chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: HEPAB
Symptoms: Erythema
Clinical narrative: Per tel. conversation, pt came in to imms. to turn in paperwork. When they noticed redness on his left side. Was immed seen by a provider, gave IV - drip of SOLUMEDROL, monitored and was released with inst. of to go to ER if sx worsen and SOB. Gave Epi Pen as needed. TWINRIX was given as subs for Hep B due to shortage.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Myositis
Clinical narrative: Pt states left upper arm swollen and hot onset 3 hrs after immunization.
Age: 0.79
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia
Clinical narrative: Fever 100 degrees-103 degrees.
Age: 1.27
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema, Swelling
Clinical narrative: Swelling, redness.
Age: 3.0
Sex: F
Vaccine: FLUN3, PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Child developed cellulitis at injection site.
Age: 85.0
Sex: U
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Chills, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Arm swollen & red to elbow. Next day chills & fever by evening 102 degrees. Doctor prescribed cephalexin. Said I had cellulitis in arm. It took 3-4 days for swelling to recede.
Age: 5.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid 2-3 + swelling, redness covering entire muscle area, area hot to touch.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Dehydration, Diarrhoea, Injection site erythema, Nausea, Pyrexia
Clinical narrative: Swollen face, nausea, vomiting, diarrhea, fever, dehydration for 5 days and redness around vaccination sight. Left upper thigh.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Swelling face, Vomiting
Clinical narrative: Swollen face, nausea, vomiting, diarrhea, fever, dehydration for 5 days and redness around vaccination sight. Left upper thigh.
Age: 1.01
Sex: F
Vaccine: HEP, HEPA, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever 103.0 noted on 11-3-10 at 3:00 AM. Spoke with mother at 0730 on 11-3-10 & temperature was 100.3. No other symptoms, no redness, no swelling, no other symptoms of illness. No return call when attempted to check on child's status 11-3-10 2:00 pm.
Age: 2.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Developed redness, swelling, tenderness at injection site 12 degrees after PCV 13. Area about 3" x 4" size.
Age: 75.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema
Clinical narrative: Patient received injection of Tetanus 0.5mg IM Right Deltoid. On 10/13/10 reported redness from site of injection to elbow that covered the whole diameter of the upper arm.
Age: 7.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema infectiosum, Flushing, Injection site rash, Rash
Clinical narrative: Initial case received on 04 November 2009 from a consumer, who is also the patient's parent. The reporter also noted that the patent's brother experienced a serious adverse event; this is captured in case number 2009-04731. A seven-year-old female patient was diagnosed with Fifth Disease after receiving H1N1 (lot not reported) on 24 October 2009. The patient had no reported medical history. One hour post-vaccination, she developed a rash at the injection site, which subsequently spread down her vaccinated arm and later to her other arm. The next day, after being in the sun, her face looked pinkish. She presented to the physician two days post-vaccination, and was diagnosed with Fifth Disease at that time. No additional information was reported. Follow-up information received on 03 December 2009 from a consumer, who is the patient's parent. The patient recovered from Fifth Disease. The symptoms lasted for five days. No treatment was required. No further information is expected. Documents held by sender: None.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Grip strength decreased, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Initial report received on 19 November 2009 from a consumer. A 43 year old female patient received H1N1 (lot number not provided) intramuscularly in the left deltoid on 07 November 2009. On 10 November 2009, three days post vaccination, the patient reported periods of intermittent muscle pain in the left shoulder and arm and weakened left hand strength. There was no swelling or redness present. The patient stated that the symptoms were getting worse. The patient was not recovered at the time of the report. List of Documents held by Sender: none.
Age: 0.12
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Crying, Drug exposure via breast milk, Faeces discoloured, Hypophagia, Opisthotonus
Clinical narrative: Initial report received from a consumer, who is also the patient's mother, on 23 November 2009. A seven-week-old infant was exposed via breast milk to H1N1 (lot number UP012AA) when her mother received the vaccine on 16 November 2009. The patient had a history of lactose intolerance and cow protein intolerance. She was taking approximately 80% of her dietary intake from breast milk, and supplementing with Nutramigen. According to the patient's mother, on 17 November 2009, one day post-vaccination, the patient began experiencing pain, inconsolable crying, back arching, and pulling her knees up. She consumed only half of her normal intake, and had orange streaks in her stool. On 20 November 2009, the patient's mother stopped breast feeding, and by that evening the patient was doing better. Within 24 hours, no orange streaks were noted in the patient's stool. The patient was not on any concomitant medications; her mother was taking prenatal vitamins. Follow-up information was received on 02 February 2010 from a physician. The female baby was born vaginally at 37 weeks gestation and weighed 5 pounds 14 ounces and was 18 and 3/4 inches in length. The baby's Apgar was 8 at 1 minute and 9 at 5 minutes and she had no congenital anomalies. This reporter also noted that she had received seasonal influenza vaccine while pregnant; this is reported in case number 2009-05153. Follow-up information received from a physician on 02 February 2010, confirmed that the mother had received FLUARIX (lot number AFLUA468CA) and not a sanofi-pasteur product. The linked case number 2009-05153 will be deleted from the database.
Age: 0.12
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain
Clinical narrative: Initial report received from a consumer, who is also the patient's mother, on 23 November 2009. A seven-week-old infant was exposed via breast milk to H1N1 (lot number UP012AA) when her mother received the vaccine on 16 November 2009. The patient had a history of lactose intolerance and cow protein intolerance. She was taking approximately 80% of her dietary intake from breast milk, and supplementing with Nutramigen. According to the patient's mother, on 17 November 2009, one day post-vaccination, the patient began experiencing pain, inconsolable crying, back arching, and pulling her knees up. She consumed only half of her normal intake, and had orange streaks in her stool. On 20 November 2009, the patient's mother stopped breast feeding, and by that evening the patient was doing better. Within 24 hours, no orange streaks were noted in the patient's stool. The patient was not on any concomitant medications; her mother was taking prenatal vitamins. Follow-up information was received on 02 February 2010 from a physician. The female baby was born vaginally at 37 weeks gestation and weighed 5 pounds 14 ounces and was 18 and 3/4 inches in length. The baby's Apgar was 8 at 1 minute and 9 at 5 minutes and she had no congenital anomalies. This reporter also noted that she had received seasonal influenza vaccine while pregnant; this is reported in case number 2009-05153. Follow-up information received from a physician on 02 February 2010, confirmed that the mother had received FLUARIX (lot number AFLUA468CA) and not a sanofi-pasteur product. The linked case number 2009-05153 will be deleted from the database.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Feeling abnormal, Malaise
Clinical narrative: Initial report received on 21 November 2009 from a company representative, who received the original report from a consumer. A female patient (demographics not reported) had received on 20 November 2009 a dose of H1N1 (lot number not reported) along with a steroid shot for her arthritic left hip pain. The patient reported she has had problems with her hip for quite a while. At an unspecified amount of time after receiving the vaccination, the patient reported that she felt like she had been hit by a truck. It was not reported whether the patient had received any medical evaluation or treatment. Follow-up information provided by the patient on 09 December 2009 via telephone call to the patient. The patient reported she had felt "generally unwell" for 3-4 days after receiving the H1N1 vaccine, but symptoms had spontaneously resolved without treatment or physician visit. The event was updated with this new information. The patient requested that she not be contacted again regarding this event. No further information is expected. Documents held by sender: None.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Increased upper airway secretion, Myalgia, Palpitations, Respiratory tract congestion
Clinical narrative: Initial report received on 24 November 2009 from a consumer. A 58 year old female with a history of diabetes developed a headache, muscle aches, congestion, and "phlegm in her throat" three hours after receiving H1N1 (lot number UT019AA, lot not valid) intramuscularly in the right deltoid. On 23 November 2009 the patient also experienced palpitations. The patient had not sought medical attention by the time of report. The patient was not recovered. List of documents held by Sender: none.
Age: 35.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Laryngitis, Oropharyngeal pain, Respiratory tract congestion, Sinusitis
Clinical narrative: Initial report received on 07 December 2009 from a consumer, who is the patient. A 35 year old female patient, with no known allergies and a history of hypothyroidism treated with LEVOXYL, received a dose of H1N1 (lot number unknown) on 04 November 2009. As per the patient, she thought that she received more than a 0.5 ml dose. The patient was 32 weeks pregnant at the time of vaccination. The date of her last menstrual period was not reported and the estimated date of confinement was 03 January 2010 (reported as 2009). The patient's obstetric history was not reported. On 06 November 2009, the patient developed congestion, a sore throat, a sinus infection, and laryngitis. Corrective treatment was not reported. At the time of the report, the symptoms persisted and the patient had not recovered.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood glucose increased
Clinical narrative: This case was received on 27 January 2010 from a healthcare professional. A 62 year old female patient received an injection (site and route not reported) of Influenza vaccine (Manufacturer unknown, lot not reported) on 23 January 2010. "That night" she experienced blood sugar levels of 348. The patient stated that on 19 January 2010 her blood sugar level was 320 and on an unspecified date her blood sugar level was 73. The patient's concomitant medication was LANTUS SOLOSTAR once a day (sliding scale) for diabetes mellitus type 2. She had a history of a foot operation on 28 October 2009, which the patient stated was for arthritis on the top of her foot. It was not reported if the patient had any illness at the time of the vaccination. The outcome of the patient's elevated blood sugars was not reported. Follow-up information was received on 22 March 2010 from the patient, who stated the event of elevated blood sugars was "a problem with the LANTUS, not the flu shot". Follow-up information was received on 31 March 2010 from the patient. On 23 January 2010, the patient received H1N1, lot number UP057AA. She had a ten year history of diabetes. She reported that her doctor attributed her blood sugar elevations to her recent foot surgery and subsequent infection. The start and stop dates for the blood sugar elevations were unknown. The patient stated she had recovered and had not had any additional problems controlling her blood sugar levels since 23 January 2010. She stated she did not have an adverse event following administration of the H1N1 vaccine. It should be noted that the information received in the initial version of this case on 27 January 2010 was provided by the patient and not a health care professional. The case is not medically confirmed. Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Chest discomfort, Sensory disturbance
Clinical narrative: Initial report received on 01 February 2010 from the mother of the patient. A 2 year 6 month old female child received a left deltoid intramuscular injection of FLUZONE (lot number U3350AA) and a left deltoid intramuscular injection of H1N1 (lot number UP053AA) on 29 January 2010. On an unspecified date within 4 weeks prior, she had received a right deltoid intramuscular injection of VAQTA (Merck lot number 1397Y). On 30 January 2010 the patient's mother noted the child was "pointing to different body parts (chest, arms, legs)" and stating it felt "picky." There were no signs of a rash or redness in the areas where the child was pointing. The patient had no illness at the time of the vaccine and no known allergies. She had a medical history of a sinus infection. Cefdinir was a concomitant medication. It was unknown if the child recovered. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Anxiety, Computerised tomogram normal, Laboratory test normal, Nuclear magnetic resonance imaging normal, Panic attack
Clinical narrative: Initial report received from a consumer's mother on 11 August 2010. An 11-year-old male child, who received a flu shot given September 2009 within 4 weeks prior to receiving H1N1, received an injection in October 2009 of H1N1 (lot number UP005AA) and experienced panic/anxiety attacks one month after receiving vaccine. The patient's mother reported that all tests were normal which included a magnetic resonance imaging (MRI), computed tomography (CT) scan and all laboratory work. A homeopathic health care professional (HCP) told mother that the vaccine probably triggered something. The patient was evaluated by a pediatrician, ear, nose and throat (ENT) specialist, psychiatrist, neurologist and endocrinologist who all found nothing wrong with her son. The patient was taking anti-anxiety medication. The outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site urticaria
Clinical narrative: Initial report received from a consumer on 08 September 2010. A female patient (age not provided) received on 20 December 2009 an injection (route not provided) to an arm of H1N1, lot number UP044AA. The patient reported that she still has welts on the arm at location of injection. No other information provided. The outcome was not reported. Documents held by sender: None.
Age: 23.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Cough, Ocular hyperaemia, Oropharyngeal pain, Wheezing
Clinical narrative: Initial report received from a health care provider on 29 September 2009. A 23 year-old female patient reported that she was vaccinated with FLUZONE (sanofi pasteur, Lot # U2363AA) and H1N1 (sanofi pasteur, Lot # UP001AA) on 29 September 2009. Later in the afternoon (approximately 4:00 PM) of the day of vaccination, the patient reported cough, wheezing, sore throat and bloodshot eyes. It was also reported that she was getting over a cold at the time of vaccination. The outcome was not reported. No further information is expected. Follow-up information received 28 October 2009 from a health care professional. The outcome for the symptoms of cough, wheezing, sore throat and bloodshot eyes was reported as two days. According to the reporter, the events did not require a doctor's visit. List of documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Chills, Cough, Throat irritation
Clinical narrative: Initial report was received 02 October 2009 from a health care professional. A 49-year-old female patient with no concurrent illness, had received an intramuscular injection (site not reported) of H1N1, lot number UP001AA and an intramuscular injection (site not reported) of FLUZONE, lot number U3213AA on 30 September 2009 at 02:00 PM, and the following day at 10:30 PM she developed chills. On 02 October 2009, the patient developed a scratchy throat and cough. The events did not require a doctor's visit. At the time of the report, the patient's recovery status was unknown. Documents held by sender: None.
Age: 54.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: Initial report received on 06 October 2009 from a health professional. A 54 year old male patient, with a history of high cholesterol, received a first left deltoid intramuscular injection of an H1N1 (Sanofi Pasteur, lot number not reported) on 01 October 2009 at 03:15 p.m. Concomitant medication included ZOCOR and vitamins. He had no illness at the time of vaccination. The patient had previously received a first left deltoid intramuscular injection of FLUZONE (lot number not reported) on 10 September 2009. The patient had no adverse event following prior vaccination. On 01 October 2009, at approximately 07:00 p.m, the patient developed a headache, chills, sweats and body aches which lasted 2.5 days. The patient also had left arm soreness. Corrective treatment was not reported. The patient recovered.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: Initial report received from a health care professional on 13 October 2009. A cluster of three patients out of 200 vaccinated with H1N1 (lot number UP001AA) experienced a "black dot" immediately after the withdrawal of the needle from the injection site (deltoid). The "black dot" only occurred in patients where some of the vaccine ran down the needle prior to injection. The needles had not been used to draw up the vaccine. They were 23 gauge, 1 inch needles. The "black dots" could be wiped off with alcohol. The three patients recovered.  List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Initial report received from a health care professional on 14 October 2009. A 5 year old male patient with a history of cat and nut tree pollen allergies and mild respiratory illness at the time of vaccination received the following vaccines 11 October 2009: a right deltoid injection of FLUZONE (lot number not reported) and a left deltoid H1N1 (lot number not reported). Approximately 6 hours after vaccination, the patient developed a fever of 101.4 to 103 degrees Fahrenheit, chills, cough, fatigue and loss of appetite. At the time of the report, the patient had not recovered. List of documents held by sender: none.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Musculoskeletal pain
Clinical narrative: Initial report received on 21 October 2009 from a health care professional. A male patient (demographics not reported) had received a dose of H1N1 (lot number unknown) on the morning of 20 October 2009. It was unknown if the patient had any concurrent illnesses or pre-existing medical history. The same day after receiving the vaccination, the patient experienced shoulder pain (site not reported). It was not reported whether the patient was medically evaluated or received any treatment. It was unknown if the patient had any relevant diagnostic tests or laboratory data. The patient's recovery status was unknown. Documents held by sender: None.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: Information was received from a health care professional on 30 October 2009 and 02 November 2009 which consisted of a cluster of 14 identified patients who experienced adverse events after receiving H1N1. This case represents one patient out of the cluster of 14 identified patients. A male patient (age and date of birth not reported) with a medical history of asthma and GERD (gastroesophageal reflux disease)had received an injection of H1N1 (route and site of administration not reported), lot number UP006AA on 30 October 2009 and one hour later, he experienced a sore throat and cough. Recovery status was reported as unknown. No additional information was provided at the time of the report. The reporter for this case is the same as for case numbers 2009-04661, -04662, -04663, -04664, -04665, -04666, -04667, -04668, -04669, -04670, -04671, -04672 and -04673. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthenopia, Dizziness, Pruritus
Clinical narrative: Information was received from a health care professional on 30 October 2009 and 02 November 2009 which consisted of a cluster of 14 identified patients who experienced adverse events after receiving H1N1. This case represents one patient out of the cluster of 14 identified patients. A 16-year-old female patient had received an injection of H1N1 (route and site of administration not reported), lot number UP006AA on 30 October 2009, and one hour later she experienced dizziness and her eyes felt heavy. She also developed itching on both of her arms; however there was no visible sign of anything on her arms. Prior to vaccination her blood pressure was 118/76 mmHg, and after vaccination, her blood pressure was 94/62 mmHg. At the time of the report, her recovery status was unknown and no additional information was provided. The reporter for this case is the same as for case numbers 2009-04660, -04661, -04663, -04664, -04665, -04666, -04667, -04668, -04669, -04670, -04670, -04671, -04672 and -04673. Documents held by sender: None
Age: 54.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Adverse event, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial report received on 04 November 2009 from a health care professional. A 54 year old male patient with no reported medical history noticed limited movement and pain in the left arm 18 hours (on 29 September 2009 at 8 PM) after receiving an initial dose of FLUZONE SV (lot number not reported) intramuscularly in the right deltoid and H1N1 (lot number UP001AA) intramuscularly in the left deltoid on 28 September 2009 at 2 PM. The patient recovered. No additional information was provided. Follow-up information received on 07 December 2009 from a health care professional. The patient has medical history of gallstones. The lot number for the FLUZONE was UT3251BA, and as a result, the product received was updated to FLUZONE (previously reported as FLUZONE SV). The FLUZONE and H1N1 vaccines were administered on 30 September 2009 (previously reported as 28 September 2009) with no change in the time administered. The onset date of the adverse events was 01 October 2009 (previously reported as 29 September 2009) without change in the time of onset and latency. The patient did not require treatment or a doctor's visit for the adverse events. Per the reporter, the patient recovered on 30 November 2009. The reporter has no additional information to add to the case. List of Documents held by Sender: none.
Age: 8.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Chest pain, Full blood count normal, Muscle spasms
Clinical narrative: Initial report received on 05 November 2009 from a healthcare professional. An 8 year old female patient, with no medical history, received a right deltoid intramuscular injection of H1N1 (lot number UP004AA) and a left deltoid intramuscular injection of FLUZONE (lot number U3210AA) on 16 October 2009. The patient had no concomitant medications and no illness at the time of vaccination. She has received no other vaccinations within the previous four weeks and she had no adverse event following prior vaccinations. On 23 October 2009, one week post vaccination, the patient experienced severe muscle cramps in both arms. The pain spread across the chest in the biceps area. At the time of the report, the symptoms were reported to have worsened over the previous few days. The patient was seen by a physician on 04 November 2009. Corrective treatment was NAPROSYN 250 mg. At the time of the report, the patient had not recovered. Follow-up information received on 07 December 2009 from a health care professional. The H1N1 and FLUZONE vaccines were the first doses the patient had received on 16 October 2009. No other vaccinations were received within four weeks of that date. Diagnostic tests included a CBC (complete blood count) test that was normal; however the date the test was competed was not reported. At the time of this report, the patient had recovered. No further information is expected. Documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1), PPV
Symptoms: Diplopia, Eyelid disorder
Clinical narrative: Initial report received on 06 November 2009 from a healthcare professional. An unidentified patient, whose medical history was not reported, received a dose of FLUZONE (lot number not reported) in one arm and a dose of PNEUMOVAX (manufacturer and lot number not reported) in the other arm on 04 November 2009. Within four hours of vaccination, the patient developed double vision and dropping eyelid. The patient was sent to an eye doctor and an internist. The symptoms spontaneously resolved while the patient was at the physician's office. The physician thought that the vaccine possibly caused the "MS like onset" and was scheduling the patient for an MRI. No other information was provided. Follow-up information was received on 28 December 2009 from a healthcare professional. The patient, a 62-year-old female, had a medical history of hypertension. Other medications were reported as LIPITOR, NORVASC and aspirin (81mg). The  lot number for the intramuscular dose of FLUZONE administered on 04 November 2009 was reported as UP010AA; this lot number, however, corresponds to H1N1. PNEUMOVAX 23 (manufacturer Merck), administered intramuscularly on that same date, had a lot number of 0527Y. No additional details were provided. Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Decreased appetite, Incorrect dose administered, Malaise, Nausea
Clinical narrative: Initial report was received 06 November 2009 from a health care professional, who is also the patient. Of note, this event involved a case of misuse (i.e., inappropriate dose administered). A 67-year-old female patient with a history of a penicillin allergy, hypertension and osteoporosis, had received a "half dose" first dose injection of H1N1 (lot number, route and site not reported) "two weeks ago", and two hours later, she developed nausea, loss of appetite and malaise. The symptoms lasted 36 hours. The patient had previously received her seasonal influenza vaccine (manufacturer, lot number, route and site not reported) three weeks before: however that vaccine had been administered in two doses (dosage amounts not reported) separated by four days. Concomitant medications included Lisinopril, propranolol, LIPITOR and EVISTA. At the time of the report, the patient had recovered. Documents held by sender: None.
Age: 1.1
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Nasopharyngitis
Clinical narrative: Initial report received on 11 November 2009 from a company representative for the manufacturer, who is a health care professional. A 13-month-old male patient had received a dose of H1N1 (lot number not reported) on 09 November 2009 that had been drawn up into a plastic syringe four days prior and kept in a refrigerator until it was given. The same day after vaccination, the patient developed "cold like symptoms". According to the father who is a physician, the patient had a cough at the time of the vaccination. No relevant diagnostic tests or laboratory data were performed. At the time of this report, it was unknown if the patient had recovered. Follow-up information received 04 December 2009 from a health care professional. The vaccine had been drawn up into a plastic syringe three days prior to administration (previously reported as four days). According to the reporter, the patient had a cold at the time of vaccination and did not experience any adverse event. The patient recovered from their cold symptoms with no issues and tolerated the vaccine well. No further information was provided. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Delivery, Dermatitis, Drug exposure during pregnancy, Herpes zoster, Laboratory test normal
Clinical narrative: Initial report received on 11 November 2009 from a health care professional. An 18-year-old female patient, who was 33 and a half weeks pregnant at the time, had received a dose of H1N1 (lot number UP002AA) on 28 October 2009. Later that day, the patient started having itching and rash on her arm. The rash then extended to hive type rash over the whole body. It was not reported whether the patient required medical evaluation or treatment. The patient had no concurrent illnesses, or other medical conditions at the time of vaccination. The patient also had no known allergies. Her expected date of delivery is on 28 December 2009. At the time of this report, it was unknown if the patient had recovered. Follow-up information was received from the health care professional on 14 January 2010. According to the reporter, "a confirmed dermatologist report indicated that this was not a reaction to the H1N1, but rather a dermatologic condition". The reporter noted that the patient's dermatitis was "actually a coincidence". No additional information was reported. Follow up information was received on 16 February 2010 from a health care professional. The date of the patient's last menstrual period was 01 April 2009. Route of vaccine administration was intramuscular. On 11 January 2010 the patient delivered via vaginal delivery at 40 weeks gestation. APGAR scores included eight at one minute and nine to five minutes. The baby boy was without congenital anomalies. The reporter noted an "incidental shingles outbreak" during pregnancy; date of onset and details were not provided. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Rash generalised
Clinical narrative: Initial report received on 11 November 2009 from a health care professional. An 18-year-old female patient, who was 33 and a half weeks pregnant at the time, had received a dose of H1N1 (lot number UP002AA) on 28 October 2009. Later that day, the patient started having itching and rash on her arm. The rash then extended to hive type rash over the whole body. It was not reported whether the patient required medical evaluation or treatment. The patient had no concurrent illnesses, or other medical conditions at the time of vaccination. The patient also had no known allergies. Her expected date of delivery is on 28 December 2009. At the time of this report, it was unknown if the patient had recovered. Follow-up information was received from the health care professional on 14 January 2010. According to the reporter, "a confirmed dermatologist report indicated that this was not a reaction to the H1N1, but rather a dermatologic condition". The reporter noted that the patient's dermatitis was "actually a coincidence". No additional information was reported. Follow up information was received on 16 February 2010 from a health care professional. The date of the patient's last menstrual period was 01 April 2009. Route of vaccine administration was intramuscular. On 11 January 2010 the patient delivered via vaginal delivery at 40 weeks gestation. APGAR scores included eight at one minute and nine to five minutes. The baby boy was without congenital anomalies. The reporter noted an "incidental shingles outbreak" during pregnancy; date of onset and details were not provided. Documents held by sender: None.
Age: 48.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Oropharyngeal pain, Swelling
Clinical narrative: Initial report received on 12 November 2009 from a health care professional. A 48 year old female patient with no reported medical history developed swelling under the right ear and a mild sore throat one day after receiving an initial dose of H1N1 (lot number UP010AA) intramuscularly in the right deltoid on 10 November 2009. On 28 September 2009 the patient also received on initial dose of FLUVIRIN (manufacturer Novartis, lot number 98432PI). The patient did not have a fever. The swelling persisted at the time of the report. The patient did not recover. List of documents held by Sender: none.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dissociation, Dizziness, Dysgeusia, Feeling abnormal, Parosmia
Clinical narrative: Initial report received on 12 November 2009 from a health care professional. This case (involving a 55-year-old female) is part of a cluster of three cases received from the same reporter with the same product and lot number. Information regarding the other two patients is reported in cases 2009-04810 and 2009-04930. A 55-year-old female patient, who had no concurrent illness, had received an intramuscular right deltoid injection of H1N1 (lot number UP009AA) on 09 November 2009. Shortly after vaccination, the patient reported having a strong metallic taste in her mouth and she smelled a metallic scent. The patient stated she "felt funny", "disconnected", and "lightheaded". The patient was going to be prescribed Prednisone, but called the doctor office two days later and stated she felt better. No relevant diagnostic tests or laboratory data were performed. At the time of this report the patient had recovered. Follow up information received on 18 December 2009 from a health care professional. The patient has a history of hypothyroidism. Concomitant therapy included SYNTHROID, ZYRTEC, and MIRALAX. The patient did not receive treatment. The patient's date of recovery was 12 November 2009. Documents held by sender: None.
Age: 36.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Local swelling, Neck mass, Tenderness
Clinical narrative: Initial report received on 12 November 2009 from a healthcare professional. A 36 year old male patient, with no known allergies and no medical history, received a first right deltoid intramuscular injection of H1N1 (lot number UP010AA) on 11 November 2009. The patient had previously received FLUVIRIN (Novartis, lot number not reported) on 20 October 2009. On the night of 11 November 2009, the patient had a "knotty area" on the left side of his neck which was tender to touch. The next day, on 12 November 2009, the patient still had a palpable lump of the left side of his neck as well as swelling to the left side of his neck. Corrective treatment was not reported. At the time of the report, the patient had not recovered.
Age: 47.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Dysgeusia
Clinical narrative: Initial information received on 05 January 2010 from a health care professional. A 47 year old female patient with a history of COPD, asthma, HTN, hypothyroidism, anxiety, hypokalemia developed a metallic taste and dizziness with head movement after receiving H1N1 (lot number UP078AA) in the left deltoid on 05 January 2010. Concomitant therapy included Albuterol, "ADVIR", SINGULAIR, SPIRIVA, SYNTHROID, theophylline, MUCINEX, PROAIR, potassium, hydrochlorothiazide, "NEFOCAL XL", "DOXIPRIM", lorazepam. The reporter stated that the patient was to be "possibly" evaluated by a physician. Recovery status was unknown. No further information was provided. Follow-up information was received on 16 February 2010 from a healthcare professional. The previously reported events or metallic taste and dizziness with head movement had an onset of 5 minutes post vaccination. The patient had no illness at the time of the vaccination and had no other vaccinations within the four weeks prior. Her concomitant medications were verified: "NEFOCAL XL" was NIFEDICAL XL, "DOXIPRIM" was Doxipen and "ADVIR" was ADVAIR. The patient was evaluated by physician and the reporter stated "all" within normal limits. The patient recovered without adverse effects after several hours and without treatment. List of Documents held by Sender: none.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain upper, Chills, Condition aggravated, Nasopharyngitis, Nausea
Clinical narrative: Initial case received from a consumer, who is also the patient's parent, on 13 November 2009. A five-year-old male patient received an intramuscular right thigh injection of H1N1 (lot number UP006AA) on 11 November 2009. The patient had a history of asthma and a cardiac valve defect, and had been ill with cold symptoms including nasal drainage and cough for 10 days prior to vaccination. Concomitant medications included FLOVENT and Enalapril. On 12 November 2009, one day post-vaccination, the patient developed a fever of 103 degrees Fahrenheit, body aches, chills, nausea, and stomach pain. His cold symptoms also became worse. His parent noted that his fever reduced with alternating use of MOTRIN and TYLENOL. At the time of the report, the event had not yet recovered. Follow-up information received 28 December 2009 from a health care professional. Additional corrective treatments included ZITHROMAX. According to the reporter, the events lasted for five days and the patient recovered.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pain, Pyrexia
Clinical narrative: Initial case received from a consumer, who is also the patient's parent, on 13 November 2009. A five-year-old male patient received an intramuscular right thigh injection of H1N1 (lot number UP006AA) on 11 November 2009. The patient had a history of asthma and a cardiac valve defect, and had been ill with cold symptoms including nasal drainage and cough for 10 days prior to vaccination. Concomitant medications included FLOVENT and Enalapril. On 12 November 2009, one day post-vaccination, the patient developed a fever of 103 degrees Fahrenheit, body aches, chills, nausea, and stomach pain. His cold symptoms also became worse. His parent noted that his fever reduced with alternating use of MOTRIN and TYLENOL. At the time of the report, the event had not yet recovered. Follow-up information received 28 December 2009 from a health care professional. Additional corrective treatments included ZITHROMAX. According to the reporter, the events lasted for five days and the patient recovered.
Age: 7.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Rash erythematous, Rash pruritic, Sinusitis
Clinical narrative: Initial report was received on 13 November 2009 from a health care professional, who also provided follow-up information on 16 November 2009 and 09 February 2009. From new information received on 09 February 2009, it was determined a case narrative was required; therefore the following narrative has captured all case information received to date. A seven-year old female patient had received an injection of H1N1 (route and site not reported), lot number UP005AA on 23 October 2009 and eight days later, she developed a fever (reported as "low grade"). The patient was administered TYLENOL as corrective treatment and her temperature returned to normal; however, during the afternoon the next day, the fever returned and recurred for several days. The patient had no recent ill contacts prior to onset. On 10 November 2009, 18 days after receiving the vaccine, the patient developed a generalized red itchy rash that was mostly on her buttocks and face. By 12 November 2009, the rash was completely gone, but recurred when the patient ran around. The patient had no past medical conditions except for allergies to amoxicillin and OMINICEF and she had not been taking any concomitant medications. According to reporter, the patient's mother stated that approximately one week after she had initially reported this event, she took the patient to her physicians for a "bad sinus infection". The physician told the patient's mother that these events were probably from the child playing in damp leaves (molds, etc). According to the reporter, the patient recovered from the events. The patient subsequently received a second dose of H1N1 vaccine in December (manufacturer, lot number, route, site and exact date of administration not reported) with no adverse events experienced. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Initial case received from a nurse practitioner on 17 November 2009. This reporter also noted similar symptoms in another patient; the event is captured in case number 2009-05022. A five-year-old female patient received an injection of H1N1 (lot number UP019AA) on 11 November 2009, and twelve hours later experienced three episodes of vomiting and diarrhea. The patient had also experienced a similar episode five days prior to vaccination. Outcome was not reported. Follow-up information was received 22 February 2010 from a health care professional who reported that the patient had fully recovered (date not reported). The event did not require treatment or a doctor's visit. No additional information was provided. Documents held by sender: None.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Gingival swelling
Clinical narrative: Initial report received from a health care professional on 18 November 2009. A male patient received H1N1 (lot not reported) and later complained of swollen gums. The patient had a history of hip surgery. No additional information was reported. Outcome was unknown.
Age: 48.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial report received from a nurse on 20 November 2009. A 48-year-old female patient received an intramuscular left deltoid injection of FLUZONE (lot number UT3251AA) and an intramuscular right deltoid injection of H1N1 (lot number UP001AA). Two hours post-vaccination, she noticed pain in the left upper deltoid with decreased range of motion. The patient had a history of penicillin allergy, and was taking CLIMARA concomitantly. Outcome was not reported.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received on 25 November 2009 from a health care professional. A 58 year old female, with no known allergies and a history of hyperlipidemia, received a right deltoid intramuscular injection of H1N1 (lot number UP016AA) and a left deltoid intramuscular injection of FLUVIRIN (Novartis, lot number not reported) on 24 November 2009. The patient had no illness at the time of vaccination and it was unknown if she had any adverse events following prior vaccination. The following day, on 25 November 2009, the patient experienced significant swelling, warmth and redness at both injection sites. She had no systemic reaction. At the time of the report, the patient had not recovered.
Age: 8.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Joint swelling, Oedema peripheral, Tenderness
Clinical narrative: Initial report received on 25 November 2009 from a health care professional. An 8 year old female patient with a history of asthma reported swelling in the left arm, elbow, and wrist after receiving H1N1 (lot number UP013A) and FLUZONE (manufacturer and lot number were reported as unknown) on 17 November 2009. The physician reported that the patient had tenderness in those areas, however no redness was noted. The symptoms continued to persist and the patient did not recover. List of Documents held by Sender: none.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Ear discomfort, Nausea, Pyrexia, Vomiting
Clinical narrative: Initial report received on 04 December 2009 from a health care professional. A 52 year old female patient developed chills, fever, nausea, vomiting and ear pressure 48 hours after receiving H1N1 (lot number UP027AB) intramuscularly in the left deltoid on 02 December 2009. The patient did not recover at the time of the report. No further information was provided. List of Documents held by Sender: none.
Age: 60.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest discomfort, Dysgeusia
Clinical narrative: Initial case received on 08 December 2009 from a physician. A 60 year old female patient received an intramuscular left deltoid injection of H1N1 (lot number UP015AA) on 08 December 2009. Five minutes post vaccination she complained of tightness in the chest lasting 10 seconds. She also developed a metallic taste in her mouth described as "continuous". No other symptoms were reported. The metallic taste was ongoing at the time of the report. Follow-up information was received on 11 January 2010 from a physician. The patient did not receive treatment and recovered from the metallic taste in her mouth. The reporter stated it was unknown if the patient was taking any other medications or had a history of chest tightness. Documents held by sender: none.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness
Clinical narrative: Initial report received on 21 December 2009 from a health care professional. A female patient had received a dose of H1N1 (lot number unknown) on 21 December 2009 at a pharmacy. The patient's medical history was not reported, and it was unknown if she had received any other vaccinations within 4 weeks of 21 December 2009. That same day after receiving the vaccination, the patient went to the doctor's office after feeling like she was going to faint. It was not reported, whether the patient received any treatment, or if any relevant diagnostic tests were completed. Recovery status at the time of this report was unknown. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site haematoma
Clinical narrative: Initial report received 30 December 2009 from a health care professional. A 75-year-old female patient had received a first dose intramuscular left deltoid of H1N1, lot number UP099AA on 28 December 2009, and one day later, she developed a five inch black and blue area at the injection site. No soreness or pain was present and the patient had no other symptoms. The event did not require a doctor's visit. The patient had been taking baby aspirin, MOBIC, "plaqeunel", ZESTRIL, folic acid, XANAX, ALLEGRA, LIPITOR and an "irregular heart med" concomitantly. She had a history of sulfa allergy, hypertension, RA (rheumatoid arthritis) and high cholesterol. The patient had no illness at the time of vaccination and she had not experienced any adverse events following prior vaccinations. At the time of the report, she had not recovered. Follow up information received on 01 March 2010 from a health care professional. Concomitant therapy also included Acebutolol 200 mg (previously reported as irregular heart medication) and "Plaqeunel". The bruising at the injection site persisted for 7-10 days and then resolved. No other information was provided. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypersomnia, Pain in extremity
Clinical narrative: Initial case received on 08 January 2010 from a healthcare professional. A 47 year old female received an injection (route and site not reported) of H1N1 (lot number UP112AA) on 08 January 2010. On the eve of the vaccination (08 January 2010), the patient experienced a sore arm all night. On 09 January 2010 the patient slept all day. She felt better on 10 January 2010. No further information was provided and no further information is expected. Documents held by sender: none.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pain, Pain in extremity
Clinical narrative: Initial case received on 11 January 2010 from a phamacist. A male patient (age unknown) received an injection of H1N1 (lot number UP062AA) on 30 December 2009. On an unknown date, the patient experienced intermittent shooting pain in the arm of injection. The pharmacist reported that as of the patient's phone call on 08 January 2010 the pain persisted. The patient had a medical history of hypertension. Documents held by sender: none.