chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 03 October 2013. An 81 year old male patient had received FLUZONE HD subcutaneous route. No adverse event was reported. List of documents held by sender: none
Age: 42.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial misuse report received on 14 October 2013 from a health care professional. A 42 year old patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient who was 42 years old received the FLUZONE HD. List of documents held by sender: none
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Initial report received on 05 November 2013 from a health care professional. A 65-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number U4783AA, expiration date, route and site of vaccination was left shoulder) on 30-Oct-2103. It was reported that 65-year-old female patient have received the FLUZONE HD. On 30-Oct-2013, patient experienced pain with immunization. Felt it was too high on arm and increased pain day of vaccination with difficulty movement but now just soreness and cannot lift arm higher than her chest. List of documents held by sender: none
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Eye discharge, Peripheral swelling, Pyrexia
Clinical narrative: Initial report received from a health care professional on 05-Nov-2013. A 66 year old male received FLUZONE HD (batch number U47878A, expiry date: unknown) intramuscularly in left deltoid on 04 November 2013). The patient's medical history and concomitant medications were not reported. On 04 November 2013, within 2 hours of vaccination the patient experienced some swelling in his hands, yellow drainage from his eyes, intense chills, shivering, fever, severe vomiting and feeling week. At the time of this report the outcome of the events were resolved.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Initial report received from a health care professional on 05-Nov-2013. A 66 year old male received FLUZONE HD (batch number U47878A, expiry date: unknown) intramuscularly in left deltoid on 04 November 2013). The patient's medical history and concomitant medications were not reported. On 04 November 2013, within 2 hours of vaccination the patient experienced some swelling in his hands, yellow drainage from his eyes, intense chills, shivering, fever, severe vomiting and feeling week. At the time of this report the outcome of the events were resolved.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received on 05 November 2013 from a health care professional  3 patients whose age, gender, medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number U4765AA, expiration date unknown and site of vaccination was unknown) administered intramuscularly in 2013. It was reported that 3 patients have received the FLUZONE HD. In 2013, 3 patients reported significant injection site reaction 7-8 cm of swelling, redness and warm to touch. List of documents held by sender: none
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Immediate post-injection reaction, Throat irritation
Clinical narrative: Initial report received from a health care professional on 05-Nov-2013. A female received FLUZONE HD (batch number, expiry date and route were unknown). The patient's medical history and concomitant medications were not reported. Immediately after the vaccination the patient experienced diarrhea and throat itching. At the time of this report the outcome of the events was unknown. Documents held by sender: none
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Disorientation, Muscle spasms, Ocular hyperaemia, Pyrexia
Clinical narrative: Initial report received on 06-November-2013 from a pharmacist. A 77-year-old female patient, whose medical history included allergy to codeine, PCN and statin. Concomitant medications were not reported. The patient received a dose of FLUZONE HD (lot number U4781AA) via intramuscular route at left deltoid on 04-November-2013. On 04-November-2013, 4 hours later the patient went to the emergency room with disorientation, fever, chills, bloodshot eyes, and leg cramps.  Corrective treatment was not reported. At the time of this report the outcome of events was not resolved. List of documents held by sender: none
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Initial report received on 05 November 2013 from a pharmacist. An 90 year old female patient, medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot # unknown) at unknown site on an unspecified date. It was reported that a patient had muscle ache and pain. Event outcome was unknown at the time of report. List of documents held by sender: none
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Initial report received from a health care professional on 31 October 2013. A 73-year-old female patient who had no illness at time of vaccination, no pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported, had received FLUZONE HD in left deltoid (lot number U4764AA) on 10 October 2013. On 10  October 2013, the patient had soreness around the injection site for 21 days. Looks ok externally, no redness, no bruising. If she lies on the side it hurts. Laboratory investigations were not reported. At the time of this report, the patient was recovered from the event. Documents held by sender: none
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Initial report received from a consumer on 30 October 2013. A male patient (date of birth 07 August 1942), had received FLUZONE HD, batch number: unknown, route and site of administration was not reported) for first time last year 2012 (date was not reported). The patient had received numerous intramuscular flue vaccines (lot number, dose, route and site of vaccine administration was not reported and had allergies to Penicillin and Allergies to Eggs. The patient's concomitant medications were not reported.  It was reported that after vaccination experienced to 6 days of "explosive diarrhea". Relevant diagnostic tests and laboratory data were not reported. As of 30 October 2013, the outcome of the event was not reported. Documents held by sender: none
Age: 63.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial medication error report received from a health care professional on 16 April 2013.  A 63 year old patient had received FLUZONE HD, dose, anatomical site of vaccination and date of vaccination was unknown. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Feeling cold, Nasopharyngitis
Clinical narrative: Initial report received on 08 November 2013 from a health care professional. A 89 year old female, medical history included allergy (not known) and concomitant medications was unknown received a dose of FLUZONE HD at left arm intramuscular on 12-Oct-2013. The day after vaccination (13-Oct-2013) patient experienced cold with chills and felt did not want to do anything. It was reported that patient required emergency room or doctor visit. Events lasted for three weeks. List of documents held by the sender: none
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Malaise
Clinical narrative: Initial report received from a patient's husband on 13-Nov-2013. A patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE High-Dose (dose, frequency, route unknown) (batch number and expiration date unknown) few weeks ago. On an unspecified date, after receiving vaccine the patient experienced soreness at the injection site fro at least two weeks, and general malaise. At the time of reporting, outcome of the events were recovered. No further relevant information was reported.
Sex: F
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: Initial information received from a health care professional on 15 November 2013. A female patient (date of birth reported as 7.4.21) whose medical history was not reported had received FLUZONE HD (batch number, route and site of administration not reported) on an unspecified date. After vaccination the patient was sick for three days after vaccination. Lab investigations and treatment medications were not reported. At the time of this report, the outcome was not reported. List of documents held by sender: none
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Initial misuse report received from a health care professional on 15 November 2013. A female patient (date of birth and age at the time of event was not reported) had received subcutaneously a dose of FLUZONE (batch number, dose number and site of administration not reported) on 06 November 2013. The patient's medical history and concomitant medications were not reported. It was reported the patient had received the vaccine subcutaneously instead of intramuscular. On 06 November 2013, same day of vaccination, the patient developed red, swollen, sore at injection site with lump at injection site. As of 15 November 2013, the patient continues to had "hard knot" that was sore at injection site. Laboratory tests and corrective treatments were not reported. The event redness and swelling resolved on an unspecified date and the event lump, knot at injection site did not recover. List of documents held by sender: None  Follow-up information received from health care professional on 21 January 2014. No new information was provided.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site inflammation, Pain
Clinical narrative: Initial information received from a health care professional on 18 November 2013. A 73-year-old female patient had received first dose of FLUZONE HD (batch number: U4173AA) intramuscularly in the right deltoid on 12 September 2013. The patient was not ill at the time of vaccination . The patient had history of pacemaker, hypertension and was concomitantly taking anti-arrhythmic drugs. On an unspecified date after vaccination, the patient complained of pian and limited range of motion of her right arm. There ws inflammation at the injection site and was prescribed naprosyn (naproxen). Lab investigations were not reported. At the time of this report, the outcome was unknown. List of documents held by sender: none
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Initial report received from health care professional on 19 November 2013. The 82-year-old male patient, whose medical history and concomitant medication were not reported, had received a dose of FLUZONE HD, batch number U4781AA intramuscularly in the left deltoid on 16 November 2013. The patient had no illness at the time of vaccination and pre-existing, physician diagnosed allergies medical conditions and birth defects were unknown. On 17 November 2013, the patient had sore in her arm symptoms was progress and she was not able to mover her arm. Corrective treatment and laboratory details were not reported. At the time of this report, the patient was not recovered from adverse event. Documents held by sender: none  Follow-up report received from health care professional on 27 January 2014. As of 14 January 2014, the patient was still not recovered from the events.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a health care  professional on 03-Nov-2013.  The patient had administered only  half the does of FLUZONE HD. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial medication error report received on 09 October 2013 from a nurse. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE HD (route, lot number and site of vaccination was not reported) on an unspecified date. Patient received 2 shots 5 min apart. List of documents held by sender: none
Age: 33.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial misuse report received from a health care professional on 03-Oct-2013. A 33 year old patient whose gender, medical history and concomitant medications were unknown, received a dose of FLUZONE HD (lot number, route and site of vaccination were unknown) on an unspecified date. Mot patients did not experience any material increase in local or systemic adverse events, but some might experience. List of documents held by sender: none
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 01 October 2013.  The 62 year old female patient had received FLUZONE HD. Patient had chemo and radiation 5 years ago so she gave her the vaccine. No adverse event was reported. List of documents held by sender: none
Age: 63.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 01 October 2013. The 63 year old patient had received FLUZONE HD. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 14 October 2013. The patient had received FLUZONE HD. The patient received a dose on 25th September and another dose today. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint movement impairment, Injection site pain, Pain in extremity
Clinical narrative: Initial report received from a health care professional on 08 November 2013. A 76 year old female received dose of FLUZONE HD (lot # U4784AA) at left deltoid on 17 October 2013. Patient reported that it hurts when needle went in and patient had pain in her left arm. Patient reported that post weekend she had limited range motion in the left arm. Event outcome was unknown at the time report. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial report received from a health care professional on 08 October 2013. The patient had received expired FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 57.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial report received from a health care professional on 13-Sep-2013. A 57-months-old patient administered with FLUZONE HD. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 64.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial medication error report received on 09 October 2013 from a nurse. A 64 years old unknown patients whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE HD (route, lot number and site of vaccination was not reported) on an unspecified date. Nurse reported that gave to older than 65 years old. Patient did not have any adverse events. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a nurse on 03 October 2013. The child had received FLUZONE HD. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Initial report received on 10 December 2013 from consumer. A 65 year old male patients whose gender, age, medical history and concomitant medications were unknown, received a dose of FLUZONE HD (route was intramuscular, lot #, expiration date unknown and site was left deltoid) on 10 October 2013. Patient reported that on 17 October 2013 developed soreness at site 24 hrs post vaccination and it radiated to elbow. Symptoms lasted to mid-November then resolved until 09-December 2013 when patient notified to health care professional that symptoms came back. List of documents held by sender: none
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: Initial report received from a Consumer on 26 November 2013. A 72-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (Lot number, route and site of vaccination were not reported), on 23 October 2013. On 23 October 2013, after receiving vaccine the patient experienced severe pain at injection site. Then about 24 hours after administration of vaccine began experiencing severe pain in arm from shoulder down to hand. Pain has been persistent and he was not able to move arm in full range of motion. Pain had been so severe and he was only getting about 2 to 3 hours of sleep at night because pain in arm will wake him up. Also the patient does not have any strength in arm. Corrective treatment was not reported. At the time of this report the outcome of adverse events was not resolved. Documents held by sender: none. Follow-up information received from healthcare professional on 18 August 2014. The patient received FLUZONE HD vaccine in left deltoid. It was reported that, the patient received annual flu shots without incidents. The patient did not perform any laboratory investigations and did not receive any other vaccinations within 4 weeks prior to vaccination. The patient had no illness at the time of vaccination. The patient is allergic to acetyl salicylic acid and iodine. It was reported that, the patient and his brother or sister did not experience any adverse events to prior vaccination.
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Initial report received from a consumer on 26 November 2013: A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (Lot number unknown, route and site of vaccination were not reported), on 23 October 2013. On 23 October 2013, later night after receiving vaccine the patient woke up with severe pain in arm in which she had been vaccinated and her arm felt dead. The pain lasted few hours and then subsided. On 24 October 2013, pain had resolved and she experienced no other symptoms. Corrective treatment was not reported. At the time of this report the outcome of adverse events were recovered. Documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received from healthcare professional on 02 December 2013. A 66-year-old female patient whose medical history and concomitant medications were not reported, received FLUZONE HD (lot number U4496AA, expiration date 05-Apr-2013) intramuscular in left deltoid on 09 October 2013. On 09 October 2013, patient experienced raised, red, itchy area at injection site. Laboratory investigation and corrective treatment were not reported. As of this report, the patient was recovered from the events. Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Dyspnoea, Headache, Nausea, Respiratory rate increased
Clinical narrative: Initial report received from a health care professional on 05 December 2013. A 65-year-old female patient had received a dose of FLUZONE HD (Lot number U4785AA, site of vaccination not reported) intramuscularly on 15 November 2013. The patient does not have any illness at the time of vaccination. The patient was allergic to codeine and barbiturates. On 15 November 2013, after vaccination the patient experienced 'trouble breathing' described as rapid breathing, nausea, stomach pain and headache. The patient had not received any corrective treatment and laboratory details were not reported. On 16 November 2013, the patient was recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse case was received from a healthcare professional on 16 SEP 2013. Cases were received on 21 March 2014. A patient whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE HD vaccine on an unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received expired vaccine. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: None.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain
Clinical narrative: Initial report received from a healthcare professional on 09 December 2013. A 68-year-old male patient, who had no medical history and concomitant medications, had received an intramuscular dose of FLUZONE HD, batch number: U4782AA on 08 November 2013 (dose number and anatomical site of vaccination was not reported). On 08 November 2013, the patient developed chills and body aches. The patient recovered from the events within 48 hours without physician evaluation or any medical intervention. Laboratory investigations were not done. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 09 December 2013. A patient of unspecified demographics, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (route, dose number, batch number and anatomical site of vaccination was not reported) on unspecified date. On an unspecified date, the patient had soreness of the arm which last for a month. Corrective treatments and laboratory investigations were not reported. The outcome of the event was unknown. Documents held by sender: none.
Age: 62.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received on 14 November 2013 from a pharmacist. A 62 year old patient whose gender, medical history and concomitant medications were not reported, accidentally received a dose of FLUZONE HD (lot number, route and site of vaccination was not reported) on an unspecified date. As of 14 November 2013, patient did not have any adverse events. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 11 NOVEMBER 2013. The case is invalid as the individual patient identifiers were not reported. It was reported that FLUZONE was administered to several of the patient who are under 65 years of age. No adverse event was reported. List of documents held by sender: none.
Age: 47.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 05 November 2013. A 47-year-old patient received 0.5ml FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 62.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 13 November 2013. On unspecified date a 62 year old patient received FLUZONE HD vaccine. Drug administered to patient of inappropriate age. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 13 November 2013. The patient had received FLUZONE HD vaccine which was expired. Expired vaccine was administered. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 11 November 2013. The case is invalid as the individual patient identifiers were not reported. It was reported that 5 pregnant women had received FLUZONE HD. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a pharmacist on 08 November 2013. The patient had received 2 doses of FLUZONE HD. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a  nurse on 01 November 2013. The female patient had received FLUZONE HD (route, site not provided). Reporter stated that dose ran down her arm, should she get another HD or a regular. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Wound
Clinical narrative: Initial report received from nurse on 05-Dec-2013. A female patient (age unknown) (medical history and concomitant medications were not reported) received FLUZONE HD (lot number, expiration date, route and site unknown) on an unknown date. Patient had a 4 in open wound at injection site. Outcome of the event was unknown at the time of this report. List of documents held by sender: none.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Initial information reported by pharmacist to nurse on 12-Dec-2013: A 69-year-old male received FLUZONE HD (Lot number, intramuscular) on unknown date. Patient had severe muscle soreness, unable to get out of bed for the 2 days because he "hurt so bad". Patient experienced muscle pain for "couple days" and then symptoms resolved. No further relevant information reported.
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Initial information regarding unsolicited case received from pharmacist on 12-Dec-2013: This case involves female patient. Medical history and concomitant medication was unknown. Patient started therapy FLUZONE HD (batch number: and expiry date: unknown). Consumer experienced muscle pain. The therapy was unknown at the time of the report. At the time of the report event outcome was recovered. No further relevant information reported.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received on 09 December 2013 from pharmacist. A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number, route and site of vaccination was not reported) on an unspecified date. Administered HD to a person instead of QIV. Patient did not have any adverse events. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial medication error report received on 03 December 2013 from a medical assistant: A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE HD (route, lot number and site of vaccination was not reported) on an unspecified date. Reported stated that physician gave his parents an expired dose of FLUZONE HD. Patient did not have any adverse events. List of documents held by sender: none.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial medication error report received on 05 December 2013 from a consumer: A 32 year old male patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE HD (route, lot number and site of vaccination was not reported) on an unspecified date. Consumer stated that he received FLUZONE HD and is only 32 years of age. Patient did not have any adverse events. List of documents held by sender: none.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration, Tenderness
Clinical narrative: Initial report received from a healthcare professional on 01 November 2013. A 84-year-old female patient who had unknown illness at the time of vaccination and no known allergies, had received an intramuscular first dose of FLUZONE HD vaccine (lot number: U4783AA, Expiry date: 06-JUN-2014) in the left arm on 28 October 2013. On 01 November 2013, the patient experienced 3 inches tender and black and blue area below the site of injection. Laboratory investigations and corrective medications were not reported. At the time of this report, the outcome was not reported. Documents held by sender: None. Additional information was received on 21 April 2014: No new information was received.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Initial report received from consumer on 19 December 2013. A 69-year-old female patient whose medical history and concomitant medications were not reported received FLUZONE HD (lot number and expiration date were unknown) intramuscularly in left deltoid (dose number not reported) on 16 December 2013. On 16 December 2013, the patient got a bright red rectangular 2x3 inch mark to the left and below injection site. It was sore if she presses on it. On 19 December 2013, the area was pink. The injection was given on top of a biceps tear by the pharmacist. 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: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Cough, Discomfort, Limb discomfort, Pruritus
Clinical narrative: Initial report received from other company on 23 December 2013. The case was initially reported by a consumer. A 65-year-old female patient who had received a dose of FLUZONE HD on 25 September 2013 (anatomical site, dose and batch number were not reported). Patient has history of transplant (kidney, pancreas) and concomitant medications were not reported. On an unspecified date after 2 days of vaccination, the patient developed itching on her body on and off. The same time, the patient also had a purple rash on her groin which comes and goes. It was reported that the color had changed to red, but was persistent on and off. Corrective treatment and laboratory investigations were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: none. Follow-up information received on 04 January 2014 from non-healthcare professional. The patient received FLUZONE HD on 28 September 2013. The patient had received numerous standard flu vaccines but this was first time she received the "double dose flu vaccine". Stated later that day she had a purple rash about the size of her hand in both of the groin areas between legs and abdomen. Patient had a previous cream medication for rash and she used on other areas. The rash turned from purple to red rash. As of 03 January 2014, the patient continues to experience a red rash on and off all over her body. As of this report, the patient had not recovered from the events. Follow up information was received on 17 January 2014. The patient had received FLUZONE HD vaccine. The patient never had any reaction with regular flu vaccine. The patient developed very bad rash after the vaccination. The patient received treatment with clotrimazole, betamethasone and dipropionate topical cream for her rash. The patient agreed to send the available information. This case is linked with 2013SA134903 being the same reporter. Follow-up  information received from non-healthcare professional on 25 February 2014: The patient had further symptoms of coughing, body discomfort, rash on legs, loses her balance, some left arm problem, not specified.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash generalised
Clinical narrative: Initial report received from other company on 23 December 2013. The case was initially reported by a consumer. A 65-year-old female patient who had received a dose of FLUZONE HD on 25 September 2013 (anatomical site, dose and batch number were not reported). Patient has history of transplant (kidney, pancreas) and concomitant medications were not reported. On an unspecified date after 2 days of vaccination, the patient developed itching on her body on and off. The same time, the patient also had a purple rash on her groin which comes and goes. It was reported that the color had changed to red, but was persistent on and off. Corrective treatment and laboratory investigations were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: none. Follow-up information received on 04 January 2014 from non-healthcare professional. The patient received FLUZONE HD on 28 September 2013. The patient had received numerous standard flu vaccines but this was first time she received the "double dose flu vaccine". Stated later that day she had a purple rash about the size of her hand in both of the groin areas between legs and abdomen. Patient had a previous cream medication for rash and she used on other areas. The rash turned from purple to red rash. As of 03 January 2014, the patient continues to experience a red rash on and off all over her body. As of this report, the patient had not recovered from the events. Follow up information was received on 17 January 2014. The patient had received FLUZONE HD vaccine. The patient never had any reaction with regular flu vaccine. The patient developed very bad rash after the vaccination. The patient received treatment with clotrimazole, betamethasone and dipropionate topical cream for her rash. The patient agreed to send the available information. This case is linked with 2013SA134903 being the same reporter. Follow-up  information received from non-healthcare professional on 25 February 2014: The patient had further symptoms of coughing, body discomfort, rash on legs, loses her balance, some left arm problem, not specified.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: Initial information for this case was received from other health care professional on 02 January 2014. This 73-year-old female patient whose medical history included allergic to penicillin, concomitant medications were not reported had received an intramuscular injection of FLUZONE HD (batch number: U4785AA, dose not reported) in her left deltoid on 30 December 2013. On 01 January 2014, the patient developed pink, itchy rash at injection site on left arm which extended to the biceps muscle and felt as if it extended down arm to her wrist. The patient had not seen health care professional (HCP) for evaluation or treatment. The relevant laboratory details and corrective treatment was not reported. The outcome of the event was not reported. The list of documents held by sender: None.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy, Musculoskeletal pain
Clinical narrative: Initial report received from a consumer on 21 January 2014. A 66-year-old male patient had received a dose of FLUZONE HD (route, dose number, batch number and anatomical site of vaccination were not reported) vaccine on an unspecified date 5 months ago. The patient's medical history and concomitant medications were unknown. On an unspecified date 5 months ago, the patient had neck gland swelling and his shoulders were hurting. Corrective treatments and laboratory investigations were not reported. As of this report, the patient had not recovered from the events. Documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Pruritus generalised
Clinical narrative: Initial report received from a consumer on 03 January 2014. A female patient whose age at the time of event, medical history and concomitant medications were not reported, had received first intramuscular dose of FLUZONE HD vaccine (lot number: unknown) in the left deltoid on 28 September 2013. The patient had no illness at the time of vaccination. On an unspecified date a couple weeks later, the patient started to experience intermittent itching all over her body and feels as if "hit by Mack truck" on intermittent occasions. It was reported that the patient had received numerous standard flu vaccines. Laboratory investigations and corrective treatments were not reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Initial misuse report received from a healthcare professional on 27 September 2013. The case was received on 21 March 2014. The patient had received FLUZONE HD and FLUZONE was given to a patient at the same visit. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional (nurse) on 16 September 2013 and the case was received on 21 March 2014. It was reported that the patient (information regarding the patient was not provided) had received a subcutaneous dose of FLUZONE HD (batch number, dose in series and site of administration was not reported) on an unspecified date. The patient received FLUZONE vaccine subcutaneously instead of intramuscular. No adverse event was reported. List of documents held by sender: none.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia
Clinical narrative: Initial information was received from a consumer on 21 Feb 2014. This report represents one of a cluster of two patients reported by the same reporter. The case is linked to serious case 2014SA023341. A 89 year old male patient whose medical history and concomitant medication were not reported received, a dose of FLUZONE HD vaccine (route, site, dose and batch number not reported). It was reported that on an unspecified date patient had experienced muscle and joint aches. Patient had muscle and joint aches for several month. Laboratory investigations and corrective treatment were not reported. At the time of report outcome of event was not recovered. Documents held by sender were none.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a non-healthcare professional on 18 September 2013 and on 21 March 2014. A patient under age of 65 years of unknown gender had received FLUZONE HD on an unknown date. No adverse event was reported. The list of documents held by sender: None.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Joint stiffness, Musculoskeletal stiffness, Oropharyngeal pain, Pyrexia
Clinical narrative: Initial report received from a consumer (the patient) on 18 February 2014: A 70-year-old male patient, with a history of hypertension and concomitant medications were not reported, had received a dose of FLUZONE HD, (batch number and dose number not reported) intramuscularly in left deltoid on 03 December 2013. The patient denied any illness at the time of vaccination and the patient had received a flu shot 3 years ago (details not reported). On 08 December 2013, 5 days after vaccination, the patient developed fever 102, sore throat, cough, stiffness of the left jaw and left neck area. The patient self-treated with ice packs and ASA. The patient was evaluated by his physician and dentist. Results were negative for any ear/sinus and dental problems was referred to TMJ specialist for evaluation. No tests were conducted per reporter. The TMJ specialist prescribed physical therapy which he had 11 sessions. At the time of this report, the outcome was unknown. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional (nurse) on 20 January 2014 and the case was received on 21 March 2014. A female patient (date of birth was not reported) had received a dose of FLUZONE HD vaccine (batch number, route and site of administration was not reported) on an unspecified date. The patient had received a dose of FLUZONE HD vaccine on an unspecified date in October 2013. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 21 February 2014. A '61-year-old' patient (no information was provided regarding the patient) had received dose of FLUZONE HD on an unspecified date, i.e. inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
Age: 62.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 21 February 2014. The cases were received on 21 March 2014. A 62-years-old patient, received FLUZONE HD (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 21 February 2014. The cases were received on 21 March 2014. It was reported that less than 63-year-old patient had received FLUZONE HD vaccine on unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 63.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 21 February 2014 and on 21 March 2014. A 63-year-old patient of unknown gender had received FLUZONE HD. The patient received FLUZONE HD at an incorrect age. No adverse event was reported. The list of documents held by sender: None.
Age: 56.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 21 February 2014. The cases were received on 21 March 2014. A 56 years old patient received FLUZONE HD (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 40.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 20 February 2014. A 40-year-old patient had inadvertently administered FLUZONE HD. It was an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
Age: 54.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional (nurse) on 29 October 2013 and the case was received on 21 March 2014. A 54-year-old patient (gender was not reported) had received a dose of FLUZONE HD (batch number, route and site of administration was not reported) on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 27 February 2014. A female patient (no information was provided regarding the patient) had received a dose of FLUZONE HD during pregnancy on an unspecified and no adverse event was reported, i.e. wrong vaccine administered. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional (nurse) on 23 October 2013 and the case was received on 21 March 2014. It was reported that the patient (date of birth and gender was not provided) had subcutaneously received a dose of FLUZONE HD on an unspecified date. No adverse event was reported.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 24 October 2013. The patient had received FLUZONE HD, and after some time the patient saw that the clear liquid running down the arm. It was an underdose. No adverse event was reported. List of documents held by sender: none.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse case was received from a healthcare professional on 26 NOV 2013. Cases were received on 21 March 2014. A patient over age of 65 years whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE HD on unspecified date. (Route, site, dose and batch number not reported). It was reported that on an unspecified date patient received an expired dose from last year. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: None.
Age: 63.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 20 December 2013. A '63-year-old' patient (no information was provided regarding the patient) had received a dose of FLUZONE HD on an unspecified date, and no adverse event was reported, i.e. inappropriate age at vaccine administration. List of documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 20 December 2013 and on 21 March 2014. A 04 1/2 year old patient of unknown gender had received FLUZONE HD instead of FLUZONE. The patient received FLUZONE HD at an incorrect age. No adverse event was reported. The list of documents held by sender: None.
Age: 5.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23 December 2013 and on 21 March 2014. A '4.5 year-old' patient (no information was provided regarding the patient) had received a dose of FLUZONE HD on an unspecified date, and no adverse event was reported, i.e. inappropriate age at vaccine administration. List of documents held by sender: none.