chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Back pain, Joint stiffness, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 37 years old female patient with asthma and allergic to codeine. The patient was vaccinated intramuscularly with, .5 ml PNEUMOVAX23 on 24-OCT-2012 (Lot number H009826, exp 02/2014). Other suspect therapies included FLUZONE with dosage information as (UNK) on 24-OCT-2012 in the other arm at the same time she received the PNEUMOVAX23. Concomitant medications included: CELEBREX. On 25-OCT-2012, the patient told the reporter that her lymph nodes were swollen under the arm in which the injection was given and the pain is radiating from her back to her front side. She also reported that "all of her joints were stiff". No treatment information was reported. The outcome of all of her joints were stiff, lymph nodes swollen under the arm in which the injection was given and pain is radiating from her back to her front side was reported as recovering/resolving. The relatedness for lymph nodes swollen under the arm in which the injection was given, pain is radiating from her back to her front side and all of her joints were stiff is unknown for PNEUMOVAX23. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Arm pain.  Patient states has debilitating arm pain from injection.  Although she also admits to moving furniture, washing walls and exercising her upper body.  Does not report hives, shortness of breath, rash, weakness or dizziness.  Feels as if her "muscle has locked up".
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscle disorder, Pain in extremity
Clinical narrative: Arm pain.  Patient states has debilitating arm pain from injection.  Although she also admits to moving furniture, washing walls and exercising her upper body.  Does not report hives, shortness of breath, rash, weakness or dizziness.  Feels as if her "muscle has locked up".
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blister, Cellulitis, Pyrexia, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: Information has been received from healthcare worker regarding to a female patient of unknown age. The patient's medical history, drug reactions or allergies were not provided. On 24-OCT-2012, the patient was vaccinated with a dose of PNEUMOVAX23 (dose and route was not provided) (Lot number H013581, expiration date 03-MAR-2014). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient developed swelling at the injection site, fever and chills after received a dose of PNEUMOVAX23. The reporter was requesting a lot check due to patients having adverse events. This is two of two cases reported. The patient received antibiotic (unspecified) as treatment for the adverse events. The patient sought medical attention, saw physician. At the time of the report, the patient had not recover from the adverse events. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from healthcare worker regarding to a female patient of unknown age. The patient's medical history, drug reactions or allergies were not provided. On 24-OCT-2012, the patient was vaccinated with a dose of PNEUMOVAX23 (dose and route was not provided) (Lot number H013581, expiration date 03-MAR-2014). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient developed swelling at the injection site, fever and chills after received a dose of PNEUMOVAX23. The reporter was requesting a lot check due to patients having adverse events. This is two of two cases reported. The patient received antibiotic (unspecified) as treatment for the adverse events. The patient sought medical attention, saw physician. At the time of the report, the patient had not recover from the adverse events. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood test, Erythema, Full blood count, Injection site reaction, Injection site warmth
Clinical narrative: Spreading red hot rash radiating from pneumonia vaccination site. This was 2nd vaccination (first 7 years previous). Saw Dr. on Nov.8. Prescribed cephalexin and Benadryl.  Outcome presently unknown. I am the patient. Red area now covers front and back of upper arm, part of shoulder, and has spread to part of chest and back. This should   NOT happen. Antibiotics will cause more problems.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Rash erythematous
Clinical narrative: Spreading red hot rash radiating from pneumonia vaccination site. This was 2nd vaccination (first 7 years previous). Saw Dr. on Nov.8. Prescribed cephalexin and Benadryl.  Outcome presently unknown. I am the patient. Red area now covers front and back of upper arm, part of shoulder, and has spread to part of chest and back. This should   NOT happen. Antibiotics will cause more problems.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Spreading red hot rash radiating from pneumonia vaccination site. This was 2nd vaccination (first 7 years previous). Saw Dr. on Nov.8. Prescribed cephalexin and Benadryl.  Outcome presently unknown. I am the patient. Red area now covers front and back of upper arm, part of shoulder, and has spread to part of chest and back. This should   NOT happen. Antibiotics will cause more problems.
Age: 13.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain, Chills, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Chills, fever, diaphoretic, significant headache, dizzy, nauseated, significant abdominal pain.
Age: 13.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Pyrexia
Clinical narrative: Chills, fever, diaphoretic, significant headache, dizzy, nauseated, significant abdominal pain.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, hot, hard skin at injection site. Gave Benadryl, Ibuprofen and Tylenol. Swelling and color decreased some. Arm was very tender, difficult for her to move much. Ice pack applied, continued medications on timed schedule. Improved after 24 hours.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Pallor, Tenderness
Clinical narrative: Red, swollen, hot, hard skin at injection site. Gave Benadryl, Ibuprofen and Tylenol. Swelling and color decreased some. Arm was very tender, difficult for her to move much. Ice pack applied, continued medications on timed schedule. Improved after 24 hours.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Chest discomfort, Chest pain, Diarrhoea, Myalgia, Sleep disorder
Clinical narrative: Vomiting with no warning, almost call it projectile, never had this in my life before, severe muscle ache, tightness in ribcage, couldn't sleep hurt too much in right side of chest, diarrhea.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Vomiting with no warning, almost call it projectile, never had this in my life before, severe muscle ache, tightness in ribcage, couldn't sleep hurt too much in right side of chest, diarrhea.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Dizziness, Ear disorder
Clinical narrative: This spontaneous report as received from an approximately 60-year-old female registered nurse regarding herself. Current conditions included diabetes, asthma, kidney issues, hypothyroidism, macular degeneration in eyes, pituitary tumor on an unknown date in January 2009, arthritis, on an unknown date in September 2011 the nurse had blood coming out during urination and was diagnosed with a kidney infection. Patient was allergic to penicillin and sulfa. Lab tests included kidney sonogram done on an unknown date in October 2011. On 12-JAN-2012 the patient was vaccinated with dose 1 PNEUMOVAX23 (lot # not reported) dose and route not reported. Concomitant medications included 2 types of unspecified INSULIN, SYNTHROID and 12 other unspecified medications. The nurse was very sick (disability), had a fever (disability) and bad lung condition (disability) that occurred on an unknown date early in April 2012. She went to the physician office on 12-APR-2012 and was given dose 2 PNEUMOVAX23 (lot# not reported) dose and route not reported. The nurse was given prednisone and other unspecified medications and then recovered on approximately 03-MAY-2012 (2.5-3 weeks after visit on 12-APR-2012). She mentioned that recently she had been experiencing dizziness (disability). She did not know if this was related to her ear problems (disability) she got a lot or because of receiving 2 doses of PNEUMOVAX23 within a short time of each other. The outcome of the events dizziness and ear problems were unknown. The patient sought medical attention for the events by visiting the office. The event a lung condition was considered life threatening by the reporter. This is one of the 2 reports from the same reporter and patient. The events were considered to be other important medical events. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus
Clinical narrative: This spontaneous report as received from an approximately 60-year-old female registered nurse regarding herself. Current conditions included diabetes, asthma, kidney issues, hypothyroidism, macular degeneration in eyes, pituitary tumor on an unknown date in January 2009, arthritis, on an unknown date in September 2011 the nurse had blood coming out during urination and was diagnosed with a kidney infection. Patient was allergic to penicillin and sulfa. Lab tests included kidney sonogram done on an unknown date in October 2011. On 12-JAN-2012 the patient was vaccinated with dose 1 PNEUMOVAX23 (lot # not reported) dose and route not reported. Concomitant medications included 2 types of unspecified INSULIN, SYNTHROID and 12 other unspecified medications. The nurse was very sick (disability), had a fever (disability) and bad lung condition (disability) that occurred on an unknown date early in April 2012. She went to the physician office on 12-APR-2012 and was given dose 2 PNEUMOVAX23 (lot# not reported) dose and route not reported. The nurse was given prednisone and other unspecified medications and then recovered on approximately 03-MAY-2012 (2.5-3 weeks after visit on 12-APR-2012). She mentioned that recently she had been experiencing dizziness (disability). She did not know if this was related to her ear problems (disability) she got a lot or because of receiving 2 doses of PNEUMOVAX23 within a short time of each other. The outcome of the events dizziness and ear problems were unknown. The patient sought medical attention for the events by visiting the office. The event a lung condition was considered life threatening by the reporter. This is one of the 2 reports from the same reporter and patient. The events were considered to be other important medical events. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Dizziness, Ear disorder
Clinical narrative: This spontaneous report as received from an approximately 60-year-old female registered nurse regarding herself. Current conditions included diabetes, asthma, kidney issues, hypothyroidism, macular degeneration in eyes, pituitary tumor on an unknown date in January 2009, arthritis, on an unknown date in September 2011 the nurse had blood coming out during urination and was diagnosed with a kidney infection. Patient was allergic to penicillin and sulfa. Lab tests included kidney sonogram done on an unknown date in October 2011. On an unknown date in May 2012 (reported as 6 months ago) the nurse was vaccinated with a dose of ZOSTAVAX (lot # not reported) dose and route not reported. Concomitant medications included 2 types of unspecified insulin, SYNTHROID and 12 other unspecified medications. Nurse got shingles approximately on an unknown date in October 2012. The nurse stated she had lesions on her back and other unspecified areas. Nurse stated the lesions on her back were still a little itchy and burning. The outcome of the reported events were unknown. This is one of the 2 reports from the same reporter and patient. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus
Clinical narrative: This spontaneous report as received from an approximately 60-year-old female registered nurse regarding herself. Current conditions included diabetes, asthma, kidney issues, hypothyroidism, macular degeneration in eyes, pituitary tumor on an unknown date in January 2009, arthritis, on an unknown date in September 2011 the nurse had blood coming out during urination and was diagnosed with a kidney infection. Patient was allergic to penicillin and sulfa. Lab tests included kidney sonogram done on an unknown date in October 2011. On an unknown date in May 2012 (reported as 6 months ago) the nurse was vaccinated with a dose of ZOSTAVAX (lot # not reported) dose and route not reported. Concomitant medications included 2 types of unspecified insulin, SYNTHROID and 12 other unspecified medications. Nurse got shingles approximately on an unknown date in October 2012. The nurse stated she had lesions on her back and other unspecified areas. Nurse stated the lesions on her back were still a little itchy and burning. The outcome of the reported events were unknown. This is one of the 2 reports from the same reporter and patient. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: Patient died from unknown cause within 3 days of vaccine series. Death deemed SIDS.
Age: 5.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Asthma, Brain injury, Cognitive disorder, Condition aggravated, Electroencephalogram abnormal
Clinical narrative: Patient suffered a severe asthma attack the day after flu shot. Causing him to enter asthmaticus and respiratory failure and was intubated, during this period of respiratory failure he didn't receive oxygen and has hypoxic brain injury. Patient is a 5 year old male with a past medical history of severe asthma. Recently, patient suffered a severe asthma attack causing him to enter status asthmaticus and respiratory failure. Patient was intubated and spent a day in our Pediatric ICU before being able to transfer into our Pediatric Intermediate Care Unit and finally to General Pediatrics. During patient's period of respiratory failure, he did not receive sufficient oxygen to his brain for a sustained period which resulted in a diffuse hypoxic brain injury as evidenced by MRI and EEGs. This has left patient with severe physical and cognitive impairments. Patient is currently working very hard with therapy to regain his normal function but at present is confined to a wheelchair for an unknown amount of time until able to safely bear weight. Patient's family is unable to provide handicapped accessible transportation on this short notice and is requesting assistance in getting transportation to patient's several follow up appointments as they have spoken to staff. We are requesting handicapped-accessible transportation to patient's medical and therapy follow up appointments.
Age: 5.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Endotracheal intubation, Intensive care, Nuclear magnetic resonance imaging abnormal, Physical disability, Respiratory failure
Clinical narrative: Patient suffered a severe asthma attack the day after flu shot. Causing him to enter asthmaticus and respiratory failure and was intubated, during this period of respiratory failure he didn't receive oxygen and has hypoxic brain injury. Patient is a 5 year old male with a past medical history of severe asthma. Recently, patient suffered a severe asthma attack causing him to enter status asthmaticus and respiratory failure. Patient was intubated and spent a day in our Pediatric ICU before being able to transfer into our Pediatric Intermediate Care Unit and finally to General Pediatrics. During patient's period of respiratory failure, he did not receive sufficient oxygen to his brain for a sustained period which resulted in a diffuse hypoxic brain injury as evidenced by MRI and EEGs. This has left patient with severe physical and cognitive impairments. Patient is currently working very hard with therapy to regain his normal function but at present is confined to a wheelchair for an unknown amount of time until able to safely bear weight. Patient's family is unable to provide handicapped accessible transportation on this short notice and is requesting assistance in getting transportation to patient's several follow up appointments as they have spoken to staff. We are requesting handicapped-accessible transportation to patient's medical and therapy follow up appointments.
Age: 5.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Status asthmaticus, Weight bearing difficulty, Wheelchair user
Clinical narrative: Patient suffered a severe asthma attack the day after flu shot. Causing him to enter asthmaticus and respiratory failure and was intubated, during this period of respiratory failure he didn't receive oxygen and has hypoxic brain injury. Patient is a 5 year old male with a past medical history of severe asthma. Recently, patient suffered a severe asthma attack causing him to enter status asthmaticus and respiratory failure. Patient was intubated and spent a day in our Pediatric ICU before being able to transfer into our Pediatric Intermediate Care Unit and finally to General Pediatrics. During patient's period of respiratory failure, he did not receive sufficient oxygen to his brain for a sustained period which resulted in a diffuse hypoxic brain injury as evidenced by MRI and EEGs. This has left patient with severe physical and cognitive impairments. Patient is currently working very hard with therapy to regain his normal function but at present is confined to a wheelchair for an unknown amount of time until able to safely bear weight. Patient's family is unable to provide handicapped accessible transportation on this short notice and is requesting assistance in getting transportation to patient's several follow up appointments as they have spoken to staff. We are requesting handicapped-accessible transportation to patient's medical and therapy follow up appointments.
Age: 5.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Asthma, Brain injury, Condition aggravated, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: Patient suffered a severe asthma attack the day after flu shot. Causing him to enter asthmaticus and respiratory failure and was intubated, during this period of respiratory failure he didn't receive oxygen and has hypoxic brain injury. Patient is a 5 year old male with a past medical history of severe asthma. Recently, patient suffered a severe asthma attack causing him to enter status asthmaticus and respiratory failure. Patient was intubated and spent a day in our Pediatric ICU before being able to transfer into our Pediatric Intermediate Care Unit and finally to General Pediatrics. During patient's period of respiratory failure, he did not receive sufficient oxygen to his brain for a sustained period which resulted in a diffuse hypoxic brain injury as evidenced by MRI and EEGs. This has left patient with severe physical and cognitive impairments. Patient is currently working very hard with therapy to regain his normal function but at present is confined to a wheelchair for an unknown amount of time until able to safely bear weight. Patient's family is unable to provide handicapped accessible transportation on this short notice and is requesting assistance in getting transportation to patient's several follow up appointments as they have spoken to staff. We are requesting handicapped-accessible transportation to patient's medical and therapy follow up appointments.
Age: 5.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Pyrexia, Respiratory failure, Resuscitation
Clinical narrative: Patient suffered a severe asthma attack the day after flu shot. Causing him to enter asthmaticus and respiratory failure and was intubated, during this period of respiratory failure he didn't receive oxygen and has hypoxic brain injury. Patient is a 5 year old male with a past medical history of severe asthma. Recently, patient suffered a severe asthma attack causing him to enter status asthmaticus and respiratory failure. Patient was intubated and spent a day in our Pediatric ICU before being able to transfer into our Pediatric Intermediate Care Unit and finally to General Pediatrics. During patient's period of respiratory failure, he did not receive sufficient oxygen to his brain for a sustained period which resulted in a diffuse hypoxic brain injury as evidenced by MRI and EEGs. This has left patient with severe physical and cognitive impairments. Patient is currently working very hard with therapy to regain his normal function but at present is confined to a wheelchair for an unknown amount of time until able to safely bear weight. Patient's family is unable to provide handicapped accessible transportation on this short notice and is requesting assistance in getting transportation to patient's several follow up appointments as they have spoken to staff. We are requesting handicapped-accessible transportation to patient's medical and therapy follow up appointments.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Approximately 3 hours after shot, patient started feeling dizzy & nauseated. Taken to ER, and admitted for dizziness, diarrhea, severe headache, chills, sweating, nausea & vomiting. Stayed in hospital for 2 days.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Approximately 3 hours after shot, patient started feeling dizzy & nauseated. Taken to ER, and admitted for dizziness, diarrhea, severe headache, chills, sweating, nausea & vomiting. Stayed in hospital for 2 days.
Sex: F
Vaccine: RAB
Symptoms: Unevaluable event
Clinical narrative: Initial case received from a consumer on 26 October 2012. A female patient, was administered IMOVAX Rabies, lot # G-1377 on an unspecified date. The indication, route, site and number of previous doses were not reported. The reporter questioned the possibility of vaccine failure, but the patient history and vaccination details were not reported. Concomitant drugs and laboratory results were not reported. No further details were available at the time of this report. The patient outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Influenza virus test positive, Polymerase chain reaction
Clinical narrative: Initial case was received from a healthcare professional on 26 October 2012. A female patient (exact age not reported), whose age was estimated to be "in her twenties", received a dose of an intramuscular injection of FLUZONE, sanofi pasteur Inc., lot number UH729AA, (site not reported) on an unspecified day in September 2012. On an unspecified day, the patient was "recently tested as H3N2 positive by polymerase chain reaction (PCR) laboratory testing". The patient's outcome was not reported. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: FLUN3, HEPA, HPV4
Symptoms: Decreased appetite, Liver function test abnormal, Nausea, Neutropenia, Pyrexia
Clinical narrative: Fever x 5 days up to 104. Nausea. Decrease appetite. Neutropenia. Elevated liver function test.
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Rash
Clinical narrative: Follow-up information was received from a healthcare provider on 25 January 2012, who is also the patient. The patient had received an Intradermal (ID) injection of FLUZONE Intradermal; lot number UT4164AA. On an unspecified date, the patient developed a rash for two days and her whole arm swelled up. After applying cold compresses it eventually returned to normal. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Age: 57.0
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), 2012-00783 and 00785 (both non-serious cases). A 57 year-old female patient had received a left upper arm dose of FLUZONE Intradermal (lot number UT4163AA) on 21 December 2011 at 10:30 am 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: Injection site scar
Clinical narrative: This initial case was received from a healthcare professional on 10 February 2012. It represents a cluster of 10 unidentified patients reported by the same reporter who each experienced painful large welts at injections site following administration of FLUZONE INTRADERMAL. A group of 10 unidentified patients received an intradermal injection of FLUZONE INTRADERMAL, sanofi pasteur Inc. (lot numbers, routes, sites and dates of administration were not reported.) One of the patients, an office nurse, now has a "scar" at injection site. The patients' medical histories, concomitant medications, prior doses of vaccine, and vaccinations within four weeks prior to vaccine were not reported. The patients' outcomes were not reported. Documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Initial report was received from a healthcare professional on 05 December 2011. A 36-year-old male patient had received an injection of FLUZONE INTRADERMAL (lot number not reported) in left deltoid on 22 November 2011. On 24 November 2011, the patient developed pain from shoulder to elbow and numbness and tingling in hand. According to the patient, the nurse grabbed his muscle and injected the vaccine. The patient received corrective treatment with ibuprofen and "slight" improved. 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.
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: Initial report was received from a patient on 19 October 2011. A female patient (age and date of birth not reported) had received a FLUZONE INTRADERMAL (lot number not reported). A healthy individual patient received an injection at ten thirty am and by one thirty pm she developed flu like symptoms and thought it was "weird" response to the flu shot. In the past she has received flu shots injection without any reaction. No further information was available at the time of the report. The patient outcome recovered/resolved. Follow-up information was received from a healthcare professional on 09 January 2012. The patient had received an injection of FLUZONE INTRADERMAL on 18 October 2011. The patient did not receive any corrective treatment. No further information was available at the time of the report. Follow-up information received from a health care professional on 21 February 2012 reported that the patient had no other vaccinations within 4 weeks of the FLUZONE INTRADERMAL. The lot number of the FLUZONE INTRADERMAL was UT4163AA and was given in the left upper arm. The outcome remained recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Erythema.
Sex: U
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This is a cluster of patients who experienced adverse reactions following administration of FLUZONE INTRADERMAL (UT464AA). One patient has been identified and captured in case numbers 2011-10344. Initial report was received on 21 October 2011 from a healthcare provider. The patients (gender, ages and date of birth not reported) had received FLUZONE INTRADERMAL, lot number UT464AA (route and site of administration were not reported). The patients did not like the huge bleb left on the arm after administration. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Skin warm, Urticaria
Clinical narrative: Initial report was received from a health care professional on 21 October 2011. A 27-year-old female patient had received an Intradermal (ID) injection of FLUZONE (lot number and site of administration not reported). On an unspecified date, the patient developed a hot red patch from shoulder to elbow and the wheals have been the size of a softball. They have stopped giving the intradermal injection because several patients a day have been calling due to reactions. No further information was available at the time of the report. The patient outcome was not reported. Document held by sender: none. The follow-up information received on 21 May 2012: The outcome of the event was amended from not reported to recovered.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Lymphadenopathy, Myalgia, Oedema peripheral
Clinical narrative: Initial report was received from an office staff member on 04 October 2011. A female patient (age not reported) had received a FLUZONE INTRADERMAL, lot number UT4163AA. On an unspecified, the patient experienced left side muscle and joint pain, swelling two inches in diameter at injection site and swollen gland that necessitated a doctor visit. 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 12 January 2012. A 37-year-old female patient had received an injection of FLUZONE INTRADERMAL on 04 October. On 05 October 2011, the patient experienced the events. No additional information at this time. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraparesis
Clinical narrative: Paraparesis.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Catheter placement, Mobility decreased, Neurostimulator implantation, Nuclear magnetic resonance imaging normal
Clinical narrative: Paraparesis.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Syncope
Clinical narrative: Paraparesis.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever of 100 degrees and fussiness.
Age: 1.38
Sex: M
Vaccine: DTAPIPVHIB, FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Large red, warm induration at injection site.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PATIENT IS ONLY 60 YEARS OLD AND RECEIVED THE HIGH DOSE FLU VACCINE.
Age: 1.32
Sex: M
Vaccine: FLUX
Symptoms: Decreased appetite, Vomiting
Clinical narrative: Vomiting began about 6 hours after flu shot.  Vomiting lasted for 48 hours.  Loss of appetite also began at the same time and lasted for 36 hours.  He would drink but he would not eat anything.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Asthma, Bronchitis, Chest X-ray, Malaise
Clinical narrative: Wednesday 10/3 2 p.m. - weak and not feeling well and reported symptoms to employee health nurse.  Thursday 10/4 Severe malaise, followed by weakness, high fevers, and followed by severe asthma attacks starting Friday and multiple trips to ER/MD office for evaluation/nebulizer treatments.  Asthma attacks remain mod-severe for weeks following vaccination. Numerous respiratory/steroid treatments required.  Developed bronchitis after asthma flared.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Pulmonary function test, Pyrexia
Clinical narrative: Wednesday 10/3 2 p.m. - weak and not feeling well and reported symptoms to employee health nurse.  Thursday 10/4 Severe malaise, followed by weakness, high fevers, and followed by severe asthma attacks starting Friday and multiple trips to ER/MD office for evaluation/nebulizer treatments.  Asthma attacks remain mod-severe for weeks following vaccination. Numerous respiratory/steroid treatments required.  Developed bronchitis after asthma flared.
Age: 50.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Guillain-Barre; parasthesias, numbness, and weakness in arms and legs approx 1 week after flu vaccination.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot
Clinical narrative: WARM and REDNESS.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13
Symptoms: Rash, Rash macular
Clinical narrative: Erythematous macular rash on trunk, neck, and groin.  Not on extremities.
Age: 17.0
Sex: M
Vaccine: HEPA, MEN
Symptoms: Abdominal discomfort, Activities of daily living impaired, Blood test, Diarrhoea, Malaise
Clinical narrative: Nausea, Vomiting, Severe Stomach, Diarrhea, currently under medical supervision of Hospital and Dr. Patient is still sick, awaiting referral to specialist to see Gastroenterology. Patient is still not well and is bleeding rectally, he has lost 17 pounds is unable to attend school regularly or play sports. Due diligence has not been performed by responsible medical parties, this could be Life Threatening. We do not know. There has been no progress for his diagnosis in 9+ weeks.
Age: 17.0
Sex: M
Vaccine: HEPA, MEN
Symptoms: Nausea, Rectal haemorrhage, Stool analysis abnormal, Vomiting, Weight decreased
Clinical narrative: Nausea, Vomiting, Severe Stomach, Diarrhea, currently under medical supervision of Hospital and Dr. Patient is still sick, awaiting referral to specialist to see Gastroenterology. Patient is still not well and is bleeding rectally, he has lost 17 pounds is unable to attend school regularly or play sports. Due diligence has not been performed by responsible medical parties, this could be Life Threatening. We do not know. There has been no progress for his diagnosis in 9+ weeks.
Age: 17.0
Sex: M
Vaccine: HEPA, MEN
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: Nausea, Vomiting, Severe Stomach, Diarrhea, currently under medical supervision of Hospital and Dr. Patient is still sick, awaiting referral to specialist to see Gastroenterology. Patient is still not well and is bleeding rectally, he has lost 17 pounds is unable to attend school regularly or play sports. Due diligence has not been performed by responsible medical parties, this could be Life Threatening. We do not know. There has been no progress for his diagnosis in 9+ weeks.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Pain in extremity, Weight bearing difficulty
Clinical narrative: Right leg with pain that became increasingly worse. Leg now is numb, with excrutiating intermittent sharp pain.  Cannot bear wt.on right leg.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Neuralgia, Pain, Paralysis, Pruritus
Clinical narrative: Right leg with pain that became increasingly worse. Leg now is numb, with excrutiating intermittent sharp pain.  Cannot bear wt.on right leg.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Localised oedema
Clinical narrative: Local erythema and edema.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: 10/25/12 9:15 AM Dizziness, shortness of breath, nausea; 10/26/12 10:00 AM Dizziness, shortness of breath, nausea, fainted at department store, pain, swelling in right upper arm, raised hot skin at injection site, very itchy, raised red lump measuring 3 inches by 3.5 inches circumference and about .25 inch high. Redness, swelling, itching, pain lasted 5 days. Shortness of breath, dizziness lasted 3 days.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Nausea, Syncope
Clinical narrative: 10/25/12 9:15 AM Dizziness, shortness of breath, nausea; 10/26/12 10:00 AM Dizziness, shortness of breath, nausea, fainted at department store, pain, swelling in right upper arm, raised hot skin at injection site, very itchy, raised red lump measuring 3 inches by 3.5 inches circumference and about .25 inch high. Redness, swelling, itching, pain lasted 5 days. Shortness of breath, dizziness lasted 3 days.
Age: 46.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Injection site pruritus, Oedema, Pyrexia, Thinking abnormal
Clinical narrative: Mild fever, and "droppsies" per patient. Then 11/7/2012 patient called with severe itching at the site of both vaccines, mild fever, and "not able to get her thoughts together."
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MMR, MNQ, TDAP, VARCEL
Symptoms: Nausea, Pallor, Vomiting
Clinical narrative: Nausea, vomited X1, pale.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Ear infection, Erythema, Rash generalised
Clinical narrative: RASH ON LEGS, ARMS, ABDOMEN AND BUTTOCKS. EARS RED. PT. WAS SEEN BY A DR. AND WAS PUT ON AN ANTIBIOTIC FOR AN EAR INFECTION. BENADRYL CREAM ORDERED FOR RASH.
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient reports that at 7 pm on the evening of receiving vaccine she had fever, chills, body aches, wheezing.  At 1:30 am on 11/08/2012 awoke with hives on chest, arm pain and swelling at site of injection. On awakening later in the day had no symptoms. Denies any problems at this time.  Did not see physician or take any meds.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria, Wheezing
Clinical narrative: Patient reports that at 7 pm on the evening of receiving vaccine she had fever, chills, body aches, wheezing.  At 1:30 am on 11/08/2012 awoke with hives on chest, arm pain and swelling at site of injection. On awakening later in the day had no symptoms. Denies any problems at this time.  Did not see physician or take any meds.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site haematoma, Musculoskeletal pain, Pain in extremity
Clinical narrative: Orange-sized bruise at injection site; severe arm and shoulder pain that has gotten progressively worse.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Dyspnoea, Hyperhidrosis, Nausea, Pallor
Clinical narrative: 2-3 hours after Fluzone injection administered student become diaphoretic, and pale with severe nausea. Family member picked student up from school.  While traveling home she start have SOB with wheezing and feeling her throat was closing up. Family member stopped at fire station. Epipen administered, O2 started.  Student was then transferred by ambulance to the nearest Emergency dept. where she receive another Epipen injection and steroids. She was discharged from the Emergency dept and instructed not to receive the influenza vaccine again.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Wheezing
Clinical narrative: 2-3 hours after Fluzone injection administered student become diaphoretic, and pale with severe nausea. Family member picked student up from school.  While traveling home she start have SOB with wheezing and feeling her throat was closing up. Family member stopped at fire station. Epipen administered, O2 started.  Student was then transferred by ambulance to the nearest Emergency dept. where she receive another Epipen injection and steroids. She was discharged from the Emergency dept and instructed not to receive the influenza vaccine again.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Culture, Injection site discharge, Injection site erythema, Injection site pain
Clinical narrative: Swelling, erythema, pain and itching around vaccine injection site. Small amt yellowish d/c at the injection site on day 3.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Swelling, erythema, pain and itching around vaccine injection site. Small amt yellowish d/c at the injection site on day 3.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain
Clinical narrative: Pain and weakness in flu shot arm.  It's now 3+ wks after the shot and although gradually getting better, still painful.  Originally so weak that I would lift my flu shot arm with the good arm as if it was broken.  Constant sore and painful achy feeling at injection site with occasional sharp shooting pain.  The shooting pain is if I'm actively using the arm.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Patient noticed some swelling of injection site 11/7/12.  Awoke on 11/8/12 with hives on left arm from shoulder to wrist, very itchy.  Also with 2cm erythematous induration at left deltoid injection site - very tender to touch.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Urticaria
Clinical narrative: Patient noticed some swelling of injection site 11/7/12.  Awoke on 11/8/12 with hives on left arm from shoulder to wrist, very itchy.  Also with 2cm erythematous induration at left deltoid injection site - very tender to touch.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Hyposmia, Nasal congestion, Parosmia
Clinical narrative: Unusual smell, partial loss of smell with nasal congestion. Change in smell persists still.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Redness area 3 inches by 3 inches, itchy, hot, swelling.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: 24 hours post injection Pt stated that the injection site became itchy, swollen and red. These symptoms lasted for 5 days.
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Asthenia, Chills, Dizziness, Feeling of body temperature change, Gaze palsy
Clinical narrative: Lightheaded, eyes went back in his head, fainting, violent body shakes, followed by sweating, hot and cold flashes, weakness, nausea.  15 minutes later my son began vomiting which lasted for 5 hours and required Zofan for nausea.  We had to stay at the Dr. office for over 2 hours until he was stable enough to return home.  Upon returning home he continued with vomiting, nausea and chills for the entire day.
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Hot flush, Hyperhidrosis, Nausea, Syncope, Tremor
Clinical narrative: Lightheaded, eyes went back in his head, fainting, violent body shakes, followed by sweating, hot and cold flashes, weakness, nausea.  15 minutes later my son began vomiting which lasted for 5 hours and required Zofan for nausea.  We had to stay at the Dr. office for over 2 hours until he was stable enough to return home.  Upon returning home he continued with vomiting, nausea and chills for the entire day.
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Vomiting
Clinical narrative: Lightheaded, eyes went back in his head, fainting, violent body shakes, followed by sweating, hot and cold flashes, weakness, nausea.  15 minutes later my son began vomiting which lasted for 5 hours and required Zofan for nausea.  We had to stay at the Dr. office for over 2 hours until he was stable enough to return home.  Upon returning home he continued with vomiting, nausea and chills for the entire day.
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Convulsion, Dyskinesia, Gaze palsy, Hyperventilation, Pallor
Clinical narrative: Lightheaded, eyes went back in his head, fainting, violent body shakes, followed by sweating, hot and cold flashes, weakness, nausea.  15 minutes later my son began vomiting which lasted for 5 hours and required Zofan for nausea.  We had to stay at the Dr. office for over 2 hours until he was stable enough to return home.  Upon returning home he continued with vomiting, nausea and chills for the entire day.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Muscle strain, Nerve compression, Pain in extremity
Clinical narrative: The next morning I woke up with pain in my arm, I was told by the nurse that it was normal. On Nov. 1, 2012 I was still in pain and not able to lift my arm so I was unable to work, I went to the ER and I was diagnosed with a pinched nerve and neck spasms. I go to see a neurologist on Nov, 20, 2012 to find out if I have any nerve damage due to the injection hitting my nerve. I also was forced to leave my job due to not being able to preform.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site pain, Insomnia, Mobility decreased, Paraesthesia
Clinical narrative: I had SEVERE pain in my left upper arm that kept me from being able to sleep. I took 4 (200mg) Ibuprofens and a 500mg Acetaminophen as well as attempted to use a warm pack or ice to help with the pain. I have had flu shots in the past and my arm was sore for a few days but I have never had pain to this extent. I was finally able to fall asleep around 4am. The next day I coninued to have pain (just below my deltoid - not in the area where the shot was given), it went down to my elbow and then I had tingling and numbness in my pinkie with numbness in the other fingers as well. This continued for at least 4 days and I still have pain (to a lesser extent) in the arm extending to my elbow with occasional numbness in my fingers. I also have had very occasional difficulty raising my arm in one fluid motion. It seems to stop midway and then I have to think about raising it higher.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Client attended the flu shot clinic.  She received a 0.5cc flu shot, Sanofi, Lot# UH734AC, Expiration date 6/30/13,  in the left deltoid muscle at 1655 hours.  Student nurse administered the dose with her instructor supervising.  After receiving the injection the client reported she felt like she was going to faint.  She was assisted to the floor to lie on her back with her feet elevated by RN.  RN applied a covered cold pack to the client's forehead.  Student nurse assessed vitals at 1705 hours: Blood pressure 80 systolic, pulse 44, and respirations 16.  This nurse was called to assist and reassessed at 1708 hours: Blood pressure 90/62, pulse 64, respirations 16.  Client rested in a lying position for another 7 minutes, states she felt better, so was allowed to sit up and had juice at 1715 hours.  Student nurse reassessed blood pressure at 100/66.  Client was then allowed to stand, which she did without problems.  Client was released with her mom and dad at 1725 hours.  This nurse called the client's parents today at 0815 hours to follow up, but had to leave a message.  This nurse then called the client's physician's office to report the incident to Dr., but left a message with Dr's nurse.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Pt developed itching of R hand, later of the L hand, then of both feet. developed mild rash of both hands and feet, pruritic, lasting about 48h, responded to self administered certrizine. Possible allergic reaction?
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Patient awoke with redness and inflammation around injection site of the Pneumovax.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise
Clinical narrative: Patient awoke with redness and inflammation around injection site of the Pneumovax.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Abdominal discomfort, Chest pain, Full blood count, Myalgia, Nausea
Clinical narrative: Chest burning, myalgias, fever, nausea, upset stomach.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pyrexia, Troponin increased
Clinical narrative: Chest burning, myalgias, fever, nausea, upset stomach.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Catheterisation cardiac, Chest pain, Echocardiogram, Electrocardiogram ST segment elevation, Headache
Clinical narrative: Chest burning, myalgias, fever, nausea, upset stomach.