chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Head discomfort
Clinical narrative: A 47-year-old female patient with no known allergies or illnesses at the time of vaccination had received an administration (route and site not reported) of FLUZONE  SV '2005-'2006 USP on 04/Nov/2005  On 08/Nov/2005 she complained of feeling "unsteadiness She said she did not feel unsteady on her feet, she felt "unsteady in her head."  She was seen by a physician.  It is unknown if the patient recovered from this event at the time of this report.
Age: 28.0
Sex: F
Vaccine: DT, FLU3, HEP, MMR
Symptoms: Erythema, Feeling hot, Influenza like illness, Injection site inflammation, Injection site reaction
Clinical narrative: A initial report received on 20/Jan/2006 from a health care professional. A female patient (date of birth not reported) had received an administration (route not reported) of DIPHYTHERIA AND TETANUS TOXOIDS (lot number not reported), in the left arm and an administration (route not reported) of FLUZONE SV '2005-'2006 USP (lot number not reported), in the right arm on 09/Jan/2006. At an unspecified time later, the patient developed a "baseball size lump" to the left arm at the injection site that was hot to touch and red. Patient was unable to bend the elbow on the left arm. She also developed a fever and "flu-like" symptoms that lasted four days. At the time of this report, the arm had a one and a half centimeter hard, red area and the patient had not fully covered. Follow-up information received on 20/Mar/2006. Per reported, the patient last had tetanus/diptheria vaccination  ten years ago. Patient has no pre-existing allergies or medical conditions and denies being on any concomitant medication  or having any illnesses at the time of vaccination. The patient received the intramuscular injection of Decavac, lot number 01703CA (expiry date 11/Jul/2007) in the left arm, the intramuscular injection of Fluzone, lot number U1935AA (expiry date 30/Jun/2006) in the right arm, the intramuscular injection of the second dose of Hepatitis B Vaccine, lot number 0336R, (site not reported) and the subcutaneous injection of MMR, lot number 0295R (site not reported) on 09/Jan/2006 at 7 AM. It was also reported the patient received the intramuscular injection of the first dose of Hepatitis B Vaccine, lot number 0336R (date received not reported) within four weeks prior the vaccines received on 09/Jan/2006. The patient's fever began at approximately 7:30-8:00 PM on 09/Jan/2006 along with arm soreness. The next morning the patient's arm was very sore and progressively got more painful with redness and swelling. By evening she could hardly lift her arm or grip the steering wheel. It "swelled to the size of softball" which could actually be seen through the patient's clothing. The arm felt very warm and tender with touch. Also, very painful to lift or move. Almost had a "bullseye" appearance. Fever of 101 began approximately eight hours after injection and continued for 24 hours. On 19/Jan/2006 when this report was made there was still a 1 1/2 diameter raided hard bump that appears to be "sunburned". The patient was seen by the physician on 20/Jan/2006. No diagnostic tests or laboratory data was performed. Per reporter, the patient recovered. No further information expected.
Age: 28.0
Sex: F
Vaccine: DT, FLU3, HEP, MMR
Symptoms: Joint range of motion decreased, Pain, Pyrexia, Swelling
Clinical narrative: A initial report received on 20/Jan/2006 from a health care professional. A female patient (date of birth not reported) had received an administration (route not reported) of DIPHYTHERIA AND TETANUS TOXOIDS (lot number not reported), in the left arm and an administration (route not reported) of FLUZONE SV '2005-'2006 USP (lot number not reported), in the right arm on 09/Jan/2006. At an unspecified time later, the patient developed a "baseball size lump" to the left arm at the injection site that was hot to touch and red. Patient was unable to bend the elbow on the left arm. She also developed a fever and "flu-like" symptoms that lasted four days. At the time of this report, the arm had a one and a half centimeter hard, red area and the patient had not fully covered. Follow-up information received on 20/Mar/2006. Per reported, the patient last had tetanus/diptheria vaccination  ten years ago. Patient has no pre-existing allergies or medical conditions and denies being on any concomitant medication  or having any illnesses at the time of vaccination. The patient received the intramuscular injection of Decavac, lot number 01703CA (expiry date 11/Jul/2007) in the left arm, the intramuscular injection of Fluzone, lot number U1935AA (expiry date 30/Jun/2006) in the right arm, the intramuscular injection of the second dose of Hepatitis B Vaccine, lot number 0336R, (site not reported) and the subcutaneous injection of MMR, lot number 0295R (site not reported) on 09/Jan/2006 at 7 AM. It was also reported the patient received the intramuscular injection of the first dose of Hepatitis B Vaccine, lot number 0336R (date received not reported) within four weeks prior the vaccines received on 09/Jan/2006. The patient's fever began at approximately 7:30-8:00 PM on 09/Jan/2006 along with arm soreness. The next morning the patient's arm was very sore and progressively got more painful with redness and swelling. By evening she could hardly lift her arm or grip the steering wheel. It "swelled to the size of softball" which could actually be seen through the patient's clothing. The arm felt very warm and tender with touch. Also, very painful to lift or move. Almost had a "bullseye" appearance. Fever of 101 began approximately eight hours after injection and continued for 24 hours. On 19/Jan/2006 when this report was made there was still a 1 1/2 diameter raided hard bump that appears to be "sunburned". The patient was seen by the physician on 20/Jan/2006. No diagnostic tests or laboratory data was performed. Per reporter, the patient recovered. No further information expected.
Sex: M
Vaccine: FLU3
Symptoms: Gastrointestinal disorder
Clinical narrative: Initial report received from a Licensed Practical Nurse on 21/Feb/2006.  A male patient, 26-28 years old with no prior egg allergies developed gastroenteritis signs and symptoms after eating eggs approximately two months after receiving Fluzone (lot number unknown) in the the deltoid, administered either in October or November 2006. The patient has not received the flu shot prior. It is not known if the patient had any illness at the time of vaccination. Per the reporter there is no further information available as this event was mentioned to her months ago and she can't remember the patient's name. Recovery status is unknown.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Psoriasis, Skin irritation
Clinical narrative: Initial report received on 24/Feb/2006 from the patient. A 58 year old female patient with a history of asthma and allergies to sulfa drugs, Penicillin, and currently taking synthroid, Theophylline and Advair, had received an intra-muscular injection of a INFLUENZA VACCINE (manufacture and lot number not reported) in the left arm, on an unspecified day in October 2005. Approximately one week later, she developed small raised bumps on her left elbow, and one month later, on both elbows and both knees. In January 2006 the bumps spread to her groin and she was seen by a dermatologist on 26/Jan/2006. She was diagnosed with Psoriasis. No other information was provided regarding the dermatology visit. Follow-up information received on 01/May/2006 from a health care provider. The product administered was Fluzone SV 2005-2006, lot number U182AA, administered on 03/Oct/2005. The patient had received annual flu vaccinations. She has received no other vaccinations within four weeks of the 03/Oct/2005 vaccination. At the time of vaccination, she had chronic asthma and allergic rhinitis. She also had a history of Hashimoto's hypothyroidism which was stable. Other medications included Claritin, albuterol and Intal. At the time of this report, the patient had not recovered.
Age: 0.88
Sex: M
Vaccine: FLU3
Symptoms: Croup infectious, Urticaria
Clinical narrative: Initial report was received from a consumer and a physician on 24/Apr/2006 and assessed as non-serious listed. Follow-up report was received on 17/May/2006 from a physician and the case is now considered non-serious, unlisted. A mother reported that her 15-month old  male child developed hives 6 hours after receiving the injection of Fluzone (dose two), lot number U1854AA in the left leg on 08/Nov/2005. The mother reported that the hives were large (half dollar size) on her son's torso, arms and legs. Per mom there was no fever or difficulty breathing.  The patient was seen by and allergist, date not reported. Symptoms resolved with p.o. Benadryl. Allergy testing confirmed the patient had no egg allergies. From information received on 17/May/2006 from the patient's primary care physician, the patient had a viral illness at the time of vaccination and the adverse event was reported as a "croup like viral illness". The patient recovered. No further information expected. New version created on 19/May/2006 to document in the narrative that the latest received date for version 2 was 17/May/2006.
Age: 1.87
Sex: M
Vaccine: FLU3
Symptoms: Feeling cold, Nasal congestion, Pharyngolaryngeal pain, Urticaria
Clinical narrative: Initial report received from nurse on 20/Sep/2005. A 22 month old male child immediately developed hives at the injection site, and an hour later had generalized hives after receiving the intramuscular injection of Fluzone (Preservative Free), lot number U1743JA in the left thigh on 17/Sep/2005. The patient received the flu vaccine last year with no adverse event. The generalized hives lasted for three days. The patient also had signs and symptoms of a cold with congestion, and "acted like their throat was sore." There was no wheezing or respiratory distress. As per reported the signs and symptoms of the sore throat were still persisting at the time of this report. Follow up information received 01/Dec/2005. The vaccination was administered on 17/Sep 2005 at 11:00. There was no illness at the time of vaccination. At the time of this report, the patient had recovered.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site inflammation, Injection site mass, Injection site pain, Myalgia
Clinical narrative: Initial report of a cluster of five cases received from a health care professional on 26/Sep/2005. It was reported that three employees complained of pain and swelling at the injection site. One employee had redness at the injection site and two other employees complained of pain and swelling and had an egg shaped lump at the injection site (and one of these reported feeling flushed without fever). All reported the area was warm to touch. Symptoms for all patients except one had resolved by 26 September 2005. All patients had received the flu shot in the past with no reactions. This case involves a female patient (age not reported) who developed a knot and soreness at the injection site after receiving the intramuscular injectionof Fluzone, lot number U177AA in the deltoid on 21/Sep/2005. Onset date of symptoms and treatment received was not reported. As per reporter the symptoms had resolved by 26/Sep/2005 and patient recovered. Follow up information received on 02/Dec/2005. It was reported that the patient was 19year old at the time of the events. Further information is not expected. Same reporter in cases 2005-01922, 2005-01924, 2005-01927.
Age: 0.75
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Initial report received from a registered nurse on 26/Oct/2005. A nine month old female infant developed a red flat rash on her stomach that spread to both upper and lower extremities to below the elbow and knee, three to four hours after receiving the intramuscular injection of Fluzone, lot number U1743HA in the thigh on 14/Oct/2005. As per reporter the mom stated the rash lasted 24 hours and then disappeared. Mom denied fever or pruritis. Patient recovered. Follow up information received from a health care provider on 23/Nov/2005. The patient was not seen by a physician, and the patient did not require treatment. The rash was gone within 24 hours. Further information is not expected.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema multiforme, Rash, Urticaria
Clinical narrative: Initial report received on 22/Nov/2005 from a health care provider. A 4 year old female patient, with a medical history of allergies to penicillin and sulfa, received an intramuscular, left thigh injection of Fluzone No Preservative 2005-2006, lot number U1802EA, on 05/Nov/2005. On 21/Nov/2005, the patient developed generalized hives and was treated with Benadryl without effect. She was diagnosed by her physician with Erythema Multiforme. Her "strep" test was negative. The patient had no illness at the time of vaccination and denied other medications. At the time of this report, the patient had not recovered. Follow-up information received on 30/Jan/2006 from a health care professional. Per the reporter, the mother called the facility on 23/Nov/2005 and indicated the patient was diagnoses by an allergist with the hives and it was felt that the hives were secondary to a random even and not the Fluzone vaccination. The patient was started on steroids and the rash was much better that day. The patient was seen by her physician on 23/Jan/2006 and she had completely recovered from all the events. No further information is expected.
Age: 1.33
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Viral infection, Vomiting
Clinical narrative: Initial report received on 15/Feb/2oo6 from a health care professional. A 17 month old had received an administration (route and site not reported) of FLUZONE SV, (lot number not reported) on an unspecified day in 2006. The next day, the patient developed a low grade fever and mild vomiting. No other information was provided. At the time of this report the patient had recovered from these events. Follow up information received on 17/Mar/2006 from a health care provider. The date of vaccination was 12/Jan/2006, and the adverse event onset date was 13/Jan/2006. The lot number for Fluzone is provided as U1765FA, and the vaccination was administered intramuscularly. Per the reporter, the patient had a second dose of "flu vaccine" on 15/Feb/2006 without any problems, and "the physician felt the symptoms were due to a virus (not the vaccine)." Adverse events have been amended to reflect this new information.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspepsia, Headache, Hot flush, Neck pain
Clinical narrative: Initial report received on 07 Oct 2005 from a patient. A 61 year old female patient with a medical history of atrial fibrillation, sino-ventricular tachycardia, osteoporosis, vertigo, ankylosing spondylitis, fibromyalgia and asthma developed chills, facial flushing, hot feeling on face, indigestion and heartburn 4 hours following the influenza vaccine (FLUZONE SV '2005-'2006), lot no: U1846AA, administration in the left arm on 06 Oct 2005. She had also experienced pounding headache, neck pain and generalized aches 8 hours following the above vaccination, among them only aches were persisting at the time of the report. It was reported that, she is taking yearly vaccination with Fluzone and was concomitantly taking treatment of Tiazac, proventil, propafenone, avista, prevacid, Claritin and xanax since an unspecified time. The patient was not recovered at the time of the report. Follow up information received on 23/Jan/2006 from a health care provider. The provider has no knowledge of the incident. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Initial report received on 07 Oct 2005 from a patient. A 61 year old female patient with a medical history of atrial fibrillation, sino-ventricular tachycardia, osteoporosis, vertigo, ankylosing spondylitis, fibromyalgia and asthma developed chills, facial flushing, hot feeling on face, indigestion and heartburn 4 hours following the influenza vaccine (FLUZONE SV '2005-'2006), lot no: U1846AA, administration in the left arm on 06 Oct 2005. She had also experienced pounding headache, neck pain and generalized aches 8 hours following the above vaccination, among them only aches were persisting at the time of the report. It was reported that, she is taking yearly vaccination with Fluzone and was concomitantly taking treatment of Tiazac, proventil, propafenone, avista, prevacid, Claritin and xanax since an unspecified time. The patient was not recovered at the time of the report. Follow up information received on 23/Jan/2006 from a health care provider. The provider has no knowledge of the incident. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Injection site inflammation
Clinical narrative: Initial report received from a consumer on 13/Oct/2005. A 66 year old female patient reported that approximately three years ago she developed local pinkness and warmth at the injection site which went down to the wrist area, 24 hours after receiving the injection of Fluzone. Lot number, route and site of administration not known by the patient. The patient reported symptoms lasted two to three days. She was diagnosed by a physician as having a thimerosal allergy. The patient recovered.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Initial report received from a consumer, the mother of a patient on 15/Oct/2005. The mother reported that her 11 year old daughter developed itchy red raised spots on the front and back of her torso and neck two days after receiving the injection of Fluzone (lot number not reported) in the deltoid on 11/Oct/2005. The spots were not on the patient's face or extremities. She had no fever and no other symptoms. The physician prescribed Benadryl. The patient also had just started on a cream for a patch of eczema on 11/Oct/2005. At the time of this report the patient had not recovered.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Flank pain, Headache, Myalgia
Clinical narrative: Initial report received from a consumer on 20/Oct/2005. A 40 year old female patient complained of her skin being "so sensitive", chills, "pounding behind eyes", aches all over, diarrhea frequently, bones ache, and flank pain over her kidneys after receiving the intramuscular injection of Fluzone, lot number U1792AA in the right deltoid on 19/Oct/2005 at 12:30 PM. It was reported the diarrhea, which was liquid in consistency started on the 19/Oct/2005 at 4:30 PM, four hours post immunization, and was still present at the time of this report on 20/Oct/2005 at 10:30 AM. Latency of other symptoms, treatment and recovery status not reported. Follow up information received on 24/Jan/2006 from a health care provider. Per the reporter, the patient did not follow up with them. He went to his own physician. Illness at the time of vaccination, other medication and pre-existing medical conditions were all unknown. Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Skin irritation
Clinical narrative: Initial report received from a consumer on 20/Oct/2005. A 40 year old female patient complained of her skin being "so sensitive", chills, "pounding behind eyes", aches all over, diarrhea frequently, bones ache, and flank pain over her kidneys after receiving the intramuscular injection of Fluzone, lot number U1792AA in the right deltoid on 19/Oct/2005 at 12:30 PM. It was reported the diarrhea, which was liquid in consistency started on the 19/Oct/2005 at 4:30 PM, four hours post immunization, and was still present at the time of this report on 20/Oct/2005 at 10:30 AM. Latency of other symptoms, treatment and recovery status not reported. Follow up information received on 24/Jan/2006 from a health care provider. Per the reporter, the patient did not follow up with them. He went to his own physician. Illness at the time of vaccination, other medication and pre-existing medical conditions were all unknown. Additional information is not expected.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal behaviour, Amnesia, Anxiety, Chills, Histrionic personality disorder
Clinical narrative: An 83 year old female patient had received an injection (Route and site not reported) of FLUZONE SV '2005-'2006 USP (lot number not reported), on 19/Oct/2005. Per the reported, one to two days later the patient complained of chills. Then 23/Oct/2005 her behavior changed drastically with mental changes and a change in her disposition. The patient suddenly became illogical and had memory loss along with anxiety and paranoia. The reporter described this with an example of the patient asking "Where is my mother in the house?" The patient did not recognize people close to her. The patient was not evaluated by a physician. The reporter states that the patient has had a similar reaction such as this in the past with the use of prednisone. Follow up information received on 15/Dec/2005 from the vaccine provider. Lot number for Fluzone SV 2005-2006 is provided as U1903AA. The vaccine provider is not the patients health care provider. Additional medical information cannot be provided for this patient. The patient is lost to follow up. Further information is not expected.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Mental impairment, Paranoia, Thinking abnormal
Clinical narrative: An 83 year old female patient had received an injection (Route and site not reported) of FLUZONE SV '2005-'2006 USP (lot number not reported), on 19/Oct/2005. Per the reported, one to two days later the patient complained of chills. Then 23/Oct/2005 her behavior changed drastically with mental changes and a change in her disposition. The patient suddenly became illogical and had memory loss along with anxiety and paranoia. The reporter described this with an example of the patient asking "Where is my mother in the house?" The patient did not recognize people close to her. The patient was not evaluated by a physician. The reporter states that the patient has had a similar reaction such as this in the past with the use of prednisone. Follow up information received on 15/Dec/2005 from the vaccine provider. Lot number for Fluzone SV 2005-2006 is provided as U1903AA. The vaccine provider is not the patients health care provider. Additional medical information cannot be provided for this patient. The patient is lost to follow up. Further information is not expected.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Eye irritation, Influenza like illness, Nausea
Clinical narrative: Initial report received on 01 Nov 2005 from a patient. A 53 year old female patient with a medical history of allergy to cats and intravenous iodine developed coughing for 15 minutes and her eyes began to feel gritty and turned blood shot red around 3:00pm following the influenza vaccine (Fluzone SV '2005-'2006) administration on 26 Oct 2005 at 11:00am. It was reported that, by 6:00pm she had a hard time seeing. Lather in the evening, she reported to have flu like symptoms with nausea and feeling weak. She was on prevacid from an unspecified time for gastroesophaeal reflux disease. She went to bed at an unspecified time and next day she was fine. Follow up information received on 27/Mar/2006 from the patient. There was no illness at the time of vaccination, and the patient was on no other medications. Additional information was not provided.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Visual acuity reduced
Clinical narrative: Initial report received on 01 Nov 2005 from a patient. A 53 year old female patient with a medical history of allergy to cats and intravenous iodine developed coughing for 15 minutes and her eyes began to feel gritty and turned blood shot red around 3:00pm following the influenza vaccine (Fluzone SV '2005-'2006) administration on 26 Oct 2005 at 11:00am. It was reported that, by 6:00pm she had a hard time seeing. Lather in the evening, she reported to have flu like symptoms with nausea and feeling weak. She was on prevacid from an unspecified time for gastroesophaeal reflux disease. She went to bed at an unspecified time and next day she was fine. Follow up information received on 27/Mar/2006 from the patient. There was no illness at the time of vaccination, and the patient was on no other medications. Additional information was not provided.
Sex: F
Vaccine: FLU3
Symptoms: Sinus congestion, Urinary tract infection
Clinical narrative: Initial report received on 10 Nov 2005 from a patient. A female patient of no reported age and medical history immediately developed a severe sinus infection and urinary tract infection following flu vaccine at a pharmacy about a week ago. Outcome was not reported.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Nasal congestion, Pulmonary congestion
Clinical narrative: Initial report received on 14-NOV-2005 from a health care professional. A 42-year-old male patient with patient with a medical history of moderate asthma experienced congestion of the sinus and lungs, laryngitis, and felt feverish, 24 hrs following the influenza vaccine (Fluzone SV '2005-'2006) administration in the left deltoid. Signs and symptoms were less than 2 days ago but it still persisted at the time of the report. It was also reported the patient had dark sputum and he was not recovered at the time of the report. Patient was receiving yearly vaccination with the same vaccine since an unspecified time. Follow-up information received on 12/Jun/2006 from the patient. At the time of this report, the patient had recovered.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Initial report received on 21-NOV-2005 from a patient in USA. A 50-year-old male patient with no reported medical history but ongoing head cold or sinus infection experienced injection site pain within an hour following influenza vaccine (Fluzone SV '2005-'2006), lot no: U1865AA administration in the right deltoid. He had received the one dose of the same vaccine previously at an unspecified time. He has pain in the shoulder joint and when he sleeps with his arm over his head, after these 2 and half weeks sore, dull pain in the right shoulder. The patient was not recovered at the time of the report.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint stiffness, Laboratory test abnormal, Oedema peripheral
Clinical narrative: Initial report received on 08-DEC-2005 from a patient in USA. A 41-year-old female patient with a medical history of no known allergies, increased cholesterol and asthma woke up with pain and stiffness in her fingers and joints bilaterally, i.e. approximately 2 days after the influenza vaccine (Fluzone SV '2005-'2006), lot no.: U1804AA administration in the left deltoid on 11-Oct-2005. Also she had some pain in the inner side of her elbows. Additionally, she complained of a "travelling pain" in her lower back, wrist and achilles tendon area bilaterally. The laboratory tests performed at an unspecified time revealed mycoplasma pneumonia elevated. Pain continues to persist. Patient also stated that her left middle finger appears swollen at the joint at the time of the report. Outcome was not reported. Of note that, the patient was taking Lipitor and Zyrtec occasionally.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a consumer concerning her 20 year old daughter who on 02-OCT-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. The patient experienced dizziness for a short period of time after the vaccination. Medical attention was sought. It was reported that the patient has a fear of needles and that may have been a causal factor. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a consumer concerning her 20 year old daughter who on 02-OCT-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. The patient experienced dizziness for a short period of time after the vaccination. Medical attention was sought. It was reported that the patient has a fear of needles and that may have been a causal factor. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acne, Rash
Clinical narrative: Information has been received from a health professional concerning a 21 year old Caucasian female with no known allergies who on 11-OCT-2006 at 9:00 was vaccinated with a first dose of HPV rL1 6 11 15 18 VLP vaccine (yeast), intramuscularly in the deltoid. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN). On 11-OCT-2006 at 9:00 a.m. the patient experienced "face/neck rash, pimple like stinging." It was reported to be unknown if the patient recovered.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain, Rash
Clinical narrative: Information has been received from a health professional concerning a 21 year old Caucasian female with no known allergies who on 11-OCT-2006 at 9:00 was vaccinated with a first dose of HPV rL1 6 11 15 18 VLP vaccine (yeast), intramuscularly in the deltoid. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN). On 11-OCT-2006 at 9:00 a.m. the patient experienced "face/neck rash, pimple like stinging." It was reported to be unknown if the patient recovered.
Age: 1.03
Sex: F
Vaccine: FLU3, HEPA, HIBV, VARZOS, VARZOS
Symptoms: Medication error
Clinical narrative: Information has been received from a nurse concerning a 12 month old female who on 17-OCT-2006 was accidentally vaccinated with a 0.5 mL sc dose of varicella-zoster virus vaccine live instead of a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (MSD). The patient was asymptomatic at the time of the report. Additional information has been received from a health professional who reported that the patient was fine and had no reported adverse experiences. The reporter believed that the error occurred likely due to the fact that both vaccines were stored in the freezer and that the vials looked very similar. She noted that although the vial caps were color-coded and different for each vaccine, this was not readily or easily seen upon first glance. She added that it would be very helpful if the actual boxes containing the vaccines were different colors or somehow very distinct from each other. She felt that in general, the vaccine boxes were all very similar. The patient's sister was also inadvertently vaccinated with varicella-zoster virus vaccine live (WAES 0610USA10818). This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a nurse concerning a 12-month-old female who on 17-OCT-2006 was accidentally vaccinated with a 0.5 mL SC dose of ZOSTAVAX (Merck) (lot # 652936/0981F) instead of a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Merck upgrade process) (MSD). The patient was asymptomatic at the time of the report. Additional information has been received from a health professional who reported that the patient was fine and had no reported adverse experiences and no chickenpox rash was noted. The reporter believed that the error occurred likely due to the fact that both vaccines were stored in the freezer and that the vials looked very similar. She noted that although that the vial caps were color-coded and different for each vaccine, this was not readily or easily seen upon first glance. She added that it would be very helpful if the actual boxes containing the vaccines were different colors or somehow very distinct from each other. She felt that in general, the vaccines boxes were all very similar. The patient's sister was also inadvertently vaccinated with ZOSTAVAX vaccine (Merck) (WAES # 0610USA10818).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARZOS, DTAP, VARZOS
Symptoms: Medication error
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female who on 17 Oct 2006 was accidentally vaccinated with a .5mL SC dose varicella-zoster virus vaccine live instead of a dose of measles virus vaccine live. mumps virus vaccine live + rubella virus vaccine live + varicella virus vaccine live.  Concomitant vaccination on the same day included a dose of diphtheria toxoid + pertusissis acellular 5-component vaccine + tetanus toxoid.  The patient was asymptomatic at the time of the report.  Additional information has been received from health professional who reported that the patient was fine and had no reported adverse experiences.  The reporter believed that the error occurred likely due to the fact that both vaccines were stored in the freezer and that the vials looked very similar.  She noted that although the via caps were color-coded and different for each vaccine, this was not readily or easily seen upon first glance.  She added that it would be very helpful if the actual boxes containing the vaccines were different colors or somehow very distinct from each other. She felt that in general, the vaccine boxes were all very similar.  Follow-up information was received from the registered nurse who indicated that on the day after vaccination, 18 Oct 2006, the patient developed a fever of 102 which resolved in the afternoon of the same day.  At the time of the report, the patient was fine, had no injection site reactions and no chicken pox rash was noted.  The patient's sister was also inadvertently vaccinated with varicella-zoster virus vaccine live.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARZOS, DTAP, VARZOS
Symptoms: Medication error, Pyrexia, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female who on 17 Oct 2006 was accidentally vaccinated with a .5mL SC dose varicella-zoster virus vaccine live instead of a dose of measles virus vaccine live. mumps virus vaccine live + rubella virus vaccine live + varicella virus vaccine live.  Concomitant vaccination on the same day included a dose of diphtheria toxoid + pertusissis acellular 5-component vaccine + tetanus toxoid.  The patient was asymptomatic at the time of the report.  Additional information has been received from health professional who reported that the patient was fine and had no reported adverse experiences.  The reporter believed that the error occurred likely due to the fact that both vaccines were stored in the freezer and that the vials looked very similar.  She noted that although the via caps were color-coded and different for each vaccine, this was not readily or easily seen upon first glance.  She added that it would be very helpful if the actual boxes containing the vaccines were different colors or somehow very distinct from each other. She felt that in general, the vaccine boxes were all very similar.  Follow-up information was received from the registered nurse who indicated that on the day after vaccination, 18 Oct 2006, the patient developed a fever of 102 which resolved in the afternoon of the same day.  At the time of the report, the patient was fine, had no injection site reactions and no chicken pox rash was noted.  The patient's sister was also inadvertently vaccinated with varicella-zoster virus vaccine live.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, DTAP, HPV4
Symptoms: Blister, Eosinophil count increased, Herpes simplex, Herpes simplex serology negative, Lip swelling
Clinical narrative: Information has been received from a business manager in a physicians office concerning a 15 year old female who on 16 Oct 2006 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine.  Concomitant therapy that day included diphtheria toxoid + pertussis acellular vaccine + tetanus toxoid. Subsequently, the patient experienced an allergic reaction, her face and body began to swell. The physician recommended the patient take an unspecified dose of diphenhydramine hydrochloride (Benadryl). After taking diphenhydramine hydrochloride the patients face and body swelling "went down". On 20 Oct 2006 it was reported that "the swelling became worse again".  At the time of this report the patient had not recovered from the event.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, DTAP, HPV4
Symptoms: Swelling face
Clinical narrative: Information has been received from a business manager in a physicians office concerning a 15 year old female who on 16 Oct 2006 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine.  Concomitant therapy that day included diphtheria toxoid + pertussis acellular vaccine + tetanus toxoid. Subsequently, the patient experienced an allergic reaction, her face and body began to swell. The physician recommended the patient take an unspecified dose of diphenhydramine hydrochloride (Benadryl). After taking diphenhydramine hydrochloride the patients face and body swelling "went down". On 20 Oct 2006 it was reported that "the swelling became worse again".  At the time of this report the patient had not recovered from the event.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, DTAP, HPV4
Symptoms: Hypersensitivity, Swelling
Clinical narrative: Information has been received from a business manager in a physicians office concerning a 15 year old female who on 16 Oct 2006 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine.  Concomitant therapy that day included diphtheria toxoid + pertussis acellular vaccine + tetanus toxoid. Subsequently, the patient experienced an allergic reaction, her face and body began to swell. The physician recommended the patient take an unspecified dose of diphenhydramine hydrochloride (Benadryl). After taking diphenhydramine hydrochloride the patients face and body swelling "went down". On 20 Oct 2006 it was reported that "the swelling became worse again".  At the time of this report the patient had not recovered from the event.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Injection site reaction, Pruritus, Thermal burn
Clinical narrative: Information has been received from a consumer concerning her 22 year old female with sulfa drug allergy and a history of depression, panic disorder, an "interstitial distritis" who on 09 Oct 2006 was vaccinated with first injection of HPV rL1 6 11 16 18 VLP vaccine 0.5ml "vial" injection. Concomitant therapy included venlafazine HC1 and drospirenone + ethinyl estradiol.  On 16 Oct 2006, after being administered the first injection shot in the series of HPV rL1 6 11 16 18 VLP vaccine, her daughter experienced "swelling at the injection site, and a red raised, hot area at the injection site as well as a headache, and a low grade fever of 99 degrees".  Medical attention was sought. No laboratory studies were performed. At the time of reporting, the patient had not recovered.  No other information was provided at the time of reporting.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a consumer concerning her 22 year old female with sulfa drug allergy and a history of depression, panic disorder, an "interstitial distritis" who on 09 Oct 2006 was vaccinated with first injection of HPV rL1 6 11 16 18 VLP vaccine 0.5ml "vial" injection. Concomitant therapy included venlafazine HC1 and drospirenone + ethinyl estradiol.  On 16 Oct 2006, after being administered the first injection shot in the series of HPV rL1 6 11 16 18 VLP vaccine, her daughter experienced "swelling at the injection site, and a red raised, hot area at the injection site as well as a headache, and a low grade fever of 99 degrees".  Medical attention was sought. No laboratory studies were performed. At the time of reporting, the patient had not recovered.  No other information was provided at the time of reporting.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 22 year old female with sulfa drug allergy and a history of depression, panic disorder, an "interstitial distritis" who on 09 Oct 2006 was vaccinated with first injection of HPV rL1 6 11 16 18 VLP vaccine 0.5ml "vial" injection. Concomitant therapy included venlafazine HC1 and drospirenone + ethinyl estradiol.  On 16 Oct 2006, after being administered the first injection shot in the series of HPV rL1 6 11 16 18 VLP vaccine, her daughter experienced "swelling at the injection site, and a red raised, hot area at the injection site as well as a headache, and a low grade fever of 99 degrees".  Medical attention was sought. No laboratory studies were performed. At the time of reporting, the patient had not recovered.  No other information was provided at the time of reporting.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 21 year old female with an allergy to penicillin who was receiving contraceptive therapy, who on 06-OCT-2006 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 mL). Concomitant therapy included ethinyl estradiol/norethindrone acetate (ESTROSTEP). On 07-OCT-2006 or 08-OCT-2006 the patient experienced nausea and vomiting. Unspecified medical attention was sought. Subsequently, the patient recovered from the nausea and vomiting. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 21 year old female with an allergy to penicillin who was receiving contraceptive therapy, who on 06-OCT-2006 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 mL). Concomitant therapy included ethinyl estradiol/norethindrone acetate (ESTROSTEP). On 07-OCT-2006 or 08-OCT-2006 the patient experienced nausea and vomiting. Unspecified medical attention was sought. Subsequently, the patient recovered from the nausea and vomiting. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL, MER, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Rash after Varivax.
Age: 7.0
Sex: M
Vaccine: VARCEL, MER, VARCEL
Symptoms: Rash, Vaccination complication
Clinical narrative: Rash after Varivax.
Age: 0.17
Sex: M
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 2-month-old male with no medical history who on 29-AUG-2006 was vaccinated PO with a dose of ROTATEQ (lot # 654247/0600F). Concomitant vaccinations administered on that same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of COMVAX, a dose of poliovirus vaccine inactivated (unspecified) and a dose of PREVNAR. The CMA reported that on 29-AUG-2006, within a few minutes of receiving ROTATEQ, the patient began vomiting which lasted throughout the night. Unspecified medical attention was sought and no laboratory / diagnostic tests were performed. On 30-AUG-2006, the patient's vomiting resolved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006.  Information has been received from a certified medical assistant (CMA) concerning an 8-week-old male with no medical history who on 29-AUG-2006, at 1400, was vaccinated PO with the first dose of ROTATEQ (Lot # 654247/0600F).  There was no illness at the time of vaccination.  Concomitant vaccinations administered on that same day included a dose of DTAP (unspecified), a dose of COMVAX, a dose of poliovirus vaccine inactivated (unspecified) and a dose of PREVNAR.  The CMA reported that on 29-AUG-2006, within a few minutes of receiving ROTATEQ, the patient began vomiting which lasted throughout the night.  The patient was noted to have vomited a total of 5-6 times.  Unspecified medical attention was sought and no laboratory/diagnostic tests were performed.  On 30-AUG-2006, the patient's vomiting resolved.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Disorientation, Dizziness, Dyspnoea, Nausea, Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on 30-OCT-2006 was vaccinated IM with her first dose of GARDASIL, lot #653978/0955F. Immediately after receiving the vaccination the patient fainted. She was sent to the emergency room, where it was determined she had fainted "due to nervousness over the needle." The patient recovered "a few hours" after the vaccination. There was no product quality complaint involved. Additional information has been requested. 01/05/2007 Follow up information has been received from a healthcare worker and an emergency room physician concerning the 17 year old female (previously reported as 18) student with no medical history who on 30-OCT-2006 at 2:58 p.m. received her first dose of GARDASIL, lot #653978/0955F, in the left deltoid. The ER physician reported that on the way back to the waiting room, she felt very lightheaded. She sat down, did not feel well at all and then had an episode of syncope. She did not fall or injure anything. She woke up when she became horizontal. She felt fine in the ER. Her supine blood pressure was 105/50 with a pulse of 74. Standing up, it was 108/60 with a heart rate of 84. The ER physician's impression was that the patient probably had a vasovagal reaction to her injection. She was asked to return immediately if she has any recurrence of these signs or symptoms. He did not feel laboratory testing was indicated for this isolated incident of vasovagal syncope. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Syncope vasovagal
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on 30-OCT-2006 was vaccinated IM with her first dose of GARDASIL, lot #653978/0955F. Immediately after receiving the vaccination the patient fainted. She was sent to the emergency room, where it was determined she had fainted "due to nervousness over the needle." The patient recovered "a few hours" after the vaccination. There was no product quality complaint involved. Additional information has been requested. 01/05/2007 Follow up information has been received from a healthcare worker and an emergency room physician concerning the 17 year old female (previously reported as 18) student with no medical history who on 30-OCT-2006 at 2:58 p.m. received her first dose of GARDASIL, lot #653978/0955F, in the left deltoid. The ER physician reported that on the way back to the waiting room, she felt very lightheaded. She sat down, did not feel well at all and then had an episode of syncope. She did not fall or injure anything. She woke up when she became horizontal. She felt fine in the ER. Her supine blood pressure was 105/50 with a pulse of 74. Standing up, it was 108/60 with a heart rate of 84. The ER physician's impression was that the patient probably had a vasovagal reaction to her injection. She was asked to return immediately if she has any recurrence of these signs or symptoms. He did not feel laboratory testing was indicated for this isolated incident of vasovagal syncope. Additional information is not expected.