chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Ocular hyperaemia
Clinical narrative: Initial report received from healthcare professional on 15 November 2013: A 73-year-old female patient had received a first intramuscular dose of FLUZONE right arm (batch number: UH900AA, previous dose: 0) on 15 November 2013. Patient had vaccine at 9:30 am and came back to the doctor's office later in the day with ocular hyperemia and facial flushing. The subject had medical history of MICARDIS, Simvastatin, omeprazole, fish oil, ASA, codeine allergy. Any other vaccinations within 4 weeks of vaccinations was not reported. The subject's illness at the time of vaccination was not reported. The subject was not recovered from the events. Lab investigation was not reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 08 October 2013. The patient had received PPD (M) 5 Tubersol and FLUZONE. Patient received 0.5ml Tubersol intramuscularly instead of FLUZONE. (No information was provided reqarding the patient). List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Initial information was reported by a health care professional to Merck (Case ID 1-9368050839) and received by Sanofi on 08-Nov-2013: this was a invalid case as number of patients were unspecified. Unspecified number of patient, whose age, gender, medical history and concomitant medications were not reported, received FLUZONE (lot number, expiration date unknown, route and site of administration) on an unspecified date. On an unspecified date, patients received FLUZONE that was stored at 34 degrees F for 39 hours. Laboratory investigation and corrective treatment were not reported. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Initial report received on 02-October-2013 from a pharmacist. A female patient whose age, medical history and concomitant medications were not reported, received a dose of FLUZONE (lot number C3264CA) via intramuscular route (site of vaccination was not reported) on 2009. On an unspecified date, after receiving vaccine the patient experienced hives. Lists of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 23 September 2013. A female patient whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE (Route, dose number, batch number and anatomical side of vaccination was not reported) in arm on 19 September 2013. On an unspecified date, the patient had pain in arm. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the event was not reported. List of documents held by the sender none.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 11 November 2013. A 03-year-old patient (gender was not reported) had received a dose of 0.25 ml of FLUZONE. No adverse event was reported. Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: Initial report received from a nurse practitioner on 30 October 3013. A 37 year old female patient, concomitant medications were not reported, had received a dose of FLUZONE (Lot number UH917AA, intramuscularly, site of administration was unknown) on 29 October 2013. On 30 October 2013 after receiving vaccine the patient experienced back pain. Patient's medical history included thyroid disease, vitamin D deficiency, anxiety and lumpectomy. At the time of this report the outcome of adverse events was not recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site discolouration
Clinical narrative: Initial report received from a healthcare professional on 03 October 2013. This is an invalid case of several patients. Several patients of unspecified demographics, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID intramuscularly in deltoid, batch number: UH899AC (dose number not reported) on an unspecified date. It was reported that, multiple patients received vaccination from FLUZONE MDVs and after vaccination when needle removed from patients' arm there was a "gray spot" at needle injection site. Stated gray spot "easily wiped off" and no other symptoms or reactions occurred. Product complaint also filed for this situation as PR 236930. The laboratory tests and corrective treatments were not reported. The event was event recovered. Documents held by sender were none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case is a part of two cluster cases and linked to the case 2013SA100252. this case is invalid as the individual patient identifiers were not reported. Initial spontaneous report  received from Healthcare professional on 03 October 2013. This case included 3 patiens, whose demographic details including initials, date of birth and gender were not reported. The patient had received a dose FLUZONE (batch number UH898AA and site of vaccination was not reported) intramuscularly on an unspecified date in September 2013. The medical history of the individual patients and concomitant medications were not reported. The illness at the time of vaccination and pre-existing, physician diagnosed allergies, medical conditions and birth defects were unknown. It was reported that three patients had experienced tenderness at the injection site. Corrective treatment was not reported and the patient has no laboratory test. The patient was recovered on an unspecified date. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Limb discomfort
Clinical narrative: This case is associated with case 2013SA100252. Initial report received from a pharmacist on 03-Oct-2013. Two patient (age and gender unknown) had received an intramuscular dose of FLUZONE (batch number: UH898AA, dose number and site of administration not reported) on September 2013. The patient's medical history was unknown. Concomitant medication was unknown. On September 2013, 2 patients reported having a heavy feeling to their arm. No laboratory tests were performed and corrective treatments were not reported. Outcome of event was recovered. List of documents held by sender: None.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Hypoaesthesia, Injection site discolouration, Limb discomfort
Clinical narrative: Initial report received from healthcare professional on 03 October 2013. A 43-year-old female patient whose medical history and concomitant medications were not reported, received FLUZONE (lot number UH898AA and expiration date 30-Sep-2014) intramuscularly in left deltoid (dose was not reported) on 27-Sep-2013. On 27-Sep-2013 by 4:30 pm on day of vaccination, patient began having symptoms, her left arm felt heavy and she had numbness. Patient reported that she didn't felt right. Numbness progressed down the left side of her body. She went to emergency room (ER) and was given FLEXERIL, DECADRON and MOTRIN. Spent 4.5 hours in the emergency room and was sent home. The numbness has resolved except for a localized area on the left arm. The patient also developed a black and blue mark the size of a thumbprint below and to the right of the injection site. Laboratory investigation was not reported. As of this report, the patient had not recovered from the events. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Initial report received from a healthcare professional on 4 October 2013. A patient received FLUZONE (lot # UH920AC, expiration date unknown) intramuscularly at left deltoid on 04-Oct-2013. After vaccination, on 04-Oct-2013 the patient experienced metallic taste in mouth. The patient did not recover from the event. Documents held by sender: none.
Age: 57.0
Sex: U
Vaccine: FLU3, HEPAB, PPV
Symptoms: Lethargy, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Initial information regarding unsolicited case received from Pharmacist on 08-Oct-2013: This case involves a 57-year-old patient (gender unknown). The patient's past medical history hypertension and hypothyroid. Concomitant medications were not reported. On 04-Sep-2013, the patient received FLUZONE (dose and indication were not reported) (Lot# UH909AA and expiration date unknown) at left deltoid site. The patient also received PNEUMOVAX (Lot # H014196) at left deltoid site and TWINRIX (Lot # AHABB276AB) at right deltoid site on 05-Sep-2013. On 05-Sep-2013, the patient woke up the morning after the vaccine was administered and felt lethargic, had difficulty lifting her head, neck stiffness, body aches. No fever reported. The outcomes of the events were recovered. No further information provided. List of documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pruritus, Throat tightness
Clinical narrative: Initial report received on 09 October 2013 from a health care professional. A 43-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number U4898AD, expiration date 30-Jun-3014) by unknown route and site of vaccination was deltoid 19-Oct-2013. It was reported that a patient over 43-year-old have received the FLUZONE ID. On 2-Oct-2013, reporter states patient had stuffiness in throat and itching in ears 5 hours after vaccination, lasting 3 to 4 hours. List of documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Initial report received on 09 October 2013 from a health care professional. A 60-year-old male patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number UH904AA, expiration date 30-Jun-2014) by unknown route and site of vaccination was deltoid 19-Sep-2013. It was reported that a patient over 60-year-old have received a FLUZONE ID. On 19-Sep-2013, patient reported soreness at the injection site. It has been 3 weeks and there is more pain. Trouble lifting his arm up. Hurting in the area where it was injected. List of documents held by sender: none.
Age: 1.84
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased
Clinical narrative: Initial report received from a pharmacist on 07-Oct-2013: The patient had received FLUZONE (lot number U4694A and expiration date unknown) IM on 03-Oct-2013. On 04-Oct-2013, the patient reported child had temp as high as 102F with no other symptoms. Patient's medical history includes PCN (penicillin allergy). List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial case was received from a health care professional on 07 October 2013. A 06 patients (gender and sex unknown) had no medical history reported, received a dose FLUZONE intramuscularly on an unspecified date in September (year not reported) (site, batch number not reported). Patient had no reported concomitant medication. It was reported that on an unspecified date in September (year not reported) 06 patients felt that they developed redness and swelling at the injection site. Prednisone (route, dose, site not reported) was given as a corrective treatment. At the time of report the outcome of event was unknown.
Sex: U
Vaccine: FLU3
Symptoms: Back pain, Dizziness, Headache, Hyperhidrosis, Vomiting
Clinical narrative: Initial information received from a consumer (the patient) on October 2013. A patient (demographics unknown) had received a dose of FLUZONE, (batch number: UH926AA, dose number, route and site of administration not reported) on 03 October 2013 at 10 hours. The patient was not sick prior to the vaccination. On 04 October 2013 at 5:30 hours, the patient experienced headache, dizziness, vomiting, sweating when she stood up and had slight low back pain without fever. These symptoms lasted and were severe all day. The patient was concerned because the patient had received flu vaccine for over 10 years and have never had a reaction like this. Laboratory details and corrective treatments were not reported. At the time of this report, the outcome was unknown. Documents held by sender: None.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Initial case was received from a health care professional on 07 October 2013. A 50-year-old male patient had a history of Insulin Dependent Diabetes Mellitus, received a dose FLUZONE MDV vaccine on 25 September 2013 (route, site not reported and batch number UH906AB). Patient had not reported concomitant medication. It was reported that on 03 October 2013 patient feels feverish (temperature noted as 99.6F), exhausted and aching all over. No corrective treatment was reported. At the time of report the outcome of event was unknown.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Initial report received from a consumer 02 October 2013. A 26-year-old female patient had received a dose of FLUZONE vaccine (lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date, the patient had developed experienced tingling down arm and into hand, site became red, sore, swollen. Laboratory investigation was and corrective treatments were not reported. At the time of this report, the patient had not recovered from events. Documents held by sender: none.
Age: 0.94
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site rash, Injection site swelling, Rash macular
Clinical narrative: Initial report received from a healthcare professional 14 October 2013. An 11-month-old male patient had received an intramuscular dose of FLUZONE vaccine (lot number: U4697CA, dose number was not reported) in the left thigh on 14 November 2013. On 22 April 2013, the patient had received an intramuscular dose 1 of DAPTACEL vaccine (lot number: C4378AA) in the right thigh and patient developed blotchy rash on thigh at injection site and had superficial rash, facial flushing. In 20 minutes the symptoms were resolved and patient had no other symptoms. On the same day the patient had also received ActHIN, IPOL, PREVNAR and ROTATEQ vaccines (lot number, dose number, route and anatomical site of administration were not reported. On 24 June 2013, the patient had received an intramuscular dose 2 of DAPTACEL vaccine (lot number: C4383AA) in the left thigh and patient developed blotchy rash at injection site. In 20 minutes the symptoms were resolved and patient had no other symptoms. On the same day the patient had also received Hepatitis B and ROTATEQ vaccine (lot number, dose number, route and anatomical site of administration were not reported. On 14 November 2013 same day after vaccination immediately the patient had developed blotchy, rash and swelling at injection site. Laboratory investigation was and corrective treatments were not reported. On the same day 20 mins after, the patient had recovered from events. Documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Initial case was received from a health care professional on 14 October 2013. A 10 patients (gender and sex unknown) had no medical history reported, received a dose FLUZONE intramuscularly on an unspecified date in 2012 (Site, batch number not reported) Patient had not reported concomitant medication. It was reported that on an unspecified date in 2012 patients felt that they had low grade temp, and body aches for one week. No corrective treatment was reported. At the time of report the outcome of event was recovered.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Rash, Urticaria, Vaccination site swelling
Clinical narrative: Initial case was received from a healthcare professional on 14 October 2013. A 46-year-old female patient had received an intramuscular dose of FLUZONE TIV vaccine, batch number: UH906AF in the left arm (dose number was not reported) on 03 October 2013. Patients illness at time of vaccination and medical history was unknown. It was reported that the patient had received many doses of flu vaccine since 1998. On 08 October 2013, the patient developed itching and swelling at the vaccination site on left arm. Patient also had hives all over body and rash on her other arm. Corrective treatments were not reported and laboratory investigations were not reported. At the time of this report, the patient had not recovered from the event. Documents held by sender: none
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration
Clinical narrative: Initial report received from a healthcare professional on 14 OCTOBER 2013. A female patient whose, date of birth, age at the time of vaccination was not reported and medical history and concomitant medications was unknown, had received an intramuscular dose of FLUZONE, batch number, dose, site of administration were not reported) on 30 SEPTEMBER 2013. On 01 OCTOBER 2013, one day after vaccination, the patient noticed a discoloration of her skin at the injection site. IT was about the size of a pencil eraser. The skin in this area. Lightened up in color. NO other symptoms reported.  Corrective treatments were not reported and laboratory investigations were not performed.  At the time of this report the patient was not recovered from the event.  Documents held by sender: None.  Follow-up received on 14-OCTOBER 2013: Lot # 134224 and vaccination site, arm. Updated
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a consumer through social media site on 11 OCTOBER 2013.  A patient had received a dose of FLUZONE (lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date.  On an unspecified date, the patient had developed experienced slightly sore in arm. Laboratory investigation was and corrective treatments were not reported. At the time of this report, the patient had not recovered from events. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Initial case was received from a health care professional on 16 OCTOBER 2013. An adult female patient (age unknown) had no medical history reported, received a dose of FLUZONE vaccine in right arm on 15 OCTOBER 2013. (Route, batch number not reported). Patient had not reported concomitant medication. IT was reported that on 15 OCTOBER 2013 patient had injection site pain. No corrective treatment was reported. At the time of report the outcome of event was not recovered.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Initial report received from a healthcare professional on 23 SEPTEMBER 2013. A female patient, whose age, medical history and concomitant medication were not reported and has had flu vaccine in the past, had received a FLUZONE (batch number, dose, site of administration were not reported) intramuscularly on 19 JANUARY 2012.  On unspecified date, the patient complaint that hands and feet were swollen for 3 days with itchy skin. The patient received ZYRTEC as corrective treatments and laboratory investigations were not reported. At the time of this report, the event was resolved.  Documents held by sender: None.  Additional information received  from the nurse on 13 NOVEMBER 2013. Outcome of the event changed from unknown to resolved.
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthma, Condition aggravated
Clinical narrative: Initial report received on 23 September 2013 from a health care professional. A male patient of unknown age, whose medical history included asthma and concomitant medications was not reported, received a dose of FLUZONE via intramuscular route 1 in each deltoid from 23-Sep-2013. After vaccination, on same day he experienced stomach distress and had to use asthma inhaler. List of documents held by sender: none.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Initial report received from a healthcare professional on 23 September 2013. A male patient, whose age, medical history and concomitant medication were not reported and has had flu vaccine in the past, had received FLUZONE (batch number, dose, site of administration were not reported) intramuscularly on 19 January 2012. On unspecified date, the patient complaint that hands and feet were swollen for 3 days with itchy skin. The patient received ZYRTEC as corrective treatment and laboratory investigations were not reported. On an unspecified date, the patient was recovered from the event. Documents held by sender: none. Follow-up received on 21 November 2013: No new information received.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Initial report received from a healthcare professional on 20 September 2013. A 70-year-old female patient with no medical history had received a dose of FLUZONE (batch number: UH906AB) intramuscularly in the left deltoid on 19 September 2013. On 19 September 2013, one hour post vaccination the patient experienced pain at the injection site that radiated down to the elbow of her left arm. The patient was advised by the reporter to take nonprescription pain relievers she normally uses and if no relief to contact the reporter. Laboratory investigations and treatment medications 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 was received on 11 November 2013. On an unspecified date outcome of event was recovered.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site vesicles, Underdose
Clinical narrative: Initial report received from a consumer on 16 September 2013. A female patient whose age at the time of event was not reported had received an intradermal dose of FLUZONE (batch number, dose number and anatomical site of administration were not reported) on an unspecified date of September 2013. The patient's medical history and illness at the time of vaccination were unknown and concomitant medication was not reported. It was also reported that when FLUZONE dose was administered some vaccine ran down the patient's arm leading to vaccine underdose On an unspecified date of September 2013, after vaccination the patient developed small bleb and experienced little redness at the injection sire. Corrective treatments and laboratory investigations were not reported. On an unspecified date, the patient had recovered from the events. Documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Vaccination site bruising, Vaccination site swelling
Clinical narrative: Initial report received from a healthcare professional on 16 September 2013. A 52-year-old female patient had received an intramuscular dose of FLUZONE (batch number: UH906AB, expiry date-06/30/2014) in the left deltoid on 13 September 2013. The patient had received numerous previous doses of Influenza vaccine. The patient had no known pre-existing physician diagnosed drug allergies, birth defects, medical history and illness at time of vaccination. Concomitant medications were not reported. Patient did not receive any other concomitant vaccines. On 16 September 2013, the patient had experienced swelling, bruising at vaccination site of left arm, soreness of her ankle and wrist joints. The corrective treatments and laboratory investigations were not reported. At the time of this report, the patient had not recovered from the events. Follow up information received from a healthcare professional on 21 October 2013. The patient had received 0.5 ml dose of FLUZONE at 14:30 hours. The patient had adverse event at 07:15 hours. The patient had no illness at the time of vaccination. The patient had received CRESTOR 10 mg and Zolpidem 10 mg as concomitant medication. The patient had not received any corrective treatments and no laboratory investigation were done. List of documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial report received from a pharmacist on 24-Sep-2013: A 43 year old female patient had received intramuscular (IM) FLUZONE (lot # UH891AA and expiration date unknown) on left deltoid on 19-SEP-2-13. On 19-Sep-2013, the patient experienced soreness in left arm at injection site. On 20-Sep-2013 she experienced generalized body aches and difficulty raising left, on 22-Sep-2013, she experienced blurred vision, dizziness and nausea, as well as on 09/23/13 and on 09/24/13, complaining of diaphoresis and weakness. The patient was not recovered. Documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Vision blurred
Clinical narrative: Initial report received from a pharmacist on 24-Sep-2013: A 43 year old female patient had received intramuscular (IM) FLUZONE (lot # UH891AA and expiration date unknown) on left deltoid on 19-SEP-2-13. On 19-Sep-2013, the patient experienced soreness in left arm at injection site. On 20-Sep-2013 she experienced generalized body aches and difficulty raising left, on 22-Sep-2013, she experienced blurred vision, dizziness and nausea, as well as on 09/23/13 and on 09/24/13, complaining of diaphoresis and weakness. The patient was not recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Two patients whose medical history and concomitant medications were not reported, received a dose of FLUZONE (lot number: UH899AD, expiry date: 30 Jun 2014) intramuscularly on deltoid on 01 October 2013. On 01 October 2013, patients had red raised welts like an itchy rash 1 hour after the vaccine that lasted 1 hour then went away. The events were resolved. Listed of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Initial report received from a consumer on 02 October 2013. A 5 year old female received FLUZONE (Lot # 08AA1201BC, expiration date 01-May-2015) intramuscularly at left deltoid on 12-Sep-2013. Within 24 hours of vaccination, on 13-Sep-2013, the patent developed a 1/4 inch red, raised bump below the injection site. The bump then became itchy and that lasted for one week. The patient had history of environmental and food allergies. Documents held by sender: None.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Ear pruritus, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Initial report received from a Non healthcare professional via consumer on 26 September 2013. A 72 year(s) old female, patient received FLUZONE on 24-Sept-2013; i.e. same day the patient also received the PNEUMOCOCCAL VACCINE. On 24-Sep-2013; 1.e same day the patient experienced mild fever (100.2 degree F), achy, sore throat, and stuffy nose. She also reports very itchy inside her ears. The patient medical history and concomitant medications were not reported. The patient's outcome was not reported. Document held by sender: none
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Initial case was received from a health care professional on 30 September 2013. A-40-year old female patient whose concomitant medications were not reported had received intramuscular FLUZONE (Lot number UH917AB, dose not reported) on her left deltoid on 27 September 2013. The patient was allergic to PCN and Sulfa. On 27 September 2013, the patient took off bandaid from the injection site. On the next day, there was red mark outlining the bandaid and blister in one of the corners of the red mark outling the bandaid. The blister was 2 inches from the injection. No corrective treatment or laboratory details were reported. The outcome of the event was not recovered. List of documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: Initial case received from a health care professional on 27 SEPTEMBER 2013. This female patient of unknown demographics whose medical history and concomitant medications were not reported had received FLUZONE 1 ml (route, lot number and anatomical site of administration not reported) on an unspecified date. On an unspecified date, after receiving FLUZONE the patient became pregnant. Patient's last date of menstruation, estimated date of delivery and pregnancy ongoing status was not reported. She did not experience any other event. No laboratory details were reported. List of documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Initial report received on 26 SEPTEMBER 2013 from a health care professional. A female patient whose age, medical history and concomitant medications were not reported, received a dose of FLUZONE ID, lot number, route and site of vaccination was not reported) on an unspecified date.  It was reported that a patient have received the FLUZONE ID. On September 2013. Patient reported numbness from below the elbow to her fingertips. List of documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Initial report received on 26 SEPTEMBER 2013 from a health care professional. Five patients whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE (lot # UH898AC and expiration date 30-JUN-2013) intramuscular (site of vaccination was not reported) within the last month.  It was reported that within the last month those five patients have experienced rash, swelling and pain at injection sites.  Patients were given previous does of influenza USP trival a-b subvirion vaccine. As of 25 SEPTEMBER 2013: The outcome of the events was unknown. List of documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 01 OCTOBER 2013. A female patient (date of birth and age at the time of event was not reported) had received a dose of FLUZONE (lot number, route, dose in series and site of administration was not reported) on 01 OCTOBER 2013.  The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) and concomitant medications were not reported. The patients last menstrual period date was unknown and the expected date of delivery was not reported. As of the time of this report, the patient did not experience any adverse event. List of documents held by the sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: Initial report received from a healthcare professional on 26 SEPTEMBER 2013 whose medical history and concomitant medication were not reported., had received FLUZONE (lot number 6H889AA, expiry date: 30 JUN 2014, route and site were not reported) on an unspecified date. It was reported that patient experience adverse reaction on an unspecified date. Laboratory details and corrective treatment were not reported. The patient's outcome was unknown. List of documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Initial report received from healthcare professional on 24 OCTOBER 2013.  A female patient (age unknown) whose medical history and concomitant medications were not reported received FLUSONE (lot number UH895AB and expiration date unknown) intramuscularly in left deltoid (dose number not reported) on 18 SEPTEMBER 2013.  On an unknown date, the patient has experienced left shoulder pain, with pain upon movement of arm in forward direction, following vaccination to today 24 OCTOBER 2013.  Laboratory investigation and corrective treatment were not reported. As of 24 OCTOBER 2013, outcome of event was not recovered. Documents held by sender: None.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Limb discomfort
Clinical narrative: Initial report received from healthcare professional on 24 OCTOBER 2013. A female patient (age unknown) received FLUZONE (lot number UH895AB and expiration date unknown) intramuscularly in left deltoid (dose number not reported) on 18 SEPTEMBER 2013. The patient's medical history was not reported. The concomitant medication was not reported. On an unknown date, the patient has experienced left shoulder pain and loss of motor function of arm extending to thumb following vaccination that continues to today and she can move arm in backward direction but cannot move arm in forward direction or upward direction without discomfort. Laboratory investigation and corrective treatment were not reported.  As of this report, the patient had not recovered from the events. Documents held by sender: None.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Fatigue, Feeling cold, Injection site pain, Pruritus
Clinical narrative: Initial report received from a consumer (who is also the patient) on 24 October 2013. A 58 years old female patients whose medical history included ongoing genital herpes, allergy to ampicillin, and sulfa drugs cause nausea and concomitant medication was not reported, had received a dose of FLUZONE (lot # UH898AA, route was intramuscular and site of vaccination was right deltoid) on 16 October 2013. Patient reported that seven days after vaccination, she began having hives at different locations on her body, which were red, raised and itchy. Also reported 24 hours after vaccination she had soreness at the right deltoid for two days, began feeling like a cold was coming on and felt very tired. She was seen by a physician and who prescribed prednisone, CLARITIN in the AM and BENADRYL in the PM. She also stated that as a child, she was allergic to eggs. But as an adult, eats eggs often. She also reported that in 2009 she had Novartis Influenza product, lot # 960364P, and experienced the same reaction. She was treated with DEPOMEDROL shot. In 2010 she received a Novartis Influenza product, lot # 111815P1, with no reaction. In 2011 she received FLUZONE lot # UH454AB, with no reaction. In 2012 she received FLUZONE lot # UH719AD and had the same reaction of hives occurring 7 days after the vaccination. Vaccinated on 24 October 2012 and hives occurred on 30 October 12. Events were not recovered at the time of report. List of documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Urticaria
Clinical narrative: Initial report received from a consumer (who is also the patient) on 24 October 2013. A 58 years old female patients whose medical history included ongoing genital herpes, allergy to ampicillin, and sulfa drugs cause nausea and concomitant medication was not reported, had received a dose of FLUZONE (lot # UH898AA, route was intramuscular and site of vaccination was right deltoid) on 16 October 2013. Patient reported that seven days after vaccination, she began having hives at different locations on her body, which were red, raised and itchy. Also reported 24 hours after vaccination she had soreness at the right deltoid for two days, began feeling like a cold was coming on and felt very tired. She was seen by a physician and who prescribed prednisone, CLARITIN in the AM and BENADRYL in the PM. She also stated that as a child, she was allergic to eggs. But as an adult, eats eggs often. She also reported that in 2009 she had Novartis Influenza product, lot # 960364P, and experienced the same reaction. She was treated with DEPOMEDROL shot. In 2010 she received a Novartis Influenza product, lot # 111815P1, with no reaction. In 2011 she received FLUZONE lot # UH454AB, with no reaction. In 2012 she received FLUZONE lot # UH719AD and had the same reaction of hives occurring 7 days after the vaccination. Vaccinated on 24 October 2012 and hives occurred on 30 October 12. Events were not recovered at the time of report. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Nodule
Clinical narrative: Initial report received from a reporter on 24 OCTOBER 2013. A female adult patient had received FLUZONE MDV (lot # UH900AD and expiration date unknown) right/left deltoid on past two weeks. On 24-OCT-2013 within 24 hours, the patient had reported about a knot in her arm. At the time of the report, the outcome of the event was unknown. No further relevant information reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Computerised tomogram, Ear pain, Fall, Injection site joint pain
Clinical narrative: Initial report received from a consumer on 24 OCTOBER 2013. At 55 years old female patients whose medical history was not reported and concomitant medication included antibiotics, had received a dose of FLUZONE (lot number, route was intramuscular and site of vaccination was left deltoid on 06 OCTOBER 2013). Caller reported that during the injection (on 06 OCTOBER 2013), a pain traveled to left ear to elbow which lasted 1 hour, left arm was sore for 2 days. On 10 OCTOBER 2013, she could not get up and she kept falling back and her head was spinning. She took vertigo medication from the pharmacy. On 16 OCTOBER 2013 she went to a neurologist, who did MRI and CT scans and diagnosed vertigo which continues when she turns to the left on the side she got the vaccine. Events were not recovered at the time of report. List of documents held by sender: None.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Vertigo
Clinical narrative: Initial report received from a consumer on 24 OCTOBER 2013. At 55 years old female patients whose medical history was not reported and concomitant medication included antibiotics, had received a dose of FLUZONE (lot number, route was intramuscular and site of vaccination was left deltoid on 06 OCTOBER 2013). Caller reported that during the injection (on 06 OCTOBER 2013), a pain traveled to left ear to elbow which lasted 1 hour, left arm was sore for 2 days. On 10 OCTOBER 2013, she could not get up and she kept falling back and her head was spinning. She took vertigo medication from the pharmacy. On 16 OCTOBER 2013 she went to a neurologist, who did MRI and CT scans and diagnosed vertigo which continues when she turns to the left on the side she got the vaccine. Events were not recovered at the time of report. List of documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a reporter on 24 OCTOBER 2013. Sixteen adult patients had received FLUZONE MDV (lot # UH900AD and expiration date unknown) right/left deltoid on past two weeks. On 24 OCT 2013 within 24 hours, the patients reported about severe arm pain in the whole arm that they received the vaccine and one patient, had a knot in her arm. Some had some redness and swelling. At the time of the report, the outcome of the event was unknown. No further relevant information reported.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a nurse on 24 OCTOBER 2013. Four patients had received FLUZONE (lot # UH907AB and expiration date unknown) intramuscular (IM) on 22-OCT-2013. On 23-OCT-2013, the patients complained of red, swollen, hot injection sites with some hardness under the redness. On 24-OCT-2013, the whole deltoid on one female was red. At the time of this report, the outcome of the event was not recovered. No further relevant information reported.
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Initial report received from health care professional on 23 OCTOBER 2013. A female patient (age unknown), medical history and concomitant medications were not reported, had received a dose of FUZONE (lot number unknown, route intramuscular and site of vaccination was unknown) on an unknown date. On an unknown date, after receiving vaccine, the patient experienced numbness and major pain for several hours. At the time of this report, outcome of events were unknown. Documents held by sender: None.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site paraesthesia, Paraesthesia
Clinical narrative: Initial report received from a healthcare professional on 22 October 2013. A 39-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE (lot number: UH907AB, expiry date: unknown) intramuscularly on left deltoid on 22 October 2013. On 22 October 2013, patients experienced tingling at the injection site and her left foot. The outcome of the event was unknown. Patient received FLUZONE also last year. List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU3, FLUX, FLUX
Symptoms: Eye swelling
Clinical narrative: This case was received from a health care professional on 22-Oct-2013. A 56 year old female patient received an injection of FLUZONE (batch number UH890AB), dose in series, route and site of administration not reported, on an unreported date. Patient experienced eyes swollen after 12 hours of vaccination. Ocular reaction alone. Previous two years with flu vaccine had the same. Not sure if FLUZONE in past years.
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Pain in extremity
Clinical narrative: Initial spontaneous report received from a consumer on 21 October 2013. A female received FLUZONE (Lot # and expiration date unknown) in 2013. Within 2 hours of vaccination, the patient had pain from shoulder bone to fingers and cannot pick up things. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Paraesthesia, Rash, Throat tightness
Clinical narrative: Initial report received from a nurse 18 October 2013. A 27 year old female patient, whose medical history were not reported, had received a dose of FLUZONE (Lot number UH926A6, intramuscularly on left deltoid) on 11 October 2013. On 11 October 2013, after receiving vaccine the patient experienced dizziness within one minute of injection. Patient also experienced throat feeling tight, hot sensation, and feeling of tingling down her spine and had rash on chest. Corrective treatment included BENADRYL 50 mg. Concomitant medication included low dose of beta blocker. At the time of this report the outcome of adverse events were resolved. Documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling
Clinical narrative: Initial report received from a consumer's grandmother to health care professional on 25 October 2013. A 5 year old female patient, medical history of Dandy-Walker syndrome and concomitant medications were not reported, had received a dose of FLUZONE (lot number, route and site of vaccination were unknown), on an unspecified date in September 2013. On an unspecified date, after receiving vaccine next day, the patient experienced hip on opposite side from vaccination was swollen. Reporter stated swelling of hip had continued to today, 25 September 2013. She did not know lot number of vaccine. Documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Limb injury
Clinical narrative: Initial report received from a health care professional on 28 October 2013. A 61 year old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE vaccine (Lot number UH904AA, route and site of vaccination were not reported), on unknown date. On 28-Oct-2013, when she tried to flip the cap off the MDV the vial broke off at the neck and a piece of glass went into her right thumb. There was no bleeding and the shred of glass was easily removed. At the time of reporting, outcome of the event was unknown. No further relevant information was reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: A patients of unknown age, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (Lot number UH907AD via intramuscular route, site of vaccination were not reported), on last week (2013). On an unspecified date, after receiving vaccine the patients experienced site reactions and high amount of pain at injection site. At the time of this report the outcome of adverse event was unknown. Documents held by sender: none. Follow up information was received on 17 January 2014: On an unspecified date, the event of "site reactions" and "high amount of pain at injection site" was recovered.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Initial report received from healthcare professional on 16 October 2013. A patient (age, gender, unknown) whose medical history and concomitant medications were not reported received dose of FLUZONE (route, from, frequency and batch number not reported) on an unspecified date. The reported asked for possible side effects for FLUZONE. No adverse event reported at this time. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial report received from a healthcare professional on 24-Oct-2013. A patient whose age, gender, medical history and concomitant medications were not reported, received a dose of FLUZONE (lot number, route and site of administration was unknown) on an unknown date. On an unknown date, patient experienced adverse event. The outcome of the event was unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU3, IPV, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 01 October 2013. The patient had received FLUZONE, ADACEL and IPOL vaccine on 01 October 2013 and temperature was 30 F each day when they thought this temperature was the storage temperature. The patient was given unstable vaccine. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Abdominal pain upper, Headache, Nausea
Clinical narrative: Initial report received consumer on 01 November 2013. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE (route, lot # UH894AA and site of vaccination was not reported) on 30 October 2013. Reporter stated that three patients who received FLUZONE on 30 October 2013 and that day began experiencing headache, nausea, and stomach cramping. Also stated symptoms continue to today, on 01-November-2013. List of documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Induration, Injection site discolouration, Pain in extremity, Peripheral swelling
Clinical narrative: Initial report received from healthcare professional on 04 November 2013. A 13-year-old male patient and his mother, whose medical history and concomitant medications were not reported and had the vaccine every year since 2003, were both received a dose of Flu vaccine (manufacturer, batch number, route and anatomical site of administration were not reported) on an unspecified date of Saturday.  It was reported that, after vaccination in the same day at 2:30 PM patient told to his mother his arm hurt and was swollen. There was a black and blue mark around the injection site, about 1 cm in diameter. His shoulder was noticeably swollen compared with the arm, and it was hard to the touch. He didn't have a fever. Patient's mother gave him 200 mg Ibuprofen. later that night (around 9 pm) the swelling was reduced but still there. His arm was still sore. On Sunday (the next day), his arm was still sore but not to the point. Documents held by sender: none. Follow up information received on 28 April 2014. It was reported that patient had received FLUZONE vaccine on 02 November 2013. The patient had illness at the time of vaccination was reported as none and patient had allergic to sulfa antibiotics. The patient other medications were reported as none. On 02 November 2013 i.e. on same day of vaccination patient had experienced his arm hurt and was swollen. There was a black and blue mark around the injection site, about 1 cm in diameter. The outcome of the event was recovered on an unspecified date.