chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Initial report received from Healthcare professional on 07 November 2014. A more than 65-year-old male patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number U5063AA, expiry date 04 Jun 2015, a dose number was not reported) in the left arm on 03 November 2014. On an unspecified date, the patient had experienced large black, blue and yellowish bruise at injection site. Lab investigations and corrective treatment were not reported. The patient's illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were not reported. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Gallbladder obstruction, Scan abnormal
Clinical narrative: Initial report received from a healthcare professional on 07 November 2014. A female patient with no medical history and unknown concomitant medications, had received an intramuscular dose of FLUZONE QIV (batch number, expiry date not reported), in left arm, on 09 October 2014. The patient had received a previous dose of FLUZONE QIV. The patient had previously called on 05 November 2014 and reported that on an unspecified date 3 weeks after aminotransferase. The patient called back on 07 November 2014, to state that she had further testing done and her scan of gall bladder indicated blockage. The patient stated that she believes that gall bladder blockage was what actually caused elevation of her liver enzymes and not the Flu vaccine. The patient declined to provide any contact information for herself of her HCP. Corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none. This case is linked to case# 2014SA153498 (cluster case).
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Erythema, Pruritus
Clinical narrative: Initial report received from a healthcare professional on 5 November 2014. A female patient, whose age and concomitant medications was not reported, had received an intramuscular dose of FLUZONE QIV (Batch number UI159AA and expiry date 30 June 2015, dose number and site of vaccination were not reported), on 27 October 2014. The patient had hypertension in the past. On 27 October 2014, within few hours after receiving vaccination the patient had chest tightness, shortness of breath, redness and itching. Illness at the time of vaccination was none, Pre-existing physician diagnosed allergies and birth defects were unknown. The patient was treated with BENADRYL and steroids and laboratory data was unknown. The patient required ER visit. On an unspecified date, the patient was recovered. List of documents held by sender: none. Follow-up information received from healthcare professional on 20 March 2014. It was reported that, received no additional information to provide. List of documents held by sender: none.
Age: 63.0
Sex: U
Vaccine: FLUX
Symptoms: Alopecia, Insomnia, Mobility decreased, Pain
Clinical narrative: Initial unsolicited report received from a consumer on 03 November 2014. A patient (age and gender not reported), whose medical history and concomitant medication were not reported, had received a dose of FLU VACCINE, (batch number, dose, cycle in series, route and site of vaccination not reported, on 27-Oct-2014. On an unspecified date, patient experienced hurting "all over", barely able to move, inability to sleep and hair thinning out. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none. Follow-up information received from a consumer on 02 March 2015: The patient was 63 years of age. The patient did not receive any concomitant vaccine. The patient's illness at the time of vaccination includes multiple sclerosis and was allergic to iodine and macrodantin. The patient did not experience any adverse event following prior vaccination. Documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity, Vaccination complication
Clinical narrative: Initial unsolicited report received from healthcare professional on 29 Dec 2014 and follow up received on 30 Dec 2014. A patient, whose age, gender and concomitant medications were not reported, had received a dose of flu vaccine (lot number, dose, dose number, route and site of vaccination not reported) on an unspecified date. The patient had a medical history of allergy to egg products. It was reported that the patient developed allergy (reaction) flu vaccine on an unspecified date. The patient had a medical history of allergy to egg products. It was reported that the patient developed allergy (reaction) flu vaccine on an unspecified date. Lab details and corrective treatments were not reported. The outcome of the event was unknown. Documents held by sender: None. Follow-up information received from a healthcare professional on 06 February 2015. No additional information was provided. List of Documents held by sender: None.
Sex: M
Vaccine: FLUX
Symptoms: Laryngitis, Nasopharyngitis, Viral infection, Viral test positive
Clinical narrative: Initial unsolicited report received from a Physician on 05 January 2015. A male patient had received a dose of Influenza vaccine (manufacturer unknown, batch number, dose number, route and site of vaccination not reported) on an unspecified date. The patient had a history of multiple sclerosis and had received medications like REBIF and Copaxone from 01 January 2002 to 05 January 2002. Patient stated he was on REBIF again from 05 January 2002 to 05 January 2009 and then SOLUMEDROL was added to REBIF from 05 January 2009 to 05 January 2012. Patient was on Clinical Trial from 05 January 2012 to 09 January 2012, for Tcelna, and wasn't sure if he received Med or Placebo. Patient stated he then was put on SOLUMEDROL again from 03 January 2013 to 04 January 2013. The patient had a history of sinus problems. The patient was concomitantly treated with Tecfidera and Lemtrada. On an unspecified date, after vaccination, the patient experienced cold and laryngitis for last 3 weeks. Patient stated he has tested positive for JC Virus. The patient took Z-Pak for 3 days and was doing better. At the time of this report, the patient was recovering from the symptoms. Documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest pain, Injection site pain, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: Upon internal review, significant correction done on date (20 May 20155) to correct the product as reported term and modify the narrative introductory sentence. Initial unsolicited report received from Consumer on 14 January 2014. A 72-year-old female patient, whose concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number, expiry date and dose number was not reported) in deltoid left on an unspecified date in September 2014. On an unspecified date in September 2014 i.e., one week after vaccination the patient had experienced stiffness to the arm; pain is now present in the whole left arm, muscular pain in the left arm, similar to a pulled muscle, the neck, and across the chest, pain on ROM and symptoms became worsened. It was also reported that patient has an upcoming appointment with the cardiologist and will discuss the symptoms. The patient required emergency room or doctor visit. The patient had no laboratory investigations and corrective treatment was not reported. The patient had no illness at the time of vaccination, and pre-existing diagnosed seasonal allergies, hypertension, and triple bypass. At the time of this report, the outcome of the event was not resolved. List of documents held by sender: none. Follow-up information received from a physician on 16 March 2015. Additional information received from the pharmacy on 17 March 2015. The date of vaccine administration was updated on 18 September 2014. Lot number of FLUZONE HD was reported as U5016AA. The reporter had no additional information to provide. List of documents held by sender: none. Addendum: 20 May 2015. Upon second medical examination of case at time of internal review the following has been modified in this case. To correct product screen as reported term and modify the narrative introductory sentence.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Upon internal review, significant correction done on date (20 May 20155) to correct the product as reported term and modify the narrative introductory sentence. Initial unsolicited report received from Consumer on 14 January 2014. A 72-year-old female patient, whose concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number, expiry date and dose number was not reported) in deltoid left on an unspecified date in September 2014. On an unspecified date in September 2014 i.e., one week after vaccination the patient had experienced stiffness to the arm; pain is now present in the whole left arm, muscular pain in the left arm, similar to a pulled muscle, the neck, and across the chest, pain on ROM and symptoms became worsened. It was also reported that patient has an upcoming appointment with the cardiologist and will discuss the symptoms. The patient required emergency room or doctor visit. The patient had no laboratory investigations and corrective treatment was not reported. The patient had no illness at the time of vaccination, and pre-existing diagnosed seasonal allergies, hypertension, and triple bypass. At the time of this report, the outcome of the event was not resolved. List of documents held by sender: none. Follow-up information received from a physician on 16 March 2015. Additional information received from the pharmacy on 17 March 2015. The date of vaccine administration was updated on 18 September 2014. Lot number of FLUZONE HD was reported as U5016AA. The reporter had no additional information to provide. List of documents held by sender: none. Addendum: 20 May 2015. Upon second medical examination of case at time of internal review the following has been modified in this case. To correct product screen as reported term and modify the narrative introductory sentence.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity, Stress echocardiogram normal
Clinical narrative: Upon internal review, significant correction done on date (20 May 20155) to correct the product as reported term and modify the narrative introductory sentence. Initial unsolicited report received from Consumer on 14 January 2014. A 72-year-old female patient, whose concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number, expiry date and dose number was not reported) in deltoid left on an unspecified date in September 2014. On an unspecified date in September 2014 i.e., one week after vaccination the patient had experienced stiffness to the arm; pain is now present in the whole left arm, muscular pain in the left arm, similar to a pulled muscle, the neck, and across the chest, pain on ROM and symptoms became worsened. It was also reported that patient has an upcoming appointment with the cardiologist and will discuss the symptoms. The patient required emergency room or doctor visit. The patient had no laboratory investigations and corrective treatment was not reported. The patient had no illness at the time of vaccination, and pre-existing diagnosed seasonal allergies, hypertension, and triple bypass. At the time of this report, the outcome of the event was not resolved. List of documents held by sender: none. Follow-up information received from a physician on 16 March 2015. Additional information received from the pharmacy on 17 March 2015. The date of vaccine administration was updated on 18 September 2014. Lot number of FLUZONE HD was reported as U5016AA. The reporter had no additional information to provide. List of documents held by sender: none. Addendum: 20 May 2015. Upon second medical examination of case at time of internal review the following has been modified in this case. To correct product screen as reported term and modify the narrative introductory sentence.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest pain, Injection site pain, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: Initial unsolicited report received on 14-Jan-2015. A female patient (date of birth, age at onset, weight and height not reported) whose medical history and concomitant medications were not provided, had received a dose of Influenza vaccine (dose details, batch number, route of administration and site of administration not provided) in Sep 2014. On an unspecified date in Sep 2014, the patient stated that patient received the high dose flu shot and had a reaction to it after vaccination. It was reported that patient had flu shots many times before and this was the first time patient had a reaction to it (details not reported). Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none. Follow Up information received from a Consumer on 03-Apr-2015. A 72 years old patient had received a dose of FLUZONE HD (manufacturer: Sanofi Pasteur Inc, batch number: V5016AA, in the "left deltoid") on 18 -Sep-2014. The patient did not take any concomitant medications. On 19-Sep-2014, 24 hours post vaccination, the patient experienced pain in left arm which was very sore, got stiff and spread to neck and back area. Laboratory investigations included stress EKG test with the doctor. The results were not provided. At the time of this report, the patient had not recovered from the above mentioned event.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received on 14-Jan-2015. A female patient (date of birth, age at onset, weight and height not reported) whose medical history and concomitant medications were not provided, had received a dose of Influenza vaccine (dose details, batch number, route of administration and site of administration not provided) in Sep 2014. On an unspecified date in Sep 2014, the patient stated that patient received the high dose flu shot and had a reaction to it after vaccination. It was reported that patient had flu shots many times before and this was the first time patient had a reaction to it (details not reported). Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none. Follow Up information received from a Consumer on 03-Apr-2015. A 72 years old patient had received a dose of FLUZONE HD (manufacturer: Sanofi Pasteur Inc, batch number: V5016AA, in the "left deltoid") on 18 -Sep-2014. The patient did not take any concomitant medications. On 19-Sep-2014, 24 hours post vaccination, the patient experienced pain in left arm which was very sore, got stiff and spread to neck and back area. Laboratory investigations included stress EKG test with the doctor. The results were not provided. At the time of this report, the patient had not recovered from the above mentioned event.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity, Stress echocardiogram normal
Clinical narrative: Initial unsolicited report received on 14-Jan-2015. A female patient (date of birth, age at onset, weight and height not reported) whose medical history and concomitant medications were not provided, had received a dose of Influenza vaccine (dose details, batch number, route of administration and site of administration not provided) in Sep 2014. On an unspecified date in Sep 2014, the patient stated that patient received the high dose flu shot and had a reaction to it after vaccination. It was reported that patient had flu shots many times before and this was the first time patient had a reaction to it (details not reported). Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none. Follow Up information received from a Consumer on 03-Apr-2015. A 72 years old patient had received a dose of FLUZONE HD (manufacturer: Sanofi Pasteur Inc, batch number: V5016AA, in the "left deltoid") on 18 -Sep-2014. The patient did not take any concomitant medications. On 19-Sep-2014, 24 hours post vaccination, the patient experienced pain in left arm which was very sore, got stiff and spread to neck and back area. Laboratory investigations included stress EKG test with the doctor. The results were not provided. At the time of this report, the patient had not recovered from the above mentioned event.
Age: 0.62
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash macular, Urticaria
Clinical narrative: Initial unsolicited report received from a Healthcare on 16 January 2015. A 7-months old female patient, whose medical history and concomitant medications were not reported had received an FLUZONE (batch number U5085AA), (dose, dose number were not reported), via intramuscular route in Left Thigh on 15 January 2015. It was also reported that the patient had previously received a dose of FLUZONE QIV Batch number: U5085AA, (dose, dose number were not reported) via Intramuscular route in Thigh on 1 December 2014. It was reported that 1 to 2 hours post vaccination on 15 January 2015 the child broke out in a rash on both legs and face. Stated the rash is red and blotchy and looks like welts. The patient required emergency room or doctor visit. Rash resolved overnight then reappeared on 16 January 2015. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was unknown. Documents held by sender: none. Follow-up report received from a nurse on 30 March 2015. It was reported that the adverse event was resolved on its own and no further treatment was required. Document held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Blood urine present, Diarrhoea, Nausea, Vomiting
Clinical narrative: Initial report received from a healthcare professional on 29 October 2014. A male patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (Batch number UI189AE and expiry date 30-JUN-2015, dose number, site and route of vaccination was not reported), on 25-OCT-2014. On 27-OCT-2014, two days after vaccination the patient had experienced severe nausea, vomiting, diarrhea, and blood in urine. Illness at the time of vaccination, Pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. Corrective treatment and Laboratory data were not reported. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction, Skin test positive
Clinical narrative: Initial unsolicited report received from a non healthcare professional (corrected) on 23 Oct 2014. This is an invalid case as the adverse reaction is not specified. A child patient, whose age, gender, medical history and concomitant medications were not reported, had received a dose of INFLUENZA VACCINE (batch number, dose, dose number, route and site of vaccination not reported) in the year 2014. The patient had previously vaccinated with FLUZONE QIV (lot number: U476AA) in 2013 and had developed a reaction (not specified). It was reported that patient had developed reaction (not specified) to this year's FLUZONE QIV on an unspecified date. Lab details and corrective treatments were not reported. The outcome of the event was reported as unknown. Documents held by sender: none. Follow Up information received by a non healthcare professional on 03-Feb-2015. It was reported that the initial report was incorrect. A 3 years old patient (age reported as 4 years) had received a dose of FLUZONE QIV (batch number: U4766AA, dose, dose number, route and site of vaccination not reported) on an unspecified date. On 09-Oct-2013, the patient had reacted to the FLUZONE QIV vaccine. Laboratory investigations included skin prick testing which showed positive responses to mercury, gelatin and neomycin on 13-Nov-2014. On 11-Dec-2014, the patient received "FLUARIX" vaccine (manufacturer, GSK, batch number: 5R9EG). It was reported that she tolerated the injection without any problem. She was observed for 1 hour and discharged in the usual state of health. She did not have a reaction to the flu vaccine in 2014.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site swelling, Muscle strain
Clinical narrative: Initial report received from a consumer (patient) on 20 October 2014. A 45-year-old female patient had received an intradermal dose of FLUZONE ID (lot number, dose number was not reported) in left upper arm on 17 October 2014. The patient had no illness at the time of vaccination. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as seasonal allergies, reaction to bug bites. On 17 October 2014 i.e. same day after vaccination feeling feverish and having the chills, the injection site was itchy and on next day patient felt better, but the injection site became swollen to the size of a lemon, red, and itchy. Patient also had pain from her shoulder to her breast on the left side. It was reported that patient seen by physician who stated that pain was a muscle strain and not related to vaccination. Corrective treatment and laboratory details were not reported. At the time of this report, patient outcome was not recovered; however the swelling has gone down some, redness was lighter in color, and it was not as itchy. Documents held by sender: None. Follow-up information received from consumer on 23 March 2015: The batch number of FLUZONE HD was UT4993BA.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initial report received from a consumer (patient) on 20 October 2014. A 45-year-old female patient had received an intradermal dose of FLUZONE ID (lot number, dose number was not reported) in left upper arm on 17 October 2014. The patient had no illness at the time of vaccination. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as seasonal allergies, reaction to bug bites. On 17 October 2014 i.e. same day after vaccination feeling feverish and having the chills, the injection site was itchy and on next day patient felt better, but the injection site became swollen to the size of a lemon, red, and itchy. Patient also had pain from her shoulder to her breast on the left side. It was reported that patient seen by physician who stated that pain was a muscle strain and not related to vaccination. Corrective treatment and laboratory details were not reported. At the time of this report, patient outcome was not recovered; however the swelling has gone down some, redness was lighter in color, and it was not as itchy. Documents held by sender: None. Follow-up information received from consumer on 23 March 2015: The batch number of FLUZONE HD was UT4993BA.
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Wrong drug administered
Clinical narrative: Initial unsolicited report received from Healthcare professional (nurse) in on 16 October 2014. A female patient (age was no reported), whose medical history and concomitant medications were not reported, had received a subcutaneous dose of FLUZONE QIV (Batch number, expiry date and dose number was not reported) on an unspecified date. The patient had received dose subcutaneous instead of intramuscularly i.e. wrong route of administration and the patient had experienced painful arm and swollen arm after vaccination on an unspecified date. Lab investigation and corrective treatment were not reported. The patient illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were not reported. At the time of this report the outcome of the event was unknown. List of documents held by sender: none. Follow-up information received from a nurse on 06 April 2015. No new information was provided. List of Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Initial report received from a healthcare professional on 16 October 2014. A patient, whose gender, age, medical history and concomitant medication was not reported, had received a dose of FLUZONE (batch number, dose, dose in series, route of administration and site of administration was not reported) on 15 October 2014. On 15 October 2014 after vaccination, the patient experienced vaccine reaction. Laboratory investigations and corrective treatment was not reported. At the time of this report the outcome of event was not reported. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Tinnitus
Clinical narrative: Initial unsolicited report received from a Consumer (the patient) on 08 December 2014. A female patient, age not reported, had received an intramuscular dose of FLUZONE HD, (batch number, dose number and site of vaccination not reported) on 08 December 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. On 08 December 2014, same day after vaccination, the patient had headache. The pain level was a 5-6 on an scale from 1-10, 1 being lowest. The patient also experienced ringing in her ears which came and went. Laboratory tests were not performed and corrective treatments were not reported. At the time of this report, the patient had not recovered. Documents held by sender: none. Follow-up information received from a Consumer on 27 January 2015: The patient was 68 years. The patient did not receive a flu shot since she was a child and never had an issue and never had the flu. Headache and ringing in the ears went away the next day, 09 December 2014. The patient did not take any medications.
Sex: U
Vaccine: FLU4
Symptoms: Body temperature increased, Diarrhoea, Erythema, Nausea, Pain
Clinical narrative: Initial report received from a healthcare professional on 10 Dec 2014. This case is a part of 3 cluster cases and is linked to case no 2014SA172329 and 2014SA172330 (same reporter). A cluster of 2 patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (batch number UI245AB and expiry date 30 Jun 2014) in the deltoid between (11/25/14-12/10/14). On an unknown date after vaccination, the patients experienced redness and pain below the injection site. Laboratory investigations and corrective treatments were not reported. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. At the time of this report the patient outcome was unknown. Documents held by sender: none. Follow-up information received from a nurse on 07 April 2015. The patient had received a dose of FLUZONE QIV on 27 November 2014 in the morning. On 27 November 2014, on the same day after vaccination patient had experienced swollen armpits, nausea, vomiting, diarrhea and temperature (102). Other relevant diagnostic test/laboratory data, other medications, illness at time of vaccination, pre-existing physician-diagnosed allergies, birth defects, medical conditions reported as no. On an unknown date, the patient recovered from all the events. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Swelling, Vomiting
Clinical narrative: Initial report received from a healthcare professional on 10 Dec 2014. This case is a part of 3 cluster cases and is linked to case no 2014SA172329 and 2014SA172330 (same reporter). A cluster of 2 patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (batch number UI245AB and expiry date 30 Jun 2014) in the deltoid between (11/25/14-12/10/14). On an unknown date after vaccination, the patients experienced redness and pain below the injection site. Laboratory investigations and corrective treatments were not reported. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. At the time of this report the patient outcome was unknown. Documents held by sender: none. Follow-up information received from a nurse on 07 April 2015. The patient had received a dose of FLUZONE QIV on 27 November 2014 in the morning. On 27 November 2014, on the same day after vaccination patient had experienced swollen armpits, nausea, vomiting, diarrhea and temperature (102). Other relevant diagnostic test/laboratory data, other medications, illness at time of vaccination, pre-existing physician-diagnosed allergies, birth defects, medical conditions reported as no. On an unknown date, the patient recovered from all the events. Documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Lymphadenopathy, Pyrexia, Vomiting
Clinical narrative: Initial report received from a Healthcare professional on 10 December 2014. This case is a part of 3 cluster cases and this case is linked to case 2014SA172329 and 2014SA172324. A patient, whose medical history and concomitant medications was not reported, had received a intramuscular dose of FLUZONE QIV (Batch number UI245AB, expiry date 30 Jun 2014) in the deltoid, on an unspecified date. On an unspecified date after vaccination the patient had experienced fever. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as unknown. The patient required ER visit. At the time of this report, the patient was recovered within 8 hours of onset of event. List of documents held by sender: none. Follow-up information received from nurse on 07 April 2015. A 35-year-old female patient, whose medical history was reported as an egg allergy, had received a dose of FLUZONE QIV on 27 November 2014. On 28 November 2014, one day after vaccination patient had experienced high fever (104 degree celsius), swollen arm pit glands, vomiting and loose stools. It was reported that, patient was healthy at the time of vaccination but patient's children was sick at home and patient's sister had a site reaction to injection. Patient had no vaccine within 4 weeks prior to vaccination, laboratory data and other medications. Patient was vaccinated at hospital and vaccine purchased from hospital funds. It was reported that, patient did not required emergency room. The patient had recovered from all events on an unspecified date. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Productive cough, Pyrexia
Clinical narrative: Initial report received from a consumer on 16 October 2014. A male patient had received a dose of Influenza vaccine (Manufacturer and batch number unknown, expiry date and dose in series was not reported) intramuscularly in left deltoid on an unspecified date in 2013. The patient's illness at the time of vaccination includes COPD had alpha tripsin deficiency. On an unspecified date in 2013, 7 days post vaccination; the patient developed a fever and a productive cough. He was productive he had the flu. The patient was sent to emergency room 3 times and was evaluated by doctor. Laboratory details and corrective treatments were not reported. On an unspecified date, the patient had recovered. Documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Chills, Erythema, Pyrexia, Swelling
Clinical narrative: Initial report received from a healthcare professional on 06 October 2014. This case is a part of cluster of 3 cases (same vaccine, vaccine lot number and reporter) and is linked to case numbers 2014SA138930 and 2014SA143203. A patient (out of 4 patients). whose demographics were not reported, had received a dose of FLUZONE QIV, (batch number UI158AA, dose in series, route and site of vaccination were not reported) on an unspecified date (mentioned as 30 September 2014 and 02 October 2014). The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not asked. On an unspecified date, the patients experienced a band of redness around arm with swelling and also complained of low grade temp and chills. Corrective treatment was not reported and no lab tests were performed. The patient recovered on an unspecified date (24 to 48 hours). Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Rash, Tinnitus
Clinical narrative: Initial report received from a healthcare professional on 10 DECEMBER 2014. This case is linked to 2014SA172324 and 2014SA172330. A patient (age and gender not reported), whose medical history and concomitant medication were not reported, had received intramuscularly a dose of FLUZONE QIV, (batch number: UI245AB), (dose of vaccination not reported) in deltoid from 24-NOV-2014 to 10-DEC-2014. On an unspecified date, patient experienced rash on the opposite arm with redness and ringing in the ars. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. The patient required ER visit. Documents held by sender: none. Follow-up information received from a nurse on 07 APRIL 2015. A patient had received a dose of FLUZONE QIV on 10 DECEMBER 2014. On DECMEBER 2014, 20-30 minute after vaccination patient had experienced rash on the opposite arm with redness and ringing in ears. The patient did not received any vaccine within 4 weeks prior to vaccination. The patient had no known drug allergies (NKDA) and illness at time of vaccination. It was reported that, patient did not required emergency room visit. Patient did not had any laboratory investigations. Corrective treatment was reported as BENADRYL for reaction. The patient had recovered from all events on an unspecified date. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Initial report received from healthcare professional on 18 November 2014. A 3 patient (age and gender was not reported), whose medical history and concomitant medications were not reported, had received an intradermal dose of FLUZONE ID (Batch number UT4993BA, expiry date 6 May 2015, site of vaccination and dose number was not reported) on an unspecified date. On an unspecified date, the patient had experienced 3 inch to 5 inch round, hard, red warm area around injection site. Lab investigations and corrective treatment were not reported. The patient required emergency room or doctor visit. The patient's illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were reported as unknown. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Initial case report received from a healthcare professional on 14 Oct 2014. A 53-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (Lot number U5022BA, intramuscularly in the left deltoid) on 08 October 2014. On 14 October 2014, the patient complained of fever 102.2 Fahrenheit and congestion and back pain. The patient had required ER visit. Corrective treatment details and laboratory details were not reported. The patient had recovered on an unspecified date. Document held by sender: None. Follow up information received from health care professional on 05 January 2015. The patient did not receive any other vaccinations within 4 weeks of vaccinations of FLUZONE HD and no previous dose of FLUZONE HD. The patient had medical history of anxiety disorder, arthritis and "chrons dz" (Crohn's disease). Patient had received AUGMENTIN from 14 Oct 2014 to 24 Oct 2014 for 10 days twice a day as a corrective treatment and medication given by staff of nursing home included: NEXIUM 40 Mg tablet daily, potassium chloride 20 miliequivalent table daily, LASIX 40 mg tablet twice a day, ABILIFY 10 mg tablet daily, Trazodone tablet 150 mg daily, LYRICA 150 tablet twice daily, VALIUM 5 mg tablet three times a daily, ULTRAM 50 mg tablet every 4 hours as needed and FLAGYL 500 mg tablet twice daily for 7 day from 12 December 2014 to 19 December 2014. Laboratory investigations were unavailable. On 24 October 2014 patient was recovered from the event.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Injection site induration, Migraine, Pain
Clinical narrative: Based on the follow-up information received on 29 JANUARY 2015, this case is medically confirmed. Initial unsolicited report received from consumer on 17 NOVEMBER 2014. A 24-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (batch number, expiry date, dose number was not reported) in the deltoid on 18 OCTOBER 2014. On 18 OCTOBER 2014, the patient had experienced migraine, headache, generalized body aches, fatigue and a site reaction of induration 2 inches. Lab investigations were not reported and corrective treatment included self medication with EXCEDRIN, PHENERGAN, IMITREX from an unspecified date. The patient had denied to provide an information on illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects included history of migraine headache. At the time of this report, the outcome of the event was resolved on an  unspecified date. List of documents held by sender: none. Follow up information received from consumer on 29 JANUARY 2015. It was reported that no additional information to provide.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal stiffness
Clinical narrative: Initial report received from a healthcare professional on 19 NOVEMBER 2014.  A 63-year-old male patient had received an intramuscular first dose of FLUZONE QIV, (batch number UT159AA) in left deltoid on 31 OCTOBER 2014. The patient had no illness at the time of vaccination and no known allergies. On an unspecified date, the patients complained of pain at the injection site. The patient had pain from day one, with stiffness, a throbbing pain in the injection site area. Visual inspection showed no redness, swelling or bruising. The patient was taken to emergency room and was evaluated. Corrective treatment was not reported. No laboratory tests were performed.  At the time of this report, the patient outcome was unknown. Documents held by sender: none.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pain, Pyrexia
Clinical narrative: Initial unsolicited reports received from pharmacist on 25 November 2014 and follow up on 01 December 2014. A 68-year-old male patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number U5042CA, expiry date 30 June 2015 and dose number was not reported) in the deltoid left on 01 November 2014. On 01 November 2014, the patient had experienced blood shot eyes, fever and body aches. The patient had no laboratory investigations and corrective treatment was not reported. The patient does not have any illness at the time of vaccination, pre-existing diagnosed allergies and birth defects. The event of blood shot eyes was resolved after one week, and the event of fever and body aches was resolved after few days. At the time of this report, the outcome of the event was resolved on an unspecified date. List of documents held by sender: none. Follow up information received from a non-healthcare professional on 25 February 2015. No new information was provided. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Musculoskeletal pain, Rotator cuff syndrome
Clinical narrative: Initial report received from a healthcare professional (patient) on 16 OCTOBER 2014. An adult female patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE (batch number, expiry date, route and site of vaccination not reported), on 29-SEP-2014. On an unspecified date, after vaccination the patient was having worsening of shoulder pain, subacromial bursitis and rotator cuff tendonitis.  Laboratory data and corrective treatment were not reported. At the time of this report, the outcome was unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea
Clinical narrative: Initial report received from a healthcare professional on 10 OCTOBER 2014. A female patient, whose age and concomitant medication was not reported and medical history was reported as No per reporter, had received a dose of FLUZONE QIV (batch number-UI196AE, expire date - 30 JUNE 2015) dose, dose in series was not reported intramuscularly in left deltoid on 05 OCTOBER 2014. On 05 OCTOBER 2014, after vaccination, the patient presented episode of diarrhea. Laboratory investigation was not reported. Patient had not received any corrective treatment. On an unspecified date the patient was recovered from event. Documents held by sender: none.
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Disturbance in attention, Dizziness, Flushing, Malaise
Clinical narrative: Initial report received from  healthcare professional on 10 OCT 2014. A male patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE (lot number, dose, dose  number, route and site of vaccination not reported on 10 OCT 2014. It was reported that, after unspecified time after vaccination, the patient did not feel well, could not focus, was flushed, dizzy and light headed. The patient had no hives. The patient was moved to the emergency room. Lab investigation details and corrective treatment were not reported. The outcome of the event was reported as unknown.  Documents held by sender: none. Follow-up information received from a health care professional on 26 FEBRUARY 2015. On 10 OCTOBER 2014, same day after vaccination the patient did not feel well, could not focus, was flushed, dizzy and light headed. On 10 OCTOBER 2014, the patient was completely recovered from the events.  Documents held by sender: none.
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Disturbance in attention, Dizziness, Flushing, Nausea, Rash
Clinical narrative: Initial report received from  healthcare professional on 10 OCT 2014. A male patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE (lot number, dose, dose  number, route and site of vaccination not reported on 10 OCT 2014. It was reported that, after unspecified time after vaccination, the patient did not feel well, could not focus, was flushed, dizzy and light headed. The patient had no hives. The patient was moved to the emergency room. Lab investigation details and corrective treatment were not reported. The outcome of the event was reported as unknown.  Documents held by sender: none. Follow-up information received from a health care professional on 26 FEBRUARY 2015. On 10 OCTOBER 2014, same day after vaccination the patient did not feel well, could not focus, was flushed, dizzy and light headed. On 10 OCTOBER 2014, the patient was completely recovered from the events.  Documents held by sender: none.
Age: 24.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Disturbance in attention, Dizziness, Flushing, Malaise
Clinical narrative: Initial report received from a healthcare professional on 10 OCTOBER 2014. A 24-year-old male patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (batch number U4996AA and expiry date 30-JUN-2015) in the left deltoid, on 10-OCT-2014. On 10-OCT-2014, 5-10 minutes after vaccination the patient had feeling of light headed, dizzy and nauseous. The patient sat down for a few minutes and symptoms worsened. It was reported that the patient could not focus, felt dizzy and his face became flushed, and little white bumps appeared on his arms. The patient had no illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as none. The patient had received IM BENADRYL as a corrective treatment and Laboratory data was not reported. The patient required a doctor or ER visit. At the time of this report, the outcome of the adverse events was unknown. Documents held by sender: None. Follow up information received from Health care professional on 13 FEBRUARY 2015. It was reported that patient had completely recovered on an unspecified date. No previous history of reaction to flu shot.
Age: 24.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Disturbance in attention, Dizziness, Flushing, Nausea, Rash
Clinical narrative: Initial report received from a healthcare professional on 10 OCTOBER 2014. A 24-year-old male patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (batch number U4996AA and expiry date 30-JUN-2015) in the left deltoid, on 10-OCT-2014. On 10-OCT-2014, 5-10 minutes after vaccination the patient had feeling of light headed, dizzy and nauseous. The patient sat down for a few minutes and symptoms worsened. It was reported that the patient could not focus, felt dizzy and his face became flushed, and little white bumps appeared on his arms. The patient had no illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as none. The patient had received IM BENADRYL as a corrective treatment and Laboratory data was not reported. The patient required a doctor or ER visit. At the time of this report, the outcome of the adverse events was unknown. Documents held by sender: None. Follow up information received from Health care professional on 13 FEBRUARY 2015. It was reported that patient had completely recovered on an unspecified date. No previous history of reaction to flu shot.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Arthritis
Clinical narrative: Initial report received from consumer on 01 DEC 2014. A male patient (62 years at the time of report), whose medical history and concomitant medications were not reported, had received a dose of INFLUENZA (batch number, dose, dose number, route and site of vaccination not reported) on an unspecified date (reported as 20 years back). It was reported that the patient had been strenuously hiking two days before vaccination. It was reported that on an unspecified date following vaccination, the patient experienced pain in both knees. The patient experienced severe arthritis in knees for two months. The patient had not consulted a physician. Lab details and corrective treatments were not reported. The outcome of event was recovered. Document held by sender: none.