chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pyrexia, Troponin I increased
Clinical narrative: Chest burning, myalgias, fever, nausea, upset stomach.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Feeling hot, Hypophagia, Vomiting
Clinical narrative: Daughter vomited violently right when I got her home from day care.  She had complained of a stomach ache during the afternoon.  She threw up again about one hour later.  She has felt a little warm but not too feverish.  She has not eaten anything since.  It is now 8:22 PM.  I will watch her closely during the night.
Age: 49.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: LUE cellulitis with erythema, induration 18 cm in length on left lateral deltoid. Pt admitted to hospital x2 days with IV antibiotic administration.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Soon after injection arm area became red and swollen. Swelling was large enough to cause clothing to be very tight.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: DEVELOPED SHINGLES AFTER FLU SHOT.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Chest discomfort, Pruritus
Clinical narrative: This case was reported by a physician and described the occurrence of anaphylaxis in a 53-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included asthma, congestive heart failure, epilepsy, ill-defined condition and lupus. Historic vaccination included INFLUENZA;GlaxoSmithKline;unknown;unknown given in 2006. In 2007 the subject received a dose of FLUARIX (.5 ml, unknown route/site). In 2007, 30 minutes after vaccination with FLUARIX, the subject experienced anaphylaxis, diffuse itching and chest tightness. The subject was hospitalised and the physician considered the events were life threatening and clinically significant (or requiring intervention). The subject was administered the FLUARIX in 2006 and 2007. According to the physician, the subject reacted to FLUARIX in 2007 with anaphylaxis, diffuse itching and chest tightness. The reporting physician was a new provider for the subject. The "reaction in 2007 happened at a different facility". The reporting physician asked about the "ingredients in FLUARIX that may have caused the reaction". At the time of reporting the outcome of the events was unspecified. The physician considered the events were possibly related to vaccination with FLUARIX.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple patients (number unspecified) of unknown age. The patients were vaccinated subcutaneously with doses of ZOSTAVAX (lot # and dose not reported) on unspecified dates. No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that a medical assistant at the physician's office told her that she administers ZOSTAVAX intramuscularly because they get too many reactions when it is administered subcutaneously. No treatment information was provided. It was unknown if the patients sought medical attention. At the time of the report the outcome of the patients was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Cardiac enzymes increased, Catheterisation cardiac normal, Electrocardiogram change, Myocardial infarction
Clinical narrative: Case number PHEH2012US021954 is an initial spontaneous report received from a consumer on 06 Nov 2012. This report refers to a 72-years-old male patient. His medical history included cardio vascular symptom of heaviness on 23 Oct 2012. On 24 Oct 2012, he went for a routine checkup and was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on to unspecified site. The physician asked him to do an EKG as the patient had cardiovascular symptom of heaviness before vaccination. He did an electrocardiogram in physician's office and "had changes'. He was sent to hospital for blood test. About an hour after blood tests, he was instructed to get back to hospital immediately and his enzymes were elevated. He was transferred to hospital by an ambulance. A second electrocardiogram was performed. He also had enzymes test and heart catheterization and it was report that from heart catheter, they did not find blockage, but he just had weakness. On 26 Oct 2012, his enzyme levels started going down. It was reported that initially doctor stated that it could have been a heart attack or broken heart syndrome, but later it was confirmed as a heart attack. He was hospitalized on an unknown date (duration of hospitalization was not reported). The patient's wife reported that he did not have any pain during any of the event. The reporter believed that the event was a reaction to the flu vaccine. The outcome of the event was not reported. No further information was available.
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Urticaria
Clinical narrative: This is a cluster of 2 patients who experienced adverse events following administration of FLUZONE INTRADERMAL; lot number UT4163BA. The event for the other patient was captured in case number 2011-10002. Initial report was received on 13 October 2011 from a healthcare provider. A female patient (age and date of birth not reported) had received FLUZONE INTRADERMAL (ID) injection; lot number UT4163BA on 07 October 2011. On an unspecified date, the patient developed a welt "3 inches in diameter" which turned into a bruise and painful to the touch. The bruise is still visible to the eye five days post vaccination. No further information was available at the time of the report. The patient outcome was not reported. Follow-up information was received on 09 January 2012 from a health care professional. The patient was reported as recovered (date not reported). Documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: Initial report received from a health care professional on 20 January 2012. This case involves 1 of a cluster of 4 patients who had received FLUZONE INTRADERMAL (lot number UT4163AA) and experienced reactions. Information regarding the other 3 patients is captured in case numbers 2011-10556 (serious cases), 2012-00784 and 00785 (both non-serious cases). A 32 year-old female patient had received a right arm dose of FLUZONE INTRADERMAL (lot number UT4163AA) on 27 October 2011 at 9:00 am and 4 days later on 31 October 2011 at 9:00 am experienced extensive swelling of the vaccinated limb. It was not reported whether the patient required any medical evaluation or treatment. The patient recovered on an unspecified date. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Initial report was received 14 October 2011 from a health care professional which involved a cluster of two patients. This case captures one patient. The other patient has been captured in case number 2011-09997. A 31-year-old female patient had received a left arm injection of FLUZONE INTRADERMAL, lot number UT4163AA and an unspecified amount of time later, she developed itching at the injection site which extended down her arm. She had not received any other vaccines during the four weeks prior to receiving FLUZONE INTRADERMAL. Past medical history, concurrent illness and concomitant medications were not reported. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Malaise, Nausea
Clinical narrative: This case is a cluster of 5 patients who experienced adverse events following administration of FLUZONE INTRADERMAL; lot number UT4163AA. The event for the other patients were captured in case number 2012-01380. Initial report was received from a company representative on 31 January 2012. A patient (gender and age not reported) had received an Intradermal (ID) injection of FLUZONE; lot number UT4163AA (site, route and date of administration were not provided). On an unspecified date, the patient felt nauseous and didn't feel well. No further information was available at the time of this report. The patient outcome was reported as recovered/resolved. Documents held by sender: No medical follow-up required. Follow up information receive on 30 April 2012. The patient's birth of birth was updated and gender as female. Vaccination date was added as 10 October 2012. Route of administration was updated as intradermal and site as right arm. Injection site redness and pruritus were added to the adverse events. Event onset date was added as 10 October 2011.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Injection site vesicles, Vaccination site erythema, Vaccination site pain
Clinical narrative: Initial report was received from a healthcare professional on 15 December 2011. A 53-year-old female patient had received an Intradermal (ID) injection of FLUZONE INTRADERMAL; lot number UT4164AA in left arm on 13 December 2011. On the same day of the injection, the patient developed a blister 13mm in diameter, pain and erythema at the vaccination site left arm. The patient was seen on 15 December 2011, and received corrective treatment with ALEVE and ice. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Follow-up information received on 27 February 2012 from a nurse. The reporter spoke with the patient and the patient stated the blister opened and healed which took about 2 weeks, and then she had a residual knot at the site of injection that was non-tender. The patient sought no further treatments and recovered on 27 December 2011. The reporter reviewed the case and has no additional information at this time. Documents held by sender: None.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Malaise, Nausea
Clinical narrative: This case is a cluster of 5 patients who experienced adverse events following administration of FLUZONE INTRADERMAL; lot number UT4163AA. The event for one patient was captured in case number 2012-01403. Initial report was received from a company representative on 31 January 2012. Five patients had received an Intradermal (ID) injection of FLUZONE; lot number UT4163AA (site, route and date of administration were not provided). On an unspecified date, the patients developed redness, swelling and itching at injection site. No further information was available at the time of this report. The patient's outcome was reported as recovered/resolved. Documents held by sender: No medical follow-up required. Follow up information received on 30 April 2012. Patient's date of birth and gender as female. Nausea and feeling ill were added as new events. Vaccination date was updated to 29 September 2011 and event onset date as 29 September 2011. FLUZONE lot number was updated as UT4163AA. Route of vaccination was updated as intra-dermal and site as Right upper arm.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Initial report was received from a healthcare professional on 24 January 2012. The patients (age and gender not reported) had received an injection of FLUZONE INTRADERMAL; lot number UT4163AA (route, site and date of administration not reported). On an unspecified date, the patients had reactions similar to the reactions described in our literature. No further information was available at the time of this report. The patient's outcome was not reported. Documents held by sender: None.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: Initial report received from a health care professional on 20 January 2012. This case involves 1 of a cluster of 4 patients who had received FLUZONE INTRADERMAL (lot number UT4163AA) and experienced reactions. Information regarding the other 3 patients is captured in case numbers 2011-10556 (serious case), 2012-00783 and 00784 (both non-serious cases). A 51 year-old male patient had received a right arm dose of FLUZONE INTRADERMAL (lot number UT4163AA) on 27 October 2011 at 5:00 pm and the following day experienced extensive swelling of the vaccinated limb. It was not reported whether the patient required any medical evaluation or treatment. The patient recovered on an unspecified date. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Headache, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Initial report received from a healthcare professional on 30 May 2012. A patient, gender, medical history and concomitant medication were not reported, had received a dose of FLUZONE ID (As per triage suspect product perhaps should be FLUZONE) on an unspecified date (lot number, site of vaccination were not reported). It was reported that, the patient presented fever, headache, aches, swelling and redness of whole deltoid and running nose. The lab details and corrective treatment details were not reported. The outcome was not reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Initial report received from a healthcare professional on 30 May 2012. A patient, gender, medical history and concomitant medication were not reported, had received a dose of FLUZONE ID (As per triage suspect product perhaps should be FLUZONE) on an unspecified date (lot number, site of vaccination were not reported). It was reported that, the patient presented fever, headache, aches, swelling and redness of whole deltoid and running nose. The lab details and corrective treatment details were not reported. The outcome was not reported. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Initial report was received from a health care professional, who was also the patient, on 22 March 2012. This reporter also reported another adverse event which was captured in case 2011-11668. A female patient (age and date of birth not reported) had received an injection of FLUZONE INTRADERMAL (lot number, route, site and date of administration not reported) and an unspecified amount of time later had a "painful experience." No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Follow up report received from a Healthcare professional on 08 May 2012. Local Reference number: 12-0185.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Erythema, Inflammation, Pain, Pruritus
Clinical narrative: This report involved a cluster of three patients who experienced adverse events following administration of FLUZONE INTRADERMAL, lot number UT4163AA. The other two patients have been captured in case numbers 2012-02397 and 2012-02398. Initial report was received from a health care professional on 24 February 2012. A female patient (age and date of birth not reported) had received an injection of FLUZONE INTRADERMAL, sanofi pasteur Inc. lot number UT4163AA (route, site and date of administration not reported). One to two hours after the vaccination, the patient experienced swelling and redness that was itchy "about a 50 cent size are" that was okay by the following morning. Then two days later, the patient developed a larger area traveling down the arm that was red, warm, itchy and painful that extended about four inches from the injection site that lasted for about a week. The patient took BENADRYL at night and CLARITIN during the day to relieve the itching and inflammation as well as cold packs for the discomfort. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None. Follow up information received on 08 May 2012: Patient age was reported as 57 years at the time of event. The patient's medical history and other vaccinations included none. Product therapy dates added as 19 October 2011. Product route of administration added as subcutaneous route and site of administration added as deltoid left. Event onset dates added as 21 October 2011 and event cessation dates added as 29 October 2011.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Swelling
Clinical narrative: This report involved a cluster of three patients who experienced adverse events following administration of FLUZONE INTRADERMAL, lot number UT4163AA. The other two patients have been captured in case numbers 2012-02397 and 2012-02398. Initial report was received from a health care professional on 24 February 2012. A female patient (age and date of birth not reported) had received an injection of FLUZONE INTRADERMAL, sanofi pasteur Inc. lot number UT4163AA (route, site and date of administration not reported). One to two hours after the vaccination, the patient experienced swelling and redness that was itchy "about a 50 cent size are" that was okay by the following morning. Then two days later, the patient developed a larger area traveling down the arm that was red, warm, itchy and painful that extended about four inches from the injection site that lasted for about a week. The patient took BENADRYL at night and CLARITIN during the day to relieve the itching and inflammation as well as cold packs for the discomfort. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None. Follow up information received on 08 May 2012: Patient age was reported as 57 years at the time of event. The patient's medical history and other vaccinations included none. Product therapy dates added as 19 October 2011. Product route of administration added as subcutaneous route and site of administration added as deltoid left. Event onset dates added as 21 October 2011 and event cessation dates added as 29 October 2011.
Sex: M
Vaccine: FLU3
Symptoms: Bronchitis, Injection site reaction, Mucosal discolouration, Oropharyngeal pain, Pain
Clinical narrative: Initial report was received from a patient on 02 December 2011. A male patient (age not reported) had received an injection of FLUZONE Intradermal (lot number, route and site of administration were not reported) on 30 November 2011. On the same day during the evening after the injection, the patient developed a sore throat, felt achy, sinus infection, bronchitis, green mucous and a red bump the size of a "bug  bite" at the injection site. The patient received corrective treatment with antibiotic. No further information was available at the time of the report. The patient outcome was not reported. Follow-up information was received on 06 February 2012 from a health care professional. The patient had received FLUZONE Intradermal; lot number UT4163AA in the left deltoid. No further information was available at the time of the report. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Sinusitis
Clinical narrative: Initial report was received from a patient on 02 December 2011. A male patient (age not reported) had received an injection of FLUZONE Intradermal (lot number, route and site of administration were not reported) on 30 November 2011. On the same day during the evening after the injection, the patient developed a sore throat, felt achy, sinus infection, bronchitis, green mucous and a red bump the size of a "bug  bite" at the injection site. The patient received corrective treatment with antibiotic. No further information was available at the time of the report. The patient outcome was not reported. Follow-up information was received on 06 February 2012 from a health care professional. The patient had received FLUZONE Intradermal; lot number UT4163AA in the left deltoid. No further information was available at the time of the report. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Inflammation, Pain
Clinical narrative: Patient received vaccine 11/8 afternoon, she later started experiencing pain & inflammation, burning, etc. Informed patient to take MOTRIN for the pain and inflammation. Also an ice pack, if no improvement see a doctor.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt. states experienced itching and hives all over body after receiving live-virus influenza vaccine. Pt. denies taking any medications for symptoms.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Cough, Dizziness, Dry throat, Eye pruritus
Clinical narrative: Red itchy eyes, throat dry, coughing more. BP elevated from normal range 149/93 Pulse 113; earlier BP checked was much lower during dental visit, dizziness/lightheaded. During PHA screening, BP 122/77.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Ocular hyperaemia
Clinical narrative: Red itchy eyes, throat dry, coughing more. BP elevated from normal range 149/93 Pulse 113; earlier BP checked was much lower during dental visit, dizziness/lightheaded. During PHA screening, BP 122/77.
Age: 27.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Dizziness, Palpitations
Clinical narrative: Pt reported feeling like her heart was racing and dizziness. No c/o shortness of breath, or chest pain. VS BP 100/75 HR 78. Pt was brought to ED for further eval & documentation. (Per pt normal BP is 80s/50s).
Age: 21.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Syncope
Clinical narrative: Fainted after 3rd shot administered.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Extensive swelling of vaccinated limb, Injection site erythema, Nausea, Pain in extremity
Clinical narrative: Initial report was received on 04 November 2011 from a health care professional. A female patient had received FLUZONE Intradermal, lot number UT4163AA (site and date of administration not reported) and an unspecified amount of time later, experienced extensive swelling at the injection site with redness, pain that shot down the patient's arm and a systemic reaction of nausea and chills. No further information was available at the time of the report. Outcome was not reported. Documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Cough, Influenza, Myalgia
Clinical narrative: Standard flu shot received at 12:00 PM on 10/24/12. Full blown flu onset at 5:00 PM on 10/24. The flu lasted 4 days: coughing, chills, muscle aches, sneezing, weakness, fever.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Sneezing
Clinical narrative: Standard flu shot received at 12:00 PM on 10/24/12. Full blown flu onset at 5:00 PM on 10/24. The flu lasted 4 days: coughing, chills, muscle aches, sneezing, weakness, fever.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth & swelling 8 1/2 cm x 5 1/2 cm at injection site.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Swelling pain at injection site. Fever illness that led patient to go to ER. Vaccination PPV23 given 8 yrs after previous PPV23.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Musculoskeletal pain
Clinical narrative: Case received on 04 October 2011 from a healthcare professional. A female patient, with no medical history reported, had received on an unspecified date her dose of FLUZONE HIGH DOSE (batch number UH468AB, number in series, route and site of administration not reported). No concomitant therapy was reported. On an unspecified date, the patient developed redness and severe arm swelling. No corrective therapy was reported. The final outcome was not reported. Follow-up information was received from a health care professional on 12 January 2012. The reporter claimed the initial report had the wrong patient and vaccine. The correct patient was a 34-year-old (reported as 35) female who received an injection in the left arm of FLUZONE Intradermal, lot number UT4163BA on 29 October 2011 and an unspecified amount of time later experienced a red, swollen raised dime sized area at the injection site "like a TB test". The patient's arm also got hot, red and swollen 24 hours later and the site was the size of a silver dollar. The patient experienced arm pain and shoulder pain. The patient was seen on 29 October 2011 with a large, red, swollen arm and was seen again on 05 January 2012 and the arm was still sore with a dime size and red spot still on the arm. It was very hard for the patient to lift child or lay on that part of the arm. No medical history was reported, no concomitant medications were reported and the patient had no illness at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Case received on 04 October 2011 from a healthcare professional. A female patient, with no medical history reported, had received on an unspecified date her dose of FLUZONE HIGH DOSE (batch number UH468AB, number in series, route and site of administration not reported). No concomitant therapy was reported. On an unspecified date, the patient developed redness and severe arm swelling. No corrective therapy was reported. The final outcome was not reported. Follow-up information was received from a health care professional on 12 January 2012. The reporter claimed the initial report had the wrong patient and vaccine. The correct patient was a 34-year-old (reported as 35) female who received an injection in the left arm of FLUZONE Intradermal, lot number UT4163BA on 29 October 2011 and an unspecified amount of time later experienced a red, swollen raised dime sized area at the injection site "like a TB test". The patient's arm also got hot, red and swollen 24 hours later and the site was the size of a silver dollar. The patient experienced arm pain and shoulder pain. The patient was seen on 29 October 2011 with a large, red, swollen arm and was seen again on 05 January 2012 and the arm was still sore with a dime size and red spot still on the arm. It was very hard for the patient to lift child or lay on that part of the arm. No medical history was reported, no concomitant medications were reported and the patient had no illness at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Skin red & swollen from shoulder to elbow also hot to touch.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Left arm pain x 12 days s/p flu vaccine administration.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain, Pain
Clinical narrative: Pt says it hurt when she received vaccine. She came back on 10/30/12 and said was still sore and bruised (pale greenish bruise about the size of a nickel). Pt also said she called 911 the previous weekend because it hurt.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Heart rate increased, Heart rate irregular
Clinical narrative: Rapid heartbeat, weakness, dizziness, irregular heartbeat.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle tightness, Musculoskeletal discomfort, Oropharyngeal discomfort, Throat tightness
Clinical narrative: Pt rcd flu vaccine (injection) given on 10/5/12 and developed "tightness" and extreme discomfort in neck and throat. Seen & tx'd for allergic Rx at ER.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysphonia, Dyspnoea, Vision blurred
Clinical narrative: Pt stated trouble breath after 5 hours of having flu vaccine IM. Pt stated allergies to lactose & nuts. Pt states dizzy, blurred vision. Pt voice hoarse, taken across the street Medical Center by personnel and nurse.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Flu vaccine administered approximate 15 min prior to 12N on 10/24/12. Client returned to nurse reporting his right arm sore at injection site. Assessed area noted redness out 3 inch diameter from injection. At 3pm returned the site was red, hot with induration and soreness. No difficulty breathing or other complaints.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Tremor
Clinical narrative: Shaking chills 2 nights post injection redness and slightly warm, mild swelling (L) arm around injection site. 4 inch x 4 inch in diameter.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Dizziness, Hypoaesthesia, Nausea
Clinical narrative: Loose stools, numbness in hands & legs, nausea, weakness, lightheaded Naproxen every 4 hours per Dr.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Groin pain, Headache, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Initial report was received from a patient on 04 November 2011. A 46-year-old male patient received an Intradermal (ID) injection in left deltoid of FLUZONE (lot number not reported) on 29 October 2011. In the evening of the injection, the patient developed pain on the left side of his groin which subsided. On 30 October 2011, in the morning he woke up with nausea, vomiting, a pounding headache and two in a half inch wide reddened area and pain in left deltoid. No further informational was available at the time of the report. The patient outcome was reported as recovered/resolved. Follow-up information was received on 26 March 2012 from a health care professional. The lot number of FLUZONE Intradermal was UT4163AA. The patient's outcome remained recovered. Documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Initial report was received from a patient on 04 November 2011. A 46-year-old male patient received an Intradermal (ID) injection in left deltoid of FLUZONE (lot number not reported) on 29 October 2011. In the evening of the injection, the patient developed pain on the left side of his groin which subsided. On 30 October 2011, in the morning he woke up with nausea, vomiting, a pounding headache and two in a half inch wide reddened area and pain in left deltoid. No further informational was available at the time of the report. The patient outcome was reported as recovered/resolved. Follow-up information was received on 26 March 2012 from a health care professional. The lot number of FLUZONE Intradermal was UT4163AA. The patient's outcome remained recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Mobility decreased, Neck pain, Skin warm
Clinical narrative: Initial report was received from a health care professional staff member on 25 October 2011. A female patient (age and date of birth not reported) had received a FLUZONE Intradermal injection (lot number, route and site of administration not reported). On an unspecified date, the patient was having trouble lifting her arm. She developed a large red circle, very hot and painful. The pain radiates up into her neck and unable to turn it. The patient neck feels a little better but has other symptoms still ongoing. She was advice to put a cool cloth or ice on the site and see if it would help and after the patient was able to fall asleep. No further informational was available at the time of the report. The patient outcome was not reported. Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Initial report was received from a health care professional on 18 October 2011. A 37-year-old female patient had received an Intradermal (ID) injection of FLUZONE; lot number UT4164BA in right deltoid on 17 October 2011. On 18 October 2011, the patient developed a "2.5" inch diameter red, swollen, painful, sore and burning at the right deltoid. She also experienced headache and nausea. No further informational was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Paraesthesia oral, Swollen tongue, Throat tightness
Clinical narrative: Approximately 2 hours after receiving vaccine, employee had tightening of throat, swelling eyes, lips, tongue, and tingling of gums and mouth. Was home -> went to ED.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a healthcare professional on 04 September 2012. A female patient whose age, medical history and concomitant medications were not reported; had received intradermal FLUZONE ID (lot number was not provided) in arm on 24 August 2012. On 24 August 2012, the patient developed 2x2" swollen, hard, red lump at the injection site, hot to touch, muscle weakness in injection site arm. The patient also had difficulty sleeping due to pain in her arm which continued for 11 days with itching and peeling. Details of lab tests were not reported. The patient was prescribed "BENEDRYL". The patient's outcome was recovered on unspecified date. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Muscular weakness, Pain in extremity, Pruritus, Skin exfoliation
Clinical narrative: Initial report received from a healthcare professional on 04 September 2012. A female patient whose age, medical history and concomitant medications were not reported; had received intradermal FLUZONE ID (lot number was not provided) in arm on 24 August 2012. On 24 August 2012, the patient developed 2x2" swollen, hard, red lump at the injection site, hot to touch, muscle weakness in injection site arm. The patient also had difficulty sleeping due to pain in her arm which continued for 11 days with itching and peeling. Details of lab tests were not reported. The patient was prescribed "BENEDRYL". The patient's outcome was recovered on unspecified date. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Injection site haematoma, Oedema peripheral
Clinical narrative: Initial information received from a Health care professional on 04 September 2012. A 29-year-old male patient whose medical history and concomitant medication were not reported received an intradermal dose of FLUZONE ID vaccine (Batch lot number UT4463BA) (Expiry date 26 March 2013) in right arm on 27 August 2012. The reporter stated that on the 03 September 2012, the patient had bruising down length of upper right arm, beginning into right forearm and slightly swollen right arm. Laboratory details and corrective treatment were not reported. Outcome of the event was unknown. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Oedema peripheral, Urticaria
Clinical narrative: Initial report received from a health care professional also the consumer on 14 September 2012. A male patient, had received a dose of FLUZONE intradermal vaccine (site and dose no. was not reported) on an unspecified date (lot number: UT4467AA). Medical history and concomitant medications were not reported. The patient reported that after receiving FLUZONE ID vaccine he had a wheal immediately which was followed by arm swelling at the same spot. Corrective measures were not reported. At the time of this report, the patient's outcome was unknown. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Nonspecific reaction
Clinical narrative: Initial report received from a health care professional on 14 September 2012. 20+ patients (date of birth and gender not reported) with no reported medical history and concomitant medications had received FLUZONE intradermally on an unspecified date (batch number UT4474AA). According to the reporter, the patients had a couple of "weird reactions" that may not be associated with the vaccine. Laboratory investigations and corrective treatment was not reported. The outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Injection site pain
Clinical narrative: Initial report received from a healthcare professional who is also patient, on 05 September 2012. A female patient whose age, medical history and concomitant medications were not reported had received a dose of FLUZONE intradermal injection (lot number UT4163AA, anatomical site of administration was not reported) on an unspecified date. The patient reported that she received the FLUZONE ID shot last season and she received a red mark on her arm which was lasted for 03 weeks, she also experienced induration on an unspecified date. She also stated that she didn't tolerate it well and it got hurt while it was being administered. Corrective treatment and laboratory investigation were not reported. The patient's outcome was not reported. Documents held by sender: None.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Pain in extremity, Swelling
Clinical narrative: Initial report received from a healthcare professional on 13 September 2012. A 49-year-old female patient, whose medical history and concomitant medication were not reported, had received FLUZONE intradermal vaccine (Lot number UT4470BA, anatomical site of administration not reported) on 10 September 2012. On an unspecified date, the patient had large swelling, bruising- redness looked like the size of an egg and arm pain. On 13 September 2012, all of these symptoms still persisted. Corrective treatment was not reported. The patient's outcome was not recovered. List of documents held by the sender: None.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Dermatitis contact, Injection site discharge, Injection site irritation, Injection site vesicles, Urticaria
Clinical narrative: Initial report received from a healthcare professional on 12 September 2012. A 47-year-old male patient received first dose of FLUZONE intradermal (batch number: UT4470BA) in the left deltoid on 11 September 2012. The patient's medical history included latex and unknown if other allergies. Concomitant medications were not reported. It was reported that it was not sure whether the patient received full dose or some vaccine leaked out. On 12 September 2012, the patient developed wheal. The patient took the band aid off the next day and dabbed with a towel, the "blister" was seeping and when he wiped it off the skin came off. There was irritation in the shape of the band aid which was latex free. The corrective treatment and lab investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Feeling abnormal, Urticaria
Clinical narrative: This case is linked with the case# 2012-08034 (0). Initial information received from a health care professional on 29 August 2012. A patient (unknown age and gender) whose medical history and concomitant medication were not reported received an intradermal dose of FLUZONE ID vaccine (Batch lot number, anatomical position and dose: not reported) on 27 August 2012. It was reported that the patient who was 1 of the 12 employees had a funny feeling at the time of the injection and later in the afternoon. Also the patient had welts, it was mosquito bite size to 1/2 dollar size and some were red. Laboratory details and corrective treatment were not reported. Outcome of the event was not reported. Documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Maternal exposure during pregnancy
Clinical narrative: This case was retrieved via a search of the scientific literature on 17 July 2012. The following is verbatim: Case report with FLUZONE ID. "During this first influenza season, the company received only one report of exposure during pregnancy. A 31-year-old woman, who received FLUZONE ID experienced injection site inflammation after vaccination and recovered three days after the onset. The date of last menstrual period and expected date of delivery were not reported." Documents held by sender: None.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Nausea, Visual impairment, Vomiting
Clinical narrative: This is a cluster of 2 patients who had received FLUZONE ID and experienced some reactions. The event for the one patient was captured in case 2011-09633. A female patient (age not reported) received FLUZONE Intradermal injection in deltoid, lot number UT4163AA. On 05 October 2011, within minutes after receiving the injection the patient complained of lightheadedness, dizzy, diaphoresis, vomiting, nausea and seeing spots. However, diaphoresis and lightheadedness were resolved after vomiting; all other symptoms remain. The patient has never had an allergic reaction to any vaccine. No further informational was available at the time of the report. The patient outcome was not resolved/not recovered. Follow-up information received on 29 February 2012 from a nurse. The patient had no concurrent illnesses at the time of vaccination with FLUZONE vaccine, which was at 9:40am on 05 October 2011. The onset time of the reactions were 9:41am the same day. The patient recovered the same date at 14:00pm. The reporter reviewed the case and has no additional information at this time. No further information is expected. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Immediate post-injection reaction, Insomnia, Swelling
Clinical narrative: Initial report was received from a company representative on 03 October 2011. A female patient (age and date of birth not reported) had received a FLUZONE Intradermal (lot number not reported). On an unspecified date, the patient experienced immediate swelling and couldn't sleep on her side during the night. The patient also developed dizziness and faintness which lasted for a few hours. No further informational was available at the time of the report. The patient outcome was not reported. Documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: FLUN3, MMR, VARCEL
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Last night developed hives on her left thigh around injection site. This morning she woke up with hives from neck to toes that are itchy. No trouble breathing. Gave BENADRYL & sent her to school.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: This is a cluster of 2 patients who experienced adverse events following administration of FLUZONE Intradermal (UT4163AA). The events for the other patient was captured in case number 2011-09894. Initial report was received on 11 October 2011 from a healthcare provider. A 61-year-old female patient had received FLUZONE Intradermal; lot number UT4163AA in left arm on 05 October 2011. On the same day within two in half to three hours, the patient developed a dime sized area of redness in between her fourth and fifth fingers and itchiness on left hand. No further informational was available at the time of the report. The patient's outcome was reported as unknown. Follow-up information was received from a healthcare professional on 03 January 2012. No additional information at this time. The patient outcome was reported as recovered/resolved on 11 October 2011. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: This case is a cluster of five patients who experienced adverse events following administration of FLUZONE Intradermal, (lot number not reported). Initial report was received on 06 October 2011 from a healthcare provider. Five patients (gender, age and date of birth not reported) had received FLUZONE Intradermal (lot number, route and site of administration not reported). On an unspecified date, the patients developed redness and itching. No further informational was available at the time of the report. The patients outcome was not reported. Documents held by sender: none.
Age: 1.27
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: MISADMINISTRATION. Pt in for scheduled age appropriate vaccinations and Flu vaccine. Received no doses of flu vaccine last year. Child was inadvertently given FLUZONE 0.5mL IM instead of 0.25mL. Mother was notified. No adverse reactions reported as of 18 hours post injection.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Mass, Oedema peripheral, Pain of skin, Pyrexia
Clinical narrative: Initial report was received from a health care professional staff member on 03 October 2011. A female patient (age and date of birth not reported) had received a FLUZONE Intradermal injection (lot number, site and route of administration not reported). On an unspecified date, the patient experienced stinging immediately as the vaccine went under her skin, she noticed that her skin continued to sting and hurt to the touch. The patient also developed a lump which was getting bigger as the day went on. On Friday 30 September 2011, her whole upper arm was swollen like a "softball" and fever. The patient held ice pack as a corrected treatment. On 03 October 2011, her arm was still a little swollen and hot to the touch. No further informational was available at the time of the report. The patient outcome was not reported. Follow-up information was received from a healthcare professional on 03 January 2012. A 41-year-old female patient outcome was reported as recovered/resolved. Documents held by sender: none.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Initial report was received from a health care professional staff member on 03 October 2011. A female patient (age and date of birth not reported) had received a FLUZONE Intradermal injection (lot number, site and route of administration not reported). On an unspecified date, the patient experienced stinging immediately as the vaccine went under her skin, she noticed that her skin continued to sting and hurt to the touch. The patient also developed a lump which was getting bigger as the day went on. On Friday 30 September 2011, her whole upper arm was swollen like a "softball" and fever. The patient held ice pack as a corrected treatment. On 03 October 2011, her arm was still a little swollen and hot to the touch. No further informational was available at the time of the report. The patient outcome was not reported. Follow-up information was received from a healthcare professional on 03 January 2012. A 41-year-old female patient outcome was reported as recovered/resolved. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Initial report received from a health care professional on 06 October 2011. This case is a cluster of 2 unidentified patients who experienced similar adverse events following vaccination with FLUZONE Intradermal. This reporter also reported another adverse event, which was captured in case number 2011-09901 and case 2011-09902. A group of 2 unidentified patients received an intradermal injection of FLUZONE Intradermal, sanofi pasteur Inc. lot number UT4163AA, on 06 October 2011. On 06 October 2011, both patients developed nausea and dizziness on the way home after vaccination. The nausea and dizziness continued the next day. The patients had swelling, redness and pain at the injection site. The outcome was reported as recovered for both patients. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial report was received on 11 October 2011 from a health care professional, which involved a cluster of three female patients who experienced adverse events after receiving FLUZONE Intradermal (lot number not reported). This case captures one of the female patients. The other two patients have been captured in case number 2011-09897 and 2011-0989. Documents held by sender: none.