chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Blood pressure increased, Endotracheal intubation, Eosinophil count, Muscular weakness
Clinical narrative: Case number PHHY2013US069560, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471274) website on 03 Jul 2013, with the follow-up received from Quality Assurance Department (reference number: 239155) on 17 Dec 2013. This report refers to a 46-year-old female patient. Her medical history included Bells palsy. Her current conditions included bronchitis and diarrhea. She was vaccinated with FLUVIRIN (batch number: 12265P, Expiry date: 30 Jun 2013) intramuscularly on 28 Sep 2012. On 14 Oct 2012, she experienced paralysis, tingling in lower legs, weakness in lower extremities, and elevated blood pressure (values not reported). She was unable to walk and she was intubated and received plasmapheresis. She was taken to the emergency room. Lab tests revealed neutrophils: 79 (units not reported), eosinophil: 10 (units not reported). The outcome was reported as condition unchanged as of 24 Oct 2012. The events were assessed as life threatening. The causality was not reported. Based on the investigation performed, QA department stated that, the concerned FLUVIRIN (batch number: 12265P) 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: 239155) on 17 Dec 2013: Updated batch review report.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Neutrophil count, Paraesthesia, Paralysis, Plasmapheresis
Clinical narrative: Case number PHHY2013US069560, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471274) website on 03 Jul 2013, with the follow-up received from Quality Assurance Department (reference number: 239155) on 17 Dec 2013. This report refers to a 46-year-old female patient. Her medical history included Bells palsy. Her current conditions included bronchitis and diarrhea. She was vaccinated with FLUVIRIN (batch number: 12265P, Expiry date: 30 Jun 2013) intramuscularly on 28 Sep 2012. On 14 Oct 2012, she experienced paralysis, tingling in lower legs, weakness in lower extremities, and elevated blood pressure (values not reported). She was unable to walk and she was intubated and received plasmapheresis. She was taken to the emergency room. Lab tests revealed neutrophils: 79 (units not reported), eosinophil: 10 (units not reported). The outcome was reported as condition unchanged as of 24 Oct 2012. The events were assessed as life threatening. The causality was not reported. Based on the investigation performed, QA department stated that, the concerned FLUVIRIN (batch number: 12265P) 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: 239155) on 17 Dec 2013: Updated batch review report.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Borrelia test negative, Eosinophil count decreased, Immunoglobulins, Mechanical ventilation, Monocyte count increased
Clinical narrative: Case number PHHY2013US014933 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471276) website on 08 Feb 2013 with a follow up received from quality assurance department (reference number: 211099) on 18 Dec 2013. This report refers to a 73 year old female patient. She had a recent diagnosis of left femur sarcoma for which she underwent radiation therapy for the "last 5 weeks which she ended last week". She was vaccinated with FLUVIRIN (batch number: 1204601) intramuscularly to left arm on 04 Oct 2012. On the same day after vaccination, she experienced paresthesia and "questionable weakness in bilateral lower extremity", as well as paresthesia of all fingers and weakness of respiratory muscles. She visited emergency room. She underwent plasmapheresis. She was put on a ventilator and also experienced monocytosis. Diagnostic lab data revealed negative Lyme disease with laboratory data of immunoglobulin 43, M Protein 0.3, leukocytes 100, eosinophil 0.6, monocytes 1.5 and neutrophils 14.1. Outcome of the events were reported as condition unchanged as of 24 Oct 2012. Seriousness was reported as life threatening. Causality was not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1204601) 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 (reference number: 211099) on 18 Dec 2013: Updated batch review report.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Monocytosis, Neutrophil count increased, Paraesthesia, Plasmapheresis, Protein total decreased
Clinical narrative: Case number PHHY2013US014933 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471276) website on 08 Feb 2013 with a follow up received from quality assurance department (reference number: 211099) on 18 Dec 2013. This report refers to a 73 year old female patient. She had a recent diagnosis of left femur sarcoma for which she underwent radiation therapy for the "last 5 weeks which she ended last week". She was vaccinated with FLUVIRIN (batch number: 1204601) intramuscularly to left arm on 04 Oct 2012. On the same day after vaccination, she experienced paresthesia and "questionable weakness in bilateral lower extremity", as well as paresthesia of all fingers and weakness of respiratory muscles. She visited emergency room. She underwent plasmapheresis. She was put on a ventilator and also experienced monocytosis. Diagnostic lab data revealed negative Lyme disease with laboratory data of immunoglobulin 43, M Protein 0.3, leukocytes 100, eosinophil 0.6, monocytes 1.5 and neutrophils 14.1. Outcome of the events were reported as condition unchanged as of 24 Oct 2012. Seriousness was reported as life threatening. Causality was not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1204601) 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 (reference number: 211099) on 18 Dec 2013: Updated batch review report.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory muscle weakness, White blood cell count decreased
Clinical narrative: Case number PHHY2013US014933 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471276) website on 08 Feb 2013 with a follow up received from quality assurance department (reference number: 211099) on 18 Dec 2013. This report refers to a 73 year old female patient. She had a recent diagnosis of left femur sarcoma for which she underwent radiation therapy for the "last 5 weeks which she ended last week". She was vaccinated with FLUVIRIN (batch number: 1204601) intramuscularly to left arm on 04 Oct 2012. On the same day after vaccination, she experienced paresthesia and "questionable weakness in bilateral lower extremity", as well as paresthesia of all fingers and weakness of respiratory muscles. She visited emergency room. She underwent plasmapheresis. She was put on a ventilator and also experienced monocytosis. Diagnostic lab data revealed negative Lyme disease with laboratory data of immunoglobulin 43, M Protein 0.3, leukocytes 100, eosinophil 0.6, monocytes 1.5 and neutrophils 14.1. Outcome of the events were reported as condition unchanged as of 24 Oct 2012. Seriousness was reported as life threatening. Causality was not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1204601) 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 (reference number: 211099) on 18 Dec 2013: Updated batch review report.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case PHHY2013US000473, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471437) on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 209074) on 18 Dec 2013. This report refers to 40-year-old female patient. Her medical history was not reported. Concomitant medications include Nasonex and Allegra. She was vaccinated FLUVIRIN 2012/2013 (batch number: 1204601, Expiry date: 31 May 2013) intramuscularly on 23 Oct 2012. Patient fainted for a few seconds (briefly) after shot was administered. She quickly woke up and was given a cool compress, Ibuprofen and Gatorade. She stayed seated for half hour afterwards. No serious injuries occurred. The outcome of the events was recovered. The seriousness and causality assessment was not reported.  Based on the investigation performed, QA department stated that, Fluvirin 2012/2013 vaccine (batch number: 1204601) 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: 209074) on 18 Dec 2013: Updated batch review report.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Fall, Headache, Syncope
Clinical narrative: Case PHHY2013US000606, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471507) on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 209069) on 18 Dec 2013. This report refers to a 28-year-old female patient. She was vaccinated with FLUVIRIN 2012/2013 (batch number: 1204601, Expiry date 31 May 2013) intramuscularly in left arm on 24 Oct 2012. On 24 Oct 2012, after the vaccination, she fainted and fell on floor. She woke up a minute later, but when she tried to sit up, she fainted again. So when she woke up again, she was made to lie down on the floor with pillow under her head until the paramedics came. She stated that her head and stomach hurt. She went to emergency room for the events. The outcome of events was reported as condition unchanged as 25 Oct 2012. The seriousness and causality of the events was not reported. Based on the investigation performed, QA department stated that, Fluvirin 2012/2013 vaccine (batch number: 1204601) 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: 209069) on 18 Dec 2013: Updated batch review report.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Hypoaesthesia, Hypoaesthesia oral, Motor dysfunction, Paraesthesia
Clinical narrative: Case number PHHY2013US000525 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 472101) on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 209071) on 18 Dec 2013. This report refers to a 77-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1204601, Expiry date: 31 May 2013) intramuscularly in right arm on 22 Oct 2012. On 24 Oct 2012, after the vaccination, she experienced numb bottom lip on right side, right hand numbness, tingling in her right hand fingers, dexterity issues with right hand and finger and alteration of taste. The outcome of events was reported as condition unchanged as of 30 Oct 2012. The seriousness and outcome of the events was not reported. Based on the investigation performed, QA department stated that the FLUVIRIN vaccine (batch number: 1204601) 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: 209071) on 18 Dec 2013: Updated batch review report.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Case PHHY2013US000784, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 472938) on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 208857) on 17 Dec 2013. This case refers to a 48-year-old male patient. He had been diagnosed with idiopathic thrombocytopenic purpura 20 years before. It was reported that it has since gone into remission. His concomitant medications included Effexor, Lipitor, Azor and Testim. He was vaccinated with FLUVIRIN 2012/2013 (batch number: 12265P, Expiry date: 30 Jun 2013) intramuscularly into his right arm on 23 Sep 2012. On 01 Oct 2012 he had acute idiopathic thrombocytopenic purpura (ITP) with platelet count of 29000. He had an emergency doctor visit due to this event. It was reported that he was under the care of an oncologist. The seriousness of event ITP was reported as life threatening. The final outcome was reported as condition unchanged as of 05 Nov 2012. The causality was not reported.  Based on the investigation performed, QA department stated that, the concerned Fluvirin 2012/2013 vaccine (batch number: 12265P) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. No other information was available. Follow-up received from Quality Assurance Department (reference number: 208857) on 17 Dec 2013: Updated batch review report.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Loss of consciousness
Clinical narrative: Case PHHY2013US000806, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 473016) website on 11 Nov 2013, with the follow-up received from Quality Assurance Department (reference number: 209065) on 17 Dec 2013. This report refers to a 33-year-old male patient. His medical history included neurocardiogenic syncope. Concomitant medication was not reported. He was vaccinated Fluvirin 2012/2013 (batch number: 1204601) IM into left arm on 01 Nov 2012. On the same day the patient began to feel funny, started to sit down and passed out. He called the emergency and they arrived approximately in 3-5 minutes. The outcome of the events was completely recovered. The seriousness and causality assessment was not reported. Based on the investigation performed, QA department stated that, the Fluvirin 2012/2013 vaccine (batch number: 1204601) 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: 209065) on 17 Dec 2013: Updated batch review report.
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: Case number PHHY2013US012139 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 475129) web site on 08 Feb 2013 with a follow up information received from QA department (reference number: 210434) on 20 Dec 2013. This report refers to a 70-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1204601) intramuscularly on to her left arm on 10 Nov 2012. On 12 Nov 2012, she experienced atrial fibrillation and went to hospital. An electrocardiogram was performed and she had treatment to slow heart rate. Based on the review performed, this product batch 1204601 was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. The outcome of the events was reported as complete recovery. The causality and seriousness of the event were not reported. Follow up information received from QA department on 20 Dec 2013: Updated batch review report.
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Anosmia, Eyelid oedema, Headache, Intracranial pressure increased
Clinical narrative: Case number PHHY2012US012278 is an initial spontaneous report received from vaccine adverse event reporting system web site (VAERS reference number: 475987) on 08 Feb 2013, with the follow-up received from Quality Assurance Department (reference number: 211604) on 18 Dec 2013. This case refers to a 58-year-old female patient. Her medical history included of allergy to BACTRIM, Hashimoto's thyroiditis, Sjogren's syndrome, type II diabetes, asthma, depression/anxiety, hypertension, and hyperlipidemia. Her concomitant medications included of SYNTHROID, AMARYL, metformin, PAXIL, lisinopril/HCTZ and albuterol. She was vaccinated with FLUVIRIN (batch number: 1204601, Expiry date: 31 May 2013) intramuscularly in her left arm on 21 Oct 2012. On 22 Oct 2012, she experienced vertigo, muscle tightness, night sweats, tinnitus, tendon weakness (at site of pre-existing injury), loss of smell, loss of taste (except for saltiness), headache, pressure (cranial and sinus) and puffy eyes. She had an emergency doctor visit due to these events. The final outcome was reported as condition unchanged. The seriousness and causality were not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1204601) 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: 211604) on 18 Dec 2013: Updated batch review report.
Sex: F
Vaccine: FLU3
Symptoms: Muscle tightness, Night sweats, Sinus headache, Tinnitus, Vertigo
Clinical narrative: Case number PHHY2012US012278 is an initial spontaneous report received from vaccine adverse event reporting system web site (VAERS reference number: 475987) on 08 Feb 2013, with the follow-up received from Quality Assurance Department (reference number: 211604) on 18 Dec 2013. This case refers to a 58-year-old female patient. Her medical history included of allergy to BACTRIM, Hashimoto's thyroiditis, Sjogren's syndrome, type II diabetes, asthma, depression/anxiety, hypertension, and hyperlipidemia. Her concomitant medications included of SYNTHROID, AMARYL, metformin, PAXIL, lisinopril/HCTZ and albuterol. She was vaccinated with FLUVIRIN (batch number: 1204601, Expiry date: 31 May 2013) intramuscularly in her left arm on 21 Oct 2012. On 22 Oct 2012, she experienced vertigo, muscle tightness, night sweats, tinnitus, tendon weakness (at site of pre-existing injury), loss of smell, loss of taste (except for saltiness), headache, pressure (cranial and sinus) and puffy eyes. She had an emergency doctor visit due to these events. The final outcome was reported as condition unchanged. The seriousness and causality were not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1204601) 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: 211604) on 18 Dec 2013: Updated batch review report.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Case number PHHY2013US012497, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 476314) website on 08 Feb 2013, with the follow-up received from the Quality Assurance Department (reference number: 211596) on 17 Dec 2013: This report refers to a 41-year-old male patient. His had no medical history and his concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1204601) intramuscularly into right arm on 01 Nov 2012. On 03 Nov 2012, one and half day after vaccination, he had intense pain radiating up the neck and down the arm. He also had difficulty in raising arm and he could not sleep because of the pain. He received ALEVE for the pain and would consult the physician if he could not feel better. The outcome of the events was reported as not recovered as of 04 Dec 2012. The causality and seriousness of the events were not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN vaccine (batch number: 1204601) 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: 211596) on 17 Dec 2013: Updated batch review report.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Anaemia haemolytic autoimmune, Asthenia, Jaundice, Pallor
Clinical narrative: Case PHHY2013US127806, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 499972) website on 11 Nov 2013, with the follow-up received from Quality Assurance Department (reference number: 265286) on 17 Dec 2013: This report refers to a 08-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with S-OIV Fluvirin (batch number: 102125F1, Expiry date: 16 Oct 2010) in the left arm on 24 Nov 2009. On 07 Dec 2009, he experienced jaundice, weakness and lack of color. He visited the emergency room. Diagnostic lab data revealed auto-immune hemolytic anemia. The event outcome was condition unchanged as of 20 Aug 2013. The seriousness was reported as disability. The causality was not reported. Based on the investigation performed, QA department stated that, the S-OIV Fluvirin vaccine (batch number: 102125F1) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. No additional information was available. Follow-up received from Quality Assurance Department (reference number: 265286) on 17 Dec 2013: Updated batch review report.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Asthenia, Autoimmune haemolytic anaemia, Jaundice, Laboratory test abnormal, Pallor
Clinical narrative: Case PHHY2013US127806, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 499972) website on 11 Nov 2013, with the follow-up received from Quality Assurance Department (reference number: 265286) on 17 Dec 2013: This report refers to a 08-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with S-OIV Fluvirin (batch number: 102125F1, Expiry date: 16 Oct 2010) in the left arm on 24 Nov 2009. On 07 Dec 2009, he experienced jaundice, weakness and lack of color. He visited the emergency room. Diagnostic lab data revealed auto-immune hemolytic anemia. The event outcome was condition unchanged as of 20 Aug 2013. The seriousness was reported as disability. The causality was not reported. Based on the investigation performed, QA department stated that, the S-OIV Fluvirin vaccine (batch number: 102125F1) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. No additional information was available. Follow-up received from Quality Assurance Department (reference number: 265286) on 17 Dec 2013: Updated batch review report.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Dizziness, Supraventricular tachycardia, Tachycardia
Clinical narrative: Case PHHY2013US127762, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502499) website on 11 Nov 2013, with the follow-up received from Quality Assurance Department (reference number: 264300) on 17 Dec 2013: This report refers to a 52-year-old female patient. Her medical history included asthma and paroxysmal supraventricular tachycardia (PSVT). Her concomitant medications were not reported. She was vaccinated with Fluvirin 2013/2014 (seasonal influenza vaccine, batch number: 1307601, expiry date: 31 Mar 2014)), intramuscularly in the left arm on 13 Sep 2013. On the same day, she experienced tachycardia, dizziness (history of PSVT). It was reported that stress from her job and vaccine administration caused her to flare up her condition (PSVT) which made her have the symptoms. She treated herself by massaging carotid artery and lying down. She recovered within 15 minutes. She was feeling better and confident that she's fine due to her experience in the past. The event outcome was completely recovered. The seriousness and causality were not reported. Based on the investigation performed, QA department stated that, the Fluvirin 2013/2014 vaccine (batch number: 1307601) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. No additional information was available. Follow-up received from Quality Assurance Department (reference number: 264300) on 17 Dec 2013: Updated batch review report.
Age: 24.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abnormal behaviour, Disturbance in attention, Dizziness, Malaise
Clinical narrative: Case PHHY2013US127735, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502904) website on 11 Nov 2013, with the follow-up received from Quality Assurance Department (reference number: 264318) on 17 Dec 2013: This report refers to a 24-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 2013/2014 (seasonal influenza vaccine, batch number: 1308601), intramuscularly in the left arm on 17 Sep 2013. On the same date, after vaccination she had lack of mental focus, dizziness, she was overall not feeling well and "not acting well/right"). She was taken to ER. The outcome of the events was reported as not recovered as of 17 Sep 2013. The seriousness and causality of the events were not reported. Based on the investigation performed, QA department stated that, the Fluvirin 2013/2014 vaccine (batch number: 1308601) 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: 264318) on 17 Dec 2013: Updated batch review report.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Face oedema, Oedema peripheral, Paraesthesia
Clinical narrative: Case number PHEH2013US024749, is an initial spontaneous report received from a consumer on 21 Nov 2013 with a follow up information received from a consumer on 17 Dec 2013. This report refers to a 61-years-old male patient. He did not have known drug allergies. His concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1309701, expiry date: May 2014) on an unknown date. On an unknown date after vaccination, the patient experienced an allergic reaction. It was reported that he experienced angioedema and urticaria. He was treated with BENADRYL, KEPPRA, phenobarbital and prednisone. The final outcome and seriousness of the event were not reported. The causality was reported as suspected to administration of FLUVIRIN. No further information was available. Follow up information received from a consumer on 17 Dec 2013: Patient demographics (date of birth, age, gender, weight and height), events and treatment updated.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Angioedema, Hypersensitivity, Urticaria
Clinical narrative: Case number PHEH2013US024749, is an initial spontaneous report received from a consumer on 21 Nov 2013 with a follow up information received from a consumer on 17 Dec 2013. This report refers to a 61-years-old male patient. He did not have known drug allergies. His concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1309701, expiry date: May 2014) on an unknown date. On an unknown date after vaccination, the patient experienced an allergic reaction. It was reported that he experienced angioedema and urticaria. He was treated with BENADRYL, KEPPRA, phenobarbital and prednisone. The final outcome and seriousness of the event were not reported. The causality was reported as suspected to administration of FLUVIRIN. No further information was available. Follow up information received from a consumer on 17 Dec 2013: Patient demographics (date of birth, age, gender, weight and height), events and treatment updated.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Dyspnoea, Erythema, Induration, Pain in extremity
Clinical narrative: Seen in clinic 11/22/13 with wheeze and (L) local reaction - spirometry, VENTOLIN and KEFLEX prescribed. MEDROL dose pack prescribed, left arm paresthesia 11/27/13. Seen ED - prednisone increased (5 office visits 1 ED visit).
Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Palpitations, Spirometry, Wheezing
Clinical narrative: Seen in clinic 11/22/13 with wheeze and (L) local reaction - spirometry, VENTOLIN and KEFLEX prescribed. MEDROL dose pack prescribed, left arm paresthesia 11/27/13. Seen ED - prednisone increased (5 office visits 1 ED visit).
Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest X-ray normal, Local reaction, Paraesthesia, Wheezing
Clinical narrative: Seen in clinic 11/22/13 with wheeze and (L) local reaction - spirometry, VENTOLIN and KEFLEX prescribed. MEDROL dose pack prescribed, left arm paresthesia 11/27/13. Seen ED - prednisone increased (5 office visits 1 ED visit).
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Pruritus
Clinical narrative: This spontaneous report as received from a 72 year old female patient regarding herself. The patient does not have any pertinent medical history and previous drug allergies. On 25-OCT-2013, the patient was vaccinated with ZOSTAVAX (0.65 ml, standard dose) subcutaneously. Concomitant therapies included FLUZONE HD. On 25-OCT-2013, immediately after ZOSTAVAX developed a quarter sized injection site reaction. On 07-DEC-2013, the patient developed lesion (reported as lesions) on her left shoulder which spread from her left shoulder over her breast and bicep area. On 09-DEC-2013, the patient experienced shooting pain and by 10-DEC-2013, the patient realized that she had developed a full blown shingles outbreak and went in for an office visit (sought medical attention) and treatment with her primary care physician. The patient was treated with Gabapentin and valacyclovir (manufacturers/dose unspecified). It was reported that ordered lab work that would be conducted 2 weeks after her symptoms resolves. The outcome of shingles outbreak, shooting pain, injection site reaction and lesions on her left shoulder which spread from her left shoulder over her breast and biceps area was reported as not recovered/not resolved. No PQC was involved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site reaction, Pain, Skin lesion
Clinical narrative: This spontaneous report as received from a 72 year old female patient regarding herself. The patient does not have any pertinent medical history and previous drug allergies. On 25-OCT-2013, the patient was vaccinated with ZOSTAVAX (0.65 ml, standard dose) subcutaneously. Concomitant therapies included FLUZONE HD. On 25-OCT-2013, immediately after ZOSTAVAX developed a quarter sized injection site reaction. On 07-DEC-2013, the patient developed lesion (reported as lesions) on her left shoulder which spread from her left shoulder over her breast and bicep area. On 09-DEC-2013, the patient experienced shooting pain and by 10-DEC-2013, the patient realized that she had developed a full blown shingles outbreak and went in for an office visit (sought medical attention) and treatment with her primary care physician. The patient was treated with Gabapentin and valacyclovir (manufacturers/dose unspecified). It was reported that ordered lab work that would be conducted 2 weeks after her symptoms resolves. The outcome of shingles outbreak, shooting pain, injection site reaction and lesions on her left shoulder which spread from her left shoulder over her breast and biceps area was reported as not recovered/not resolved. No PQC was involved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Insomnia
Clinical narrative: Very sore arm. Unable to use arm.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Very sore arm. Unable to use arm.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Exposure during pregnancy, Pregnancy test positive, Ultrasound scan, Vaginal haemorrhage
Clinical narrative: This spontaneous prospective pregnancy report as received from a now 24 year old female patient refers to herself with endometriosis. On 14-OCT-2013 the patient was vaccinated with third dose of GARDASIL (lot #, expiration date, dose not reported, injection). There was no concomitant medication. And the patient reported that she was 9 weeks pregnant after receiving the third shot of GARDASIL, and she was now 13 weeks pregnancy. The LMP was approximately 25-SEP-2013 and EDD was 02-JUL-2014. The pregnancy outcome was unknown. The patient did not provide the first and second shot of GARDASIL (dates unknown). No other adverse events were reported at the time of the report. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a now 24 year old female patient refers to herself with endometriosis. On 14-OCT-2013 the patient was vaccinated with third dose of GARDASIL (lot #, expiration date, dose not reported, injection). There was no concomitant medication. And the patient reported that she was 9 weeks pregnant after receiving the third shot of GARDASIL, and she was now 13 weeks pregnancy. The LMP was approximately 25-SEP-2013 and EDD was 02-JUL-2014. The pregnancy outcome was unknown. The patient did not provide the first and second shot of GARDASIL (dates unknown). No other adverse events were reported at the time of the report. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: FLUN4, HPV4, FLUN4, HEPA, HPV4
Symptoms: Suicidal ideation
Clinical narrative: Patient sent suicide/goodbye text to a friend and admitted to suicidal ideations/plan during suicide assessment on 12/13/2013. Assessed as experiencing depression. (Patient received routine adolescent depression scale screening at annual physical on day of Gardasil first dose administration and was not assessed as depressed on 11/12/2013)
Age: 15.0
Sex: M
Vaccine: FLUN4, HPV4, FLUN4, HEPA, HPV4
Symptoms: Depression, Suicidal ideation
Clinical narrative: Patient sent suicide/goodbye text to a friend and admitted to suicidal ideations/plan during suicide assessment on 12/13/2013. Assessed as experiencing depression. (Patient received routine adolescent depression scale screening at annual physical on day of Gardasil first dose administration and was not assessed as depressed on 11/12/2013)
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Angiogram abnormal, Colour vision tests normal, Fundoscopy abnormal, Intraocular pressure test normal, Ophthalmological examination
Clinical narrative: Case number PHHY2013US147575, is an initial literature report received on 13 Dec 2013. The authors in this article discussed about a case of multiple evanescent white dot syndrome following recent influenza vaccination. This report refers to a 53-year-old male patient. Ocular history was significant for remote pterygium excision in right eye. Medical history, in addition to hepatitis B and C, was significant for polysubstance abuse, for which he had recently entered rehabilitation. Concomitant medications included buprenorphine and naloxone. He was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, he complained of seeing a purple haze in his right eye for 3 days. On an unknown date, initial examination revealed corrected visual acuity of 20/25 (-2) in right eye and 20/20 in left eye. However, the results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. Anterior segment examination was unremarkable and quiet vitreous were noted. On an unknown date, fundus examination in right eye revealed multiple white lesions at the level of outer retina/retinal pigment epithelium (RPE) with a granular foveal appearance and fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. On an unknown date initial Humphrey 30-2 visual field testing was of low reliability, however the follow-up testing revealed residual enlargement of the blind spot with a para-central scotoma which improved over time. He was given a diagnosis of multiple evanescent white dot syndrome (MEWDS). He was followed with serial examinations. At the 1-month visit, there was improvement in symptoms, fundus lesions resolved and vision recovered to 20/20. The author concluded that the exact pathophysiology behind the development of MEWDS was yet to be determined. Both infectious and autoimmune-mediated inflammatory mechanisms have been implicated as underlying causes. MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult. However, with the common use of the influenza vaccine, it would be prudent for ophthalmologists to be aware of this finding and consider this association.
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Ophthalmological examination abnormal, Pupillary light reflex tests normal, Retinal exudates, Retinal pigment epitheliopathy, Scotoma
Clinical narrative: Case number PHHY2013US147575, is an initial literature report received on 13 Dec 2013. The authors in this article discussed about a case of multiple evanescent white dot syndrome following recent influenza vaccination. This report refers to a 53-year-old male patient. Ocular history was significant for remote pterygium excision in right eye. Medical history, in addition to hepatitis B and C, was significant for polysubstance abuse, for which he had recently entered rehabilitation. Concomitant medications included buprenorphine and naloxone. He was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, he complained of seeing a purple haze in his right eye for 3 days. On an unknown date, initial examination revealed corrected visual acuity of 20/25 (-2) in right eye and 20/20 in left eye. However, the results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. Anterior segment examination was unremarkable and quiet vitreous were noted. On an unknown date, fundus examination in right eye revealed multiple white lesions at the level of outer retina/retinal pigment epithelium (RPE) with a granular foveal appearance and fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. On an unknown date initial Humphrey 30-2 visual field testing was of low reliability, however the follow-up testing revealed residual enlargement of the blind spot with a para-central scotoma which improved over time. He was given a diagnosis of multiple evanescent white dot syndrome (MEWDS). He was followed with serial examinations. At the 1-month visit, there was improvement in symptoms, fundus lesions resolved and vision recovered to 20/20. The author concluded that the exact pathophysiology behind the development of MEWDS was yet to be determined. Both infectious and autoimmune-mediated inflammatory mechanisms have been implicated as underlying causes. MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult. However, with the common use of the influenza vaccine, it would be prudent for ophthalmologists to be aware of this finding and consider this association.
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Vision blurred, Visual acuity reduced, Visual field tests normal, Visual impairment
Clinical narrative: Case number PHHY2013US147575, is an initial literature report received on 13 Dec 2013. The authors in this article discussed about a case of multiple evanescent white dot syndrome following recent influenza vaccination. This report refers to a 53-year-old male patient. Ocular history was significant for remote pterygium excision in right eye. Medical history, in addition to hepatitis B and C, was significant for polysubstance abuse, for which he had recently entered rehabilitation. Concomitant medications included buprenorphine and naloxone. He was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, he complained of seeing a purple haze in his right eye for 3 days. On an unknown date, initial examination revealed corrected visual acuity of 20/25 (-2) in right eye and 20/20 in left eye. However, the results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. Anterior segment examination was unremarkable and quiet vitreous were noted. On an unknown date, fundus examination in right eye revealed multiple white lesions at the level of outer retina/retinal pigment epithelium (RPE) with a granular foveal appearance and fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. On an unknown date initial Humphrey 30-2 visual field testing was of low reliability, however the follow-up testing revealed residual enlargement of the blind spot with a para-central scotoma which improved over time. He was given a diagnosis of multiple evanescent white dot syndrome (MEWDS). He was followed with serial examinations. At the 1-month visit, there was improvement in symptoms, fundus lesions resolved and vision recovered to 20/20. The author concluded that the exact pathophysiology behind the development of MEWDS was yet to be determined. Both infectious and autoimmune-mediated inflammatory mechanisms have been implicated as underlying causes. MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult. However, with the common use of the influenza vaccine, it would be prudent for ophthalmologists to be aware of this finding and consider this association.
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Angiogram abnormal, Angiogram retina abnormal, Colour vision tests normal, Fundoscopy abnormal, Intraocular pressure test normal
Clinical narrative: Case number PHHY2013US147575, is an initial literature report received on 13 Dec 2013. The authors in this article discussed about a case of multiple evanescent white dot syndrome following recent influenza vaccination. This report refers to a 53-year-old male patient. Ocular history was significant for remote pterygium excision in right eye. Medical history, in addition to hepatitis B and C, was significant for polysubstance abuse, for which he had recently entered rehabilitation. Concomitant medications included buprenorphine and naloxone. He was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, he complained of seeing a purple haze in his right eye for 3 days. On an unknown date, initial examination revealed corrected visual acuity of 20/25 (-2) in right eye and 20/20 in left eye. However, the results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. Anterior segment examination was unremarkable and quiet vitreous were noted. On an unknown date, fundus examination in right eye revealed multiple white lesions at the level of outer retina/retinal pigment epithelium (RPE) with a granular foveal appearance and fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. On an unknown date initial Humphrey 30-2 visual field testing was of low reliability, however the follow-up testing revealed residual enlargement of the blind spot with a para-central scotoma which improved over time. He was given a diagnosis of multiple evanescent white dot syndrome (MEWDS). He was followed with serial examinations. At the 1-month visit, there was improvement in symptoms, fundus lesions resolved and vision recovered to 20/20. The author concluded that the exact pathophysiology behind the development of MEWDS was yet to be determined. Both infectious and autoimmune-mediated inflammatory mechanisms have been implicated as underlying causes. MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult. However, with the common use of the influenza vaccine, it would be prudent for ophthalmologists to be aware of this finding and consider this association.
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Pupillary light reflex tests normal, Retinal exudates, Retinal pigment epitheliopathy, Scotoma, Vision blurred
Clinical narrative: Case number PHHY2013US147575, is an initial literature report received on 13 Dec 2013. The authors in this article discussed about a case of multiple evanescent white dot syndrome following recent influenza vaccination. This report refers to a 53-year-old male patient. Ocular history was significant for remote pterygium excision in right eye. Medical history, in addition to hepatitis B and C, was significant for polysubstance abuse, for which he had recently entered rehabilitation. Concomitant medications included buprenorphine and naloxone. He was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, he complained of seeing a purple haze in his right eye for 3 days. On an unknown date, initial examination revealed corrected visual acuity of 20/25 (-2) in right eye and 20/20 in left eye. However, the results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. Anterior segment examination was unremarkable and quiet vitreous were noted. On an unknown date, fundus examination in right eye revealed multiple white lesions at the level of outer retina/retinal pigment epithelium (RPE) with a granular foveal appearance and fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. On an unknown date initial Humphrey 30-2 visual field testing was of low reliability, however the follow-up testing revealed residual enlargement of the blind spot with a para-central scotoma which improved over time. He was given a diagnosis of multiple evanescent white dot syndrome (MEWDS). He was followed with serial examinations. At the 1-month visit, there was improvement in symptoms, fundus lesions resolved and vision recovered to 20/20. The author concluded that the exact pathophysiology behind the development of MEWDS was yet to be determined. Both infectious and autoimmune-mediated inflammatory mechanisms have been implicated as underlying causes. MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult. However, with the common use of the influenza vaccine, it would be prudent for ophthalmologists to be aware of this finding and consider this association.