chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site rash
Clinical narrative: Initial report received from a healthcare professional (pharmacist) on 29 August 2012. A male patient with medical history of diabetes and elevated cholesterol and no reported concomitant medications received intradermal FLUZONE (batch number: UT4463BA) in the deltoid on 27 August 2012. On 27 August 2012, after vaccination the patient experienced large red, rash, itching area around injection site on arm and lump at injection site. At the time of this report, the events had not resolved. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Initial report received from a healthcare professional on 23 August 2012. A male patient whose age, medical history and concomitant medications were not reported; had received FLUZONE intradermal (batch number and anatomical site of administration were not reported) on an unspecified date. On unspecified date, the patient developed red wheal and itching after vaccination. The laboratory details and corrective treatments were not reported. The patient's outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Pruritus
Clinical narrative: Initial report received from a Healthcare professional (Nurse) on 03 July 2012. A female patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of FLUZONE intradermal (batch number, site of administration were not reported) on an unspecified date. The reporter stated that, the receptionist of the clinic had a stain on her arm where she received FLUZONE intradermal. It looked like her skin was bleached and the stain is about the size of a dime. The patient had a lot of itching several days after being immunized. Corrective treatments and laboratory investigations were not reported. The outcome was not reported. Documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration
Clinical narrative: Initial report received from healthcare professional, who is also patient on 14 September 2012. A 36-year-old male patient had received intradermal (ID) FLUZONE intradermal in left deltoid (lot number UT4466BA and anatomical site of administration were not reported) on 08 September 2012. The patient had Gluten allergy and intolerance. The patient had no ongoing illness. On 09 September 2012 i.e. one day post vaccination, the patient had induration and erythema measuring 2 x 3 inches. The patient's outcome was unknown. List of documents held by the sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Initial report received from a health care professional on 07 September 2012. 6 female patients of unspecified demographics, with no reported medical history and concurrent conditions, had received an intradermal dose of FLUZONE ID (Lot number: UT4472AA) on 06 September 2012. On 07 September 2012 i.e. within 24 hours of vaccination, all 6 patients had grade 3 erythema. The patients had put band aid over the injection site post vaccination. The outcome of grade 3 erythema was not reported. No treatment was given till the time of this report. List of documents held by the sender: None.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Bladder cancer
Clinical narrative: Initial report received on 05 December 2011 and follow-up received on 06 December 2011 from an investigator participating in a study. A 74-year-old male subject was diagnosed with bladder cancer on 02 December 2011, i.e. 78 days after receiving first dose of study vaccine (FLUZONE High dose or FLUZONE) on 15 September 2011 (Batch Number, route, and site of administration not reported). The subject had no reported medical history. The subject was diagnosed with bladder cancer (details not reported) and was hospitalized on 02 December 2011. Lab investigations and corrective treatments were not reported. The event of bladder cancer was ongoing at the time of report; however stop date of event was reported as 03 December 2011. The subject was discharged from the hospital on 03 December 2011. The information regarding whether the event of bladder cancer was related to the study vaccine or trial procedure or not; was not reported. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by the sender: None.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Initial report was received 18 October 2011 from a health care professional. A female patient (age not reported) had received an injection of FLUZONE High-Dose (lot number, route, site and date of administration not reported) and an unspecified amount of time later, the patient developed cellulitis. Outcome was not reported. No additional information was provided at the time of the report. Follow-up information was received from a health care professional on 18 November 2011 reported that the patient had no illnesses at the time of vaccination. The outcome was reported as recovered. Follow-up information received from a nurse on 20 December 2011. The patient who was an 84-year-old female required antibiotic therapy for the cellulitis at the injection site. No other relevant medical information was provided. Coding was amended to "vaccination site cellulitis" from just "cellulitis" as the cellulitis was confirmed to be at the injection site. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Stridor
Clinical narrative: Later that evening developed stridor that was not relieved w/ steam/cool air. Mom took to ER where he received racemic epinephrine & oral DECADRON.
Age: 101.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Rash erythematous, Rash generalised
Clinical narrative: Patient received flu shot and after about an hour started feeling warm. He got a rash all over body (red) and bumpy. Went to doctor and was prescribed MEDROL Dose Pak. Pt is fine.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Injection site haematoma, Injection site nodule, Injection site swelling, Pain in extremity
Clinical narrative: (L) arm - swollen, bruise, knot at location of flu shot on Nov 7th. Per pt had lots of bleeding following admin. arm hurting/sore, held off on PNA shot 2/2 above. Tried to go MD 11/9 office closed.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site mass, Mobility decreased, Ultrasound scan
Clinical narrative: Patient presented in office today 11/9/12 c/o that he cannot lift arm ever since receiving high dose Flu vac 10/15/12. Also had lump at inj site.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dysphagia, Throat tightness, Tremor
Clinical narrative: C/o feeling of tightness around throat and diff. swallowing when drinking a smoothie. Took CLARITIN and legs with intermittent shaking. C/o burning in chest. Eval. in ER on 10/30/12 - observed 4h. Treated w/ normal saline, SOLU-MEDROL, PEPCID, BENADRYL, ZOFRAN, ATIVAN.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Oedema peripheral, Pulse absent, Pyrexia
Clinical narrative: Right arm. Received shot at about 4PM. By 7PM pt states her pulse was not measurable. Developed a headache & fever. Received shot in deltoid and arm developed swelling down to mid-forearm that didn't go away for 3 or 4 days.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Vomiting
Clinical narrative: 10/25/12 about 11:35 AM per patient report to pharmacy. 1st day (10/19/12) vomiting and terrible chills, chill lasted for 2 days then off and on until 10/24/12. 10/26/12 I called to check-up (left message). 10/27/12 Patient was shopping in the store per patient she is fine now.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Unevaluable event
Clinical narrative: 11/09/2012 MODERATE Other.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Pain & swelling, limited mobility.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Left shoulder pain. Started 1 hr after flu shot, has continued since, approximately 3 wks. Dr prescribed MOBIC and physical therapy.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: Myalgia, fever & tremor.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Angina pectoris, Echocardiogram abnormal, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 28 October 2011. A 20-year-old male subject had received on 31 May 2011 a dose of ACAM2000 (lot number not reported), and a dose of Anthrax vaccine (manufacturer name and lot number not reported). An Echocardiogram performed on 27 June 2011 was abnormal (not specified) and the subject was diagnosed the same day with angina pectoris (other unspecified). Per the investigator, result of Troponin I test was not available. MRI (brain, spinal cord, or heart) and lumbar puncture (spinal tap) were not performed. Exact onset date of angina pectoris was not reported. The subject's medical records did not reveal any significant medical history. Recovery status was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram, Electrocardiogram abnormal, Pericardial disease, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 28 October 2011. A 23 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 12 days after he had received on 22 July 2011 an injection of ACAM2000 (lot number, route and site of administration not reported). The subject also received on 20 July 2011 an injection of TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 00.28 and an abnormal ECG on 03 August 2011. The subject's Echocardiogram was not available. A Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: SMALL
Symptoms: Electrocardiogram, Encephalitis post immunisation
Clinical narrative: This study case was received from the investigator in a trial on 28 October 2011. A 44 year-old female subject with no significant medical history was found to have encephalitis following immunization procedures 8 days after she had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 11 June 2011. She also received on 09 June 2011 an injection of TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). The subject's ECG was not available. A Troponin I, Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram, Electrocardiogram abnormal, Prinzmetal angina, Troponin I increased
Clinical narrative: This study case was received from the investigator on 28 October 2011. A 37 year-old male subject was found to have an Prinzmetal angina 27 days after he had received on 02 September 2011 an injection of ACAM2000 (lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 03.10 on 17 September 2011 and an abnormal ECG on 15 September 2011. The subject's echocardiogram was not available. A lumbar puncture and MRI of the brain, spinal cord and heart rate were not performed. Treatments were not reported. The subject's outcome was not reported. There is no reporter causality assessment as this is a safety surveillance study. Documents held by sender: None.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Fever, chills, nausea, vomiting, vaccination site pain. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: This non-serious unpublished literature report was received by the company on 25 September 2011 from a physician. The following is from the report: Background: Individuals with HIV infection have decreased responses to influenza vaccine. Current guidelines for HIV infected adults recommend the use of a 15 mcg dose of the trivalent flu vaccine. There is no information about the immunogenicity of higher doses of this vaccine in HIV infected adults. Methods: A randomized, double blinded study comparing the immunogenicity of FLUZONE SD (15 mcg) versus FLUZONE High-Dose (60 mcg) was conducted in HIV infected adults attending a single clinic. Antibody titers were measured using hemagglutination-inhibition assay against the H1N1, H3N2 and flu B/Brisbane/60/2008. Results: Total participants were 195, and 190 completed the 3-week follow-up visit (93 FLUZONE SD, 97 FLUZONE HD). Seventy-one percent were male, and 68% were of a certain race. Median age was 45 years of age (range was 20-78 years of age). Eighty-nine percent of them on HAART, with a median current CD4 of 452 (IQR 293-629) cells/mm^3, and a nadir CD4 of 180 (IGR 53-318) cells/mm. The HIV RNA viral load was less than 400 copies/mL in 90% and less than 200 copies/mL in 89% of the subjects receiving treatment. Approximately half of the patients had protective titers at baseline. By week 3, a higher percentage of individuals receiving FLUZONE HD had protective HAI titers (H1N1 97% vs 88%, H3N2 96% vs 92% and FluB 92 vs 80%). Both vaccines were well tolerated, with 165 adverse events (77 FLUZONE SD vs 88 FLUZONE HD, p=NS). Grade 1 myalgia (19%), malaise (14%), local pain (10%), local tenderness (10%) and headache (9%) were the most frequent adverse events. There were no serious adverse events. Conclusions: HIV infected patients reached higher levels of protection when vaccinated with single dose FLUZONE HD vs standard dose trivalent vaccine. High dose antigen vaccines may be used when vaccinating individuals with HIV infection against seasonal flu. Documents held by sender: None.
Sex: M
Vaccine: FLU3
Symptoms: Eye discharge, Fatigue, Flushing
Clinical narrative: Case received from a Healthcare Professional on 28 September 2011 under the reference number 11-0645. The reporter of this case is the same as for case 2011-09412 and 2011-09411. A male patient (date of birth not reported), with no reported medical history and concomitant therapy, had received a dose of FLUZONE (batch number, route and site of administration not reported) on an unspecified date. 5 to 6 hours post-vaccination, the patient experienced eye discharge, eye drainage, flushing and fatigue. The patient's outcome was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Conjunctivitis infective, Eye discharge
Clinical narrative: Case received from a Healthcare Professional on 28 September 2011 under the reference number 11-0645. The reporter of this case is the same as for case 2011-09413 and 2011-09411. A female patient (date of birth not reported), with no reported medical history and concomitant therapy, had received a dose of FLUZONE (batch number, route and site of administration not reported) on an unspecified date. On an unspecified date, the patient experienced eye discharge, eye drainage and pink eye. The patient's outcome was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Initial report received on 29 September 2011 from a health care professional; and follow-up information was received on 03 October 2011 from a company representative who had received the information from a health care professional. This case involves a cluster of 8 unidentified patients with unknown medical histories who had received a dose of FLUZONE HIGH-DOSE (lot number UH452AA) at various sites on unknown dates. Between 2 and 24 hours post vaccination (varied between patients), the patients experienced warmth, rash, itching, erythema, swelling and pain at the injection sites lasting approximately 4 days. It was not reported without any of the patients required any medical evaluations or treatments. The patients recovered. The reporter for this case is the same as for case number 2011-09437. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Initial report received on 29 September 2011 from a health care professional; and follow-up information was received on 03 October 2011 from a company representative who had received the information from a health care professional. This case involves a cluster of 8 unidentified patients with unknown medical histories who had received a dose of FLUZONE HIGH-DOSE (lot number UH452AA) at various sites on unknown dates. Between 2 and 24 hours post vaccination (varied between patients), the patients experienced warmth, rash, itching, erythema, swelling and pain at the injection sites lasting approximately 4 days. It was not reported without any of the patients required any medical evaluations or treatments. The patients recovered. The reporter for this case is the same as for case number 2011-09437. Documents held by sender: None.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain in extremity, Tremor, Vomiting
Clinical narrative: Initial report was received from a healthcare provider on 29 September 2011. An 80-year-old male patient had received an intramuscular (IM) injection of FLUZONE High-Dose; lot number UH436AD in right arm on 29 September 2011. On the same day of the injection, the patient experienced shaking, chills, vomiting and arm soreness in right arm. No further information was available at the time of the report. The patient outcome was reported not recovered/not resolved. Documents held by sender: none.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Chills, Hyperhidrosis, Injection site reaction, Local reaction
Clinical narrative: Initial report was received from a health care professional staff member on 30 September 2011. A 78-year-old male patient had received a FLUZONE Intradermal injection; lot number UH458AA in right deltoid on 19 September 2011. On 22 September 2011, the patient experienced nausea, vomiting, chills, diaphoresis and unstable balance which lasted twenty four hours and resolved. He also developed an unknown local reaction at injection site. No further information was available at the time of the report. The patient outcome was reported as resolved/recovered. Follow-up information was received from a healthcare professional on 24 January 2012. The patient had received an Intramuscular (IM) injection of FLUZONE HIGH-DOSE; lot number UH458AA in right deltoid. No additional information available. Documents held by sender: none.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Initial report was received from a health care professional staff member on 30 September 2011. A 78-year-old male patient had received a FLUZONE Intradermal injection; lot number UH458AA in right deltoid on 19 September 2011. On 22 September 2011, the patient experienced nausea, vomiting, chills, diaphoresis and unstable balance which lasted twenty four hours and resolved. He also developed an unknown local reaction at injection site. No further information was available at the time of the report. The patient outcome was reported as resolved/recovered. Follow-up information was received from a healthcare professional on 24 January 2012. The patient had received an Intramuscular (IM) injection of FLUZONE HIGH-DOSE; lot number UH458AA in right deltoid. No additional information available. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site streaking
Clinical narrative: Follow-up information was received from a health care professional on 03 January 2012. Initial case received on 03 October 2011 was non-serious listed. Based on follow-up information the case has been changed to non-serious unlisted. This narrative contains information from both dates. This reporter also reported another adverse event that was captured in case number 2011-09657. A 68-year-old female patient had received a dose one intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE, sanofi pasteur Inc., lot number UH459A on 30 September 2011. Following the vaccination, the patient experienced a rash on arm starting below the injection site to the elbow, red streaks from the injection site to 2-3 inches below the injection site and expanding to a "patch" of rash. The events lasted 4 to 5 days. No further information was available at the time of the report. The patient's outcome was reported as recovered on 10 December 2011. Documents held by sender: None.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Lip blister, Nausea, Pyrexia, Vomiting
Clinical narrative: Initial report was received from a healthcare provider on 05 October 2011. A 90-year-old female patient had received an Intramuscular (IM) injection of FLUZONE High-Dose; lot number UH452AA (site of administration not reported) on 27 September 2011. On the same day of the injection, the patient complained of nausea, vomiting for six hours, fever (102) for forty eight hours and blisters on upper lip which have dried out. 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: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Oedema peripheral, Pain in extremity, Synovial cyst, Ultrasound scan abnormal
Clinical narrative: Initial report was received from a health care professional on 05 October 2011. An 85-year-old female patient received an intramuscular injection of FLUZONE HIGH-DOSE; lot number UH436A on 10 October 2011. On an unspecified date following the vaccination, the patient experienced a swollen arm. Concomitant medications included baby aspirin, SYNTHROID, omeprazole, simvastatin and vitamin D. Allergies to medications include doxycycline, erythromycin, LEXAPRO, BIAXIN, CIPRO and sulfa. No further information was available at the time of the report. Outcome was not reported. Follow-up information was received from a healthcare professional on 25 January 2012. The patient outcome was reported as recovered/resolved. Follow-up information was received on 26 March 2012 form a health care professional. The patient with an extensive past medical history including severe osteoarthritis of the knees had received on 01 October 2011 (previously reported as 10 October 2011) a left deltoid injection of FLUZONE HIGH-DOSE; lot number UH436AB (previously reported as UH436A) and two days later, experienced left arm swelling. The patient was advised by her physician to use ice and BENADRYL which she did for "several days". The patient presented to a clinic three weeks later stating she felt her left arm continued to be swollen. The patient also reported left leg and foot swelling but did not know how long she had it but reported "maybe one week". The patient reported the foot was painful and she had left knee pain. A physical exam revealed the left arm with no redness, no warmth and "maybe slight generalized edema (comparing arm size to right), but no pitting edema". The arm was neurovascularly (NV) intact and "NT". The left leg had "maybe slight generalized edema (comparing to right), but minimal pitting at distal leg. No foot edema. The left foot was slightly warmer than the right. Leg was neurovascularly (NV) intact with no calf tenderness. An ultrasound of the arm was negative. An ultrasound of the left leg revealed no DVT but showed a Baker's cyst which "may be causing the mild lower extremity edema. Treatment included TYLENOL. No further information was available at the time of the report. The patient's outcome was not reported (previously reported as recovered). Documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Ocular hyperaemia, Productive cough, Pyrexia, Vision blurred
Clinical narrative: Initial non-serious report received from a consumer on 10 October 2011 under the local reference number 11-0767. A 72-year-old female patient with no reported medical history had received an intramuscular dose of FLUZONE HIGH-DOSE (batch number UH458AB) in the left deltoid on 09 October 2011 at 6:45 p.m. The patient had received FLUVIRIN vaccine the year before with no adverse events reported. On 09 October 2011 at 7:00 p.m., the patient had coughing, white foam expectoration, bilateral red eyes, blurred vision, muscle aches and slight fever. At the time of the report, the patient had not recovered.
Sex: M
Vaccine: FLU3
Symptoms: Chills, Ocular hyperaemia
Clinical narrative: Case received on 07 October 2011 from a healthcare professional. A male patient, with no medical history reported, had received on an unspecified date his dose of FLUZONE HD (batch number UH444AB, number in series, route and site of administration not reported). No concomitant therapy was reported. On an unspecified date after immunization, the patient developed chills and red eyes. No corrective treatment was reported. The final outcome was not reported. Documents held by sender: none.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Vaccination site rash. Vaccination site erythema. Vaccination site pain.
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Initial report was received from a staff member at a health center on 31 October 2011. A female patient (age not reported) had received an injection of FLUZONE (site and route of administration not reported) lot number UT481AA on 21 October 2011. On an unspecified date, the patient seeked medical attention due to arm pain. Twelve days later after the vaccinations, she was unable to move or lift her arm without pain. The pain worsens at night. 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: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Initial report was received on 18 October 2011 from a health care professional. An 81 year-old female patient had received FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported) and an unspecified amount of time later, experienced a red and swollen arm. No further information was available at the time of the report. Outcome was not reported. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Vaccination site reaction, Vaccination site urticaria
Clinical narrative: Inflammation localised. Vaccination site urticaria. Vaccination site reaction.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Tenderness, pain in arm.
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Pain
Clinical narrative: Initial report was received from a health care professional on 03 November 2011. A female patient (reported to be "about 80", date of birth not reported) had received FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported) and within several hours, experienced nausea, diarrhea, aches and pains. No further information was available at the time of the report. Outcome was not reported. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Nausea, Neck pain
Clinical narrative: Initial report was received from a healthcare professional on 15 November 2011. A female patient had received an intramuscular FLUZONE; lot number UT425AA in right deltoid on 06 October 2011. On the same day of the injection in the evening, the patient developed chills, body aches and neck ache. On 07 October 2011 in the am, the patient experienced nausea, arm swelling, pain at right deltoid and difficulty using her arm. The symptoms progressed and she was seen in the emergency room (ER) prior to office visit. No further information was available at the time of the report. The patient outcome was not recovered/not resolved. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain
Clinical narrative: Initial report was received from a healthcare professional on 15 November 2011. A female patient had received an intramuscular FLUZONE; lot number UT425AA in right deltoid on 06 October 2011. On the same day of the injection in the evening, the patient developed chills, body aches and neck ache. On 07 October 2011 in the am, the patient experienced nausea, arm swelling, pain at right deltoid and difficulty using her arm. The symptoms progressed and she was seen in the emergency room (ER) prior to office visit. No further information was available at the time of the report. The patient outcome was not recovered/not resolved. Documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Initial report was received from a healthcare provider on 08 November 2011. A 69-year-old female patient had received an injection of FLUZONE HIGH-DOSE (lot number, route and site of administration not reported) on 03 November 2011. On an unspecified date, the patient developed swelling, very red in upper arm from elbow to shoulder which was sore and hot to the touch. The patient received corrected treatment with BENADRYL. No further information was available at the time of the report. The patient outcome was reported as recovered/resolved on 05 November 2011. Documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain, Pain in extremity
Clinical narrative: Initial report was received from a healthcare professional on 15 November 2011. A 59-year-old female patient had received an Intramuscular (IM) injection of FLUZONE; lot UT492AB in left deltoid on 27 September 2011. On the same day of the injection, the patient developed a sore arm and unable to move or lift arm without discomfort. The reporter stated that the patient felt "a snap" when the needle was inserted; she thought that the injection "was too high" in her arm. The patient has not seen her own health care provider. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: This is a cluster of 2 patients who experienced adverse events following administration of FLUZONE HIGH-DOSE; lot number UH436AB. The event for the other patient was captured in case number 2011-10928. Initial report was received from a healthcare professional, on 08 November 2011. A 70-year-old female patient had received an Intramuscular (IM) injection of FLUZONE HIGH-DOSE; lot number UH436AB on 18 October 2011. On an unspecified date, the patients arm swelled up from the shoulder to the elbow; the area was red and painful. The patient received corrected treatment with pain medications and ice packs. No further information was available at the time of the report. The patient outcome was reported as resolved/recovered. Follow-up information was received from a healthcare professional on 17 January 2012. The patient received an Intramuscular injection of FLUZONE HIGH-DOSE in upper arm. The patient was not seen in follow-up for the symptoms described and no additional corrective treatment provided. Documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Malaise, Nausea, Oropharyngeal pain
Clinical narrative: Initial non-serious report received from a healthcare professional on 19 October 2011 under the local reference number 11-0875. A 59-year-old female patient had received a dose of FLUZONE (batch number UT480AA) on 12 October 2011. The patient had no illness at time of vaccination. Route and anatomical site of vaccine administration were not reported. On 13 October 2011, the patient experienced nausea, headache, sore throat, general malaise and feeling dizzy. At the time of the report, the patient had not recovered.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: This is a cluster of 2 patients who experienced adverse events following administration of FLUZONE HIGH-DOSE; lot number UH436AB. The event for the other patient was captured in case number 2011-10927. Initial report was received from a healthcare professional, on 08 November 2011. A 72-year-old female patient had received an Intramuscular (IM) injection of FLUZONE HIGH-DOSE; lot number UH436AB on 18 October 2011. On an unspecified date, the patients arm swelled up from the shoulder to the elbow; the area was red and painful. The patient received corrected treatment with pain medications and ice packs. No further information was available at the time of the report. The patient outcome was reported as resolved/recovered. Follow-up information was received from a healthcare professional on 17 January 2012. The patient received an Intramuscular injection of FLUZONE HIGH-DOSE in upper arm. The patient was not seen in follow-up for the symptoms described and no additional corrective treatment provided. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Chills, Middle insomnia, Tremor
Clinical narrative: Initial report was received from a health care professional on 24 October 2011. Two patient's (gender, date of birth and age were not reported) received an intramuscular injection of FLUZONE, lot number UH493AA (site of administration were not reported) on 02 October 2011. Ten hour post vaccination the patient's woke up from their sleep with chills and uncontrollable shakes. The symptoms lasted about forty five minutes. No further information was available at the time of the report. The patient outcome was reported as resolved/recovered. Follow-up information was received from a healthcare professional on 23 January 2012. The patient received FLUZONE in left arm. No further information was available at the time of the report. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: Initial report was received from a health care professional on 10 November 2011. A patient (gender, age and date of birth not reported) had received a FLUZONE HIGH-DOSE injection (lot number, site and route of administration not reported). On an unspecified date, the patient experienced flu-like symptoms after receiving high dose. No further information was available at the time of the report. The patient outcome was not reported. Follow-up information was received from a healthcare provider, on 26 January 2012. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Initial report received from a health care professional on 07 June 2012. Several patients (number not specified), whose age, gender, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD vaccine (batch number UH452AC, site and route of administration-not reported) on unspecified dates. It was reported that on unspecified dates last year, several patients had reactions (NOS) to the dose of FLUZONE HD vaccine. Corrective treatment and laboratory investigations were not reported. As of 07 June 2012, the outcome was not reported. Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Swelling
Clinical narrative: Initial report was received from a healthcare professional on 22 November 2011. A 65-year-old female patient had received an Intramuscular (IM) injection of FLUZONE HIGH-DOSE; lot number UH489AA in left deltoid and PNEUMOVAX; lot number 1138AA in right deltoid on 11 November 2011. On the same day of the injection, the patient complained of immense pain in her left arm with difficulty moving it. On Saturday, the patient went to the emergency room (ER) because the pain continued and the redness and swelling; she received corrected treatment with antibiotics. On Sunday, the patient returned back to the emergency room due to increased swelling and was given an antihistamine. On 16 November 2011, the patient arm was still sore, but the redness and swelling resolved. No further information was available at the time of the report. The patient outcome for pain in arm with difficulty moving was reported as unknown. Follow-up information was received from a healthcare professional on 24 January 2012. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nasopharyngitis, Productive cough, Pyrexia
Clinical narrative: Initial report was received from a health care professional on 03 November 2011. A 63-year-old female patient had received a FLUZONE intramuscular injection in left deltoid, lot number UH462AB on 26 October 2011. On 27 October 2011, the patient developed chest and sinus congestion, headache, fever, chills, cold symptoms and productive cough. In 2010, the patient had the similar symptoms but not as severe. No further information was available at the time of the report. The patient outcome was reported as unknown. Follow-up information was received from a healthcare professional on 17 January 2012. The reported stated that the symptoms in 2010 were the same as 2011, but not as severe. The patient has two daughters who are medical doctors (MD) and they both agreed on this reaction to the flu vaccine. The patient did not receive any corrective treatment by our doctors for the symptoms in 2010 and 2011. The patient outcome was reported as recovered/resolved on 02 November 2011. Follow-up information was received 19 March 2012 from a health care professional. The patient received an intramuscular injection of FLUZONE, lot number U3728AA prior to experiencing the same symptoms as the current event (but not as severe) in 2010. The reporter had no further additional information to provide. Documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion, Sinus congestion
Clinical narrative: Initial report was received from a health care professional on 03 November 2011. A 63-year-old female patient had received a FLUZONE intramuscular injection in left deltoid, lot number UH462AB on 26 October 2011. On 27 October 2011, the patient developed chest and sinus congestion, headache, fever, chills, cold symptoms and productive cough. In 2010, the patient had the similar symptoms but not as severe. No further information was available at the time of the report. The patient outcome was reported as unknown. Follow-up information was received from a healthcare professional on 17 January 2012. The reported stated that the symptoms in 2010 were the same as 2011, but not as severe. The patient has two daughters who are medical doctors (MD) and they both agreed on this reaction to the flu vaccine. The patient did not receive any corrective treatment by our doctors for the symptoms in 2010 and 2011. The patient outcome was reported as recovered/resolved on 02 November 2011. Follow-up information was received 19 March 2012 from a health care professional. The patient received an intramuscular injection of FLUZONE, lot number U3728AA prior to experiencing the same symptoms as the current event (but not as severe) in 2010. The reporter had no further additional information to provide. Documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Dysstasia, Influenza like illness, Muscular weakness, Myalgia
Clinical narrative: Initial report was received from a healthcare professional, who is also the patient on 28 November 2011. A 72-year-old male patient had received an Intramuscular (IM) injection of FLUZONE HIGH-DOSE; lot number UH448AA (site of administration was not reported) on 14 October 2011. On 15 October 2011, the patient developed flu like symptoms, legs became weak with difficulty standing and myalgia. The symptoms lasted four days and the patient recovered completely. No further information was available at the time of the report. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Laceration, Skin injury, Syringe issue
Clinical narrative: Initial report was received from a health care professional on 11 January 2012. A female patient (age and date of birth not reported) had sustained a cut from a syringe of FLUZONE, lot number UT4176BA because the barrel of the syringe was cut. The patient had a minor scratch, no skin breakage/bleeding and no physician/medical intervention was needed. 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 19 March 2012. The patient received a cut from the vaccine barrel being chipped. The vaccine was never given and the syringe was disposed of. The patient had recovered. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Injury, Syringe issue
Clinical narrative: This case is a cluster of unidentified patients who experienced injuries when the phalange of the syringe broke for FLUZONE. Initial report was received from a health care professional on 23 February 2012. Unidentified patients (genders, ages and date of birth not reported) had experienced injuries after the phalange of FLUZONE (lot number not reported) syringes broke. No additional information was available at the time of the report. The patients' outcomes were not reported. Documents held by sender: None.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Mobility decreased, Muscular weakness, Sensory disturbance
Clinical narrative: Initial report was received from a health care professional on 29 March 2012. A 10-year-old male patient had received an intramuscular injection in the deltoid of FLUZONE, lot number U4122BA, on 09 September 2011 and approximately 8-10 days later the patient complained that his legs felt funny, he could not run fast, ran with an abnormal gait and legs felt weak. The patient was evaluated by a neurologist and the workup was negative. The symptoms resolved shortly after. The patient had no illness at the time of vaccination, no known allergies (NKA) and a past medical history of allergic rhinitis. The patient's concomitant medications included SINGULAIR and NASONEX. The patient's outcome was recovered. Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Initial report was received from a healthcare professional on 22 November 2011. A 57-year-old female patient had received an intramuscular (IM) injection of FLUZONE; lot number UT473AB in left deltoid on 14 November 2011. On the same day of the injection, the patient stated that the needle hurt when it went in. On 16 November 2011, the patient could not raise her left arm; she also developed swelling and soreness at the site. No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: none. Follow up information received on 11 June 2012: The outcome of events was updated to unknown.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: This case was received on 29 March 2012 from Health Care Professional under reference number 12-0207. 4 patients with no reported age, gender, medical history and concomitant medication received a dose of PENTACEL (batch number C3928AA), FLUZONE (batch number: UT4114BA), ROTATEQ (batch number: various lots) and Pneumococcal Vaccine (batch number: F24141) route and site of administration not reported on an unspecified date. It was reported that one of the patients (which one not specified) had Flu when he/she was vaccinated with FLUZONE. On an unspecified date hours after vaccination the patients were presented with Fever, Excessive Crying and Vomiting. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. This is a cluster case as it was reported by same HCP for 4 patients. Follow-up information was received on 22 May 2012 from a healthcare professional. The reporter for this case is the same as for non-serious cases: 2012-05376 and 2012-05377. Information regarding the other patient (who was hospitalized) is captured in serious case number 2012-04126. A six-month-old female patient received a left thigh intramuscular injection of PENTACEL, sanofi pasteur Ltd., lot number C4059AA (previously reported as C3928AA); a left thigh intramuscular injection of FLUZONE, sanofi pasteur Inc., lot number UT4114BA; a right thigh intramuscular injection of PREVNAR 13, Wyeth, lot number F24141 and an oral dose of ROTATEQ, Merck, lot number 05438A on 20 March 2012. The next day on 21 March 2012, the patient developed a hard bump at injection site on right upper leg; and raised bumps on the upper left thigh. The patient had an office visit for rash on 21 March 2012. No laboratory or diagnostic tests were reported. No treatments were reported. The patient's past medical history or concomitant medications were not reported. The patient recovered, symptoms resolved on 05 April 2012. Documents held by sender: None. Follow-up information received on 11 June 2012: The lot number of the PENTACEL was C4059AA; the dose was 3rd in the series. The FLUZONE dose was 1st in the series. The ROTATEQ dose was 3rd in the series. The PREVNAR dose was 3rd in the series. The adverse event fever, persistent crying and vomiting no longer reported. The patient have no known allergy and patient not received any other vaccines prior 4 weeks.
Age: 0.22
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 17 May 2012. A one-month-old female patient, whose medical history and concomitant medications were not reported, received a dose of FLUZONE on 08 May 2012. It was reported that the patient received a dose of FLUZONE (lot number: U8507AA, route and site of vaccination not reported) on 10 April 2012. On 8 May 2012, she received second dose of FLUZONE (lot number, route and site of vaccination not reported). Hence the patient received an extra dose of FLUZONE. The lot number U8507AA was not valid. At the time of this report, the patient did not have any adverse event. List of documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspepsia, Ear pain, Nausea
Clinical narrative: Initial report received from a healthcare professional on 15 September 2012. A 54-year-old female patient, whose concomitant medications not reported, had received FLUZONE (batch number UH747AB) intramuscularly in left deltoid on 13 September 2012. The patient was allergic to Latex, NEOSPORIN and SUDAFED. The patient had received NAPROSYN, ZOFRAN and Birth control pills in the past. The patient had TMJ (Temporomandibular Joint) disorder, hyperlipidemia and anxiety. The patient had no acute illness at the time of vaccination. The patient experienced her usual symptoms the day after receiving flu shot. The patient reported that she experienced heartburn, nausea, "dizziness" and ear pain on 14 September 2012. Laboratory investigations and corrective treatment were none. The patient did not seek physician evaluation or treatment. The outcome at the time of report was unknown. Documents held by sender: None.