chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Sensation of foreign body
Clinical narrative: Case number PHHY2014US047000 is an initial spontaneous report received from a consumer via the vaccine adverse event reporting system (VAERS reference number: 519718) web site on 14 Apr 2014 with a follow up report received from the Quality Assurance department (QA reference number: 295588) on 25 May 2014. This report refers to a 40 year old female patient. Her current condition included hypothyroidism, mild and well controlled asthma. Her concomitant medication included SYNTHROID at a dose of 137 mcg, VENTOLIN as per need and daily Multivitamin. She was vaccinated with FLUVIRIN (batch number: 1308301, expiry date: 31 Mar 2014) via intramuscular route into left arm on 22 Oct 2013. On 25 Oct 2013, she experienced the usual achiness which was of no concern. She also experienced significant chest pain, sensations of food being stuck in her throat, gagging with and without food or beverage being consumed, frequent and extreme nausea and dizziness. She was taken to emergency room for medical support. The final outcome of the event was reported as complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality was not reported. Based on the batch 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 was received from the Quality Assurance department (QA reference number: 295588) on 25 May 2014: The expiry date and batch review report were updated.
Age: 40.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Dizziness, Dyspnoea, Hypertension, Local swelling
Clinical narrative: Case number PHHY2014US047013 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 519779) website on 14 Apr 2014 with a follow up report received from the Quality Assurance department (QA reference number: 295584) on 25 May 2014. This report refers to a 40 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly in the left arm and BOOSTRIX (other manufacturer, batch number: 9443E) intramuscularly in the right arm on 14 Jan 2014. She visited the emergency room the day after vaccines (15 Jan 2014) were administered with complaints of shortness of breath, dizziness, high blood pressure and a swollen arm (right arm). The 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 regulatory authority. The causality of the event was not reported. No additional information was available. Based on the review performed, it was concluded that this product batch was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 295584) on 23 Apr 2014: Updated QA reference number only. Follow up report was received from the Quality Assurance department (QA reference number: 295584) on 25 May 2014: The batch review report was updated.
Age: 23.0
Sex: M
Vaccine: FLU3, HEPA, TDAP, FLU3, HEPA, TDAP
Symptoms: Dizziness, Loss of consciousness, Pallor, Snoring, Tremor
Clinical narrative: Case number PHHY2014US047024, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522220) website on 14 Apr 2014 and a follow-up information was received from Quality Assurance Department (reference number: 295574) on 25 May 2014. This report refers to a 23-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 13461P) in the left arm on 07 Feb 2014. On the same date, he also received HAVRIX (batch number: 793JR) in the left arm and ADACEL (batch number: C4251AA) in the right arm. On the same date, one min after vaccination he became lightheaded, then extremely pale. It was reported that approximately one min later he lost consciousness, was shaking and snoring. He regained consciousness after approximately 15 seconds. His blood pressure 15 minutes after the events was 111/68 mmHg with heart rate of 58 bpm. The final outcome of the events reported as completely recovered. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the events was not reported. Batch review report (reference number: 295574) received from quality assurance department on 25 May 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 13461P) 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: 295574) on 23 Apr 2014: Updated QA reference number only. Follow up received from Quality Assurance Department (reference number: 295574) on 25 May 2014: Updated batch review report.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cognitive disorder, Dizziness, Dysgeusia, Electrocardiogram, Laboratory test
Clinical narrative: Case number PHHY2014US047060, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522275) website on 14 Apr 2014 and a follow-up information was received from Quality Assurance Department (reference number: 295531) on 25 May 2014. This report refers to a 51-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1310301, expiry date: 31 May 2014) intramuscularly in the left arm on 28 Jan 2014. On the same date in the evening, after vaccination she experienced dizziness and cognition changes. Next day she presented with hives, swelling of face, itchy skin, racing heart and metallic taste. She took BENADRYL total of three doses. On an unknown date, five days later she was seen at MD office and then took BENADRYL for every 6 hours for 48 hours. She underwent EKG (electrocardiogram) and lab work through her personal physician (results: not provided). The final outcome of the events reported as recovered. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the events was not reported. Batch review report (reference number: 295531) received from quality assurance department on 25 May 2014. Based on the batch review performed, it was concluded FLUVIRIN (batch number: 1310301) 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: 295531) on 23 Apr 2014: Updated QA reference number. Follow up received from Quality Assurance Department (reference number: 295531) on 25 May 2014: Updated batch review report and expiry date of vaccine.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Palpitations, Pruritus, Swelling face, Urticaria
Clinical narrative: Case number PHHY2014US047060, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522275) website on 14 Apr 2014 and a follow-up information was received from Quality Assurance Department (reference number: 295531) on 25 May 2014. This report refers to a 51-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1310301, expiry date: 31 May 2014) intramuscularly in the left arm on 28 Jan 2014. On the same date in the evening, after vaccination she experienced dizziness and cognition changes. Next day she presented with hives, swelling of face, itchy skin, racing heart and metallic taste. She took BENADRYL total of three doses. On an unknown date, five days later she was seen at MD office and then took BENADRYL for every 6 hours for 48 hours. She underwent EKG (electrocardiogram) and lab work through her personal physician (results: not provided). The final outcome of the events reported as recovered. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the events was not reported. Batch review report (reference number: 295531) received from quality assurance department on 25 May 2014. Based on the batch review performed, it was concluded FLUVIRIN (batch number: 1310301) 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: 295531) on 23 Apr 2014: Updated QA reference number. Follow up received from Quality Assurance Department (reference number: 295531) on 25 May 2014: Updated batch review report and expiry date of vaccine.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood test, Borrelia test, Ear swelling, Headache, Local swelling
Clinical narrative: Case number PHHY2014US054804 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 525557) website on 06 May 2014 with the follow up information quality assurance department with (QA reference number: 298082) on 25 May 2014. This report refers to 21 year old male patient. His medical history was not reported. Concomitant medications included methylphenidate. On 20 Feb 2014, he received FLUVIRIN (batch number: 13381P) intramuscularly. On 23 Feb 2014, the patient started to develop swelling behind his ears and neck with a terrible headache. He was prescribed with prednisone and VALTREX at his physician office. Between 01 Mar 2014 and 03 Mar 2014 he developed Bell's palsy on his left side of the face. He was not getting any better according to his mother but he was on vacation for his spring break. Blood test and magnetic resonance imaging was done to rule out Lyme disease. Reporter assessed the events as serious (permanent disability). Outcome of the events was condition unchanged. Causality assessment was not reported. Based on the batch review performed, it was concluded that the FLUVIRIN vaccine batch number (13381P) 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 25 May 2014: Batch summary updated.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging, VIIth nerve paralysis
Clinical narrative: Case number PHHY2014US054804 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 525557) website on 06 May 2014 with the follow up information quality assurance department with (QA reference number: 298082) on 25 May 2014. This report refers to 21 year old male patient. His medical history was not reported. Concomitant medications included methylphenidate. On 20 Feb 2014, he received FLUVIRIN (batch number: 13381P) intramuscularly. On 23 Feb 2014, the patient started to develop swelling behind his ears and neck with a terrible headache. He was prescribed with prednisone and VALTREX at his physician office. Between 01 Mar 2014 and 03 Mar 2014 he developed Bell's palsy on his left side of the face. He was not getting any better according to his mother but he was on vacation for his spring break. Blood test and magnetic resonance imaging was done to rule out Lyme disease. Reporter assessed the events as serious (permanent disability). Outcome of the events was condition unchanged. Causality assessment was not reported. Based on the batch review performed, it was concluded that the FLUVIRIN vaccine batch number (13381P) 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 25 May 2014: Batch summary updated.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Borrelia test, Ear swelling, Headache, Local swelling, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2014US054804 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 525557) website on 06 May 2014 with the follow up information quality assurance department with (QA reference number: 298082) on 25 May 2014. This report refers to 21 year old male patient. His medical history was not reported. Concomitant medications included methylphenidate. On 20 Feb 2014, he received FLUVIRIN (batch number: 13381P) intramuscularly. On 23 Feb 2014, the patient started to develop swelling behind his ears and neck with a terrible headache. He was prescribed with prednisone and VALTREX at his physician office. Between 01 Mar 2014 and 03 Mar 2014 he developed Bell's palsy on his left side of the face. He was not getting any better according to his mother but he was on vacation for his spring break. Blood test and magnetic resonance imaging was done to rule out Lyme disease. Reporter assessed the events as serious (permanent disability). Outcome of the events was condition unchanged. Causality assessment was not reported. Based on the batch review performed, it was concluded that the FLUVIRIN vaccine batch number (13381P) 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 25 May 2014: Batch summary updated.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Case number PHHY2014US054804 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 525557) website on 06 May 2014 with the follow up information quality assurance department with (QA reference number: 298082) on 25 May 2014. This report refers to 21 year old male patient. His medical history was not reported. Concomitant medications included methylphenidate. On 20 Feb 2014, he received FLUVIRIN (batch number: 13381P) intramuscularly. On 23 Feb 2014, the patient started to develop swelling behind his ears and neck with a terrible headache. He was prescribed with prednisone and VALTREX at his physician office. Between 01 Mar 2014 and 03 Mar 2014 he developed Bell's palsy on his left side of the face. He was not getting any better according to his mother but he was on vacation for his spring break. Blood test and magnetic resonance imaging was done to rule out Lyme disease. Reporter assessed the events as serious (permanent disability). Outcome of the events was condition unchanged. Causality assessment was not reported. Based on the batch review performed, it was concluded that the FLUVIRIN vaccine batch number (13381P) 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 25 May 2014: Batch summary updated.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Muscular weakness, Myelitis transverse, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 17 year old male patient. On an unknown date the patient was vaccinated with GARDASIL dose 2 (route, dosage and lot number unknown). It was unknown when the patient received dose no. 1. On an unknown date after receiving the second dose of GARDASIL the patient experienced transverse myelitis (date unspecified). The consumer was admitted into an unspecified hospital, on an unspecified date for an unspecified length of time. Therapy with GARDASIL was discontinued. The outcome of patient experienced transverse myelitis was reported as recovering. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 17 year old male patient. On an unknown date the patient was vaccinated with GARDASIL dose 2 (route, dosage and lot number unknown). It was unknown when the patient received dose no. 1. On an unknown date after receiving the second dose of GARDASIL the patient experienced transverse myelitis (date unspecified). The consumer was admitted into an unspecified hospital, on an unspecified date for an unspecified length of time. Therapy with GARDASIL was discontinued. The outcome of patient experienced transverse myelitis was reported as recovering. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Myelitis transverse
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 17 year old male patient. On an unknown date the patient was vaccinated with GARDASIL dose 2 (route, dosage and lot number unknown). It was unknown when the patient received dose no. 1. On an unknown date after receiving the second dose of GARDASIL the patient experienced transverse myelitis (date unspecified). The consumer was admitted into an unspecified hospital, on an unspecified date for an unspecified length of time. Therapy with GARDASIL was discontinued. The outcome of patient experienced transverse myelitis was reported as recovering. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Azotaemia, Blood creatinine increased, Blood lactate dehydrogenase increased, Blood urea increased
Clinical narrative: This case was reported in a literature article and described the occurrence of Atypical Haemolytic Uremic Syndrome in a 76-year-old male subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). No information regarding the subject's medical, family history or concurrent medication has been provided. On an unspecified date, the subject received unspecified dose of Influenza vaccine unspecified (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced generalized weakness and unsteady gait, as well as 2 episodes of non-bloody diarrhoea and decreased urine output. On clinical examination the subject was confused, lethargic and had dry mucosal membranes. The subject was hospitalised and the author considered the events were life threatening. Laboratory tests revealed creatinine of 1.8 mg/dL, blood urea nitrogen of 50mg/dL, haemoglobin of 12.1 g/dl, haematocrit of 35.6%, platelet count of 35,000/nL, LDH of 590U/L and haptoglobin of 10mg/dL. C3 and C4 complement levels were both low at 58 mg/dL and 12 mg/dL respectively. Schistocytes were seen on peripheral smear. Urinalysis showed a trace of proteinuria and 1 rbc/hpf. Plasma ADAMTS13 activity was normal and his stool was negative for Shiga toxin-producing Escherichia coli. Genetic analysis did not demonstrate any factor H gene mutation. The subject was diagnosed with Atypical Haemolytic Uremic Syndrome. The subject was treated initially with 7 days of therapeutic plasma exchange after which the haemolysis still persisted, the thrombocytopenia had worsened and the subject had developed multi-organ failure. In view of this haemodialysis was introduced on day 10 of admission for controlling the uremia and volume overload and he was started on eculizumab (900 mg weekly for 4 weeks; 1200 mg in the fifth week followed by 1200 mg bi-weekly for a total of 16 doses). No further therapeutic plasma exchange was performed. Subject's platelets normalised, LDH improved and he came off haemodialysis by the fourth dose of eculizumab. His creatinine stabilized at 1.1 mg/dL and his respiratory failure and hepatic injury also resolved. At the time of reporting the events were resolved. Author's conclusion: None related to the vaccination included.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Body temperature increased, Complement factor C3, Complement factor C4 decreased, Complement factor normal, Confusional state
Clinical narrative: This case was reported in a literature article and described the occurrence of Atypical Haemolytic Uremic Syndrome in a 76-year-old male subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). No information regarding the subject's medical, family history or concurrent medication has been provided. On an unspecified date, the subject received unspecified dose of Influenza vaccine unspecified (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced generalized weakness and unsteady gait, as well as 2 episodes of non-bloody diarrhoea and decreased urine output. On clinical examination the subject was confused, lethargic and had dry mucosal membranes. The subject was hospitalised and the author considered the events were life threatening. Laboratory tests revealed creatinine of 1.8 mg/dL, blood urea nitrogen of 50mg/dL, haemoglobin of 12.1 g/dl, haematocrit of 35.6%, platelet count of 35,000/nL, LDH of 590U/L and haptoglobin of 10mg/dL. C3 and C4 complement levels were both low at 58 mg/dL and 12 mg/dL respectively. Schistocytes were seen on peripheral smear. Urinalysis showed a trace of proteinuria and 1 rbc/hpf. Plasma ADAMTS13 activity was normal and his stool was negative for Shiga toxin-producing Escherichia coli. Genetic analysis did not demonstrate any factor H gene mutation. The subject was diagnosed with Atypical Haemolytic Uremic Syndrome. The subject was treated initially with 7 days of therapeutic plasma exchange after which the haemolysis still persisted, the thrombocytopenia had worsened and the subject had developed multi-organ failure. In view of this haemodialysis was introduced on day 10 of admission for controlling the uremia and volume overload and he was started on eculizumab (900 mg weekly for 4 weeks; 1200 mg in the fifth week followed by 1200 mg bi-weekly for a total of 16 doses). No further therapeutic plasma exchange was performed. Subject's platelets normalised, LDH improved and he came off haemodialysis by the fourth dose of eculizumab. His creatinine stabilized at 1.1 mg/dL and his respiratory failure and hepatic injury also resolved. At the time of reporting the events were resolved. Author's conclusion: None related to the vaccination included.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Cytogenetic analysis normal, Diarrhoea, Escherichia test negative, Fluid overload, Gait disturbance
Clinical narrative: This case was reported in a literature article and described the occurrence of Atypical Haemolytic Uremic Syndrome in a 76-year-old male subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). No information regarding the subject's medical, family history or concurrent medication has been provided. On an unspecified date, the subject received unspecified dose of Influenza vaccine unspecified (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced generalized weakness and unsteady gait, as well as 2 episodes of non-bloody diarrhoea and decreased urine output. On clinical examination the subject was confused, lethargic and had dry mucosal membranes. The subject was hospitalised and the author considered the events were life threatening. Laboratory tests revealed creatinine of 1.8 mg/dL, blood urea nitrogen of 50mg/dL, haemoglobin of 12.1 g/dl, haematocrit of 35.6%, platelet count of 35,000/nL, LDH of 590U/L and haptoglobin of 10mg/dL. C3 and C4 complement levels were both low at 58 mg/dL and 12 mg/dL respectively. Schistocytes were seen on peripheral smear. Urinalysis showed a trace of proteinuria and 1 rbc/hpf. Plasma ADAMTS13 activity was normal and his stool was negative for Shiga toxin-producing Escherichia coli. Genetic analysis did not demonstrate any factor H gene mutation. The subject was diagnosed with Atypical Haemolytic Uremic Syndrome. The subject was treated initially with 7 days of therapeutic plasma exchange after which the haemolysis still persisted, the thrombocytopenia had worsened and the subject had developed multi-organ failure. In view of this haemodialysis was introduced on day 10 of admission for controlling the uremia and volume overload and he was started on eculizumab (900 mg weekly for 4 weeks; 1200 mg in the fifth week followed by 1200 mg bi-weekly for a total of 16 doses). No further therapeutic plasma exchange was performed. Subject's platelets normalised, LDH improved and he came off haemodialysis by the fourth dose of eculizumab. His creatinine stabilized at 1.1 mg/dL and his respiratory failure and hepatic injury also resolved. At the time of reporting the events were resolved. Author's conclusion: None related to the vaccination included.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Haematocrit decreased, Haemodialysis, Haemoglobin decreased, Haemolysis, Haemolytic uraemic syndrome
Clinical narrative: This case was reported in a literature article and described the occurrence of Atypical Haemolytic Uremic Syndrome in a 76-year-old male subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). No information regarding the subject's medical, family history or concurrent medication has been provided. On an unspecified date, the subject received unspecified dose of Influenza vaccine unspecified (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced generalized weakness and unsteady gait, as well as 2 episodes of non-bloody diarrhoea and decreased urine output. On clinical examination the subject was confused, lethargic and had dry mucosal membranes. The subject was hospitalised and the author considered the events were life threatening. Laboratory tests revealed creatinine of 1.8 mg/dL, blood urea nitrogen of 50mg/dL, haemoglobin of 12.1 g/dl, haematocrit of 35.6%, platelet count of 35,000/nL, LDH of 590U/L and haptoglobin of 10mg/dL. C3 and C4 complement levels were both low at 58 mg/dL and 12 mg/dL respectively. Schistocytes were seen on peripheral smear. Urinalysis showed a trace of proteinuria and 1 rbc/hpf. Plasma ADAMTS13 activity was normal and his stool was negative for Shiga toxin-producing Escherichia coli. Genetic analysis did not demonstrate any factor H gene mutation. The subject was diagnosed with Atypical Haemolytic Uremic Syndrome. The subject was treated initially with 7 days of therapeutic plasma exchange after which the haemolysis still persisted, the thrombocytopenia had worsened and the subject had developed multi-organ failure. In view of this haemodialysis was introduced on day 10 of admission for controlling the uremia and volume overload and he was started on eculizumab (900 mg weekly for 4 weeks; 1200 mg in the fifth week followed by 1200 mg bi-weekly for a total of 16 doses). No further therapeutic plasma exchange was performed. Subject's platelets normalised, LDH improved and he came off haemodialysis by the fourth dose of eculizumab. His creatinine stabilized at 1.1 mg/dL and his respiratory failure and hepatic injury also resolved. At the time of reporting the events were resolved. Author's conclusion: None related to the vaccination included.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Haptoglobin, Lethargy, Liver injury, Mucosal dryness, Multi-organ failure
Clinical narrative: This case was reported in a literature article and described the occurrence of Atypical Haemolytic Uremic Syndrome in a 76-year-old male subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). No information regarding the subject's medical, family history or concurrent medication has been provided. On an unspecified date, the subject received unspecified dose of Influenza vaccine unspecified (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced generalized weakness and unsteady gait, as well as 2 episodes of non-bloody diarrhoea and decreased urine output. On clinical examination the subject was confused, lethargic and had dry mucosal membranes. The subject was hospitalised and the author considered the events were life threatening. Laboratory tests revealed creatinine of 1.8 mg/dL, blood urea nitrogen of 50mg/dL, haemoglobin of 12.1 g/dl, haematocrit of 35.6%, platelet count of 35,000/nL, LDH of 590U/L and haptoglobin of 10mg/dL. C3 and C4 complement levels were both low at 58 mg/dL and 12 mg/dL respectively. Schistocytes were seen on peripheral smear. Urinalysis showed a trace of proteinuria and 1 rbc/hpf. Plasma ADAMTS13 activity was normal and his stool was negative for Shiga toxin-producing Escherichia coli. Genetic analysis did not demonstrate any factor H gene mutation. The subject was diagnosed with Atypical Haemolytic Uremic Syndrome. The subject was treated initially with 7 days of therapeutic plasma exchange after which the haemolysis still persisted, the thrombocytopenia had worsened and the subject had developed multi-organ failure. In view of this haemodialysis was introduced on day 10 of admission for controlling the uremia and volume overload and he was started on eculizumab (900 mg weekly for 4 weeks; 1200 mg in the fifth week followed by 1200 mg bi-weekly for a total of 16 doses). No further therapeutic plasma exchange was performed. Subject's platelets normalised, LDH improved and he came off haemodialysis by the fourth dose of eculizumab. His creatinine stabilized at 1.1 mg/dL and his respiratory failure and hepatic injury also resolved. At the time of reporting the events were resolved. Author's conclusion: None related to the vaccination included.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Plasmapheresis, Platelet count decreased, Protein urine present, Proteinuria, Red blood cell schistocytes present
Clinical narrative: This case was reported in a literature article and described the occurrence of Atypical Haemolytic Uremic Syndrome in a 76-year-old male subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). No information regarding the subject's medical, family history or concurrent medication has been provided. On an unspecified date, the subject received unspecified dose of Influenza vaccine unspecified (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced generalized weakness and unsteady gait, as well as 2 episodes of non-bloody diarrhoea and decreased urine output. On clinical examination the subject was confused, lethargic and had dry mucosal membranes. The subject was hospitalised and the author considered the events were life threatening. Laboratory tests revealed creatinine of 1.8 mg/dL, blood urea nitrogen of 50mg/dL, haemoglobin of 12.1 g/dl, haematocrit of 35.6%, platelet count of 35,000/nL, LDH of 590U/L and haptoglobin of 10mg/dL. C3 and C4 complement levels were both low at 58 mg/dL and 12 mg/dL respectively. Schistocytes were seen on peripheral smear. Urinalysis showed a trace of proteinuria and 1 rbc/hpf. Plasma ADAMTS13 activity was normal and his stool was negative for Shiga toxin-producing Escherichia coli. Genetic analysis did not demonstrate any factor H gene mutation. The subject was diagnosed with Atypical Haemolytic Uremic Syndrome. The subject was treated initially with 7 days of therapeutic plasma exchange after which the haemolysis still persisted, the thrombocytopenia had worsened and the subject had developed multi-organ failure. In view of this haemodialysis was introduced on day 10 of admission for controlling the uremia and volume overload and he was started on eculizumab (900 mg weekly for 4 weeks; 1200 mg in the fifth week followed by 1200 mg bi-weekly for a total of 16 doses). No further therapeutic plasma exchange was performed. Subject's platelets normalised, LDH improved and he came off haemodialysis by the fourth dose of eculizumab. His creatinine stabilized at 1.1 mg/dL and his respiratory failure and hepatic injury also resolved. At the time of reporting the events were resolved. Author's conclusion: None related to the vaccination included.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Respiratory failure, Thrombocytopenia, Urine output decreased
Clinical narrative: This case was reported in a literature article and described the occurrence of Atypical Haemolytic Uremic Syndrome in a 76-year-old male subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). No information regarding the subject's medical, family history or concurrent medication has been provided. On an unspecified date, the subject received unspecified dose of Influenza vaccine unspecified (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced generalized weakness and unsteady gait, as well as 2 episodes of non-bloody diarrhoea and decreased urine output. On clinical examination the subject was confused, lethargic and had dry mucosal membranes. The subject was hospitalised and the author considered the events were life threatening. Laboratory tests revealed creatinine of 1.8 mg/dL, blood urea nitrogen of 50mg/dL, haemoglobin of 12.1 g/dl, haematocrit of 35.6%, platelet count of 35,000/nL, LDH of 590U/L and haptoglobin of 10mg/dL. C3 and C4 complement levels were both low at 58 mg/dL and 12 mg/dL respectively. Schistocytes were seen on peripheral smear. Urinalysis showed a trace of proteinuria and 1 rbc/hpf. Plasma ADAMTS13 activity was normal and his stool was negative for Shiga toxin-producing Escherichia coli. Genetic analysis did not demonstrate any factor H gene mutation. The subject was diagnosed with Atypical Haemolytic Uremic Syndrome. The subject was treated initially with 7 days of therapeutic plasma exchange after which the haemolysis still persisted, the thrombocytopenia had worsened and the subject had developed multi-organ failure. In view of this haemodialysis was introduced on day 10 of admission for controlling the uremia and volume overload and he was started on eculizumab (900 mg weekly for 4 weeks; 1200 mg in the fifth week followed by 1200 mg bi-weekly for a total of 16 doses). No further therapeutic plasma exchange was performed. Subject's platelets normalised, LDH improved and he came off haemodialysis by the fourth dose of eculizumab. His creatinine stabilized at 1.1 mg/dL and his respiratory failure and hepatic injury also resolved. At the time of reporting the events were resolved. Author's conclusion: None related to the vaccination included.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Complement factor C3, Complement factor C4 decreased, Complement factor normal, Confusional state, Cytogenetic analysis normal
Clinical narrative: This case was reported in a literature article and described the occurrence of Atypical Haemolytic Uremic Syndrome in a 76-year-old male subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). No information regarding the subject's medical, family history or concurrent medication has been provided. On an unspecified date, the subject received unspecified dose of Influenza vaccine unspecified (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced generalized weakness and unsteady gait, as well as 2 episodes of non-bloody diarrhoea and decreased urine output. On clinical examination the subject was confused, lethargic and had dry mucosal membranes. The subject was hospitalised and the author considered the events were life threatening. Laboratory tests revealed creatinine of 1.8 mg/dL, blood urea nitrogen of 50mg/dL, haemoglobin of 12.1 g/dl, haematocrit of 35.6%, platelet count of 35,000/nL, LDH of 590U/L and haptoglobin of 10mg/dL. C3 and C4 complement levels were both low at 58 mg/dL and 12 mg/dL respectively. Schistocytes were seen on peripheral smear. Urinalysis showed a trace of proteinuria and 1 rbc/hpf. Plasma ADAMTS13 activity was normal and his stool was negative for Shiga toxin-producing Escherichia coli. Genetic analysis did not demonstrate any factor H gene mutation. The subject was diagnosed with Atypical Haemolytic Uremic Syndrome. The subject was treated initially with 7 days of therapeutic plasma exchange after which the haemolysis still persisted, the thrombocytopenia had worsened and the subject had developed multi-organ failure. In view of this haemodialysis was introduced on day 10 of admission for controlling the uremia and volume overload and he was started on eculizumab (900 mg weekly for 4 weeks; 1200 mg in the fifth week followed by 1200 mg bi-weekly for a total of 16 doses). No further therapeutic plasma exchange was performed. Subject's platelets normalised, LDH improved and he came off haemodialysis by the fourth dose of eculizumab. His creatinine stabilized at 1.1 mg/dL and his respiratory failure and hepatic injury also resolved. At the time of reporting the events were resolved. Author's conclusion: None related to the vaccination included.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Diarrhoea, Escherichia test negative, Fluid overload, Gait disturbance, Haematocrit decreased
Clinical narrative: This case was reported in a literature article and described the occurrence of Atypical Haemolytic Uremic Syndrome in a 76-year-old male subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). No information regarding the subject's medical, family history or concurrent medication has been provided. On an unspecified date, the subject received unspecified dose of Influenza vaccine unspecified (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced generalized weakness and unsteady gait, as well as 2 episodes of non-bloody diarrhoea and decreased urine output. On clinical examination the subject was confused, lethargic and had dry mucosal membranes. The subject was hospitalised and the author considered the events were life threatening. Laboratory tests revealed creatinine of 1.8 mg/dL, blood urea nitrogen of 50mg/dL, haemoglobin of 12.1 g/dl, haematocrit of 35.6%, platelet count of 35,000/nL, LDH of 590U/L and haptoglobin of 10mg/dL. C3 and C4 complement levels were both low at 58 mg/dL and 12 mg/dL respectively. Schistocytes were seen on peripheral smear. Urinalysis showed a trace of proteinuria and 1 rbc/hpf. Plasma ADAMTS13 activity was normal and his stool was negative for Shiga toxin-producing Escherichia coli. Genetic analysis did not demonstrate any factor H gene mutation. The subject was diagnosed with Atypical Haemolytic Uremic Syndrome. The subject was treated initially with 7 days of therapeutic plasma exchange after which the haemolysis still persisted, the thrombocytopenia had worsened and the subject had developed multi-organ failure. In view of this haemodialysis was introduced on day 10 of admission for controlling the uremia and volume overload and he was started on eculizumab (900 mg weekly for 4 weeks; 1200 mg in the fifth week followed by 1200 mg bi-weekly for a total of 16 doses). No further therapeutic plasma exchange was performed. Subject's platelets normalised, LDH improved and he came off haemodialysis by the fourth dose of eculizumab. His creatinine stabilized at 1.1 mg/dL and his respiratory failure and hepatic injury also resolved. At the time of reporting the events were resolved. Author's conclusion: None related to the vaccination included.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Haemodialysis, Haemoglobin decreased, Haemolysis, Haemolytic uraemic syndrome, Haptoglobin decreased
Clinical narrative: This case was reported in a literature article and described the occurrence of Atypical Haemolytic Uremic Syndrome in a 76-year-old male subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). No information regarding the subject's medical, family history or concurrent medication has been provided. On an unspecified date, the subject received unspecified dose of Influenza vaccine unspecified (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced generalized weakness and unsteady gait, as well as 2 episodes of non-bloody diarrhoea and decreased urine output. On clinical examination the subject was confused, lethargic and had dry mucosal membranes. The subject was hospitalised and the author considered the events were life threatening. Laboratory tests revealed creatinine of 1.8 mg/dL, blood urea nitrogen of 50mg/dL, haemoglobin of 12.1 g/dl, haematocrit of 35.6%, platelet count of 35,000/nL, LDH of 590U/L and haptoglobin of 10mg/dL. C3 and C4 complement levels were both low at 58 mg/dL and 12 mg/dL respectively. Schistocytes were seen on peripheral smear. Urinalysis showed a trace of proteinuria and 1 rbc/hpf. Plasma ADAMTS13 activity was normal and his stool was negative for Shiga toxin-producing Escherichia coli. Genetic analysis did not demonstrate any factor H gene mutation. The subject was diagnosed with Atypical Haemolytic Uremic Syndrome. The subject was treated initially with 7 days of therapeutic plasma exchange after which the haemolysis still persisted, the thrombocytopenia had worsened and the subject had developed multi-organ failure. In view of this haemodialysis was introduced on day 10 of admission for controlling the uremia and volume overload and he was started on eculizumab (900 mg weekly for 4 weeks; 1200 mg in the fifth week followed by 1200 mg bi-weekly for a total of 16 doses). No further therapeutic plasma exchange was performed. Subject's platelets normalised, LDH improved and he came off haemodialysis by the fourth dose of eculizumab. His creatinine stabilized at 1.1 mg/dL and his respiratory failure and hepatic injury also resolved. At the time of reporting the events were resolved. Author's conclusion: None related to the vaccination included.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Lethargy, Liver injury, Mucosal dryness, Multi-organ failure, Plasmapheresis
Clinical narrative: This case was reported in a literature article and described the occurrence of Atypical Haemolytic Uremic Syndrome in a 76-year-old male subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). No information regarding the subject's medical, family history or concurrent medication has been provided. On an unspecified date, the subject received unspecified dose of Influenza vaccine unspecified (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced generalized weakness and unsteady gait, as well as 2 episodes of non-bloody diarrhoea and decreased urine output. On clinical examination the subject was confused, lethargic and had dry mucosal membranes. The subject was hospitalised and the author considered the events were life threatening. Laboratory tests revealed creatinine of 1.8 mg/dL, blood urea nitrogen of 50mg/dL, haemoglobin of 12.1 g/dl, haematocrit of 35.6%, platelet count of 35,000/nL, LDH of 590U/L and haptoglobin of 10mg/dL. C3 and C4 complement levels were both low at 58 mg/dL and 12 mg/dL respectively. Schistocytes were seen on peripheral smear. Urinalysis showed a trace of proteinuria and 1 rbc/hpf. Plasma ADAMTS13 activity was normal and his stool was negative for Shiga toxin-producing Escherichia coli. Genetic analysis did not demonstrate any factor H gene mutation. The subject was diagnosed with Atypical Haemolytic Uremic Syndrome. The subject was treated initially with 7 days of therapeutic plasma exchange after which the haemolysis still persisted, the thrombocytopenia had worsened and the subject had developed multi-organ failure. In view of this haemodialysis was introduced on day 10 of admission for controlling the uremia and volume overload and he was started on eculizumab (900 mg weekly for 4 weeks; 1200 mg in the fifth week followed by 1200 mg bi-weekly for a total of 16 doses). No further therapeutic plasma exchange was performed. Subject's platelets normalised, LDH improved and he came off haemodialysis by the fourth dose of eculizumab. His creatinine stabilized at 1.1 mg/dL and his respiratory failure and hepatic injury also resolved. At the time of reporting the events were resolved. Author's conclusion: None related to the vaccination included.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Platelet count decreased, Protein total normal, Protein urine present, Proteinuria, Red blood cell schistocytes present
Clinical narrative: This case was reported in a literature article and described the occurrence of Atypical Haemolytic Uremic Syndrome in a 76-year-old male subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). No information regarding the subject's medical, family history or concurrent medication has been provided. On an unspecified date, the subject received unspecified dose of Influenza vaccine unspecified (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced generalized weakness and unsteady gait, as well as 2 episodes of non-bloody diarrhoea and decreased urine output. On clinical examination the subject was confused, lethargic and had dry mucosal membranes. The subject was hospitalised and the author considered the events were life threatening. Laboratory tests revealed creatinine of 1.8 mg/dL, blood urea nitrogen of 50mg/dL, haemoglobin of 12.1 g/dl, haematocrit of 35.6%, platelet count of 35,000/nL, LDH of 590U/L and haptoglobin of 10mg/dL. C3 and C4 complement levels were both low at 58 mg/dL and 12 mg/dL respectively. Schistocytes were seen on peripheral smear. Urinalysis showed a trace of proteinuria and 1 rbc/hpf. Plasma ADAMTS13 activity was normal and his stool was negative for Shiga toxin-producing Escherichia coli. Genetic analysis did not demonstrate any factor H gene mutation. The subject was diagnosed with Atypical Haemolytic Uremic Syndrome. The subject was treated initially with 7 days of therapeutic plasma exchange after which the haemolysis still persisted, the thrombocytopenia had worsened and the subject had developed multi-organ failure. In view of this haemodialysis was introduced on day 10 of admission for controlling the uremia and volume overload and he was started on eculizumab (900 mg weekly for 4 weeks; 1200 mg in the fifth week followed by 1200 mg bi-weekly for a total of 16 doses). No further therapeutic plasma exchange was performed. Subject's platelets normalised, LDH improved and he came off haemodialysis by the fourth dose of eculizumab. His creatinine stabilized at 1.1 mg/dL and his respiratory failure and hepatic injury also resolved. At the time of reporting the events were resolved. Author's conclusion: None related to the vaccination included.