chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Case number PHHY2014US169906, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544157) website on 29 Dec 2014. This report refers to a 56-year-old female patient. The patient was a smoker and had possible COPD when she was a smoker. The patient had no symptoms of COPD since she quit smoking and the patient was not taking any medications for COPD. Concomitant medications included levothyroxine. She was vaccinated with FLUVIRIN (batch number: 1411821) along with PNEUMOVAX (batch number: J013555) intramuscularly on 03 Sep 2014. On 04 Sep 2014, the patient experienced fever of about 104.9 and the patient hand was swollen (size of a golf ball) where the vaccine was administered. The patient went to an emergency room. The outcome of the events was complete recovery. The events were reported as non-serious; the event fever of about 104.9 was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Swollen tongue, Throat irritation, Urticaria
Clinical narrative: Case number PHHY2014US169304, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544448) website on 29 Dec 2014. This report refers to a 53-year-old female patient. She was allergic to latex and penicillin. She was vaccinated with FLUVIRIN (batch number: 141201) intramuscularly on 18 Sep 2014. On the same date, after vaccination she experienced itching, her throat felt full and funny, tongue started to swell and had hives. The patient visited the emergency room. The outcome of the events reported as recovered. The events reported as non-serious. Seriousness assessment of the events (itching, throat felt full and funny, tongue started to swell and hives) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Case number PHHY2014US160477 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Events Reporting System (VAERS ID: 544637) website on 28 Nov 2014. This report refers to a 63 year old male patient. His current conditions included end stage renal disease (ESRD) and type 2 diabetes. The patient was on dialysis. His concomitant medications included CRESTOR, LANTUS, SYNTHROID, Aspirin, RENVELA, COREG, LASIX, HUMULIN and PLAVIX. On 17 Sep 2014, he was vaccinated with FLUVIRIN (batch number: 1411201) into his left arm. On 18 Sep 2014, he woke up in the morning after receiving the vaccination with red raised rash to legs, arms and torso. He was treated with oral and topical BENADRYL. The outcome of the events was condition unchanged. The events were reported as non serious but the seriousness of red raised rash to legs, arms and torso was upgraded based on the information available in source documents. The causality of the events was not reported.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated
Clinical narrative: Case number PHHY2014US169719 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 544754) on 29 Dec 2014 and with follow up information received from the quality assurance department (QA reference number: 345025) on 06 Jan 2015, with the follow-up information received from Quality Assurance Department (reference number: 345025) on 04 Feb 2015. This report refers to a 44 years old female patient. Her current conditions included anxiety and asthma and concomitant medications were XANAX and VENTOLIN. She was vaccinated with FLUVIRIN (batch number: 145302) intramuscularly in the left arm on 18 Sep 2014. On 18 Sep 2014, after vaccination she had asthma attack. She went to emergency room for evaluation. The outcome of event was not reported. The event was reported as non-serious, but was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 145302) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 345025) on 06 Jan 2015: Updated QA reference number. Non-significant follow-up information received from the Quality Assurance Department (reference number: 345025) on 04 Feb 2015: Updated FLUVIRIN vaccine batch review report.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Case number PHHY2014US170219, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544971) website on 29 Dec 2014. This report refers to a 47-year-old female patient. The patient had no medical history and current conditions. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1413301) intramuscularly on 18 Sep 2014. On the same day, a couple hours after vaccination, the patient experienced itching all over. The patient took BENADRYL multiple times and EPIPEN as a treatment. The outcome of the event was complete recovery. The event was reported as non-serious; the event itching all over was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Feeling hot, Injection site pain, Lacrimation increased, Muscular weakness
Clinical narrative: Case number PHHY2014US171416, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 545440) website on 29 Dec 2014. This report refers to a 28-year-old female patient. Past medical history was not reported. Past medication history included penicillin. Concomitant medications included gabapentin and sertraline. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly into the right arm on 26 Sep 2014. On the same day after the vaccination, she experienced weakness in legs and arms, fever, pain at the injection site and the patient had nausea. Further, the patient was wheezy, shaky, sneezy, clammy and hot. The patient eyes were watering. The patient went to the emergency room. The final outcome of the events was complete recovery. The events were reported as non-serious. The event "wheezy" was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia, Sneezing, Tremor, Wheezing
Clinical narrative: Case number PHHY2014US171416, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 545440) website on 29 Dec 2014. This report refers to a 28-year-old female patient. Past medical history was not reported. Past medication history included penicillin. Concomitant medications included gabapentin and sertraline. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly into the right arm on 26 Sep 2014. On the same day after the vaccination, she experienced weakness in legs and arms, fever, pain at the injection site and the patient had nausea. Further, the patient was wheezy, shaky, sneezy, clammy and hot. The patient eyes were watering. The patient went to the emergency room. The final outcome of the events was complete recovery. The events were reported as non-serious. The event "wheezy" was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Urticaria
Clinical narrative: Case number PHHY2014US170494, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 545647) website on 29 Dec 2014. This report refers to a 62 year old female patient. Medical history was not reported. Past medications included ibuprofen. Concomitant medication included diclofenac sodium 75 mg tablet. She was vaccinated with FLUVIRIN (batch number: 145905) intramuscularly in left arm on 25 Sep 2014. On 26 Sep 2014, she developed rashes and hives all over the body for 3 to 4 days. Treatment was rendered with BENADRYL. Final outcome of the events was reported as complete recovery. Events were reported as non-serious. Seriousness assessment of the events was upgraded based on the information available in the source document. Causality of these events was not reported.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHHY2014US170578, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546086) website on 29 Dec 2014. This report refers to a 56-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 1411001) intramuscularly on 18 Sep 2014. On 19 Sep 2014 (12 hours after the vaccination), the patient experienced anaphylactic reaction. A call was made to 911 and the patient had gone to the hospital (emergency room). The final outcome of the event was complete recovery. The event was reported as non-serious. The event anaphylactic reaction was internally upgraded as medically significant based on the NVS-IME list. Causality was not reported.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Hypersensitivity, Paraesthesia, Swollen tongue
Clinical narrative: Case number PHHY2014US170150, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546419) website on 29 Dec 2014. This report refers to a 27-year-old female patient. Medical history was not reported. Concomitant medication included ORTHO TRI-CYCLEN. She was vaccinated with FLUVIRIN (batch number: 14581P) intramuscularly into right arm on 02 Oct 2014. On the same day, after vaccination, she experienced dizziness, fatigue, tingling in arms and swollen tongue. She went to emergency room where it was told that it was an allergic reaction to vaccine and advised never to have another. She was treated with steroids and BENADRYL. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of allergic reaction, swollen tongue was upgraded based on the NVS-IMS list. Following an internal review on 08 Jan 2015 of the data received on 29 Dec 2014, following correction has been performed. The events of dizziness, fatigue and tingling in arms was wrongly coded as symptoms previously hence now changed to stand alone diagnosis.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Case number PHHY2014US170150, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546419) website on 29 Dec 2014. This report refers to a 27-year-old female patient. Medical history was not reported. Concomitant medication included ORTHO TRI-CYCLEN. She was vaccinated with FLUVIRIN (batch number: 14581P) intramuscularly into right arm on 02 Oct 2014. On the same day, after vaccination, she experienced dizziness, fatigue, tingling in arms and swollen tongue. She went to emergency room where it was told that it was an allergic reaction to vaccine and advised never to have another. She was treated with steroids and BENADRYL. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of allergic reaction, swollen tongue was upgraded based on the NVS-IMS list. Following an internal review on 08 Jan 2015 of the data received on 29 Dec 2014, following correction has been performed. The events of dizziness, fatigue and tingling in arms was wrongly coded as symptoms previously hence now changed to stand alone diagnosis.
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2014US170131 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 546591) on 29 Dec 2014. This report refers to a 50 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 141101) intramuscularly on 01 Oct 2014. On the same day she also received ZOSTAVAX (other manufacturer, batch number: K007988) subcutaneously in the left arm. On 02 Oct 2014, she experienced swelling and redness in left arm the following day. She went to emergency room and saw physician and started antibiotics. The events did not improve and hence she was hospitalized for intravenous antibiotics. The final outcome of events was unknown. The events were reported as serious. The causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site pain, Urticaria, Wheezing
Clinical narrative: Case number PHHY2014US171038 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS ID: 546597) website on 29 Dec 2014. This report refers to a 66 year old female patient. Her past medical history and concomitant medications were not reported. On 26 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 145902) intramuscularly into her left arm. On the same night after the vaccination, at 01:00 AM, she had ache/pain at the injection site. On 27 Sep 2014, she developed welts. The events started going away but she had some shortness of breath and wheezing. The patient completely recovered from the events on 28 Sep 2014. The events were reported as non serious but the seriousness of welts, wheezing and shortness of breath was upgraded based on the information available in the source documents and causality of the events was not reported.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Peripheral swelling, Pruritus, Rash, Swelling face
Clinical narrative: Case number PHHY2014US170084, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546683) website on 29 Dec 2014. This report refers to a 51 year old female patient. No known drug allergy. Her medical history reported carcinoma of breast. Concomitant medication was not reported. On 25 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 1413101) IM into left arm. On 27 Sep 2014, she developed rash and swelling both hands, arms, legs and face and abdominal wall, along with itching. She went to the emergency room. Outcome of the events was unknown. Causality assessment was not reported. Events were reported as non-serious. Seriousness assessment of swelling face was upgraded based on information available in the source documents.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Peripheral swelling, Urticaria
Clinical narrative: Case number PHHY2014US170088, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546804) website on 29 Dec 2014. This report refers to a 31 year old female patient. Medical history and concomitant medication was not reported. On 02 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 1410701) IM into left arm. She went to the emergency room on unspecified date with shortness of breath and wheals. And also she went to an urgent care clinic for hand swelling on 05 Oct 2014. Outcome of the events was completely recovered. Causality assessment was not reported. Seriousness assessment of shortness of breath was upgraded based on information available in the source documents.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Injection site rash, Rash
Clinical narrative: Case number PHHY2014US170597, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547127) website on 29 Dec 2014. This report refers to a 29-year-old female patient. Past medical history included post-traumatic stress disorder (PTSD) and the patient had vaso-syncope issues. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1411301) into the left arm on 02 Oct 2014. On the same day, within 30 minutes after the vaccination, the patient experienced shortness of breath (SOB) and dizziness. The patient developed rash on the arm and at the injection site. The patient was sent to the emergency room. The patient was treated with PROAIR inhaler (two puffs) and BENADRYL (one tablet). The final outcome of the events was unknown. The events were reported as non-serious. The event shortness of breath (SOB) was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Heart rate increased, Hypoaesthesia oral, Nervousness, Pharyngeal oedema
Clinical narrative: Case number PHHY2014US161239 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Events Reporting System (VAERS ID: 547432) website on 28 Nov 2014. This report refers to a 39 year old female patient. Her current conditions included allergy to monosodium glutamate (MSG) and concomitant medications included levothyroxine, mycelium husk supplement and unnamed vitamin pack supplement. It was reported that the patient was attempting to become pregnant. Her vaccination history included a vaccination with FLUZONE (other manufacturer, batch number: not reported) and two hours after the vaccination, patient developed soreness of throat and body aches. The screening registered nurse advised to administer FLUVIRIN. On 09 Oct 2014, at 07:40 AM, she was vaccinated with FLUVIRIN (batch number 145904) intramuscularly into her left arm. She waited in the clinic for 15 minutes and left. Five minutes later, she returned to the clinic and stated that she began to experience some swelling of the throat, numbness of tongue and felt shaky. She was taken immediately to treatment room and laid down. Pulse oximetry was established with initial presentation of 99-100% and a heart rate of 100. EPIPEN was prepared for usage, and the provider, family nurse provider (FNP-C) came to evaluate patient. FNP-C noted clear lung sounds on auscultation and also observed that the patient did not have any difficulty speaking. Patient was monitored for approximately 30 minutes with a gradual decrease of mild throat swelling to none, and numbness of the tongue to numbness of the back half of the tongue. The clinic staff called the patient's supervisor to inform that she would not be returning to work. The patient stated that her commute was approximately 15 minutes by driving from the clinic and was given diphenhydramine at a dose of 25 mg per orally just before discharge for relief after patient arrived at home. The final outcome of throat swelling was complete recovery and final outcome of numbness of tongue was condition improving. The outcome of felt shaky was not reported. The events were reported as non serious but the seriousness of swelling of throat and numbness of tongue was upgraded based on the information available in the source documents. The causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dyspnoea, Feeling abnormal, Heart rate increased, Throat irritation
Clinical narrative: Case number PHHY2014US170915, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547680) website on 29 Dec 2014. This report refers to a 53 year old female patient. Medical history and concomitant medication was not reported. On 06 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 14554P) IM into left arm. About 20 minutes after vaccination, she experienced increased heart rate, difficult breathing for 2 and half hours, burning throat, achy joints and "mentally foggy" for 3 days. She was treated at emergency room and was released. Final outcome of the events was recovered. Causality assessment was not reported. Events were reported as non-serious. Seriousness assessment of difficulty breathing, heart rate increased and burning throat were upgraded based on information available in the source documents.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Sensory disturbance, VIIth nerve paralysis
Clinical narrative: Case number PHHY2014US170417, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547717) website on 29 Dec 2014 and with the follow-up information received from Quality Assurance Department (reference number: 345081) on 05 Feb 2015. This report refers to a 19 year old female patient. No known drug allergy. Current condition included right side abdominal pain. Patient was not taking any medications at the time of the vaccination. On 10 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 1411301) IM into right arm. On 13 Oct 2014, she experienced decreased sensation on the right side of her face and right side facial paralysis. She was diagnosed with Bell's palsy. Treatment medications included prednisone and BACTRIM DS. Patient to follow up next week. Outcome of the events was unknown. Causality assessment was not reported. Events were reported as non-serious. Seriousness assessment of Bell's palsy was upgraded based on information available in the source documents. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1411301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 345081) on 06 Jan 2015: Updated QA reference number. Non-significant follow-up information received from the Quality Assurance Department (reference number: 345081) on 05 Feb 2015: Updated FLUVIRIN vaccine batch review report.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Paraesthesia, Stridor
Clinical narrative: Case number PHHY2014US170415, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547867) website on 29 Dec 2014. This report refers to a 25 year old female patient. Her medical history included asthma and allergy to shellfish. Concomitant medication was not reported. On 13 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 1411001) IM into left arm. On the same day post vaccination she developed shortness of breath associated with tingling of fingers and then developed stridor approximately 20 minutes after vaccination. Epinephrine was administered and she was sent to the emergency room. Outcome of the events was recovered. Causality assessment was not reported. Events were reported as non-serious. Seriousness assessment of shortness of breath was upgraded based on information available in the source documents.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Case number PHHY2014US170409, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547893) website on 29 Dec 2014. This report refers to a 68 year old female patient. Her medical history and concomitant medication was not reported. On 25 Aug 2014, she was vaccinated with FLUVIRIN (batch number: 145223) IM into right arm. On 26 Aug 2014, her face swelled for 3 weeks. Outcome of the event was recovered. Causality assessment was not reported. Event was reported as non-serious. Seriousness assessment of swelling face was upgraded based on information available in the source documents.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2014US170450, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548099) website on 29 Dec 2014. This report refers to a 63-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1413701) intramuscularly in the right arm on 29 Sep 2014. On 01 Oct 2014, she developed hives on various parts of her body. She went to the doctor and she was given a steroid injection. The outcome of the event was unknown. The event reported as non-serious. Seriousness assessment of the event (hives) was upgraded based on the information available in the source document. The causality of the event was not reported.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2014US170465, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 548141) website on 29 Dec 2014. This report refers to a 69-year-old female patient. Current conditions included bladder infection and diabetes. Concomitant drugs included MACROBID for bladder infection till 23 Sep 2014 (for 2 weeks), also received Aspirin, BENICAR HCT, CRESTOR, DIABETA and GLUCOPHAGE. She was vaccinated with FLUVIRIN (batch number: 1411101) in the arm on 22 Sep 2014. On the same date, after vaccination she experienced hives on her entire body. The patient visited the emergency room. On an unknown date, the doctor visited the patient and two and half days after the visit on 27 Sep 2014, she received SOLU MEDROL 125 mg injection. The outcome of the event reported as recovered. The event reported as non-serious. Seriousness assessment of the event (hives on entire body) was upgraded based on the available information in the source document. The causality of the event was not reported.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Case number PHHY2014US170518, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548354) website on 29 Dec 2014. This report refers to a 09-year-old female patient. Her current condition included congenital adrenal hyperplasia. Concomitant drugs included hydrocortisone and fludrocortisone. She was vaccinated with FLUVIRIN (batch number: 1413301) intramuscularly in the left arm on 04 Oct 2014. On the same date, after vaccination she fainted and was out for several seconds before opening her eyes. She recovered shortly after awakening and returned home. On an unknown date (Monday), the father stated that the patient was fine. The events reported as non-serious. Seriousness assessment of the events (fainted and passed out) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Blood electrolytes, Blood glucose, Borrelia test, Dyskinesia
Clinical narrative: Case number PHHY2015US014503, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 548282) website on 03 Feb 2015 with a follow up information received from quality assurance department (QA reference number: 353238) on 20 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 353238) on 23 Mar 2015. This report refers to a 38 years old female patient. Concomitant medication included SPRINTEC for birth control and labetalol 200 mg for high blood pressure. She was vaccinated with FLUVIRIN (batch number: 145302) intramuscular into left arm on 03 Oct 2014. On 05 Oct 2014, right side of her tongue felt numb and loss of taste in mouth on the same side. On 10 Oct 2014, right side of her face felt very weak. Right eye lid, right side of mouth, lip and cheek were all drooping and not moving well. She went to doctor on 13 Oct 2014. Diagnosed with Bell's Palsy and started a 60 mg prednisone taper dose and acyclovir treatment for next 2 weeks. Doctor requested various laboratory work (CBC, electrolytes, Lyme Disease, glucose, hemoglobin, etc.). Results were not reported. Final outcome of the events was unknown. Events were reported as non-serious. Seriousness assessment of Bell's Palsy was upgraded based on the NVD key event list. Causality assessment was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 145302) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non significant follow up information received from quality assurance department on 20 Feb 2015: QA number updated. Non-significant follow-up information received from the Quality Assurance Department (reference number: 353238) on 23 Mar 2015: Updated FLUVIRIN vaccine batch review report.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid ptosis, Facial paresis, Full blood count, Haemoglobin, Hypoaesthesia oral
Clinical narrative: Case number PHHY2015US014503, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 548282) website on 03 Feb 2015 with a follow up information received from quality assurance department (QA reference number: 353238) on 20 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 353238) on 23 Mar 2015. This report refers to a 38 years old female patient. Concomitant medication included SPRINTEC for birth control and labetalol 200 mg for high blood pressure. She was vaccinated with FLUVIRIN (batch number: 145302) intramuscular into left arm on 03 Oct 2014. On 05 Oct 2014, right side of her tongue felt numb and loss of taste in mouth on the same side. On 10 Oct 2014, right side of her face felt very weak. Right eye lid, right side of mouth, lip and cheek were all drooping and not moving well. She went to doctor on 13 Oct 2014. Diagnosed with Bell's Palsy and started a 60 mg prednisone taper dose and acyclovir treatment for next 2 weeks. Doctor requested various laboratory work (CBC, electrolytes, Lyme Disease, glucose, hemoglobin, etc.). Results were not reported. Final outcome of the events was unknown. Events were reported as non-serious. Seriousness assessment of Bell's Palsy was upgraded based on the NVD key event list. Causality assessment was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 145302) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non significant follow up information received from quality assurance department on 20 Feb 2015: QA number updated. Non-significant follow-up information received from the Quality Assurance Department (reference number: 353238) on 23 Mar 2015: Updated FLUVIRIN vaccine batch review report.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Case number PHHY2015US014503, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 548282) website on 03 Feb 2015 with a follow up information received from quality assurance department (QA reference number: 353238) on 20 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 353238) on 23 Mar 2015. This report refers to a 38 years old female patient. Concomitant medication included SPRINTEC for birth control and labetalol 200 mg for high blood pressure. She was vaccinated with FLUVIRIN (batch number: 145302) intramuscular into left arm on 03 Oct 2014. On 05 Oct 2014, right side of her tongue felt numb and loss of taste in mouth on the same side. On 10 Oct 2014, right side of her face felt very weak. Right eye lid, right side of mouth, lip and cheek were all drooping and not moving well. She went to doctor on 13 Oct 2014. Diagnosed with Bell's Palsy and started a 60 mg prednisone taper dose and acyclovir treatment for next 2 weeks. Doctor requested various laboratory work (CBC, electrolytes, Lyme Disease, glucose, hemoglobin, etc.). Results were not reported. Final outcome of the events was unknown. Events were reported as non-serious. Seriousness assessment of Bell's Palsy was upgraded based on the NVD key event list. Causality assessment was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 145302) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non significant follow up information received from quality assurance department on 20 Feb 2015: QA number updated. Non-significant follow-up information received from the Quality Assurance Department (reference number: 353238) on 23 Mar 2015: Updated FLUVIRIN vaccine batch review report.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: Case number PHHY2015US016613, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548678) website on 03 Feb 2015. This report refers to a 45-year-old female patient. Historical conditions were none. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 196604) along with PNEUMOVAX (batch number: K009106) and ADACEL (batch number: U4870BA) on 08 Oct 2014 at 03:00 PM. On the same day after vaccination, in the evening, the patient experienced sweating and the patient fainted. The patient's husband called 911 for ambulance. The patient was hospitalized for one day. The final outcome of the events was recovered. Causality was not reported.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Hypersensitivity, Hypertension, Malaise, Swollen tongue
Clinical narrative: Case number PHHY2015US014501, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548731) website on 03 Feb 2015. This report refers to a 58 year old female patient. Her medical history and concomitant medication was not reported. On 10 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 1413701) intramuscular into left arm. She came rushing back saying her throat feels funny. Her tongue was very swollen and dry. The patient refused to administer EPIPEN. She just wanted a glass of water. Her blood pressure was 186/90. The EMS arrived quickly on scene. She came back with a prescription for prednisone. The MD said she had a non-life threatening allergic reaction to the flu shot. She said she does not feel well. She went to the emergency room. She did not inform, until after her vaccine that she does not eat eggs, but she spoke to her allergist who said its fine to get flu shot. Final outcome of the events was recovered. Causality assessment was not reported. Events were reported as non-serious. Seriousness assessment of allergic reaction and blood pressure high and symptoms was upgraded based on information available in the source documents.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Tongue dry
Clinical narrative: Case number PHHY2015US014501, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548731) website on 03 Feb 2015. This report refers to a 58 year old female patient. Her medical history and concomitant medication was not reported. On 10 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 1413701) intramuscular into left arm. She came rushing back saying her throat feels funny. Her tongue was very swollen and dry. The patient refused to administer EPIPEN. She just wanted a glass of water. Her blood pressure was 186/90. The EMS arrived quickly on scene. She came back with a prescription for prednisone. The MD said she had a non-life threatening allergic reaction to the flu shot. She said she does not feel well. She went to the emergency room. She did not inform, until after her vaccine that she does not eat eggs, but she spoke to her allergist who said its fine to get flu shot. Final outcome of the events was recovered. Causality assessment was not reported. Events were reported as non-serious. Seriousness assessment of allergic reaction and blood pressure high and symptoms was upgraded based on information available in the source documents.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: Case number PHHY2015US013899, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548740) website on 03 Feb 2015. This report refers to a 49 year old female patient. Medical history was unknown. Concomitant medication included levothyroxine 112 mcg. On 18 Oct 2014, she was vaccinated with FLUVIRIN (batch number: unknown) intramuscular into left arm. On the same day post vaccination her throat swelled. Treatment medication included epinephrine shot in the emergency room. Final outcome of the event was recovered. Event was reported as non-serious. Causality assessment was not reported. Seriousness assessment of throat swelled was upgraded based on information available in the source documents.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Back pain, Chest pain, Dyspnoea, Middle insomnia
Clinical narrative: Case number PHHY2015US031421, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 548757) website on 16 Mar 2015. This report refers to a 53-year-old male patient. His historical drugs included penicillin, Sulphur and belladonna. Current conditions included allergies to latex gloves and asthma attack every other year. He was vaccinated with FLUVIRIN (batch number: 66521011710) on 15 Oct 2014. On 17 Oct 2014, the patient had a very hard time breathing which woke him up. The patient thought he might be having an extreme asthma attack. He could not call out for his daughter for help and barely made it to his inhalers and he never been so scared and close to calling emergency for help before. The patient had back spasms from being to tense. It took a good 5 hours before he could breathe without his back and chest hurting. Two days later, he was now coughing up some real nasty stuff. The patient reported that he had no idea where it came from and he was healthy for the most part and he would never get another flu shot. Seriousness of the events reported as non serious. Outcome and causality of the events were not reported. Seriousness of the event dyspnoea was upgraded based on information available in the source document.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms, Painful respiration, Productive cough, Sleep disorder, Tension
Clinical narrative: Case number PHHY2015US031421, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 548757) website on 16 Mar 2015. This report refers to a 53-year-old male patient. His historical drugs included penicillin, Sulphur and belladonna. Current conditions included allergies to latex gloves and asthma attack every other year. He was vaccinated with FLUVIRIN (batch number: 66521011710) on 15 Oct 2014. On 17 Oct 2014, the patient had a very hard time breathing which woke him up. The patient thought he might be having an extreme asthma attack. He could not call out for his daughter for help and barely made it to his inhalers and he never been so scared and close to calling emergency for help before. The patient had back spasms from being to tense. It took a good 5 hours before he could breathe without his back and chest hurting. Two days later, he was now coughing up some real nasty stuff. The patient reported that he had no idea where it came from and he was healthy for the most part and he would never get another flu shot. Seriousness of the events reported as non serious. Outcome and causality of the events were not reported. Seriousness of the event dyspnoea was upgraded based on information available in the source document.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Blood test, Headache, Injection site reaction, Lumbar puncture, Pyrexia
Clinical narrative: Case number PHHY2015US016615, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548787) website on 03 Feb 2015. This report refers to a 44-year-old female patient. The patient medical history included sinus problems. The patient had chronic medical conditions (no further details provided). No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 146502) along with PNEUMOVAX (batch number: K007824) and ADACEL (batch number: U4874AA) intramuscularly on 13 Oct 2014. On 14 Oct 2014, the patient experienced fever, headache and injection site reaction requiring an office visit. The patient underwent bloodwork and spinal tap tests (results not reported). The patient was hospitalized for four days. The final outcome of the events was unknown. Causality was not reported.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Intensive care
Clinical narrative: Case number PHHY2015US013456, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548795) website on 03 Feb 2015. This report refers to a 66-year-old female patient. Concomitant drugs included gabapentin, omeprazole, diazepam, duloxetine, valsartan, ropinirole and ibuprofen. On 15 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 14581P) intramuscularly in the left arm. On the same date, at the same time of vaccination she experienced lightheadedness but immediately recovered from the event. On 16 Oct 2014, she experienced numbness and it resulted in hospitalization for one day with stay at ICU. The outcome of the events reported as recovered. The seriousness of the event lightheadedness was not reported. The causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dyspnoea, Hyperhidrosis
Clinical narrative: Case number PHHY2015US015322 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 548865) on 03 Feb 2015. This report refers to a 52 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145204) intramuscularly in the right arm on 19 Oct 2014. On the same day, she was sweating, clammy and had shortness of breath (SOB). She was laid on floor. She was given EPIPEN injection and emergency number (911) was called. She received second EPIPEN approximately 10 minutes later. Emergency Medical Technician (EMT) arrived. She recovered and was fully conscious. The events were reported as non-serious, but the event dyspnea was upgraded as medically significant based on the information available in the source document. The causality of the events was not reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Local swelling, Loss of consciousness, Peripheral swelling, Pharyngeal oedema
Clinical narrative: Case number PHHY2015US013504, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548963) website on 03 Feb 2015. This report refers to a 55-year-old female patient. Concomitant drugs included alprazolam, estradiol, fluoxetine and ALIVE 50 Plus. On 17 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 1410901) in the left arm. On 18 Oct 2014 at 01:00 am, she experienced itchy, swollen throat and neck. She took BENADRYL but it did not help. Her hands swelled up and had internal hives. She went to hospital and they gave her steroids. She had a seizure, got hot then passed out. She got discharged on 20 Oct 2014 after 2 days of stay. The outcome of the events reported as recovered. The events reported as serious (hospitalization). The causality of the events was not reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Seizure, Throat irritation, Urticaria
Clinical narrative: Case number PHHY2015US013504, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548963) website on 03 Feb 2015. This report refers to a 55-year-old female patient. Concomitant drugs included alprazolam, estradiol, fluoxetine and ALIVE 50 Plus. On 17 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 1410901) in the left arm. On 18 Oct 2014 at 01:00 am, she experienced itchy, swollen throat and neck. She took BENADRYL but it did not help. Her hands swelled up and had internal hives. She went to hospital and they gave her steroids. She had a seizure, got hot then passed out. She got discharged on 20 Oct 2014 after 2 days of stay. The outcome of the events reported as recovered. The events reported as serious (hospitalization). The causality of the events was not reported.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea
Clinical narrative: Case number PHHY2015US014499, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548981) website on 03 Feb 2015. This report refers to a 49 year old male patient. Medical history included bee stings. Historical drugs included LEVAQUIN, LEVOCIN, DETROL, DITROPAN, SANCTURA and ibuprofen. Concomitant medications included WELLBUTRIN, CELEXA and ZANTAC. Vaccination history included localized swelling and redness with FLULAVAL (batch number: unknown, other manufacturer) on an unknown date. On 16 Oct 2014, he was vaccinated with FLUVIRIN (batch number: 14583P) intramuscular into right arm. On the same day post vaccination he developed difficulty breathing and swallowing. EPI-PEN was administered and patient transferred to Emergency Department for evaluation. Treatment received with intravenous epinephrine, BENADRYL and steroids as well as prescribed to continue oral BENADRYL and steroids. Final outcome of the events was recovered. Causality assessment was not reported. Events were reported as non-serious. Seriousness assessment of difficulty breathing and swallowing was upgraded based on information available in the source documents.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Chills, Electromyogram, Fall, Fatigue
Clinical narrative: Case number PHHY2015US018377, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 549055) website on 03 Feb 2015. This report refers to a 72 year old male patient. Historical condition and concomitant medication were none. The patient was vaccinated with FLUVIRIN (batch number: 1310001) on 20 Sep 2013. On 01 Oct 2013, the patient experienced weakness in legs. After 2 weeks of vaccination, he experienced chills and extreme tiredness. Four weeks after vaccination, he experienced extreme chills, tiredness and backaches. Six weeks after vaccination, he developed extreme backaches. The patient experienced paralysis and fell down. He developed Guillain Barre Syndrome. On an unknown date the patient was taken to an emergency room. He was hospitalized for 23 days. Electromyogram and spinal tap was performed (results not given). Final outcome of the events was unknown. Causality was not reported.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Muscular weakness, Paralysis
Clinical narrative: Case number PHHY2015US018377, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 549055) website on 03 Feb 2015. This report refers to a 72 year old male patient. Historical condition and concomitant medication were none. The patient was vaccinated with FLUVIRIN (batch number: 1310001) on 20 Sep 2013. On 01 Oct 2013, the patient experienced weakness in legs. After 2 weeks of vaccination, he experienced chills and extreme tiredness. Four weeks after vaccination, he experienced extreme chills, tiredness and backaches. Six weeks after vaccination, he developed extreme backaches. The patient experienced paralysis and fell down. He developed Guillain Barre Syndrome. On an unknown date the patient was taken to an emergency room. He was hospitalized for 23 days. Electromyogram and spinal tap was performed (results not given). Final outcome of the events was unknown. Causality was not reported.