chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Weight decreased
Clinical narrative: Initial report was received from consumer, who is the patient's daughter on 13 January 2011. An 81 year-old female patient with a history of high cholesterol and a "heart patient with stents", had received an intramuscular injection of influenza vaccine (reported as FLUZONE, lot number and site of administration not reported) on 13 October 2010 and two days later on 15 October 2010, experienced "severe diarrhea" which lasted "two and a half months". According to the reporter everything the patient consumed "went right through her and she lost 20 pounds". concomitant medications included unspecified heart and cholesterol medications. The patient was not evaluated by a physician and treatments were not reported. No further information was available at the time of the report. The patient's outcome was reported as recovered. Follow-up information received from a health care professional on 23 February 2011 reported the patients' medical history included B12 deficiency, dysgeusia, hypertension (HTN) and coronary artery disease (CAD). The patients' concomitant medications included atenolol, CRESTOR, VICODIN prn and lorazepam prn. She had no reported illness at the time of vaccination. The FLUZONE lot number was reported as UH214AA and the injection was given in the left deltoid. The outcome remained recovered. Documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Nausea, Oedema peripheral, Pain, Palmar erythema
Clinical narrative: Initial report received from a health care professional on 13 January 2011. A 44-year-old female patient received on 07 December 2010 a left deltoid intramuscular injection (dose 1) of FLUZONE, lot number U3788AA. The patient had a history of heartburn, reflux and anxiety. He had an allergy to FLOXIN and penicillin. The patient had no illness at the time of vaccination and received no other vaccines within 4 weeks of the FLUZONE. the patient's concomitant medications included XANAX, omeprazole, potassium and PHENERGAN. The patient received no prior influenza vaccines. On 09 December 2010, the patient developed nausea, red palms, red circle around injection site, swelling of hands and "achy". The patient took BENADRYL. The outcome was not reported. Follow-up information was received 18 February 2011 from a health care professional. Allergy testing had not been performed and the reported events did not require any additional treatment medications except for BENADRYL. According to the reporter, the patient recovered (date not reported). Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye irritation, Visual acuity reduced
Clinical narrative: Initial report received from a health care professional on 16 November 2010. A 53-year-old female patient received on 23 September 2009 at 7:30 AM an intramuscular injection (site not reported) of FLUZONE, lot number U3196AA. The patient had no known allergies. The patient's medical history was not reported and her concomitant medications were not provided. She had no illness at the time of vaccination. She had no H1N1 in the past and no previous vaccination at her present location. On 23 September 2009 at 11:00 AM the patient developed scratchy eyes with decreased vision and milky drainage from both eyes for 5 hours. The outcome was reported as recovered. Documents held by sender: None.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haematoma, Nodule
Clinical narrative: Initial report received from a health care professional on 07 February 2011. An 88-year-old male patient received on 11 December 2010 a left deltoid intramuscular injection of FLUZONE HIGH-DOSE, sanofi pasteur Inc. lot number U3613AA. The patient had a history of high blood pressure and no known allergies. His concomitant medications included lisinopril and atenolol. On 12 December 2010, the patient developed a nodule on the inner side of the left arm that has been there since the day after the vaccine. The area measures 4 inches by 4 inches. The patient saw a doctor and was told to "watch it". The outcome was reported as not recovered. Follow-up information was received from a health care professional on 05 April 2011. The patient had developed an uncomplicated hematoma. The outcome remained not recovered. Follow-up information received from a health care professional on 25 April 2011. The previously reported event of hematoma was clarified by the reporter to have occurred at the injection site. The events resolved on 24 January 2011. Documents held by sender: None.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache, Pain in jaw, Retching
Clinical narrative: Initial case was received on 23 September 2010 from a healthcare professional. A 69 year old female received at 3 p.m. on 20 September 2010, a right deltoid intramuscular injection of FLUZONE HIGH-DOSE (lot number U3617AA). Within 5 hours after vaccination at 8 p.m. on 20 September 2010, the patient experienced "dry heaves, chills, dizziness, extreme headache and pain in jaw." She almost went to the emergency room (ER), but didn't go. The patient had no illness at the time of the vaccination. Her pre-existing medical conditions included asthma. She had no known allergies. Concomitant medications included SYMBICORT and PROAIR. The patient called the office "24 hours later" and reported she was "75% better." Follow-up information was received from a health care professional on 18 October 2010. The patient had no reported adverse events following prior vaccinations. The patient reported to be "70%" better in eight hours and recovered completely in 24 hours. The reporter for this case is the same as for case 2010-05339. Documents held by sender: None.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Tremor
Clinical narrative: Initial case was received on 22 September 2010 from a healthcare professional. A male patient (date of birth and age not reported) received on 21 September 2010 at 12:30 p.m., an injection of FLUZONE (lot number U3567EA). At 11:30 p.m. on 21 September 2010, he experienced "shaking uncontrollably." No further information was provided and the outcome of the event was not reported. Follow-up information was received from a health care professional on 16 November 2010. The patient had received the FLUZONE vaccine in the left deltoid at 12:30 p.m. At the time of vaccination, the patient could not sleep and had "violent shaking". It was unknown if the patient had any adverse events after prior vaccinations. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dyskinesia, Muscular weakness
Clinical narrative: Initial report received on 25 August 2011 from a consumer who is also a health care professional. A 52 year-old female patient had received an intramuscular left deltoid injection of FLUZONE (lot number UH454AD), and an intradermal dose of TUBERSOL 5 TU (lot number C3584AC, site not reported) on 16 August 2011 and the same day experienced involuntary movements of the left arm and weakness in the left leg, which did not require medication evaluation. The patient had no concurrent illnesses at the time of the vaccinations, but had current medical conditions of breast cancer, ADHD and fibromyalgia. Concomitant medications included: RITALIN, DEMEROL, DARVON, DARVOCET, ROCEPHIN, ZITHROMAX, and unspecified pain medication. Indications for the concomitant medications were not provided. It was noted the patient had received TB tests and flu vaccinations before, and had not experienced any other adverse events with past vaccinations. At the time of this report, the patient was reported as being recovered, but it was also reported the symptoms were persisting. Recovery status is unknown. Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Gait disturbance, Immediate post-injection reaction
Clinical narrative: Initial report received from a health care professional on 08 October 2010. A 2-year-old female child, with an egg allergy, received on an unknown date a 0.25 milliliter (ml) pediatric dose injection (route and site not reported) of FLUZONE, lot number not provided. Immediately following the vaccination the patient experienced an episode in which she "fell down". The patient was able to walk but she walked "wobbly" down the hallway. The patient was allergic to eggs and has a history of hives when she eats eggs. No further information was available. Follow-up information received from a health care professional on 16 December 2010 reported that the patient's concomitant medication was FLOVENT 44 mcg/act one puff inhaled twice a day (BID). The patient had no illness at the time of vaccination and her birth weight was 5 pounds 1 ounce. The patient has one younger brother. The patient received on 08 October 2010 at 9:00 AM a left arm intramuscular injection of FLUZONE, lot number UT3581AA. The outcome was reported as recovered. Follow-up information was received on 11 February 2011 from a health care professional. The patient, with a history of asthma, was evaluated by a physician and found to be neurologically intact. She was monitored for 30 minutes with eventual resolution of symptoms. Treatments were not required. No further information was provided at the time of the report. Documents held by sender: None.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Caesarean section, Injection site erythema, Injection site haemorrhage, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received from a consumer on 04 October 2010. A 25-year-old female patient, with a history of a heart murmur as a child and an allergy to bee stings, received on 30 September 2010 a left deltoid intramuscular injection (prefilled syringe) of FLUZONE, lot number unknown. The patient was pregnant and takes prenatal vitamins. She had no illness at the time of vaccination and had no other vaccinations within 4 weeks prior to FLUZONE. She received a flu vaccine annually. The patient's gestational weeks at the time of vaccination was not reported. The patient's date of last menstrual period was 23 June 2010 and her estimated date of delivery was reported as 30 March 2011. On 01 October 2010, the patient noticed her arm was swollen, red and itchy at the injection site which extended down toward the elbow. The area also turned ecchymotic. The patient was still in the process of resolving but she was improving. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 18 November 2010. The reporter reviewed and had no additional information to provide. Follow-up information was received 16 December 2010 from a health care professional. The vaccine received by the patient was FLUZONE, lot number U3564AA. The patient was recovered as of their prenatal visit on 28 October 2010 and the patient had no complaints at that time. According to the reporter, the patient's current pregnancy was uneventful and they had not experienced any pregnancy complications or adverse events since receiving FLUZONE. Follow-up information received from a nurse on 08 April 2011. The patient delivered via C-section at 39 weeks gestation on 25 March 2011. She delivered a single live baby described as being "fine". The baby had no congenital anomalies. The patient did not experience any adverse events since vaccination on 30 September 2010; and she had no complications of pregnancy, labor and / or delivery. No further information is expected. Documents held by sender: None.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Initial report received from a consumer on 04 October 2010. A 25-year-old female patient, with a history of a heart murmur as a child and an allergy to bee stings, received on 30 September 2010 a left deltoid intramuscular injection (prefilled syringe) of FLUZONE, lot number unknown. The patient was pregnant and takes prenatal vitamins. She had no illness at the time of vaccination and had no other vaccinations within 4 weeks prior to FLUZONE. She received a flu vaccine annually. The patient's gestational weeks at the time of vaccination was not reported. The patient's date of last menstrual period was 23 June 2010 and her estimated date of delivery was reported as 30 March 2011. On 01 October 2010, the patient noticed her arm was swollen, red and itchy at the injection site which extended down toward the elbow. The area also turned ecchymotic. The patient was still in the process of resolving but she was improving. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 18 November 2010. The reporter reviewed and had no additional information to provide. Follow-up information was received 16 December 2010 from a health care professional. The vaccine received by the patient was FLUZONE, lot number U3564AA. The patient was recovered as of their prenatal visit on 28 October 2010 and the patient had no complaints at that time. According to the reporter, the patient's current pregnancy was uneventful and they had not experienced any pregnancy complications or adverse events since receiving FLUZONE. Follow-up information received from a nurse on 08 April 2011. The patient delivered via C-section at 39 weeks gestation on 25 March 2011. She delivered a single live baby described as being "fine". The baby had no congenital anomalies. The patient did not experience any adverse events since vaccination on 30 September 2010; and she had no complications of pregnancy, labor and / or delivery. No further information is expected. Documents held by sender: None.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Breast pain, Nodule
Clinical narrative: Initial report was received 04 February 2011 from a health care professional, who received the report from the patient. This report involved a cluster of three patients. The other two patients have been captured in case numbers 2010-05974 and 2010-05986. A 34-year-old female patient had received a first dose right deltoid injection of FLUZONE, lot number U3720AA (route not reported) on 14 October 2010 and that same day at 10:00 P.M. (also reported as the day after receiving the vaccine), the patient began to experience pain between her breast and underarm on the same side as vaccine administration (right arm). She also felt a knot in the area of the pain. The event did not require medical intervention and no laboratory or diagnostic testing was performed. The patient had no illness at the time of vaccination and she had not received any other vaccines within four weeks prior to receiving FLUZONE. She had no identified pre-existing physician diagnosed allergies or medical conditions. Concomitant medications were unknown. Outcome was recovered (date not reported). Follow-up information was received from a health care professional on 07 March 2011. The patient received the FLUZONE intramuscularly in the right deltoid on 14 October 2010 at an unknown time. The onset of the event was reported as 10:00 PM on 14 October 2010. The patient's pain persisted for 2-3 days. She did not see a physician and therefore, no etiology or diagnosis was made. The patient recovered on 17 October 2010. No additional information was available at this time. The reporter for this case is the same as for case numbers 2010-05974 and 2010-05986. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: International normalised ratio increased
Clinical narrative: Initial report received from a health professional on 04 November 2010. A 63-year-old female patient, with a medical history of hypertension, diabetes, coronary artery disease (CAD), and hyperlipidemia, received on 22 October 2010 an injection (route and site not reported) of FLUZONE, lot number UH183AA. The patient had an allergy to penicillin, DEMEROL and "sumasin". The patient's concomitant medication was warfarin. On 03 November 2010, the patient had an increased INR with her blood work was drawn. The outcome was reported as unknown. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure, Eye irrigation, Eye irritation, Hypoaesthesia oral, Oropharyngeal pain
Clinical narrative: Initial report received on 24 August 2011 from a health care professional. This is a case of misuse where a patient inadvertently splashed vaccine in her eye while drawing a dose from a multi-dose vial. A female patient with no concurrent illnesses had been drawing up a dose of FLUZONE (lot number UH454AB) from a multi-dose vial on 24 August 2011 when she inadvertently squirted some in her eye. She flushed her eye, but an unspecified amount of time later, which was on the same day, she experienced burning in her eyes, and numbness of her tongue. At the time of this report, the burning in her eyes and numbness of her tongue had subsided, but she was experiencing a sore throat. It was not reported whether she required medication evaluation or not. The patient had not received any other vaccinations within 4 weeks prior to 24 August 2011. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5
Symptoms: Diarrhoea, Drug administered to patient of inappropriate age, Nasal congestion, Vomiting projectile
Clinical narrative: Initial report received from a consumer's parent on 07 October 2010. This is a case of misuse where the FLUZONE vaccine was given at an inappropriate age that is not recommended by the manufacturer. A 2-month-old female infant received on 05 October 2010 an injection (route and site not provided) a FLUZONE, lot number unknown. The patient's medical history was not reported. On 06 October 2010, the patient developed nasal congestion, diarrhea, and episodes of projectile vomiting. It was unknown if the infant received 0.25 milliliter (ml) or 0.5 ml. The outcome was reported as not recovered. Follow-up information received from a physician on 22 November 2010. The patient weighed 3Kg (8 pounds 7 ounces) at birth, and has one sibling. The patient had no concurrent illnesses, pre-existing medical conditions, or use of other medications at the time of vaccination on 05 October 2010. The patient has not experienced any other adverse events with prior vaccination. On 05 October 2010 the patient had received 0.5 mL of FLUZONE. Per the reporter, the patient also received additional vaccinations on the same day that included a first 0.5 mL right thigh injection of PENTACEL (lot number C3498AA); a first 0.5 mL right thigh injection of Hepatitis B vaccine (manufacturer Merck, lot number 1001X); an oral 2.0 mL dose of Rotavirus vaccine (manufacturer Merck, lot number D88183); and a 0.5 mL left thigh injection of PREVNAR (manufacture Wyeth, lot number 1442Y). The patient had not received any other vaccinations within 4 weeks of 05 October 2010. The patient's recovery status was not updated by the reported. Follow-up information was received on 10 January 2011 from a health care professional. The lot number for FLUZONE was UH224AC. The patient's symptoms of nasal congestion and occasional diarrhea lasted three weeks after injections were received on 05 October 2010. The patient recovered three weeks post injection. Documents held by sender: None.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site cellulitis, Vaccination site inflammation, Vaccination site pruritus
Clinical narrative: This case is 1 of a cluster of eight patients who experienced similar events following vaccination with FLUZONE. A 7-year-old male child received on 23 September 2010 an injection (site and route not reported) of FLUZONE, lot number UH201A. The patient developed within 5 hours or the next day vaccination site pruritus, vaccination site inflammation, and cellulitis. The patient had no illness at the time of vaccination and his medical history was not reported. The outcome was reported as recovered. The reporter for this case is the same reporter as 2010-06283, 2010-06285 and 2010-05509. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: This is a cluster of 2 unidentified patients' who experienced similar adverse events following vaccination with FLUZONE. Initial report received from a health care professional on 21 October 2010. A group of 2 unidentified patients' received an injection (route and site not reported) of FLUZONE, lot number U3703AA. The two patients have got cellulitis at the injection site. No additional information was provided. The outcome was not reported. Follow-up information was received from a health care professional on 07 December 2010. The patients' had no illness at the time of vaccination. No further information was reported at the time of the report. The patient's outcomes were reported as recovered (date not reported). Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: This case is a cluster of unidentified patients who experienced similar adverse events following vaccination with FLUZONE. Initial report received from a health care professional on 11 October 2010. A group of unidentified patients received (dates not reported) an injection (route and site not provided) of FLUZONE, lot number UH214AC. The patient(s) had residual black marks on skin. The needle was wiped and residue was found. The outcome was not reported. No other information was available. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Sensation of foreign body
Clinical narrative: Initial case was received on 14 October 2010 from a healthcare professional. The reporter provided individual patient identifiers for a cluster of three patients (previously reported in case 2010-04957 as a cluster of six patients). This case contains information for the third of the three patients who had received on 09 September 2010 an injection of FLUZONE (lot number UH214AB). The patient was a female patient (unknown age) with no known pre-existing medical conditions and no concomitant medications. On 09 September 2010, she experienced a cough, lump feeling in throat and exhaustion. She had no illness at the time of the vaccination, no other vaccinations within 4 weeks and no adverse event following prior vaccinations. The outcome was unknown. Follow-up information was received 28 December 2010 from a health care professional who reported that the patient had not seen by a physician and had not received any corrective treatments. Outcome was recovered. The reporter had no additional information to provide at the time of the report. The reporter for this case (2010-05958) is the same as case number 2010-04957 and 2010-05957. Documents held by sender: None.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Eyelid oedema, Sensation of foreign body, Throat irritation
Clinical narrative: Initial report was received on 01 October 2010 from a health care professional. A 65 year-old male patient with an allergy to "Td", had received an injection of FLUZONE HIGH-DOSE, lot number U3617AA (date, route and site of administration not reported) and unspecified amount of time later, experienced a "feeling" like something was stuck in his throat, puffy eyes with no drainage and he was "clearing his throat". The patient was treated with prednisone. No further information was available at the time of the report. The patient's outcome was reported as recovering. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Eye swelling, Ocular hyperaemia, Throat tightness
Clinical narrative: Initial was received 05 October 2010 from a health care professional. A cluster of two unidentified patients had received an injection of FLUZONE HIGH-DOSE (lot number, route and site of administration not reported) and an unspecified amount of time later, the patients developed red swollen eyes and throat tightness. Outcome was not reported and no additional information was provided at the time of the report. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site haematoma, Vaccination site pain, Vaccination site warmth
Clinical narrative: Initial case was received on 10 October from a healthcare professional. A female patient (age not reported) received on an unspecified date, an injection of FLUZONE (lot number not reported). She experienced soreness, bruising and warmth at the vaccination site one week after vaccination. No further information was provided. The outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Feeling abnormal
Clinical narrative: Initial case was received on 18 October 2010 from a healthcare professional. It contains information for a cluster of three unidentified female patients. The first of three patients who is over 65 years of age (specific age not reported) received on 09 October 2010, a deltoid intramuscular injection of FLUZONE HIGH-DOSE (lot number U3601AA). On 09 October 2010 she experienced dizziness, chills and felt "out of it". The patient had no illness at the time of the vaccination. Her pre-existing medical conditions and concomitant medications were unknown. She had no known allergies. The symptoms lasted about 24 hours. The patient recovered on an unspecified date. The reporter for this case (2010-05999) is the same as for case 2010-06000 and 2010-06001. Documents held by sender: None.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Myalgia, Nausea, Tremor, Urticaria
Clinical narrative: Initial case was received on 13 October 2010 from a consumer/patient. A 76 year old female patient received on 05 October 2010, a left deltoid intramuscular injection of FLUZONE HIGH-DOSE (lot number not reported). Within one a a half hours she experienced diarrhea, nausea and had the "shakes." The next day (06 October 2010), the patient developed a "generalized welt like rash that began on stomach and spread" and she also experienced muscle aches. The patient's pre-existing medical conditions included lung cancer and an allergy to antibiotics. Concomitant medications included LEVOXYL, "amlodipine", potassium, SYMBICORT, vitamins and calcium (CA) supplement. The patient had no adverse events following prior vaccinations. The patient was seen by a nurse practitioner on 08 October 2010 and treatment included prednisone. The symptoms were slightly better, but not resolved. Follow-up information received from a health care professional on 29 November 2010. The patient's FLUZONE HIGH-DOSE lot number was reported as U3610AA. The outcome remained not recovered. Follow-up information was received from a health care professional on 13 December 2010 reported that the patient's physician had no direct knowledge of this event. No further information was provided. The outcome remained not recovered. Follow-up information was received from a health care professional on 27 January 2011 reported that the patient received the vaccine at a private doctor's office and provided address identifiers. The outcome remained not recovered. Follow-up information was received from a health care professional on 24 February 2011. The patient's outcome was reported as recovered. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Adverse event, Chills, Pyrexia
Clinical narrative: Initial report was received from a health care professional on 18 October 2010. A report of "several" unidentified patients with no reported past medical histories, had received FLUZONE HIGH-DOSE (lot number, date, route and site of administration not reported) and an unspecified amount of time later, experienced fever, chills and "other side effects". No further information was available at the time of the report. The patients' outcomes were not reported. The reporter for this case is the same as for 2010-06068. Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Diarrhoea, Ocular hyperaemia
Clinical narrative: Initial report was received from a health care professional on 23 September 2010. A 71 year-old patient with an unreported past medical history, had received FLUZONE HIGH-DOSE, lot number U3601AA (route and site of administration not reported) on 23 September 2010 and "that night" following vaccination, experienced red eyes, diarrhea and a temperature of 101 degrees Fahrenheit. No further information was provided at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Nausea, Pyrexia
Clinical narrative: Initial report received from a health care professional on 24 November 2010. A female patient (age not reported) received on 20 November 2010 a left arm injection (route not provided) of FLUZONE, lot number U3631AA. The patient had no known allergies and her medical history was not reported. The patient's concomitant medications were FOSAMAX, tramadol, budesonide and SYMBICORT, and methocarbamol. On 24 November 2010, the patient reported experiencing fever, chills, nausea, runny nose, sneezing, coughing and headache. The outcome was reported as unknown. Follow-up information was received from the health care professional on 31 January 2011. The patient was 68 years old, had not received any other vaccines within 4 weeks of 20 November 2010. The FLUZONE HIGH-DOSE was given intramuscularly. The patient recovered on an unspecified date. Documents held by sender: None.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Initial report received from a health care professional on 24 November 2010. A female patient (age not reported) received on 20 November 2010 a left arm injection (route not provided) of FLUZONE, lot number U3631AA. The patient had no known allergies and her medical history was not reported. The patient's concomitant medications were FOSAMAX, tramadol, budesonide and SYMBICORT, and methocarbamol. On 24 November 2010, the patient reported experiencing fever, chills, nausea, runny nose, sneezing, coughing and headache. The outcome was reported as unknown. Follow-up information was received from the health care professional on 31 January 2011. The patient was 68 years old, had not received any other vaccines within 4 weeks of 20 November 2010. The FLUZONE HIGH-DOSE was given intramuscularly. The patient recovered on an unspecified date. Documents held by sender: None.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pyrexia, Torticollis, Viral infection
Clinical narrative: Initial report was received 03 December 2010 from a health care professional. A three-year-old female patient had received a 0.5 mL first dose left deltoid intramuscular injection of FLUZONE (lot number UH181AB) on 10 November 2010. Four days later on 14 November 2010, the patient began to complain of a stiff neck and fever. She went to the emergency room on 17 November 2010 and was diagnosed with torticollis of the left side. On 19 November 2010, the patient was seen by their health care provider at which time she no long had fever, but was unable to turn her neck. Corrective treatments consisted of heat, Ibuprofen and exercise (type of exercise was illegible). On 22 November 2010, the patient's outcome was much improved but not 100 percent. The patient was seen by her health care provider on 23 November 2010 at which time her outcome was recovered. Follow-up received from a health care professional on 23 February 2011 reported that the patient's maximum temperature was 102.3 orally. She had no laboratory or diagnostic testing performed. At the patient's last visit on 19 November 2010 the patient was afebrile and on ibuprofen. No etiology was determined and it was presumed viral illness. On a phone call from the office to the mother on 22 November 2010, the mother reported no fever and torticollis signs and symptoms had almost resolved. The outcome remained recovered. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Arthralgia, Asthenia, Blood test normal, Computerised tomogram normal, Convulsion
Clinical narrative: Initial report was received on 30 March 2011 from a consumer who is also the patient's parent. A 23-year-old male patient (24 years-old at time of the report) had received in November 2009 an intramuscular deltoid injection of H1N1, lot number UP019AA (exact site and date of administration not reported) and one to two days later, experienced horrible injection site pain ("like nerve pain"), trouble standing, joint pain, he was tired and debilitated. He appeared to be sad and complained of terrible headaches and pain in the eyes with sensitivity to light. The patient began to have "seizures" with reported shaking that started at the injection site arm and moved to the other extremities. Diagnostic tests included a CT scan, MRI and blood test all were reported to be normal. He was evaluated by a neurologist. The patient was diagnosed with chronic fatigue. Treatment medications and concomitant medications were not reported. The patient has a history of Down's syndrome, mitral valve regurgitation and had open heart surgery twice once at the age of five months and last in 1999. Adverse events following prior vaccinations and illness at the time of vaccination were denied. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Follow-up information was received from a health care professional on 10 June 2011. The patient had received the H1N1 intramuscularly in the left deltoid on 12 November 2009. He was not sick at the time and had no adverse events reported. The patient's neurology consult, CT and MRI were unrevealing. He was serology + (positive) for Monospot in approx. 6-10 (nothing else reported). Treatment included supportive care and specialist referral provided. According to the reporter, the etiology of the event was not known, "poss. related to the chronic fatigue syndrome from EBV, together with the vaccine, complicated by Downs' syndrome with his congenital heart disease". The patient was last seen on 02 November 2010, however the reporter states "contact with the parents outside of the office, patient slowly improving, but not yet back to previous strength level". Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Depressed mood, Dysstasia, Eye pain, Fatigue, Headache
Clinical narrative: Initial report was received on 30 March 2011 from a consumer who is also the patient's parent. A 23-year-old male patient (24 years-old at time of the report) had received in November 2009 an intramuscular deltoid injection of H1N1, lot number UP019AA (exact site and date of administration not reported) and one to two days later, experienced horrible injection site pain ("like nerve pain"), trouble standing, joint pain, he was tired and debilitated. He appeared to be sad and complained of terrible headaches and pain in the eyes with sensitivity to light. The patient began to have "seizures" with reported shaking that started at the injection site arm and moved to the other extremities. Diagnostic tests included a CT scan, MRI and blood test all were reported to be normal. He was evaluated by a neurologist. The patient was diagnosed with chronic fatigue. Treatment medications and concomitant medications were not reported. The patient has a history of Down's syndrome, mitral valve regurgitation and had open heart surgery twice once at the age of five months and last in 1999. Adverse events following prior vaccinations and illness at the time of vaccination were denied. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Follow-up information was received from a health care professional on 10 June 2011. The patient had received the H1N1 intramuscularly in the left deltoid on 12 November 2009. He was not sick at the time and had no adverse events reported. The patient's neurology consult, CT and MRI were unrevealing. He was serology + (positive) for Monospot in approx. 6-10 (nothing else reported). Treatment included supportive care and specialist referral provided. According to the reporter, the etiology of the event was not known, "poss. related to the chronic fatigue syndrome from EBV, together with the vaccine, complicated by Downs' syndrome with his congenital heart disease". The patient was last seen on 02 November 2010, however the reporter states "contact with the parents outside of the office, patient slowly improving, but not yet back to previous strength level". Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site pain, Neurological examination, Nuclear magnetic resonance imaging normal, Photophobia, Tremor
Clinical narrative: Initial report was received on 30 March 2011 from a consumer who is also the patient's parent. A 23-year-old male patient (24 years-old at time of the report) had received in November 2009 an intramuscular deltoid injection of H1N1, lot number UP019AA (exact site and date of administration not reported) and one to two days later, experienced horrible injection site pain ("like nerve pain"), trouble standing, joint pain, he was tired and debilitated. He appeared to be sad and complained of terrible headaches and pain in the eyes with sensitivity to light. The patient began to have "seizures" with reported shaking that started at the injection site arm and moved to the other extremities. Diagnostic tests included a CT scan, MRI and blood test all were reported to be normal. He was evaluated by a neurologist. The patient was diagnosed with chronic fatigue. Treatment medications and concomitant medications were not reported. The patient has a history of Down's syndrome, mitral valve regurgitation and had open heart surgery twice once at the age of five months and last in 1999. Adverse events following prior vaccinations and illness at the time of vaccination were denied. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Follow-up information was received from a health care professional on 10 June 2011. The patient had received the H1N1 intramuscularly in the left deltoid on 12 November 2009. He was not sick at the time and had no adverse events reported. The patient's neurology consult, CT and MRI were unrevealing. He was serology + (positive) for Monospot in approx. 6-10 (nothing else reported). Treatment included supportive care and specialist referral provided. According to the reporter, the etiology of the event was not known, "poss. related to the chronic fatigue syndrome from EBV, together with the vaccine, complicated by Downs' syndrome with his congenital heart disease". The patient was last seen on 02 November 2010, however the reporter states "contact with the parents outside of the office, patient slowly improving, but not yet back to previous strength level". Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site pain, Injection site reaction, Mononucleosis heterophile test positive, Neuralgia, Nuclear magnetic resonance imaging normal
Clinical narrative: Initial report was received on 30 March 2011 from a consumer who is also the patient's parent. A 23-year-old male patient (24 years-old at time of the report) had received in November 2009 an intramuscular deltoid injection of H1N1, lot number UP019AA (exact site and date of administration not reported) and one to two days later, experienced horrible injection site pain ("like nerve pain"), trouble standing, joint pain, he was tired and debilitated. He appeared to be sad and complained of terrible headaches and pain in the eyes with sensitivity to light. The patient began to have "seizures" with reported shaking that started at the injection site arm and moved to the other extremities. Diagnostic tests included a CT scan, MRI and blood test all were reported to be normal. He was evaluated by a neurologist. The patient was diagnosed with chronic fatigue. Treatment medications and concomitant medications were not reported. The patient has a history of Down's syndrome, mitral valve regurgitation and had open heart surgery twice once at the age of five months and last in 1999. Adverse events following prior vaccinations and illness at the time of vaccination were denied. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Follow-up information was received from a health care professional on 10 June 2011. The patient had received the H1N1 intramuscularly in the left deltoid on 12 November 2009. He was not sick at the time and had no adverse events reported. The patient's neurology consult, CT and MRI were unrevealing. He was serology + (positive) for Monospot in approx. 6-10 (nothing else reported). Treatment included supportive care and specialist referral provided. According to the reporter, the etiology of the event was not known, "poss. related to the chronic fatigue syndrome from EBV, together with the vaccine, complicated by Downs' syndrome with his congenital heart disease". The patient was last seen on 02 November 2010, however the reporter states "contact with the parents outside of the office, patient slowly improving, but not yet back to previous strength level". Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Photophobia, Tremor
Clinical narrative: Initial report was received on 30 March 2011 from a consumer who is also the patient's parent. A 23-year-old male patient (24 years-old at time of the report) had received in November 2009 an intramuscular deltoid injection of H1N1, lot number UP019AA (exact site and date of administration not reported) and one to two days later, experienced horrible injection site pain ("like nerve pain"), trouble standing, joint pain, he was tired and debilitated. He appeared to be sad and complained of terrible headaches and pain in the eyes with sensitivity to light. The patient began to have "seizures" with reported shaking that started at the injection site arm and moved to the other extremities. Diagnostic tests included a CT scan, MRI and blood test all were reported to be normal. He was evaluated by a neurologist. The patient was diagnosed with chronic fatigue. Treatment medications and concomitant medications were not reported. The patient has a history of Down's syndrome, mitral valve regurgitation and had open heart surgery twice once at the age of five months and last in 1999. Adverse events following prior vaccinations and illness at the time of vaccination were denied. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Follow-up information was received from a health care professional on 10 June 2011. The patient had received the H1N1 intramuscularly in the left deltoid on 12 November 2009. He was not sick at the time and had no adverse events reported. The patient's neurology consult, CT and MRI were unrevealing. He was serology + (positive) for Monospot in approx. 6-10 (nothing else reported). Treatment included supportive care and specialist referral provided. According to the reporter, the etiology of the event was not known, "poss. related to the chronic fatigue syndrome from EBV, together with the vaccine, complicated by Downs' syndrome with his congenital heart disease". The patient was last seen on 02 November 2010, however the reporter states "contact with the parents outside of the office, patient slowly improving, but not yet back to previous strength level". Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Nausea, Restless legs syndrome, Restlessness, Tremor, Vomiting
Clinical narrative: Initial case was received on 22 October 2010 from a healthcare professional. An 11 year old female patient received at 4 PM on 21 October 2010, a right deltoid injection of FLUZONE (lot number U3569CA) and an injection of GARDASIL (lot number 06642, manufacturer Merck). At 11:30 PM on 21 October 2010, she experienced a sudden onset of rigors and shaking for 20 minutes and also experienced nausea and vomiting. On 22 October 2010 at 10 AM, she had nausea, but no vomiting and experienced "restless leg feeling". The patient was treated at home with PHENERGAN. The patient had no illness at the time of the vaccination. She had no other vaccinations within four weeks. She had an allergy to amoxicillin. No pre-existing medical conditions were reported. PREVACID was a concomitant medication. There was no physician's evaluation. At the time of this report the patient's recovery status was unknown. Follow-up information was received from the health care professional on 21 December 2010. The patient recovered on 23 October 2010. No other information was available. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Chills, Nausea, Restless legs syndrome, Tremor, Vomiting
Clinical narrative: Initial case was received on 22 October 2010 from a healthcare professional. An 11 year old female patient received at 4 PM on 21 October 2010, a right deltoid injection of FLUZONE (lot number U3569CA) and an injection of GARDASIL (lot number 06642, manufacturer Merck). At 11:30 PM on 21 October 2010, she experienced a sudden onset of rigors and shaking for 20 minutes and also experienced nausea and vomiting. On 22 October 2010 at 10 AM, she had nausea, but no vomiting and experienced "restless leg feeling". The patient was treated at home with PHENERGAN. The patient had no illness at the time of the vaccination. She had no other vaccinations within four weeks. She had an allergy to amoxicillin. No pre-existing medical conditions were reported. PREVACID was a concomitant medication. There was no physician's evaluation. At the time of this report the patient's recovery status was unknown. Follow-up information was received from the health care professional on 21 December 2010. The patient recovered on 23 October 2010. No other information was available. Documents held by sender: None.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Eructation, Injection site erythema, Injection site haematoma, Injection site pruritus
Clinical narrative: 9/20/11 1035-1040 Itching, redness, hematoma at injection site. Applied ice pack and PRELONE to injection site. Feeling dizzy. Approx 1050 AM feeling dizzy and faint. Took BENADRYL 25mg orally. BPS 186. Approx. 11 AM felt dizzy, nauseated, retching, general body tremors/chills. Increased resp. rate, went to E.R. BPs 180's initially - fatigue.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling, Nausea, Syncope, Tremor
Clinical narrative: 9/20/11 1035-1040 Itching, redness, hematoma at injection site. Applied ice pack and PRELONE to injection site. Feeling dizzy. Approx 1050 AM feeling dizzy and faint. Took BENADRYL 25mg orally. BPS 186. Approx. 11 AM felt dizzy, nauseated, retching, general body tremors/chills. Increased resp. rate, went to E.R. BPs 180's initially - fatigue.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Dizziness, Fatigue, Injection site erythema, Injection site haematoma
Clinical narrative: 9/20/11 1035-1040 Itching, redness, hematoma at injection site. Applied ice pack and PRELONE to injection site. Feeling dizzy. Approx 1050 AM feeling dizzy and faint. Took BENADRYL 25mg orally. BPS 186. Approx. 11 AM felt dizzy, nauseated, retching, general body tremors/chills. Increased resp. rate, went to E.R. BPs 180's initially - fatigue.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pruritus, Nausea, Respiratory rate increased, Retching, Tremor
Clinical narrative: 9/20/11 1035-1040 Itching, redness, hematoma at injection site. Applied ice pack and PRELONE to injection site. Feeling dizzy. Approx 1050 AM feeling dizzy and faint. Took BENADRYL 25mg orally. BPS 186. Approx. 11 AM felt dizzy, nauseated, retching, general body tremors/chills. Increased resp. rate, went to E.R. BPs 180's initially - fatigue.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Dizziness, Headache, Immediate post-injection reaction, Lethargy
Clinical narrative: IMMEDIATELY FOLLOWING SHOTS PATIENT C/O DIZZINESS, HEADACHE NAUSEA, ABD PAIN AND SHAKING + LETHARGIC.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Tremor
Clinical narrative: IMMEDIATELY FOLLOWING SHOTS PATIENT C/O DIZZINESS, HEADACHE NAUSEA, ABD PAIN AND SHAKING + LETHARGIC.