct 2012. Batch review report concluded that, based on the document review, it was stated that, the concerned with 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. The seriousness and causality of the events were not reported. Follow up report received from quality assurance department on 14 May 2014: Updated batch review report.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oral mucosal blistering, Pyrexia, Tongue eruption, Vaccination complication
Clinical narrative: Case number PHHY2013US000897 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number 470570) received on 02 Jan 2013 with a follow-up was received from Quality Assurance Department (reference number: 209062) on 14 May 2014. This report refers to a 42-year-old female patient. Her medical history included asthma and allergies. Concomitant medications included SINGULAIR, Albuterol, PRILOSEC and CLARITIN. She was vaccinated with FLUVIRIN (batch number 1205001) intramuscularly in her right arm on 09 Oct 2012. On 09 Oct 2012 after vaccination, she felt lightheaded and nauseated. On 10 Oct 2012, she again felt lightheaded and nauseated. On 11 Oct 2012, she felt lightheaded and nauseated and her tongue developed rash and had a dry mouth. On 12 Oct 2012, she had blisters around the mouth, fever and her lips began swelling. On 14 Oct 2012, she began taking BENADRYL for swelling. On 15 Oct 2012, she went to a private physician. Urinalysis was completed which revealed yeast growing rapidly which became viral. The physician diagnosed as adverse reaction to flu vaccine. The outcome of the events was reported as recovered as of 19 Oct 2012. Batch review report concluded that, based on the document review, it was stated that, the concerned with 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. The seriousness and causality of the events were not reported. Follow up report received from quality assurance department on 14 May 2014: Updated batch review report.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Viral infection, Viral test positive
Clinical narrative: Case number PHHY2013US000897 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number 470570) received on 02 Jan 2013 with a follow-up was received from Quality Assurance Department (reference number: 209062) on 14 May 2014. This report refers to a 42-year-old female patient. Her medical history included asthma and allergies. Concomitant medications included SINGULAIR, Albuterol, PRILOSEC and CLARITIN. She was vaccinated with FLUVIRIN (batch number 1205001) intramuscularly in her right arm on 09 Oct 2012. On 09 Oct 2012 after vaccination, she felt lightheaded and nauseated. On 10 Oct 2012, she again felt lightheaded and nauseated. On 11 Oct 2012, she felt lightheaded and nauseated and her tongue developed rash and had a dry mouth. On 12 Oct 2012, she had blisters around the mouth, fever and her lips began swelling. On 14 Oct 2012, she began taking BENADRYL for swelling. On 15 Oct 2012, she went to a private physician. Urinalysis was completed which revealed yeast growing rapidly which became viral. The physician diagnosed as adverse reaction to flu vaccine. The outcome of the events was reported as recovered as of 19 Oct 2012. Batch review report concluded that, based on the document review, it was stated that, the concerned with 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. The seriousness and causality of the events were not reported. Follow up report received from quality assurance department on 14 May 2014: Updated batch review report.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure abnormal, Blood test, Catheterisation cardiac, Chest X-ray, Chest pain
Clinical narrative: Case number PHHY2013US000472 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 470642) on 02 Jan 2013 with a follow up information received from the quality assurance department (reference number: 209048) on 14 May 2014. This report refers to 62-year-old female patient. Concomitant medications included atenolol, CELEXA, simvastatin, tamoxifen and vitamin D supplements. The patient was vaccinated with FLUVIRIN (batch number: 1205401) intramuscularly in left arm on 18 Oct 2012. On 19 Oct 2012, after the vaccination, she experienced shortness of breath, chest pain on inhalation of breath along with neck pain. She went to emergency room and was treated as either heart attack or embolism. Embolism was ruled out but electrocardiogram (EKG) showed some minor abnormality and was transferred by ambulance to another hospital for heart catheterization. No blockage was found. Her blood pressure remained unstable overnight but an echocardiogram came back normal. She also had chest X-ray, CT scan and blood work done. The outcome of events was reported as complete recovery as of 21 Oct 2012. The seriousness and causality of the events was not reported. Upon follow up information received from the quality assurance department (reference number: 209048) on 14 May 2014. Based on the document review, it was reported that the FLUVIRIN (batch number: 1205401) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 14 May 2014: Batch summary updated.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Myocardial infarction
Clinical narrative: Case number PHHY2013US000472 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 470642) on 02 Jan 2013 with a follow up information received from the quality assurance department (reference number: 209048) on 14 May 2014. This report refers to 62-year-old female patient. Concomitant medications included atenolol, CELEXA, simvastatin, tamoxifen and vitamin D supplements. The patient was vaccinated with FLUVIRIN (batch number: 1205401) intramuscularly in left arm on 18 Oct 2012. On 19 Oct 2012, after the vaccination, she experienced shortness of breath, chest pain on inhalation of breath along with neck pain. She went to emergency room and was treated as either heart attack or embolism. Embolism was ruled out but electrocardiogram (EKG) showed some minor abnormality and was transferred by ambulance to another hospital for heart catheterization. No blockage was found. Her blood pressure remained unstable overnight but an echocardiogram came back normal. She also had chest X-ray, CT scan and blood work done. The outcome of events was reported as complete recovery as of 21 Oct 2012. The seriousness and causality of the events was not reported. Upon follow up information received from the quality assurance department (reference number: 209048) on 14 May 2014. Based on the document review, it was reported that the FLUVIRIN (batch number: 1205401) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 14 May 2014: Batch summary updated.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Painful respiration
Clinical narrative: Case number PHHY2013US000472 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 470642) on 02 Jan 2013 with a follow up information received from the quality assurance department (reference number: 209048) on 14 May 2014. This report refers to 62-year-old female patient. Concomitant medications included atenolol, CELEXA, simvastatin, tamoxifen and vitamin D supplements. The patient was vaccinated with FLUVIRIN (batch number: 1205401) intramuscularly in left arm on 18 Oct 2012. On 19 Oct 2012, after the vaccination, she experienced shortness of breath, chest pain on inhalation of breath along with neck pain. She went to emergency room and was treated as either heart attack or embolism. Embolism was ruled out but electrocardiogram (EKG) showed some minor abnormality and was transferred by ambulance to another hospital for heart catheterization. No blockage was found. Her blood pressure remained unstable overnight but an echocardiogram came back normal. She also had chest X-ray, CT scan and blood work done. The outcome of events was reported as complete recovery as of 21 Oct 2012. The seriousness and causality of the events was not reported. Upon follow up information received from the quality assurance department (reference number: 209048) on 14 May 2014. Based on the document review, it was reported that the FLUVIRIN (batch number: 1205401) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 14 May 2014: Batch summary updated.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Oedema
Clinical narrative: Case number PHHY2013US000531 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 470748) on 02 Jan 2013 with a follow up report received from the Quality Assurance department on 14 May 2014. This report refers to a 55-year-old female patient. The polymedicated patient was vaccinated with FLUVIRIN (batch number: 1204001, expiry date: 31 May 2013) in left arm on 29 Aug 2012. On 29 Aug 2012, after the vaccination, she experienced pain two hours post immunization. There was no redness or swelling. The pain became severe for which she tried one course of prednisone, but pain returned. She went to emergency room for the events. Strength, range of motion test, MRI and blood work were done. The MRI revealed edema and tear of tendon. She had lost strength and range of motion. The outcome of events was reported as condition unchanged as of 19 Oct 2012. The seriousness and causality of the events was not reported. Based on the review performed, it was concluded that this batch of FLUVIRIN was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report received from the Quality Assurance department on 14 May 2014: The expiry date, labeling and the batch review report were updated.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Tendon rupture
Clinical narrative: Case number PHHY2013US000531 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 470748) on 02 Jan 2013 with a follow up report received from the Quality Assurance department on 14 May 2014. This report refers to a 55-year-old female patient. The polymedicated patient was vaccinated with FLUVIRIN (batch number: 1204001, expiry date: 31 May 2013) in left arm on 29 Aug 2012. On 29 Aug 2012, after the vaccination, she experienced pain two hours post immunization. There was no redness or swelling. The pain became severe for which she tried one course of prednisone, but pain returned. She went to emergency room for the events. Strength, range of motion test, MRI and blood work were done. The MRI revealed edema and tear of tendon. She had lost strength and range of motion. The outcome of events was reported as condition unchanged as of 19 Oct 2012. The seriousness and causality of the events was not reported. Based on the review performed, it was concluded that this batch of FLUVIRIN was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report received from the Quality Assurance department on 14 May 2014: The expiry date, labeling and the batch review report were updated.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Case number PHHY2013US000541 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 470792) on 02 Jan 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 208859) on 14 May 2014. This report refers to a 44-year-old female patient. Concomitant medication included birth control pills. The patient was vaccinated with FLUVIRIN (batch number: 12262P) in left arm on 19 Oct 2012. On 20 Oct 2012, after the vaccination, she experienced extreme shoulder, rotator cuff pain. The pain radiated down arm. She went to emergency room for the events. She was treated with steroids and TYLENOL for 14 days which did not ease her pain. The outcome of events was reported as condition unchanged as of 22 Oct 2012. The seriousness and causality of the events was not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 12262P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 208859) on 14 May 2014: Updated batch review report.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Dyspnoea, Feeling abnormal, Immediate post-injection reaction, Influenza
Clinical narrative: Case number PHHY2013US000714 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471009) website on 02 Jan 2013, and with a follow up report received from QA department (QA reference: 209037) on 14 May 2014. This report refers to a 67-year-old female patient. Her medical history included gingivitis and low grade fevers which were off and on for the past few years. She was vaccinated with FLUVIRIN (batch number: 1206201) intramuscularly in the right arm on 21 Oct 2012. The patient also received PNEUMOVAX (batch number: 1947AA, other manufacturer) intramuscularly on the right arm on the same date. On the same date, immediately after both the vaccinations the patient grabbed chest. She said it felt like air went out and felt funny like she cannot breathe. She grabbed EPIPEN. The patient felt nauseous at that moment and after 17 mins her color and skin temperature returned. The patient seated and felt that the chest was tight and had no air. The patient followed up at 5:55 pm on the same date, she was at home and resting. The patient had 100 degrees fever and arm swollen. Patient said honestly that she felt as though she had flu with temp of 100. Patient called the MD who told her that this was not serious and not to be worried. The seriousness, outcome and causality of the events were not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1206201 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 QA department (QA reference: 209037) on 14 May 2014. Batch review report updated.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Nausea, Pallor, Pyrexia
Clinical narrative: Case number PHHY2013US000714 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471009) website on 02 Jan 2013, and with a follow up report received from QA department (QA reference: 209037) on 14 May 2014. This report refers to a 67-year-old female patient. Her medical history included gingivitis and low grade fevers which were off and on for the past few years. She was vaccinated with FLUVIRIN (batch number: 1206201) intramuscularly in the right arm on 21 Oct 2012. The patient also received PNEUMOVAX (batch number: 1947AA, other manufacturer) intramuscularly on the right arm on the same date. On the same date, immediately after both the vaccinations the patient grabbed chest. She said it felt like air went out and felt funny like she cannot breathe. She grabbed EPIPEN. The patient felt nauseous at that moment and after 17 mins her color and skin temperature returned. The patient seated and felt that the chest was tight and had no air. The patient followed up at 5:55 pm on the same date, she was at home and resting. The patient had 100 degrees fever and arm swollen. Patient said honestly that she felt as though she had flu with temp of 100. Patient called the MD who told her that this was not serious and not to be worried. The seriousness, outcome and causality of the events were not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1206201 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 QA department (QA reference: 209037) on 14 May 2014. Batch review report updated.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Epistaxis, Headache, Nausea
Clinical narrative: Case number PHHY2013US000632, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471515) website on 02 Jan 2013 and with a follow up information received from the Quality assurance department (reference number: 208950) on 14 May 2014. This report refers to a 60-year-old male patient. His current conditions include bleeding at the side (profuse), dizziness and headache. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: Not reported) intramuscularly to left arm 04 Oct 2012. On 19 Oct 2012, patient presented with bleeding from nose, headache, clot in nostrils, dizziness. Laboratory data revealed highly elevated blood pressure. Patient left work the following days with severe headache, nausea and vomiting. Patient had no allergies in the past and had previous vaccines with no fever, vital signs stable and was in excellent health. Outcome of the events were reported condition unchanged. Seriousness and causality were not reported. Upon on follow up information from the Quality assurance department (QA reference number: 208950), previously reported FLUVIRIN (batch number: 12203) was not a valid batch number. Since the valid batch number was not reported, a batch specific review could not be performed. Based on Annual Product Review (APR) of FLUVIRIN, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and supporting systems are effective in supporting the compliant production, testing and supply process for FLUVIRIN. From this conclusion there was no reason or explanation to account for the reported adverse event. Follow up information received from quality assurance department on 14 May 2014: Reported batch number was removed and Annual product review was updated.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Thrombosis, Vomiting
Clinical narrative: Case number PHHY2013US000632, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471515) website on 02 Jan 2013 and with a follow up information received from the Quality assurance department (reference number: 208950) on 14 May 2014. This report refers to a 60-year-old male patient. His current conditions include bleeding at the side (profuse), dizziness and headache. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: Not reported) intramuscularly to left arm 04 Oct 2012. On 19 Oct 2012, patient presented with bleeding from nose, headache, clot in nostrils, dizziness. Laboratory data revealed highly elevated blood pressure. Patient left work the following days with severe headache, nausea and vomiting. Patient had no allergies in the past and had previous vaccines with no fever, vital signs stable and was in excellent health. Outcome of the events were reported condition unchanged. Seriousness and causality were not reported. Upon on follow up information from the Quality assurance department (QA reference number: 208950), previously reported FLUVIRIN (batch number: 12203) was not a valid batch number. Since the valid batch number was not reported, a batch specific review could not be performed. Based on Annual Product Review (APR) of FLUVIRIN, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and supporting systems are effective in supporting the compliant production, testing and supply process for FLUVIRIN. From this conclusion there was no reason or explanation to account for the reported adverse event. Follow up information received from quality assurance department on 14 May 2014: Reported batch number was removed and Annual product review was updated.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Nerve injury, Pain in extremity
Clinical narrative: Case number PHHY2013US000643, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471525) website on 02 Jan 2013 and a follow up report received from the QA department (QA number: 209108) on 14 May 2014. This report refers to a 61-year-old female patient. Current condition of this patient include rheumatoid arthritis. Concomitant medications were unknown. She was vaccinated with FLUVIRIN (batch number: 1101001) intramuscularly on the left arm on 23 Sep 2011. On the same day patient experienced pain down the left arm soon after vaccination. There was soreness at the site after vaccine was given in 2011, and then pain down the arm and it has "still not gone away". Patient's physician said that there may be some nerve damage. No treatment was done. Outcome of the events were reported as condition unchanged. Seriousness and causality were not reported. Batch review report (reference number: 209108) received from quality assurance department on 14 May 2014. Based on the document review, it was stated that the concerned FLUVIRIN batch number 1101001 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 the QA department (QA number: 209108) on 14 May 2014: Updated batch review report.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Ear pain, Hyperhidrosis, Pallor
Clinical narrative: Case number PHHY2013US000748 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471600) website on 02 Jan 2013 and a follow up report from the QA department (QA number: 208871) received on 14 May 2014. This report refers to a 16-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 12242P) intramuscularly in the left arm on 24 Oct 2012. On the same date, 10 minutes after vaccination the patient could not breathe and became pale, sweating and complained of ear pain also. The patient visited the emergency room on an unknown date. The patient was treated with one EpiPen. The outcome of the events was reported as condition unchanged. The causality of the events was not reported. Batch review report (reference number: 208871) received from quality assurance department on 14 May 2014. Based on the document review, it was stated that the concerned FLUVIRIN batch number 12242P was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department (QA number: 208871) received on 14 May 2014: Updated batch review report.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy skin abnormal, Skin lesion, Vasculitis
Clinical narrative: Case number PHHY2013US000853 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471661) website on 02 Jan 2013, and with a follow up report received from QA department (reference number: 208925) on 14 May 2014. This report refers to a 52-year-old male patient. His medical history included an unspecified condition related to cholesterol. Concomitant medication included ZOCOR. The patient was vaccinated with FLUVIRIN (batch number: 122202) in the left arm on 18 Sep 2012. On 28 Sep 2012, 10 days after vaccination the patient experienced skin lesions and vasculitis. A skin biopsy was performed (details not known). The patient visited the emergency room on an unknown date. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 122202 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 QA department (reference number: 208925) on 14 May 2014. Batch review report updated.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Brain natriuretic peptide, Chest X-ray, Computerised tomogram head
Clinical narrative: Case number PHHY2013US000906 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number 471716) received on 02 Jan 2013 with a follow up report received from the Quality Assurance department (QA reference number: 208874) on 14 May 2014. This report refers to a 46 year old female patient. Her medical history included allergy to penicillin, mint, latex, codeine, SKELAXIN and tussin. She also had diabetes mellitus. Concomitant medications included FLEXERIL, tramadol and ibuprofen. She was vaccinated with FLUVIRIN (batch number 1224IP) in her right arm on 22 Oct 2012. On 24 Oct 2012 after vaccination, she had difficulty breathing, hoarseness, wheezing, fast heart beat and dizziness. On 27 Oct 2012, creatine kinase (CK), complete blood count (CBC), basic chemistry profile, CKMB, serum myoglobin, troponin I, natriuretic peptide, prothrombin time and international normalized ratio were done for which results were not reported. Chest X ray, CT brain without contrast, 12 lead electrocardiography (EKG), with IV insertion was done but no results were provided. EKG was repeated 30 minutes after initial EKG, Soarian Order Cardiac Profile 2nd/3rd Set, IV Hep-lock Insertion (IID) was done. Blood pressure was checked in both arms. She was administered oxygen at 2 l/min which was titrated to keep partial pressure of oxygen to 95 percent. Pain assessment was done and EKG was repeated in 30 minutes. Her vital signs were checked. No results were provided for any of the examination done. The outcome of the events was reported as recovered as of 27 Oct 2012. The seriousness and causality assessment of the events were not reported. Based on the review performed, it was concluded that this batch of FLUVIRIN: batch no 12241P was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report was received from the Quality Assurance department (QA reference number: 208874) on 14 May 2014: The labeling and batch review report were updated.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysphonia, Dyspnoea, Electrocardiogram, Full blood count
Clinical narrative: Case number PHHY2013US000906 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number 471716) received on 02 Jan 2013 with a follow up report received from the Quality Assurance department (QA reference number: 208874) on 14 May 2014. This report refers to a 46 year old female patient. Her medical history included allergy to penicillin, mint, latex, codeine, SKELAXIN and tussin. She also had diabetes mellitus. Concomitant medications included FLEXERIL, tramadol and ibuprofen. She was vaccinated with FLUVIRIN (batch number 1224IP) in her right arm on 22 Oct 2012. On 24 Oct 2012 after vaccination, she had difficulty breathing, hoarseness, wheezing, fast heart beat and dizziness. On 27 Oct 2012, creatine kinase (CK), complete blood count (CBC), basic chemistry profile, CKMB, serum myoglobin, troponin I, natriuretic peptide, prothrombin time and international normalized ratio were done for which results were not reported. Chest X ray, CT brain without contrast, 12 lead electrocardiography (EKG), with IV insertion was done but no results were provided. EKG was repeated 30 minutes after initial EKG, Soarian Order Cardiac Profile 2nd/3rd Set, IV Hep-lock Insertion (IID) was done. Blood pressure was checked in both arms. She was administered oxygen at 2 l/min which was titrated to keep partial pressure of oxygen to 95 percent. Pain assessment was done and EKG was repeated in 30 minutes. Her vital signs were checked. No results were provided for any of the examination done. The outcome of the events was reported as recovered as of 27 Oct 2012. The seriousness and causality assessment of the events were not reported. Based on the review performed, it was concluded that this batch of FLUVIRIN: batch no 12241P was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report was received from the Quality Assurance department (QA reference number: 208874) on 14 May 2014: The labeling and batch review report were updated.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, International normalised ratio, Laboratory test, Myoglobin blood, Prothrombin time
Clinical narrative: Case number PHHY2013US000906 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number 471716) received on 02 Jan 2013 with a follow up report received from the Quality Assurance department (QA reference number: 208874) on 14 May 2014. This report refers to a 46 year old female patient. Her medical history included allergy to penicillin, mint, latex, codeine, SKELAXIN and tussin. She also had diabetes mellitus. Concomitant medications included FLEXERIL, tramadol and ibuprofen. She was vaccinated with FLUVIRIN (batch number 1224IP) in her right arm on 22 Oct 2012. On 24 Oct 2012 after vaccination, she had difficulty breathing, hoarseness, wheezing, fast heart beat and dizziness. On 27 Oct 2012, creatine kinase (CK), complete blood count (CBC), basic chemistry profile, CKMB, serum myoglobin, troponin I, natriuretic peptide, prothrombin time and international normalized ratio were done for which results were not reported. Chest X ray, CT brain without contrast, 12 lead electrocardiography (EKG), with IV insertion was done but no results were provided. EKG was repeated 30 minutes after initial EKG, Soarian Order Cardiac Profile 2nd/3rd Set, IV Hep-lock Insertion (IID) was done. Blood pressure was checked in both arms. She was administered oxygen at 2 l/min which was titrated to keep partial pressure of oxygen to 95 percent. Pain assessment was done and EKG was repeated in 30 minutes. Her vital signs were checked. No results were provided for any of the examination done. The outcome of the events was reported as recovered as of 27 Oct 2012. The seriousness and causality assessment of the events were not reported. Based on the review performed, it was concluded that this batch of FLUVIRIN: batch no 12241P was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report was received from the Quality Assurance department (QA reference number: 208874) on 14 May 2014: The labeling and batch review report were updated.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Troponin I, Wheezing
Clinical narrative: Case number PHHY2013US000906 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number 471716) received on 02 Jan 2013 with a follow up report received from the Quality Assurance department (QA reference number: 208874) on 14 May 2014. This report refers to a 46 year old female patient. Her medical history included allergy to penicillin, mint, latex, codeine, SKELAXIN and tussin. She also had diabetes mellitus. Concomitant medications included FLEXERIL, tramadol and ibuprofen. She was vaccinated with FLUVIRIN (batch number 1224IP) in her right arm on 22 Oct 2012. On 24 Oct 2012 after vaccination, she had difficulty breathing, hoarseness, wheezing, fast heart beat and dizziness. On 27 Oct 2012, creatine kinase (CK), complete blood count (CBC), basic chemistry profile, CKMB, serum myoglobin, troponin I, natriuretic peptide, prothrombin time and international normalized ratio were done for which results were not reported. Chest X ray, CT brain without contrast, 12 lead electrocardiography (EKG), with IV insertion was done but no results were provided. EKG was repeated 30 minutes after initial EKG, Soarian Order Cardiac Profile 2nd/3rd Set, IV Hep-lock Insertion (IID) was done. Blood pressure was checked in both arms. She was administered oxygen at 2 l/min which was titrated to keep partial pressure of oxygen to 95 percent. Pain assessment was done and EKG was repeated in 30 minutes. Her vital signs were checked. No results were provided for any of the examination done. The outcome of the events was reported as recovered as of 27 Oct 2012. The seriousness and causality assessment of the events were not reported. Based on the review performed, it was concluded that this batch of FLUVIRIN: batch no 12241P was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report was received from the Quality Assurance department (QA reference number: 208874) on 14 May 2014: The labeling and batch review report were updated.