chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Case number PHHY2012US111528 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 468795) web site on 04 Dec 2012, and with a follow up report received from QA department (QA reference number: 210059) on 23 May 2014. This report refers to a 68 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1204701) in to left arm on 14 Sep 2012. On 15 Sep 2012, she had rash with small blisters appeared bilaterally from elbow to wrist and there was some itchiness also. She called on 02 Oct 2012 and reported that the events might have been due to yard work, but she was not sure. The final outcome of the events was reported as condition unchanged as of 02 Oct 2012. Based on the batch review report, it was concluded that the FLUVIRIN, batch number 1204701 was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from QA department (QA reference number: 210059) on 23 May 2014. Updated batch review report.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Paraesthesia
Clinical narrative: Case number PHHY2012US111577, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 468902) web site on 04 Dec 2012 and a follow up report the QA department received on 23 May 2014. This report refers to 30 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1204501) intramuscularly into the left arm on 09 Oct 2012. On the same day the patient developed tingling starting in left arm and then progressed to right arm. Patient stated that he "felt strange". Blood pressure was 152/96 with pulse 68 at onset and BP was 178/84 with pulse 64 after 20 min. The outcome of the events was recovered. Seriousness and causality assessment was not reported. Based on the batch review report, it was concluded that the concerned FLUVIRIN, batch number (1204501) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report the QA department received on 23 May 2014: Updated batch review report.
Age: 25.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2014US001246, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509622) website on 06 Jan 2014, and with a follow up report received from QA department on 17 Jan 2014. This report refers to a 25 year old female patient. Her medical history included hyperinsulinism and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly in the left arm on 01 Oct 2013. On 11 Oct 2013, she experienced painful injection site swelling and difficulty breathing. She was visited to emergency room or physician. The outcome of the event was reported as condition unchanged as of 06 Oct 2013. The seriousness and causality of the event were not reported. The QA department confirmed that the previously reported batch number 1302901 was not correct. The standard request for QA investigation was not possible to determine the correct batch number therefore, it will not be investigated. No additional information was available. Follow up report received from QA department on 17 Jan 2014. QA report updated.
Age: 33.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Dizziness, Dyspnoea, Immediate post-injection reaction, Musculoskeletal pain
Clinical narrative: Case number PHHY2014US045816 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 519254) website on 14 Apr 2014, with the follow-up received from Quality Assurance Department (reference number: 295427) on 21 May 2014. This report refers to a 33-year-old male patient. His concurrent conditions included breathing problems, hoarseness, wheezing, hives, paleness, cold sweat, weakness and dizziness. Concomitant medication included Lisinopril. He was vaccinated with FLUVIRIN (batch number: 1309501) into left arm on 23 Oct 2013. As soon as the shot was administered, an immediate reaction occurred; extremely difficult to breathe, paleness, dizziness and incapable of walking. Two EPIPENS were administered by the technician and emergency (911) was dispatched. Once they arrived, an additional EPIPEN was administered along with oxygen. After about an hour, some stabilization was realized. He was hospitalized until about 7 pm. Hives were observed and extreme soreness was felt in the arm/shoulder area. The doctor prescribed oxycodone and an EPIPEN. This case was reported a serious (life threatening). Agency assessed the event dyspnea as life threatening and other events as medically significant. Outcome of the events were reported as recovered. Causality of the events was not reported. Based on the batch investigation performed, QA department stated that, the FLUVIRIN (batch number: 1309501) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 295427) on 21 May 2014: Updated batch review report.
Age: 33.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Pallor, Urticaria
Clinical narrative: Case number PHHY2014US045816 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 519254) website on 14 Apr 2014, with the follow-up received from Quality Assurance Department (reference number: 295427) on 21 May 2014. This report refers to a 33-year-old male patient. His concurrent conditions included breathing problems, hoarseness, wheezing, hives, paleness, cold sweat, weakness and dizziness. Concomitant medication included Lisinopril. He was vaccinated with FLUVIRIN (batch number: 1309501) into left arm on 23 Oct 2013. As soon as the shot was administered, an immediate reaction occurred; extremely difficult to breathe, paleness, dizziness and incapable of walking. Two EPIPENS were administered by the technician and emergency (911) was dispatched. Once they arrived, an additional EPIPEN was administered along with oxygen. After about an hour, some stabilization was realized. He was hospitalized until about 7 pm. Hives were observed and extreme soreness was felt in the arm/shoulder area. The doctor prescribed oxycodone and an EPIPEN. This case was reported a serious (life threatening). Agency assessed the event dyspnea as life threatening and other events as medically significant. Outcome of the events were reported as recovered. Causality of the events was not reported. Based on the batch investigation performed, QA department stated that, the FLUVIRIN (batch number: 1309501) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 295427) on 21 May 2014: Updated batch review report.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Headache, Hyperhidrosis, Neutropenia, Neutrophil count decreased
Clinical narrative: Case number PHHY2014US045864 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 519274) website on 14 Apr 2014 and a follow-up information was received from Quality Assurance Department (reference number: 295426) on 23 May 2014. This report refers to a 69-year-old male patient. His medical history included myalgia due to allergies to LIPITOR, primary open-angle glaucoma, hyperlipidemia, alcohol dependence, pseudophakia, spinal stenosis and diabetes mellitus. Concomitant medications included Aspirin, metformin, simvastatin and glipizide. He was vaccinated with the third dose of FLUVIRIN (batch number: 1309301) intramuscularly into left arm on 29 Oct 2013. On 03 Nov 2013, 06 days after vaccination, he experienced arm pain, fatigue, diaphoresis, shaky and headache. Serious adverse events included neutropenia and thrombocytopenia. He was hospitalized for 3 days from an unknown date due to these events. He was treated with filgrastim 480 mcg subcutaneous once. Laboratory tests include white blood cell count (WBC) 1.8 thou/cu mm, platelets (PLT) 46 thou/cu mm and absolute neutrophil count (ANC) 0.4 thou/cu mm on 03 Nov 2013. On 04 Nov 2013, WBC 1.4 thou/cu mm, PLT 41 thou/cu mm and ANC 0.1 thou/cu mm was noted. The events neutropenia and thrombocytopenia were reported as serious (hospitalization). The seriousness of the other events were not reported. Agency considered the event of white blood cell count decreased as medically significant, and other events as non-serious. Outcome of the events was reported as condition unchanged as of 14 Jan 2014. Causality of the events was not reported. Batch review report (reference number: 295426) received from quality assurance department on 23 May 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1309301) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from Quality Assurance Department (reference number: 295426) on 23 May 2014: Updated batch review report.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Platelet count decreased, Thrombocytopenia, Tremor, White blood cell count decreased
Clinical narrative: Case number PHHY2014US045864 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 519274) website on 14 Apr 2014 and a follow-up information was received from Quality Assurance Department (reference number: 295426) on 23 May 2014. This report refers to a 69-year-old male patient. His medical history included myalgia due to allergies to LIPITOR, primary open-angle glaucoma, hyperlipidemia, alcohol dependence, pseudophakia, spinal stenosis and diabetes mellitus. Concomitant medications included Aspirin, metformin, simvastatin and glipizide. He was vaccinated with the third dose of FLUVIRIN (batch number: 1309301) intramuscularly into left arm on 29 Oct 2013. On 03 Nov 2013, 06 days after vaccination, he experienced arm pain, fatigue, diaphoresis, shaky and headache. Serious adverse events included neutropenia and thrombocytopenia. He was hospitalized for 3 days from an unknown date due to these events. He was treated with filgrastim 480 mcg subcutaneous once. Laboratory tests include white blood cell count (WBC) 1.8 thou/cu mm, platelets (PLT) 46 thou/cu mm and absolute neutrophil count (ANC) 0.4 thou/cu mm on 03 Nov 2013. On 04 Nov 2013, WBC 1.4 thou/cu mm, PLT 41 thou/cu mm and ANC 0.1 thou/cu mm was noted. The events neutropenia and thrombocytopenia were reported as serious (hospitalization). The seriousness of the other events were not reported. Agency considered the event of white blood cell count decreased as medically significant, and other events as non-serious. Outcome of the events was reported as condition unchanged as of 14 Jan 2014. Causality of the events was not reported. Batch review report (reference number: 295426) received from quality assurance department on 23 May 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1309301) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from Quality Assurance Department (reference number: 295426) on 23 May 2014: Updated batch review report.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursal fluid accumulation, Drug administered at inappropriate site, Injection site pain, Joint range of motion decreased, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2014US046101 is an initial spontaneous report received from a consumer via the vaccine adverse event reporting system (VAERS reference number: 519769) web site on 14 Apr 2014 and a follow up report from the QA department (QA number: 295394) received on 21 May 2014. This report refers to a 51 year old female patient. Her current condition included allergies to sulfa, hypertension and her medical history included mild sleep apnea. Her concomitant medication included Benicar. She was vaccinated with FLUVIRIN (batch number: 1308501) intramuscularly into left arm on 02 Oct 2013. It was reported that the vaccine was administered too high up in the left arm in posterior shoulder near shoulder joint. On 04 Oct 2013, she gradually developed worsening of severe left shoulder pain over the next several weeks. She visited an orthopedist who had administered an injection into posterior deltoid area. But the injection could not provide any relief. She experienced continued pain in shoulder and then developed restriction of movement and a frozen shoulder. On 25 Nov 2013, MRI was performed, which showed tendinopathy of supraspinatus tendon with bursal surface fraying and small amount of fluid in the subacromial sub deltoid bursa. She continued physiotherapy since 02 Dec 2013. the outcome of the events was reported as condition unchanged. Reporter assessed the events as serious due to permanent disability. However, causality was not reported. Based on the review performed, it was concluded that this batch 1308501 of FLUVIRIN was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report from the QA department (QA number: 295394) received on 21 May 2014: Updated batch review report.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Periarthritis, Tendon disorder, X-ray limb
Clinical narrative: Case number PHHY2014US046101 is an initial spontaneous report received from a consumer via the vaccine adverse event reporting system (VAERS reference number: 519769) web site on 14 Apr 2014 and a follow up report from the QA department (QA number: 295394) received on 21 May 2014. This report refers to a 51 year old female patient. Her current condition included allergies to sulfa, hypertension and her medical history included mild sleep apnea. Her concomitant medication included Benicar. She was vaccinated with FLUVIRIN (batch number: 1308501) intramuscularly into left arm on 02 Oct 2013. It was reported that the vaccine was administered too high up in the left arm in posterior shoulder near shoulder joint. On 04 Oct 2013, she gradually developed worsening of severe left shoulder pain over the next several weeks. She visited an orthopedist who had administered an injection into posterior deltoid area. But the injection could not provide any relief. She experienced continued pain in shoulder and then developed restriction of movement and a frozen shoulder. On 25 Nov 2013, MRI was performed, which showed tendinopathy of supraspinatus tendon with bursal surface fraying and small amount of fluid in the subacromial sub deltoid bursa. She continued physiotherapy since 02 Dec 2013. the outcome of the events was reported as condition unchanged. Reporter assessed the events as serious due to permanent disability. However, causality was not reported. Based on the review performed, it was concluded that this batch 1308501 of FLUVIRIN was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report from the QA department (QA number: 295394) received on 21 May 2014: Updated batch review report.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursa disorder, Bursal fluid accumulation, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Case number PHHY2014US046101 is an initial spontaneous report received from a consumer via the vaccine adverse event reporting system (VAERS reference number: 519769) web site on 14 Apr 2014 and a follow up report from the QA department (QA number: 295394) received on 21 May 2014. This report refers to a 51 year old female patient. Her current condition included allergies to sulfa, hypertension and her medical history included mild sleep apnea. Her concomitant medication included Benicar. She was vaccinated with FLUVIRIN (batch number: 1308501) intramuscularly into left arm on 02 Oct 2013. It was reported that the vaccine was administered too high up in the left arm in posterior shoulder near shoulder joint. On 04 Oct 2013, she gradually developed worsening of severe left shoulder pain over the next several weeks. She visited an orthopedist who had administered an injection into posterior deltoid area. But the injection could not provide any relief. She experienced continued pain in shoulder and then developed restriction of movement and a frozen shoulder. On 25 Nov 2013, MRI was performed, which showed tendinopathy of supraspinatus tendon with bursal surface fraying and small amount of fluid in the subacromial sub deltoid bursa. She continued physiotherapy since 02 Dec 2013. the outcome of the events was reported as condition unchanged. Reporter assessed the events as serious due to permanent disability. However, causality was not reported. Based on the review performed, it was concluded that this batch 1308501 of FLUVIRIN was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report from the QA department (QA number: 295394) received on 21 May 2014: Updated batch review report.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Periarthritis, Rotator cuff syndrome
Clinical narrative: Case number PHHY2014US046101 is an initial spontaneous report received from a consumer via the vaccine adverse event reporting system (VAERS reference number: 519769) web site on 14 Apr 2014 and a follow up report from the QA department (QA number: 295394) received on 21 May 2014. This report refers to a 51 year old female patient. Her current condition included allergies to sulfa, hypertension and her medical history included mild sleep apnea. Her concomitant medication included Benicar. She was vaccinated with FLUVIRIN (batch number: 1308501) intramuscularly into left arm on 02 Oct 2013. It was reported that the vaccine was administered too high up in the left arm in posterior shoulder near shoulder joint. On 04 Oct 2013, she gradually developed worsening of severe left shoulder pain over the next several weeks. She visited an orthopedist who had administered an injection into posterior deltoid area. But the injection could not provide any relief. She experienced continued pain in shoulder and then developed restriction of movement and a frozen shoulder. On 25 Nov 2013, MRI was performed, which showed tendinopathy of supraspinatus tendon with bursal surface fraying and small amount of fluid in the subacromial sub deltoid bursa. She continued physiotherapy since 02 Dec 2013. the outcome of the events was reported as condition unchanged. Reporter assessed the events as serious due to permanent disability. However, causality was not reported. Based on the review performed, it was concluded that this batch 1308501 of FLUVIRIN was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report from the QA department (QA number: 295394) received on 21 May 2014: Updated batch review report.
Age: 78.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Dizziness, Fall, Pain, Vision blurred
Clinical narrative: Case number PHHY2014US045990 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 520014) website on 14 Apr 2014 with a follow up report received from the Quality Assurance department (QA reference number: 295402) on 21 May 2014. This report refers to a 78 year old polymedicated female patient. Her concurrent condition included diabetic. She was vaccinated with FLUVIRIN (batch number: 13414P) intramuscularly into left arm. On the same day, she was also vaccinated with ZOSTAVAX (other manufacturer and batch number: J000430) into right arm. Post vaccinations, she went to home with few purchases, leaned over to pick up an item and things got blurry and dizzy and she fell to the floor. She went to hospital about 12 hours later due to extreme pain (assumed from the fall). She was hospitalized for 7 days. The events were reported as serious (hospitalization). Outcome of the events was reported as recovered. Causality of the events was not reported. Based on the batch review performed, it was concluded that the concerned FLUVIRIN batch number (13414P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Following internal review it was identified that initial MRD was incorrectly captured in general tab as 08 Apr 2014 instead of 14 Apr 2014. Follow up report was received from the Quality Assurance department (QA reference number: 295402): The batch review report was updated.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Feeling abnormal, Gait disturbance, Influenza virus test negative, Muscular weakness
Clinical narrative: Case number PHHY2014US046040 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 520031) website on 14 Apr 2014, with a follow-up received from Quality Assurance Department (reference number: 295398) on 21 May 2014. This report refers to a 57-year-old polymedicated female patient. Her concurrent condition included thyroid issues, seasonal allergies and reflux. She was vaccinated with FLUVIRIN (batch number: 13433P) intramuscularly into right arm. On 13 Jan 2014, she felt weird when she woke up at 5 am. At 2:00 pm, she became weak and it was hard for her to walk. She stated that her bilateral arms and legs were weak. She reported to her primary care physician (PCP) where flu test was performed and found to be negative and was sent home. On 14 Jan 2014, she gets back to her PCP; now she only feels weak on (L) side and was sent to hospital for stroke work up. She stayed in hospital overnight, ruled out stroke and diagnosed with neuropathy. PCP informed patient to never take flu shot again. The events were reported as serious (hospitalization). Outcome of the events was reported as recovered. Causality of the events was not reported. Based on the batch review report, it was concluded that the concerned FLUVIRIN (batch number: 13433P) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from quality assurance department on 21 May 2014: Updated batch review report.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Neuropathy peripheral
Clinical narrative: Case number PHHY2014US046040 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 520031) website on 14 Apr 2014, with a follow-up received from Quality Assurance Department (reference number: 295398) on 21 May 2014. This report refers to a 57-year-old polymedicated female patient. Her concurrent condition included thyroid issues, seasonal allergies and reflux. She was vaccinated with FLUVIRIN (batch number: 13433P) intramuscularly into right arm. On 13 Jan 2014, she felt weird when she woke up at 5 am. At 2:00 pm, she became weak and it was hard for her to walk. She stated that her bilateral arms and legs were weak. She reported to her primary care physician (PCP) where flu test was performed and found to be negative and was sent home. On 14 Jan 2014, she gets back to her PCP; now she only feels weak on (L) side and was sent to hospital for stroke work up. She stayed in hospital overnight, ruled out stroke and diagnosed with neuropathy. PCP informed patient to never take flu shot again. The events were reported as serious (hospitalization). Outcome of the events was reported as recovered. Causality of the events was not reported. Based on the batch review report, it was concluded that the concerned FLUVIRIN (batch number: 13433P) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from quality assurance department on 21 May 2014: Updated batch review report.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Feeling abnormal, Gait disturbance, Hemiparesis, Influenza virus test negative
Clinical narrative: Case number PHHY2014US046040 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 520031) website on 14 Apr 2014, with a follow-up received from Quality Assurance Department (reference number: 295398) on 21 May 2014. This report refers to a 57-year-old polymedicated female patient. Her concurrent condition included thyroid issues, seasonal allergies and reflux. She was vaccinated with FLUVIRIN (batch number: 13433P) intramuscularly into right arm. On 13 Jan 2014, she felt weird when she woke up at 5 am. At 2:00 pm, she became weak and it was hard for her to walk. She stated that her bilateral arms and legs were weak. She reported to her primary care physician (PCP) where flu test was performed and found to be negative and was sent home. On 14 Jan 2014, she gets back to her PCP; now she only feels weak on (L) side and was sent to hospital for stroke work up. She stayed in hospital overnight, ruled out stroke and diagnosed with neuropathy. PCP informed patient to never take flu shot again. The events were reported as serious (hospitalization). Outcome of the events was reported as recovered. Causality of the events was not reported. Based on the batch review report, it was concluded that the concerned FLUVIRIN (batch number: 13433P) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from quality assurance department on 21 May 2014: Updated batch review report.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Neuropathy peripheral
Clinical narrative: Case number PHHY2014US046040 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 520031) website on 14 Apr 2014, with a follow-up received from Quality Assurance Department (reference number: 295398) on 21 May 2014. This report refers to a 57-year-old polymedicated female patient. Her concurrent condition included thyroid issues, seasonal allergies and reflux. She was vaccinated with FLUVIRIN (batch number: 13433P) intramuscularly into right arm. On 13 Jan 2014, she felt weird when she woke up at 5 am. At 2:00 pm, she became weak and it was hard for her to walk. She stated that her bilateral arms and legs were weak. She reported to her primary care physician (PCP) where flu test was performed and found to be negative and was sent home. On 14 Jan 2014, she gets back to her PCP; now she only feels weak on (L) side and was sent to hospital for stroke work up. She stayed in hospital overnight, ruled out stroke and diagnosed with neuropathy. PCP informed patient to never take flu shot again. The events were reported as serious (hospitalization). Outcome of the events was reported as recovered. Causality of the events was not reported. Based on the batch review report, it was concluded that the concerned FLUVIRIN (batch number: 13433P) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from quality assurance department on 21 May 2014: Updated batch review report.
Age: 13.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Pallor, Syncope, Tremor
Clinical narrative: Case number PHHY2014US046518, is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 520855) website on 14 Apr 2014, and with a follow up report received from QA department (QA reference number: 295269) on 21 May 2014. This report refers to a 13 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 13472P) intramuscularly into left arm on 23 Jan 2014. She sat for 10 minutes then walked and shopped in a store. At checkout she fainted, came back to the pharmacy and sat for 40 minutes. Had shaking tremors (very slight), became white as a ghost, very weak, but did not faint again. Gave her water then she left to get something to eat with her mother and brothers. The outcome of the events was recovered. The causality of the events was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Based on the batch review report, it was concluded that the FLUVIRIN batch number 13472P was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 295269) on 22 Apr 2014: Updated QA reference number only. Follow up report received from QA department (QA reference number: 295269) on 21 May 2014. Updated batch review report.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscle spasms, Seizure like phenomena, Syncope
Clinical narrative: Case number PHHY2014US047084, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520988) website on 14 Apr 2014 and a follow up received from Quality Assurance Department (QA, reference number: 295469) on 21 May 2014. This report refers to 15-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1310301) into left arm on 17 Jan 2014. On the same day after vaccination patient fainted while sitting in a chair. Slight seizure-like hand cramping while fainted for about 30 seconds to 1 minute total time fainted. Woke up fine and oriented. The outcome of the events was recovered and causality assessment was not reported. The events were 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, FLUVIRIN (batch number: 1310301) 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: 295469) on 21 May 2014: Updated batch review report.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Feeling hot, Headache, Lethargy, Listless, Pallor
Clinical narrative: Case number PHHY2014US047071, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521200) website on 14 Apr 2014, and with a follow up report received from QA department (QA reference number: 295528) on 20 May 2014. This report refers to a 12 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with ADACEL (batch number: C3989AA, other manufacturer) intramuscularly into her left deltoid, MENVEO (batch number: M13015, expiry date: Sep 2014) intramuscularly into her left deltoid, FLUARIX (batch number: 5EE73, other manufacturer) intramuscularly into her right deltoid and GARDASIL (batch number: J008423, other manufacturer) intramuscularly into her right deltoid on 28 Jan 2014. On the same day, immediately after the administration of GARDASIL, she had a headache and shortly after that she appeared to be increasingly lethargic and hot. She was very drowsy but not completely non-responsive, pale and listless. She answered questions consistently and correctly throughout the episode. Over about a period of ten minutes, she was more and less near syncopal but never lost her consciousness completely. The patient completely recovered from feeling hot, lethargy, listlessness, pallor, presyncope and drowsiness after ten minutes but she continued to complain of headache. The events were assessed as non-serious by the reporter; however the case was internally upgraded and the events presyncope, pallor, headache and lethargy were assessed as serious and made medically significant by the agency. The causality of the events was not reported. Based on the batch review report, it was concluded that the MENVEO batch number M13015 was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from QA department (QA reference number: 295528) on 20 May 2014. Updated batch review report.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Presyncope, Somnolence
Clinical narrative: Case number PHHY2014US047071, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521200) website on 14 Apr 2014, and with a follow up report received from QA department (QA reference number: 295528) on 20 May 2014. This report refers to a 12 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with ADACEL (batch number: C3989AA, other manufacturer) intramuscularly into her left deltoid, MENVEO (batch number: M13015, expiry date: Sep 2014) intramuscularly into her left deltoid, FLUARIX (batch number: 5EE73, other manufacturer) intramuscularly into her right deltoid and GARDASIL (batch number: J008423, other manufacturer) intramuscularly into her right deltoid on 28 Jan 2014. On the same day, immediately after the administration of GARDASIL, she had a headache and shortly after that she appeared to be increasingly lethargic and hot. She was very drowsy but not completely non-responsive, pale and listless. She answered questions consistently and correctly throughout the episode. Over about a period of ten minutes, she was more and less near syncopal but never lost her consciousness completely. The patient completely recovered from feeling hot, lethargy, listlessness, pallor, presyncope and drowsiness after ten minutes but she continued to complain of headache. The events were assessed as non-serious by the reporter; however the case was internally upgraded and the events presyncope, pallor, headache and lethargy were assessed as serious and made medically significant by the agency. The causality of the events was not reported. Based on the batch review report, it was concluded that the MENVEO batch number M13015 was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from QA department (QA reference number: 295528) on 20 May 2014. Updated batch review report.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Feeling hot, Headache, Immediate post-injection reaction, Lethargy, Listless
Clinical narrative: Case number PHHY2014US047071, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521200) website on 14 Apr 2014, and with a follow up report received from QA department (QA reference number: 295528) on 20 May 2014. This report refers to a 12 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with ADACEL (batch number: C3989AA, other manufacturer) intramuscularly into her left deltoid, MENVEO (batch number: M13015, expiry date: Sep 2014) intramuscularly into her left deltoid, FLUARIX (batch number: 5EE73, other manufacturer) intramuscularly into her right deltoid and GARDASIL (batch number: J008423, other manufacturer) intramuscularly into her right deltoid on 28 Jan 2014. On the same day, immediately after the administration of GARDASIL, she had a headache and shortly after that she appeared to be increasingly lethargic and hot. She was very drowsy but not completely non-responsive, pale and listless. She answered questions consistently and correctly throughout the episode. Over about a period of ten minutes, she was more and less near syncopal but never lost her consciousness completely. The patient completely recovered from feeling hot, lethargy, listlessness, pallor, presyncope and drowsiness after ten minutes but she continued to complain of headache. The events were assessed as non-serious by the reporter; however the case was internally upgraded and the events presyncope, pallor, headache and lethargy were assessed as serious and made medically significant by the agency. The causality of the events was not reported. Based on the batch review report, it was concluded that the MENVEO batch number M13015 was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from QA department (QA reference number: 295528) on 20 May 2014. Updated batch review report.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Pallor, Presyncope, Somnolence
Clinical narrative: Case number PHHY2014US047071, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521200) website on 14 Apr 2014, and with a follow up report received from QA department (QA reference number: 295528) on 20 May 2014. This report refers to a 12 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with ADACEL (batch number: C3989AA, other manufacturer) intramuscularly into her left deltoid, MENVEO (batch number: M13015, expiry date: Sep 2014) intramuscularly into her left deltoid, FLUARIX (batch number: 5EE73, other manufacturer) intramuscularly into her right deltoid and GARDASIL (batch number: J008423, other manufacturer) intramuscularly into her right deltoid on 28 Jan 2014. On the same day, immediately after the administration of GARDASIL, she had a headache and shortly after that she appeared to be increasingly lethargic and hot. She was very drowsy but not completely non-responsive, pale and listless. She answered questions consistently and correctly throughout the episode. Over about a period of ten minutes, she was more and less near syncopal but never lost her consciousness completely. The patient completely recovered from feeling hot, lethargy, listlessness, pallor, presyncope and drowsiness after ten minutes but she continued to complain of headache. The events were assessed as non-serious by the reporter; however the case was internally upgraded and the events presyncope, pallor, headache and lethargy were assessed as serious and made medically significant by the agency. The causality of the events was not reported. Based on the batch review report, it was concluded that the MENVEO batch number M13015 was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from QA department (QA reference number: 295528) on 20 May 2014. Updated batch review report.
Age: 2.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Diarrhoea, Erythema multiforme, Rash
Clinical narrative: Case number PHHY2014US054680 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521918) website on 06 May 2014 with a follow up information received from the quality assurance department (reference number: 298019) on 22 May 2014. This report refers to a 2-year-old male patient. He had no medical history. His current condition included streptococcal throat. He had a full examination on 16 Jan 2014 and it was reported that his pharyngitis was resolving. Rapid streptococcal test performed was negative. He was vaccinated with MENVEO (batch number: M11081, expiry date: Apr 2014) in the right arm and VAQTA (other manufacturer, batch number: J011385) in the left arm on 17 Jan 2014. On 18 Jan 2014, he had rash which began on shoulder and then progressed through trunk and extremities. On 19 Jan 2014, his culture was positive for streptococcus and he began treatment with OMNICEF. On 20 Jan 2014, he had diarrhea once and he went to emergency room. On 23 Jan 2014, he was evaluated by physician in another country and was diagnosed with erythema multiforme. He had no response to trial dose of BENADRYL. The final outcome of the event was reported as complete recovery. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the event was not reported. Upon follow up information from the quality assurance department (reference number 298019) on 22 May 2014: Based on the batch review performed, it was concluded that the MENVEO vaccine batch number (M11081) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 22 May 2014: Batch summary and expiry date of MENVEO vaccine were updated.
Age: 2.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Culture positive, Diarrhoea, Erythema multiforme, Rash, Streptococcus test negative
Clinical narrative: Case number PHHY2014US054680 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521918) website on 06 May 2014 with a follow up information received from the quality assurance department (reference number: 298019) on 22 May 2014. This report refers to a 2-year-old male patient. He had no medical history. His current condition included streptococcal throat. He had a full examination on 16 Jan 2014 and it was reported that his pharyngitis was resolving. Rapid streptococcal test performed was negative. He was vaccinated with MENVEO (batch number: M11081, expiry date: Apr 2014) in the right arm and VAQTA (other manufacturer, batch number: J011385) in the left arm on 17 Jan 2014. On 18 Jan 2014, he had rash which began on shoulder and then progressed through trunk and extremities. On 19 Jan 2014, his culture was positive for streptococcus and he began treatment with OMNICEF. On 20 Jan 2014, he had diarrhea once and he went to emergency room. On 23 Jan 2014, he was evaluated by physician in another country and was diagnosed with erythema multiforme. He had no response to trial dose of BENADRYL. The final outcome of the event was reported as complete recovery. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the event was not reported. Upon follow up information from the quality assurance department (reference number 298019) on 22 May 2014: Based on the batch review performed, it was concluded that the MENVEO vaccine batch number (M11081) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 22 May 2014: Batch summary and expiry date of MENVEO vaccine were updated.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose normal, Chest X-ray normal, Chills, Computerised tomogram normal, Dyspnoea
Clinical narrative: Case number PHHY2014US047133 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522171) web site on 14 Apr 2014 and a follow up received from Quality Assurance Department (QA, reference number: 295525) on 21 May 2014. This report refers to an 80 year old female patient. Her past medical history included coronary artery disease (CAD), status post aortic valve replacement, multiple sclerosis (MS), anemia, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), atrial fibrillation (AFIB), cerebrovascular accident (CVA), hyperlipidemia and vaginal hysterectomy. Her concomitant medications included LASIX, aspirin, SYMBICORT and ZOCOR. Her vaccination history included administration of tetanus toxoid (manufacturer and batch number: not reported) which was well tolerated. She was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly on 31 Oct 2013. It was reported that she drove herself to a retail pharmacy and got vaccination and there was no complaints of illness at the time of vaccination. On 31 Oct 2013, she presented with fever, chills and shortness of breath (SOB). The patient stated that prior evening; she suddenly started having shaking chills, fever and her shortness of breath got worse and the events had been increasingly worsening over the past couple of days. There was no real cough or productive sputum noted and she denied any other symptoms. She went to emergency room and was hospitalized for 2 days. She had sinus tachycardia with a heart rate of 114. Her chest X-ray and Computerised Tomogram was normal. Her complete blood count (CBC) was done and was within normal limits. White blood cell count (WBC) was reported as 10.1 (units and normal values were not reported). Her blood pressure was 141/100, body temperature was 100.5 F, pulse rate was 114, respiratory rate was 22, Oxygen saturation was 98% on 2L/NC and blood glucose was 102 (units and normal values of laboratory tests were not reported). The outcome was reported as complete recovery. The event was reported as serious due to hospitalization. The causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1309401) 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: 295525) on 21 May 2014: Updated batch review report.