chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Diarrhoea, Neck pain, Sinus headache
Clinical narrative: Initial report was received from a health care professional on 21 September 2011. A 65-year-old female patient had received a FLUZONE HIGH-DOSE injection in left deltoid, lot number UH439AA on 15 September 2011. Six hours after vaccination the patient developed chills, diarrhea, neck and joint pain, sinus pain and vomiting. No further information was available at the time of the report. The patient's outcome was recovered/resolved. Follow-up information was received on 03 January 2012 from a health care professional. The patient recovered on 17 September 2011. Documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Initial report was received from a health care professional on 21 September 2011. A 65-year-old female patient had received a FLUZONE HIGH-DOSE injection in left deltoid, lot number UH439AA on 15 September 2011. Six hours after vaccination the patient developed chills, diarrhea, neck and joint pain, sinus pain and vomiting. No further information was available at the time of the report. The patient's outcome was recovered/resolved. Follow-up information was received on 03 January 2012 from a health care professional. The patient recovered on 17 September 2011. Documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site warmth, Nausea, Night sweats
Clinical narrative: Initial non-serious report received from a consumer on 22 September 2011 under the local reference number 11-0609. A 70-year-old female with a medical history of fibromyalgia, diabetes and sleep apnea had received an intramuscular dose of FLUZONE HIGH-DOSE (batch number unknown) in the left arm in early September 2011 at 2:00 p.m. The patient was under concomitant treatment with VICTOSA and "FORDm". The patient had no illness at time of vaccination and no known allergies. 7 hours after vaccination, the patient had her left deltoid sore and warmth at injection site. She also experienced nausea and "night sweats" all night. According to the reporter, symptoms resolved except arm which was reported as "a little sure". The patient treated herself with TYLENOL. At the time of the report, the patient's outcome was unknown. Follow-up information was received from a health care professional on 03 January 2012. The lot number for FLUZONE HIGH-DOSE was reported as UH439AA. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a health care professional on 02 March 2012 reported that the patient recovered. Documents held by sender: none.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chest pain, Dysphagia, Eye discharge
Clinical narrative: Initial non-serious report received from a consumer on 23 September 2011 under the local reference number 11-0615. A 72-year-old previously healthy male patient with an unknown medical history had received an intramuscular dose of FLUZONE HIGH-DOSE (batch number and site of administration not reported) on 22 September 2011 at 9:00 a.m. On 22 September 2011 at 1:00 p.m., i.e. 4 hours after vaccination, the patient had symptoms of generalized weakness, chest pain, difficulty swallowing and white drainage coming from his eyes. It was unknown if the patient had adverse event following prior vaccination. The patient went to emergency room. The patient recovered on an unspecified.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Feeling hot, Flushing, Throat tightness
Clinical narrative: Initial report was received from a health care professional on 23 September 2011. This case is one of a cluster of three patients who experienced adverse events following administration of FLUZONE HIGH-DOSE, lot number UH452AB. The events for the other two patients were captured in cases 2011-09289 and 2011-09290. A female patient (name and date of birth not reported) who was reported to be greater than or equal to 65 years of age, had received on 19 September 2011 an intramuscular right arm injection of FLUZONE HIGH-DOSE, lot number UH452AB and within five minutes, complained of being flushed, warm and throat tightness. Her blood pressure was increased to 200/80. The patient was transported to the ER (emergency department) by ambulance. She was evaluated, treated and released. Treatments were not reported. Concomitant medications included a blood thinner (not otherwise specified). No further information was available at the time of the report. The patient's outcome was recovered. Follow-up information was received from a healthcare professional on 31 October 2011. The patient received corrective treatment at a medical center. No further information was available at the time of this report. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Headache, Malaise, Musculoskeletal pain, Nausea, Oedema peripheral
Clinical narrative: Initial report received from a health care professional on 11 September 2012. A 80 something-year-old female patient, whose illness at the time of vaccination was unknown, had received a first dose of intramuscular FLUZONE HD (lot number, anatomical site of vaccination were not reported) on 01 September 2012. On an unspecified date, the patient developed low grade fever, headache, nausea, malaise, body aches, swollen arm and shoulder pain. The events of low grade fever, headache, nausea, malaise, body aches, swollen arm and shoulder pain were persisting. Corrective treatment was not reported. List of documents held by the sender none.
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Initial report received from a health care professional on 11 September 2012. A 80 something-year-old female patient, whose illness at the time of vaccination was unknown, had received a first dose of intramuscular FLUZONE HD (lot number, anatomical site of vaccination were not reported) on 01 September 2012. On an unspecified date, the patient developed low grade fever, headache, nausea, malaise, body aches, swollen arm and shoulder pain. The events of low grade fever, headache, nausea, malaise, body aches, swollen arm and shoulder pain were persisting. Corrective treatment was not reported. List of documents held by the sender none.
Age: 98.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure systolic increased, Chest discomfort, Electrocardiogram normal, Feeling hot, Flushing
Clinical narrative: Initial report was received from a health care professional on 23 September 2011. This case is one of a cluster of three patients who experienced adverse events following administration of FLUZONE HIGH-DOSE, lot number UH452AB. The events for the other two patients were captured in cases 2011-09288 and 2011-09290. A female patient (name and date of birth not reported) who was reported to be greater than or equal to 65 years of age with a history of A fib, had received on 09 September 2011 an intramuscular right arm injection of FLUZONE HIGH-DOSE, lot number UH452AB and within minutes, complained of her left ear felt hot, felt warm, flushed, she had chest discomfort lasting approximately two to three minutes and an irregular pulse. The patient was transported to the ER (emergency department). She was evaluated, treated and released. Treatments were not reported. Diagnostic test included a normal EKG and her systolic blood pressure was increased to 200. No further information was available at the time of the report. The patient's outcome was recovered. Follow-up information was received from a healthcare professional on 31 October 2011. The patient received corrective treatment within a hospital. No further information was available at the time of the report. Documents held by sender: none.
Age: 98.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate irregular, Skin warm
Clinical narrative: Initial report was received from a health care professional on 23 September 2011. This case is one of a cluster of three patients who experienced adverse events following administration of FLUZONE HIGH-DOSE, lot number UH452AB. The events for the other two patients were captured in cases 2011-09288 and 2011-09290. A female patient (name and date of birth not reported) who was reported to be greater than or equal to 65 years of age with a history of A fib, had received on 09 September 2011 an intramuscular right arm injection of FLUZONE HIGH-DOSE, lot number UH452AB and within minutes, complained of her left ear felt hot, felt warm, flushed, she had chest discomfort lasting approximately two to three minutes and an irregular pulse. The patient was transported to the ER (emergency department). She was evaluated, treated and released. Treatments were not reported. Diagnostic test included a normal EKG and her systolic blood pressure was increased to 200. No further information was available at the time of the report. The patient's outcome was recovered. Follow-up information was received from a healthcare professional on 31 October 2011. The patient received corrective treatment within a hospital. No further information was available at the time of the report. Documents held by sender: none.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage
Clinical narrative: Initial report was received from a healthcare professional on 10 November 2011. A 3-year-old male patient had received an Intramuscular (IM) injection of FLUZONE; lot number UH506AB in left thigh. On an unspecified date, the patient developed ecchymosis at the injection site toward anterior of thigh. While receiving the injection, the patient moved and the needle slightly moved "skipping over the area" to more anterior aspect of thigh. No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Initial report was received from a health care professional on 10 January 2012. This reporter also reported another adverse event in case 2011-00349. This case involved the same patient. A four-year-old female patient had received a first dose intramuscular injection in the left deltoid of FLUZONE, sanofi pasteur Inc., lot number U4147BA on 06 January 2012. On 06 January 2012, the patient experienced a 10 centimeter (cm) by 7cm red, hot, itchy area at the injection site. The patient had no illness at the time of vaccination and took no concomitant medications. The patient had an allergy to sulfa and previously experienced a 9 centimeter (cm) by 12cm site reaction after receiving the fifth dose injection of DAPTACEL. The patient had no previous FLUZONE vaccinations. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Pain in extremity
Clinical narrative: Initial report was received from a patient on 21 October 2011. A 26-year-old female patient had received an intramuscular (IM) injection of FLUZONE in right deltoid; lot number UT447AA on 18 October 2011. On the same day of the injection, the patient experienced a sore arm and chest tightness which resolved within twenty four hours. No further information was available at the time of the report. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during breast feeding, Injection site pain, Lactation disorder
Clinical narrative: Initial report was received from a health care professional on 24 October 2011. A 37-year-old female patient received an intramuscular injection of FLUZONE in left deltoid, lot number UH442AB on 27 September 2011. On the same day of the injection, the patient experienced tenderness at the injection site. At the time of the vaccination the patient was lactating, after the vaccination the patient had "difficulty" lactating. No further information was available at the time of the report. The patient outcome was not recovered/not resolved. Follow-up information was received from a healthcare professional on 01 February 2012. The patient had no illness but was nursing at the time of vaccination. Concomitant medication was reported as unknown. No additional information was provided at the time of the report. The patient outcome was not reported. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Immediate post-injection reaction, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Initial report was received from a patient on 25 October 2011. A 43-year-old female patient had received an intramuscular (IM) injection of FLUZONE in left deltoid; lot number UT481AB on 27 September 2011. On the same day, immediately after the vaccination the patient developed soreness in her arm which has gotten increasingly worse, sharp pain with certain movements, limited range of motion (ROM) and feels a "soft burn in her muscle". No further information was available at the time of the report. The patient's outcome was not recovered/not resolved. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Injection site swelling, Pain
Clinical narrative: Initial report was received from a health care professional on 28 October 2011. An 11-year-old female patient had received a FLUZONE Intradermal in left deltoid, lot number U4178AA and MENACTRA in right deltoid, lot number U4241AA on 24 October 2011. On 27 October 2011, 3 days after vaccination the patient was seen in the doctor office for swelling at the right deltoid in which radiates down to the mid arm. The patient also complained of pain. No further informational was available at the time of the report. The patient outcome was unknown. Follow-up information was received from a healthcare professional on 20 January 2012. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Initial information received from another manufacturer (service request number 1-5424891248) on 13 August 2012. The information was originally provided to the other manufacturer from a pharmacist. A patient with (unknown demographics) (unknown gender) with no reported medical history and concomitant medications received FLUZONE and PNEUMOVAX 23 injection (batch number, route, site of administration, dose, dose number were not reported) on an unknown date. It was reported that the patient developed rash after possibly receiving FLUZONE. Details of lab tests and treatment were not reported. The outcome of the events was not reported. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Paraesthesia, Peripheral coldness
Clinical narrative: Initial report was received on 09 January 2012 from a health care professional. A 68 year-old female patient with a history of elevated blood pressure had received on 30 November 2011 an intramuscular left deltoid injection of FLUZONE HIGH-DOSE, Lot number UH490AA, the next day on 30 November 2011, the patient experienced tingling and weakness in the left arm and sensation of coldness in the left arm. The symptoms still persist "a little over a month later." Concomitant medications included: Losartan and Furosemide. The patient had no illness at time of vaccination. No further information was available at time of the report. The patient's outcome was reported as not recovered. Documents held by sender: None.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Pain, Pyrexia, Sinus disorder
Clinical narrative: Initial report was received from a patient on 21 October 2011. A 72-year-old female patient had received a FLUZONE injection in left deltoid, lot number UH476AC on 06 October 2011. On 08 October 2011, the patient developed a scratchy throat, two day later on 10 October 2011; she developed aches, fever, cough, sinus swelling and chills which resolved on 14 October 2011. The course of treatment was not reported. No further information was available at the time of the report. The patient outcome for scratchy throat was reported as not recovered/not resolved. Follow-up information was received from a healthcare professional on 20 January 2012. The patient was not seen in follow-up for the symptoms described and no corrective treatment provided. The patient outcome was reported as recovered/resolved on November 2011. Documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Initial report was received from a patient on 21 October 2011. A 72-year-old female patient had received a FLUZONE injection in left deltoid, lot number UH476AC on 06 October 2011. On 08 October 2011, the patient developed a scratchy throat, two day later on 10 October 2011; she developed aches, fever, cough, sinus swelling and chills which resolved on 14 October 2011. The course of treatment was not reported. No further information was available at the time of the report. The patient outcome for scratchy throat was reported as not recovered/not resolved. Follow-up information was received from a healthcare professional on 20 January 2012. The patient was not seen in follow-up for the symptoms described and no corrective treatment provided. The patient outcome was reported as recovered/resolved on November 2011. Documents held by sender: none.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Nausea, Vomiting
Clinical narrative: Initial report received from a healthcare professional on 20 August 2012. A 82-year-old male patient, whose had no medical history and concomitant medications was not reported, had received intramuscular dose of FLUZONE HD vaccine in left deltoid (lot number: U4489AA) on 18 August 2012. The reported stated that, the patient presented with nausea, vomiting, short of breathing (SOB) and fatigue on 17 August 2012. The patient had no relevant diagnostic tests/laboratory data. The outcome of the event was unknown. List of documents held by sender: none.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia
Clinical narrative: Initial information received from a healthcare professional on 05 September 2012. A 87-year-old female patient whose medical history included Alzheimer's like symptoms and with no reported concomitant medications received an intramuscular dose of FLUZONE (Batch lot number UH721AB) on left deltoid on 05 September 2012. The reporter stated that the patient experienced headache, numbness of face, after receiving FLUZONE on 05 September 2012. The patient was observed in office for 20 mins and discharged without complaint on the same day i.e. 05 September 2012. Corrective treatment was not reported. The events were resolved on 05 September 2012. Documents held by sender: none.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia
Clinical narrative: Initial information received from a healthcare professional on 05 September 2012. A 92-year-old female patient with a history of TIA (Transient Ischemic Attack) had received an intramuscular (IM) dose of FLUZONE injection (lot number UH721AB) in left deltoid on 05 September 2012. On 05 September 2012, the patient experienced "HA", numbness of face, after FLUZONE, observed in office 20 mins, and discharged without complaint on 05 September 2012. The patient ongoing illness included as none. Laboratory details and corrective treatment included none. The patient's outcome was recovered on 05 September 2012.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case is one of a cluster of 3 patients who experienced adverse events following administration of FLUZONE, lot number U4124BA. The events for the other patients were captured in cases 2011-09190 and 2011-09191. Initial report was received on 22 September 2011 from a healthcare provider. A 9-year-old male patient had received FLUZONE  intramuscular injection in right deltoid on 17 September 2011. On 18 September 2011, the patient was seen for upper respiratory symptoms, fever, red arm, hot and swollen approximately seven centimeter in size. No further information was available at the time of the report. The patient's outcome was reported as not recovered/not resolved. Follow-up information was received from a healthcare professional on 06 January 2012. On 18 September 2011, the patient was seen for a follow up for red, swollen, warm to touch at the injection site. The patient received corrective treatment with Ibuprofen for fever and discomfort and ice pack. No further follow-up needed. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral, Pyrexia, Respiratory disorder, Skin warm
Clinical narrative: This case is one of a cluster of 3 patients who experienced adverse events following administration of FLUZONE, lot number U4124BA. The events for the other patients were captured in cases 2011-09190 and 2011-09191. Initial report was received on 22 September 2011 from a healthcare provider. A 9-year-old male patient had received FLUZONE  intramuscular injection in right deltoid on 17 September 2011. On 18 September 2011, the patient was seen for upper respiratory symptoms, fever, red arm, hot and swollen approximately seven centimeter in size. No further information was available at the time of the report. The patient's outcome was reported as not recovered/not resolved. Follow-up information was received from a healthcare professional on 06 January 2012. On 18 September 2011, the patient was seen for a follow up for red, swollen, warm to touch at the injection site. The patient received corrective treatment with Ibuprofen for fever and discomfort and ice pack. No further follow-up needed. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Lethargy, Pain, Pyrexia
Clinical narrative: Initial report was received from a health care professional on 26 September 2011. A 34-year-old male patient had received an FLUZONE HIGH-DOSE intramuscular injection in left deltoid, lot number UT480AA on 24 September 2011. The patient experienced chills followed by fever (102), aches and lethargy. The events resolved within twenty four hours. The patient will follow up with his primary care physician. No further information was available at the time of the report. The patient's outcome was recovered/resolved on 26 September 2011. Follow up information was received from a healthcare professional on 09 January 2012. The patient was not evaluated by healthcare professional. No corrective treatment provided. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth, Nasal congestion, Rhinorrhoea
Clinical narrative: Case received on 30 September 2011 from a healthcare professional. A female patient, with no known allergies, with no history of medical condition and no illness at the time of vaccination, had received on 27 September 2011 her dose of FLUZONE (batch number UT433AA, route of administration not reported) on her right deltoid. She had already received several doses of flu vaccine. No concomitant therapy was reported. On 27 September 2011, i.e. the day of immunization, the patient developed at 2 inches below injection site a 60x30mm wheal-like area which was pink and warm to touch. She also experienced stuffy nose and runny nose. No corrective therapy was reported. At the time of reporting, the patient had not recovered. This case has been already reported to doctor. Documents held by sender: none.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea
Clinical narrative: Case received from a Healthcare Professional on 05 October 2011 under the reference number 11-0721. A 48-year-old male patient, with unknown medical history, had received his intramuscular dose of FLUZONE (batch number UT445AA) in the left deltoid on 03 October 2011. The patient did not have illness at time of vaccination. It was not reported if the patient had experienced adverse event following prior vaccination. It was unknown if the patient had received concomitant therapy. On 03 October 2011, the patient experienced nausea and diarrhea. He recovered on an unspecified date.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Eye discharge, Eye irrigation, Nausea, Vomiting
Clinical narrative: Case received on 12 October 2011 from a healthcare professional. A 46-year-old female had received on 11 October 2011 her yearly intramuscular dose of FLUZONE (batch number UH442AB) and her dose of PNEUMOVAX (other manufacturer, batch number 0985AA). There was no other vaccination within 4 weeks prior to 11 October 2011. Other medications were unknown. The patient had no illness at time of vaccination. She had a medical history of allergy to AROPAX. On 11 October 2011, 3 hours post-immunization, the patient developed nausea, vomiting and dark green drainage from eyes. The patient treated herself with eye wash and compresses. The reporter stated that the patient reported that symptoms resolved overnight. Documents held by sender: none.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Skin rash. Documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Paraesthesia
Clinical narrative: Initial report was received from a consumer on 27 October 2011, who is also the parent of the patient. A 17-year-old female patient had received an Intramuscular (IM) injection of INFLUENZA VACCINE (lot number not reported) in left deltoid on 25 October 2011. On 26 October 2011, the patient developed numbness and tingling in both hands, pins and needle feeling and tips of fingers were red across the palms of hands. The patient received corrective treatment with two doses of BENADRYL with no improvement. The fingertips are no longer red, however all other symptoms remain. The patient will see her primary care physician (PCP) "today". No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Follow-up information was received from a health care professional on 14 March 2012. The patient received FLUZONE, lot number UH469AB. The patient recovered on 28 October 2011. No additional information was available at the time of the report. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Initial report was received from a health care professional on 19 January 2012. This case is one of a cluster of seven patients reported by the same reporter who each experienced adverse events following administration of FLUZONE (lot number not reported). The events for the other patients were captured in case numbers 2012-00770, 2012-00771, 2012-00772, 2012-00773, 2012-00775 and 2012-00776. A female patient had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, route, site and date of administration unknown) and an unspecified amount of time later experienced achiness, feverish for 2-3 days, joint pain and muscle aches. Illness at the time of vaccination, pre-existing medical conditions and concomitant medications were unknown. The patient had several doses of influenza vaccines in the past. The patient also had the same reactions (achiness, feverish for 2-3 days, joint pain and muscle aches) following an influenza vaccine in the past. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none. Follow-up information received from a healthcare professional on 21 February 2012 reported that the 51-year-old patient had no illnesses at the time of vaccination. The patient received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur Inc. lot number UH467AB, on 17 October 2011 in the AM. On 18 October 2011, Tuesday morning, the patient felt achy and took MOTRIN every four hours (q4h) and hot baths. On Wednesday she became feverish and achier. She continued with MOTRIN and hot baths. Wednesday evening and Thursday, the fever continued and "felt like a semi truck kept driving over me and backing up and driving over me again". Every muscle and joint hurt and she continued with MOTRIN and hot baths. She had no respiratory symptoms. The outcome remained recovered. No additional information was available. Documents held by sender: Medical timeline.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Injection site haemorrhage
Clinical narrative: Initial report was received from a health care professional on 06 March 2012, as well as another manufacturer under reference number 1-367160101. A 26-year-old male patient had received an intramuscular injection in the left deltoid of FLUZONE, sanofi pasteur Inc. lot number UH463AA on 06 March 2012. Right after the vaccination, the patient experienced dizziness and cold sweats. The patient was treated with BENADRYL and sat down for 10-15 minutes. After 10 minutes, the patient's symptoms subsided and the patient stated he "was fine". The patient also noticed "more bleeding at the injection site than any other injections he has received in the past." The patient had no illness at the time of vaccination and had no known allergies. It was unknown if the patient took any concomitant medications. The patient received no other vaccinations within four weeks of FLUZONE. The patient's outcome was recovered. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Initial report was received from a health care professional on 19 January 2012. This case is one of a cluster of seven patients reported by the same reporter who each experienced adverse events following administration of FLUZONE (lot number not reported). The events for the other patients were captured in case numbers 2012-00770, 2012-00771, 2012-00772, 2012-00773, 2012-00774 and 2012-00776. A female patient had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, route, site and date of administration unknown) and an unspecified amount of time later developed diarrhea, red knot at injection site, headaches, body aches, nausea and low grade fever. Illness at the time of vaccination, pre-existing medical conditions and concomitant medications were unknown. It was also unknown if the patient had received any prior doses of influenza vaccine or received any other vaccinations within four weeks prior to FLUZONE. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none. Follow-up information received from a healthcare professional on 21 February 2012. The patient received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur Inc. lot number UH486AF (reported as invalid lot number UHF486AF), on 07 November 2011 in pm. The patient had severe diarrhea for two days and a hard knot on the left arm at injection site for a week that slowly decreased in size. On 12 November 2011, she had a headache and body ache. On 13 November 2011, she had a headache, body ache and nausea. On 14 November 2011, she had a headache, body ache, nausea and dry heaves. On 15 November 2011, she had a headache, body ache, nausea, dry heaves and then started having diarrhea. She also was vomiting up small amounts of bile and had low grade fevers between 100.1 and 101. The next day was the same. On 17 November 2011, she was back to nausea, diarrhea, and aches all over. On 18 November 2011, she had decreased diarrhea, aches still but less. On 19 November 2011, she just was slightly achy. The outcome remained recovered. No additional information was available. Follow-up information was received on 28 March 2012 from a health care professional. The lot number of FLUZONE was amended to UH486A. No additional information was available at the time of the report. The patient's outcome remained recovered. Documents held by sender: Medical timeline.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Pyrexia, Retching, Vomiting
Clinical narrative: Initial report was received from a health care professional on 19 January 2012. This case is one of a cluster of seven patients reported by the same reporter who each experienced adverse events following administration of FLUZONE (lot number not reported). The events for the other patients were captured in case numbers 2012-00770, 2012-00771, 2012-00772, 2012-00773, 2012-00774 and 2012-00776. A female patient had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, route, site and date of administration unknown) and an unspecified amount of time later developed diarrhea, red knot at injection site, headaches, body aches, nausea and low grade fever. Illness at the time of vaccination, pre-existing medical conditions and concomitant medications were unknown. It was also unknown if the patient had received any prior doses of influenza vaccine or received any other vaccinations within four weeks prior to FLUZONE. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none. Follow-up information received from a healthcare professional on 21 February 2012. The patient received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur Inc. lot number UH486AF (reported as invalid lot number UHF486AF), on 07 November 2011 in pm. The patient had severe diarrhea for two days and a hard knot on the left arm at injection site for a week that slowly decreased in size. On 12 November 2011, she had a headache and body ache. On 13 November 2011, she had a headache, body ache and nausea. On 14 November 2011, she had a headache, body ache, nausea and dry heaves. On 15 November 2011, she had a headache, body ache, nausea, dry heaves and then started having diarrhea. She also was vomiting up small amounts of bile and had low grade fevers between 100.1 and 101. The next day was the same. On 17 November 2011, she was back to nausea, diarrhea, and aches all over. On 18 November 2011, she had decreased diarrhea, aches still but less. On 19 November 2011, she just was slightly achy. The outcome remained recovered. No additional information was available. Follow-up information was received on 28 March 2012 from a health care professional. The lot number of FLUZONE was amended to UH486A. No additional information was available at the time of the report. The patient's outcome remained recovered. Documents held by sender: Medical timeline.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Initial report was received from a health care professional on 19 January 2012. This case is one of a cluster of seven patients reported by the same reporter who each experienced adverse events following administration of FLUZONE (lot number not reported). The events for the other patients were captured in case numbers 2012-00770, 2012-00771, 2012-00772, 2012-00773, 2012-00774 and 2012-00775. A 26-year-old female patient had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, route and site unknown) on 13 October 2011 and an unspecified amount of time later experienced a fever to 102, body aches and nausea. Illness at the time of vaccination, pre-existing medical conditions, any other vaccinations within four weeks of FLUZONE and number of previous doses of influenza vaccine were unknown. The patient's also took CLOMID, estrogen and metformin. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None. Follow-up information received from a healthcare professional on 21 February 2012. The patient received an intramuscular right deltoid injection of FLUZONE, sanofi pasteur Inc. lot number UH467AB, on 12 October 2011. On 14 October 2011, the patient's symptoms were fever (102), body achy and very nauseous. The patient's concomitant medications included CLOMID, estrogen, metformin and progesterone (taking all medications through the month of October, not all at one time). The patient was concerned about interference with her fertility medications. The outcome remained recovered. No additional information was available. Documents held by sender: Medical timeline.
Sex: M
Vaccine: FLU3
Symptoms: Skin test negative, Swelling face
Clinical narrative: Initial report received from the scientific literature on 17 January 2012. This reporter also reported another adverse event, which was captured in case number 2012-00728 and 2012-00738. A male child (age not reported) received an injection (route and site not reported) of influenza vaccine, manufacturer and lot number not reported, on an unknown date. The patient at age one year had a history of facial swelling after eating scrambled egg. During an egg oral food challenge at age 5-years, he experienced hives, cough, and rhinorrhea and received epinephrine and antihistamine. The patient had a history of egg and influenza skin prick test (SPT) responses which were both positive (10-mm wheal with a 20-mm flare and 4-mm wheal with a 5-mm flare, respectively). The patient had a history of previous reaction to influenza vaccine of eczema flare and hives on his wrists after 0.05 mL of influenza vaccine where he was treated with oral antihistamine and did not receive the remainder of the vaccine. He had no history of asthma. Verbatim from article: "The following year, the influenza SPT response was negative. He still received the vaccine in 2 doses. Six hours after the last dose of vaccine, facial swelling was reported, which was treated at home with oral antihistamine. A year later, his influenza SPT response consisted of a 2-mm wheal with a 3-mm flare. He had no reaction to the vaccine given in 2 doses". The outcome was not reported. Follow-up information was received from a health care professional on 28 March 2012. The patient received a dose two intramuscular injection of FLUZONE, lot number U2804AA on 14 November 2008. Six hours later on 14 November 2008, the patient experienced the facial swelling. The patient's outcome was recovered. Documents held by sender: None.
Sex: M
Vaccine: FLU3
Symptoms: Eczema, Urticaria
Clinical narrative: Initial report received from the scientific literature on 17 January 2012. This reporter also reported another adverse event, which was captured in case number 2012-00729 and 2012-00738. Verbatim from article: "Patient A was a 2-year-old boy without asthma. At age 1 year, he experienced facial swelling after eating scrambled egg. During an egg oral food challenge at age 5 years, he experienced hives, cough, and rhinorrhea and received epinephrine and antihistamine. Before influenza vaccination, his egg and influenza skin prick test (SPT) responses were both positive (10-mm wheal with a 20-mm flare and 4-mm wheal with a 5-mm flare, respectively). He had an eczema flare and hives on his wrists after 0.05 mL of vaccination. He received oral antihistamine and did not receive the remainder of the vaccine". The outcome was not reported. Follow-up information was received from a health care professional on 28 March 2012. The patient received the dose one intramuscular injection of FLUZONE, lot number U2463AA, on 11 December 2007 at 11:35. The patient's outcome was recovered. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site dryness, Injection site erythema, Injection site exfoliation, Injection site pruritus
Clinical narrative: Initial report was received from a healthcare professional on 04 January 2012. A 52-year-old female patient had received an intramuscular (IM) injection of FLUZONE; lot number UH454AD (site of administration was not reported) on 30 December 2011. On an unspecified date two to three days after vaccination, the patient developed red, scaly, dry and itchy area at injection site and surrounding area; stated better than it was. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Follow-up information was received from a health care professional on 23 February 2012. The patient recovered. No further information was available at the time of the report. The patient's outcome was recovered. Follow up information received on 27 April 2012: The onset of the adverse event was reported as 02 Jan 2012. The corrective treatments included cool compress in interim and BENADRYL for itch. Follow up information received on 15 June 2012: The patient resolved incompletely. Itch resolved however the area of reaction was still slightly visible. Updated the outcome for vaccination site exfoliation and erythema from recovered to recovering. Documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Acoustic stimulation tests, Audiogram abnormal, Brain stem auditory evoked response normal, Deafness neurosensory, Eczema
Clinical narrative: Initial report was received from a health care professional on 13 December 2011. A 59-year-old female patient had received an injection of FLUZONE, sanofi pasteur, lot number UH463AB (route and site of administration not reported) on 19 October 2011 and three days later, she developed ringing in the ears. Hearing tests were performed on 12 December 2011 and the report was pending. The patient had no known allergies and took ALLEGRA concomitantly. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none. The follow up information received on 07 May 2012: The patient had history of neomycin allergy, when she applies it topical and was told that this shot contain neomycin like product as well. The patient otherwise had allergies to erythromycin, ciprofloxacin and IV contrast. The patient reported that 10 years ago she had shingles on the left side of her face and had vesicles and was not sure whether there was any hearing loss associated with it. The patient denies any vertigo. Denies any hearing change, although states that she favors her left ear and always had slight difficulty with speech discrimination. The physical examination revealed blood pressure- 112/70, Respiratory rate- 20 and Temperature: 97.3. Nose: nasal examination shows mild rhinitis, septal deviation towards left more than right with large turbinate. Oral cavity: normal findings. Neck: No abnormalities. Ears: No any overt skin changes. Ear canals show chronic eczematoid changes. No sign of acute inflammation. The patient underwent audiogram and tympanogram which showed a slight asymmetrical high frequency sensorineural hearing loss, worse on the right than on the left. The patient underwent an ABR which showed no evidence of any retrochochlear pathology. The patient had subjective tinnitus with mild sensorineural hearing loss on the right side. The patient still not recovered from the event.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal septum deviation, Rhinitis, Tinnitus, Tympanometry abnormal
Clinical narrative: Initial report was received from a health care professional on 13 December 2011. A 59-year-old female patient had received an injection of FLUZONE, sanofi pasteur, lot number UH463AB (route and site of administration not reported) on 19 October 2011 and three days later, she developed ringing in the ears. Hearing tests were performed on 12 December 2011 and the report was pending. The patient had no known allergies and took ALLEGRA concomitantly. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none. The follow up information received on 07 May 2012: The patient had history of neomycin allergy, when she applies it topical and was told that this shot contain neomycin like product as well. The patient otherwise had allergies to erythromycin, ciprofloxacin and IV contrast. The patient reported that 10 years ago she had shingles on the left side of her face and had vesicles and was not sure whether there was any hearing loss associated with it. The patient denies any vertigo. Denies any hearing change, although states that she favors her left ear and always had slight difficulty with speech discrimination. The physical examination revealed blood pressure- 112/70, Respiratory rate- 20 and Temperature: 97.3. Nose: nasal examination shows mild rhinitis, septal deviation towards left more than right with large turbinate. Oral cavity: normal findings. Neck: No abnormalities. Ears: No any overt skin changes. Ear canals show chronic eczematoid changes. No sign of acute inflammation. The patient underwent audiogram and tympanogram which showed a slight asymmetrical high frequency sensorineural hearing loss, worse on the right than on the left. The patient underwent an ABR which showed no evidence of any retrochochlear pathology. The patient had subjective tinnitus with mild sensorineural hearing loss on the right side. The patient still not recovered from the event.
Sex: U
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: Initial report received from a Healthcare professional on 21 June 2012. A patient (age and gender- unknown), whose medical history and concomitant medications were not reported, had received dose of FLUZONE HD vaccine (batch number, route of administration and site of administration were not reported) on unspecified date. It was reported that the patient experienced increased adverse reactions (not specified) with FLUZONE HD vaccine. The patient had gone to the ER. Corrective treatment and laboratory investigations were unknown. As of 21 June 2012, the outcome of event was reported as unknown. The reporter does not correlate the ER visit with the vaccine. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Follow-up information was received from a healthcare professional on 03 January 2012. No additional information. No further information was available at the time of the report. The patient outcome was reported as recovered/resolved. Documents held by sender: None.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dysphonia
Clinical narrative: Initial report was received from a health care professional on 10 October 2011. A 41-year-old female patient had received a FLUZONE injection in left deltoid, lot number UH467AB on 06 October 2011. On the same day, 2 hours also reported as "4 hours" after vaccine the patient developed a raspy voice. When the patient tried to eat it was hard for the food to go down her throat. The patient course of treatment was BENADRYL. No further information was available at the time of the report. The patient outcome reported as recovered/ resolved on 07 October 2011. Documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Incorrect dose administered
Clinical narrative: Initial report was received on 17 October 2011 from a health care professional, which involves a case of misuse. A two-year-old male patient had received on 14 October 2011 a second dose of FLUZONE (lot number, route and site of administration not reported) and the night of 14 October 2011, the patient complained of a headache. According to the reporter, the patient had inadvertently received a two dose series of FLUZONE when the patient had only needed one dose. The patient's mother reported that the patient had a headache from Friday evening through Sunday evening. The patient's mother reported no mention of a headache on Monday morning. No other symptoms developed. Treatments were not reported. The patient had received dose on of the series in September. No further information was available at the time of the report. The patient's outcome was reported as recovered. Follow-up information was received from a health care professional on 23 February 2012. The patient received the dose 2 injection of FLUZONE, lot number UH486AD, intramuscularly. The patient had a headache for two days. The patient had no illness at the time of vaccination and no adverse events to prior vaccinations. The patient's outcome remained recovered. Documents held by sender: None.