chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Wheezing
Clinical narrative: From initial information received on 11/07/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that an 11 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1097AA, administered intra-muscularly in the left deltoid on 11/06/2003.  Immediately after receiving the vaccination, the patient developed wheezing and numbness in the left arm down to the wrist.  Treatment included Albuterol via hand held nebulizer.  The symptoms resolved within 15 minutes and the patient was observed for 45 minutes.  The patient was to follow up with an allergist.  The patient recovered from these events.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Raynaud's phenomenon
Clinical narrative: From initial information received on 11/10/2003 from a physician regarding an adverse event occurring in the USA, it was reported that a 5 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1131AA, administered intra-muscularly in the right deltoid on 10/23/2003.  48 hours later, the patient developed Raynauds of both feet and hands.  The patient has a history of egg allergy which reportedly resolved.  At the time of this report ANA, metabolic panel and thyroid testing had been completed (no results provided) and the patient was continuing to undergo tests to determine etiology.  Reportedly, the patient did not recover from this event.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Muscular weakness
Clinical narrative: From initial information received on 11/10/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 25 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1255AA, administered in the left deltoid (route of administration not reported) on 11/06/2003 at 3:20PM.  Approximately six hours later, the patient developed a fever with a temperature of 101 degrees Fahrenheit.  She had chills and felt cold, weak and was shaky.  Both of her arms were red from the shoulder to the wrist area.  The patient took Tylenol and went to sleep.  She awok in the morning with continued weakness and arm redness.  The reporter spoke with the patient on 11/10/2003 and the symptoms were gone.  The patient recovered from these events. From additional information received on 12/11/2003 from a nurse.  It was reported that the patient received the vaccine intra-muscularly in the left deltoid.  Other medications during vaccination included multivitamin.  The patient has previously received the influenza vaccine without any indicents.  There were no diagnostic tests performed.  The patient's medical history includes dizziness.  Otherwise the patient is healthy and has not allergies.  No other information was provided at this time.  No further information is anticipated, this case is considered closed.
Age: 1.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: From initial information received on 11/11/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a one year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1095AA, administered intra-muscularly in the right thigh on 11/07/2003.  30 minutes later, the patient developed a generalized rash.  Oral Benadryl was given and the reaction was gone within one hour.  The patient recovered from  this event.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Pain
Clinical narrative: From initial information received on 11/12/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that 19 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number not reported, administered in her deltoid (route of administration not reported), on an unspecified date.  According to patient's mother, the patient complained of arm pain beginning the evening of injection.  The arm pain has resolved, but shoulder pain persists.  The patient's primary care physician made a diagnosis of bursitis.  Reportedly, the patient did not recover from these events.  No other information was provided at this time. Follow up VAERS form received on 02/23/2004.  No additional information was provided. No further information is anticipated, this case is considered closed.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Feeling hot, Injection site pain, Injection site swelling
Clinical narrative: From initial information received on 11//11/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 56 year old female patient received a dose of Fluzone SV '2003-2004' USP, lot number U1139AA, administered intra-muscularly in the left deltoid on 11/11/2003 at 10:00AM.  One hour and 15 minutes later, the patient developed local tenderness and swelling at the site, which measured approximately 7 to 10 cm in diameter.  The site was very warm.  The patient also complained of dizziness.  She denied shortness of breath initially after receiving the vaccine, but complained of it three hours later.  The patient used an inhaler, which relieved the symptoms.  At the time of this report the patient had not recovered.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Face oedema, Pruritus, Rash
Clinical narrative: Swelling of face Rash Itching From initial information received on 11/17/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 46 year old male patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1095AA, administered intra-muscularly in the right deltoid on 10/11/2003. Within one hour of vaccination, the patient developed facial swelling, itching and rash on the upper trunk and face. Reportedly, the patient did not recover from these events. It was reported that the patient is allergic to the flu vaccine. From additional information received on 02/25/2004 from the initial reporter, it was reported that the patient did not receive any other vaccines within four weeks of receiving FLUZONE SV '2003-"2004 USP. Reportedly, the patient recovered from these events. No further information is anticipated, this case is considered closed.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dizziness, Dyspnoea, Injection site erythema, Myalgia
Clinical narrative: Shortness of breath Chest pain Dizziness Generalized rash Muscle pain From initial information received on 11/20/2003 from a registered nurse regarding an adverse event occurring in the U.S.A., it was reported that a 38 year old female patient, after having had an unspecified reaction to the 'flu vaccine' the previous year, received FLUZONE SV '2003-'2004 USP in two 0.25 ml. split doses. She received the first dose, lot number not reported, administered intra-muscularly in the left deltoid on 10/24/2003. Sometime after the first injection, the patient developed local redness and tenderness at the injection site. The patient received her second dose, lot number U1089AA, administered intra-muscularly in the left deltoid on 11/07/2003. Three days after receiving the second dose, on 11/10/2003, the patient complained of shortness of breath, chest pain, muscle pain in her left arm, dizziness and generalized red rash. The patient was evaluated by a doctor. The reporter stated that the condition has resolved, but she unsure of the exact timing of the events.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Tenderness
Clinical narrative: Shortness of breath Chest pain Dizziness Generalized rash Muscle pain From initial information received on 11/20/2003 from a registered nurse regarding an adverse event occurring in the U.S.A., it was reported that a 38 year old female patient, after having had an unspecified reaction to the 'flu vaccine' the previous year, received FLUZONE SV '2003-'2004 USP in two 0.25 ml. split doses. She received the first dose, lot number not reported, administered intra-muscularly in the left deltoid on 10/24/2003. Sometime after the first injection, the patient developed local redness and tenderness at the injection site. The patient received her second dose, lot number U1089AA, administered intra-muscularly in the left deltoid on 11/07/2003. Three days after receiving the second dose, on 11/10/2003, the patient complained of shortness of breath, chest pain, muscle pain in her left arm, dizziness and generalized red rash. The patient was evaluated by a doctor. The reporter stated that the condition has resolved, but she unsure of the exact timing of the events.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pain, Pyrexia, Urticaria
Clinical narrative: Ache Fever Shortness of breath Hives From initial information received on 11/21/2003 from a health care professional, regarding an adverse event occurring in U.S.A., it was reported that a 45 year old female patient received FLUZONE SV '2003-'2004 USP, lot number U1139AA, administered intramuscularly in the left deltoid on 10/14/2003. The next day, on 10/15/2003, the patient developed a fever of 102 degrees Fahrenheit, shortness of breath and body aches. The patient took Advil and was fine. On 10/18/2003, the patient developed hives, but was already on Claritin. The patient informed the office on 10/27/2003 that the hives resolved on an unspecified date. The patient has recovered from these events.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Pallor, Throat tightness
Clinical narrative: Throat tightness Diaphoresis Pale From initial information received on 12/01/2003 from a physician regarding an adverse event occurring in the USA, it was reported that a ten year old male patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1098AA, route and site of administration not reported, on 11/29/2003. Within ten minutes after vaccination, the patient developed diaphoresis, pale color and felt like his throat was closing. No shortness of breath. The symptoms resolved before paramedics arrived. The patient's pre-existing medical history includes migraines, headaches and ADD. At the time of vaccination he was also taking Concerta. Reportedly, the patient recovered from these events. From additional information received on 04/27/2004 from the initial reporter, the patient's full name was provided. It was reported that the patient experienced symptoms approximately five minutes after vaccination. Reportedly, the patient was vaccinated at a private doctor's office/hospital. No further information is anticipated, this case is considered closed.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Stomach pain Vomiting From initial information received on 03/Dec/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a three-year-old male patient received his first dose of Fluzone SV 2003-2004 USP, lot number U1092AA, administered intra-muscularly (site not reported) on the afternoon of 02/dec/2003.  That evening, the child developed severe stomach pain and vomiting.  At the time of this report, the symptoms were still persisting.  The patient's pas medical history is significant for asthma and egg allergy.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Pain, Vomiting
Clinical narrative: Vomiting, Diarrhea, Ache, Nausea From initial information received on 10/Dec/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 31-year-old male patient received a dose of Fluzone SV 2003-2004 USP, lot number U1123AA, administered intra-muscularly in the deltoid and a PPD test ( lot number, manufacturer, route and site of adminstration not reported) on 08/Dec/2003 at noon.  The patient had also received a HEPATTIS A vaccine (lot number, manufacturer, route and site of administration not reported) within four weeks of receiving the products given on 08/Dec/2003.  On 09/Dec/2003 at 4:00 am, the patient developed nausea, vomiting, diarrhea and complained of body aches.  The patient's recovery status is currently unknown.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain
Clinical narrative: Pain in arm From initial information received on 11/Dec/2003 from the patient, who is a nurse, regarding an adverse event occurring in U. S. A., it was reported that the 30-year-old female received a first dose of Fluzone SV 2003-2004 USP, lot number not reported, administered in the deltoid on 08/Dec/2003.  Within several hours (also reported as onset date of 10/Dec/2003), the patient developed arm soreness, which was described as becoming "very painful and tender with pain down the arm".  The patient reported that she took Advil for her symptoms.  Reportedly, the patient did not recover from thses events.  No other information was provided.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Difficulty in walking, Joint swelling, Pyrexia
Clinical narrative: From initial information received on 12/12/03 from the patient's father who is a physician regarding an adverse event occurring in the USA, it was reported that a 16 year old female patient received her first dose of FLUZONE, lot number U1076AA, administered IM in the left deltoid on 12/7/03. One day later, the patient developed joint swelling, difficulty ambulating, and a low grade fever. There was no nausea, vomiting, or diarrhea. No hematuria. At the time of vaccination, the patient also took contraceptives. Her pre-existing medical history includes allergies to horses, feathers, and cats. Otherwise, no medical conditions. The patient was treated with non-steroidal medications. Reportedly, the patient is feeling better, but is still sore.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: From initial information received on 15Dec03 from a physician regarding an adverse event occurring, it was reported that a 12 year old female pt received a dose of Fluzone SV 2003-2004 USP, lot number U1127AA, administered IM in the right deltoid on 12Dec03. Within 24 hours, the pt developed a fever of 105 degrees F and flu like symptoms. The pt was given Tamiflu and Tylenol as treatment. Reportedly, she recovered from these events. The reporter of this case is the same reporter of case 2003-03399.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: From initial information received on 15Dec03 from a health care professional regarding and adverse event occurring, it was reported that a four year old female pt received a dose of Fluzone SV 2003-2004 USP, lot number U1127AA, administered IM in the right side of an unspecified site on 12Dec03. Within 24 hours the pt developed a fever of 103 Degrees F and flu-like symptoms, which resolved after being treated with Motrin. The pt recovered from these events. The reporter of this case is the same reporter of case 2003 03398.
Age: 0.97
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: From initial information received on 18Dec03 from a nurse regarding an adverse event occurring, it was reported that an 11 month old male pt received his first dose of Fluzone SV 2003-2004 USP, lot number U1111AA, administered IM in the left thigh on 17Dec03. The reporter received a voice mail from the pt's mother stating that on either 17Dec03 or 18Dec03, the pt developed rash on his head, shoulders and diaper area. The pt's recovery status was not reported. No other information was provided at this time.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: From initial information received on 19Dec03 from manufacturer, regarding an adverse event occurring, it was reported by a physician that a 46 year old female pt received a dose of Fluzone SV 2003-2004 USP on an unspecified date. Sometime later, the pt developed lump at the injection site. The pt recovery status was not reported. From additional information received on 30Jan04, from another manufacturer (no reference number provided), it was reported by the pt's physician that the pt experienced a swollen arm one day after receiving the injection. The specific vaccination date was not provided. The physician reported that the pt called the office and stated that she had to take pain medication because of the swollen arm. The pt's recovery status was not provided. The adverse event coding for this case was updated to include arm swelling and injection site pain. Further information is not anticipated, this case is considered closed.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pharyngitis, Rhinitis, Tinnitus, Vaccine positive rechallenge
Clinical narrative: From initial information received on 22Dec03 from the pt who is a pharmacist, it was reported that the 46 year old male received a Fluzone SV 2003-2004 vaccination lot number U1078AA, administered SC in the left upper arm on 15Oct03. In the fall of 2003, the pt developed a low frequency tinnitus, which he described as being like the rumbling of a distant train. The pt had previously experienced the same symptoms in Nov of 2002 after receiving Fluzone SV 2002-2003 (lot not reported) SC in the left upper arm on 14Oct02. His symptoms had resolved by late summer 2003. He noticed the return of these symptoms following receipt of the influenza vaccine in 2003.The tinnitus is most noticeable in a quiet room or when camping in the wilderness. His symptoms became much worse, described as a throbbing, when pt developed a cold in November of 2003. The pt noted that the tinnitus has mostly resolved, however not completely.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Hypokinesia, Pyrexia, Tonsillitis
Clinical narrative: From initial information received on 05Jan04 from the pt's uncle, who is also a physician, regarding an adverse event occurring, it was reported that a female pt (age and date of
Sex: U
Vaccine: FLU3
Symptoms: Cough, Hypokinesia, Pyrexia, Tonsillitis
Clinical narrative: From initial information received on 05Jan04 from the pt parent, who is also a physician, regarding an adverse event occurring, it was reported that the pt (gender, age and date of birth not reported) received a Fluzone SV 2003-2004 vaccination, lot number U1291AA, administered IM in the thigh on 08Dec03. Three days post vaccination, on 11Dec03, the pt developed a temp of 104 degrees F, tonsillitis, cough and decreased activity. According to the physician 'supportive care' was given. Reportedly the pt recovered from this experience. 10/Aug/2004: No additional information has been obtained from the reporter. Case is closed. The reporter of this case is the same reporter of case numbers 2004-00024, 2004-00027 and 2004-00028.
Sex: U
Vaccine: FLU3
Symptoms: Cough, Hypokinesia, Pyrexia, Tonsillitis
Clinical narrative: From initial information received on 05Jan04 from the pt's parent, who is also a physician, regarding an adverse event occurring, it was reported that the pt (gender, age and date of birth not reported) received of Fluzone SV 2003-2004 vaccination, lot number U1291AA, administered IM in the thigh on 08Dec03. Three days post vaccination, on 11Dec/03, the pt developed a temp of 104 degrees F, tonsillitis, cough and loss of activity. According to the physician supportive care was given. The pt's recovery status was not reported. 10Aug04: No additional information has been obtained from the reporter. Case is closed. The reporter of this case is the same reporter of case number 2004-00024, 2004-00026 and 2004-00028.
Sex: U
Vaccine: FLU3
Symptoms: Cough, Hypokinesia, Pyrexia, Tonsillitis
Clinical narrative: From initial information received on 05Jan04 from the pt's parent, who is also a physician, regarding an adverse event occurring, it was reported that a pt (gender, age and date of birth not specified) received a Fluzone SV 2003-2004 vaccination, lot number U129AA, administered IM in the anterolateral thigh on 08Dec03. Three days post vaccination, on 11Dec03; the pt developed a 104 degree F temp, cough,loss of activity and tonsillitis.  According to the physician the pt received "supportive care".  Reportedly the pt recovered from this experience. 10Aug04: No additional information has been obtained from the reporter. Case is closed. The reporter of this case is the same reporter of case number 2004-00024, 2004-00026 and 2004-00027.
Age: 1.01
Sex: F
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Rash macular, Urticaria
Clinical narrative: From initial information received on 01/20/04, from a health care professional regarding an adverse event occurring in the USA, it was reported that a one year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1145AA, administered in the left thigh as well as a dose of MMR, lot number 0512N, a dose of Varicella, lot number 0579N and a dose of Prevnar, lot number 491178, on 12/23/03. The routes and sites of administration were not reported. On week later, the patient developed eight small red dots located on her head, torso and genitals. Reportedly, the spots may have been hives. The patient's recovery status was not reported. From additional information received on 05/18/04 from the initial reporter, a correction was made to the patient's initials. It was reported that the patient had no illnesses at the time of vaccination and had no relevant past medical history. She required no treatment or evaluation following the adverse event and has had no reoccurrence of the symptoms.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Rash maculo-papular
Clinical narrative: From initial information received on 01/21/04 from a physician, regarding an adverse event occurring in the USA, it was reported that a 34 year old female patient received a Fluzone SV '200-'2004 USP vaccination, lot number not reported, administered intramuscularly on 12/10/03 at 10:00 AM. 12 hours post vaccination the patient developed a maculo-papular rash over her body lasting 12 days. The rash resolved after treatment with Medrol. The patient reportedly did recover from this event. From information received on 05/18/04 from a physician, it was reported that the information has been reviewed and no additional information is available. No further information is anticipated, this case is considered closed.
Sex: F
Vaccine: FLU3
Symptoms: Drug ineffective, Influenza
Clinical narrative: From initial information received on 03/12/04 from another manufacturer, initially reported by the patient, regarding an adverse event occurring in the USA, it was reported that a female patient (age not reported) received a dose of Fluzone SV '203-'2004 USP, lot number unknown, administered intramuscularly in an unspecified site on an unspecified date. Two to three weeks later, the patient developed a flu. The patient went to see a doctor and was told that "2-3 weeks was too soon for her to develop immunity". Reportedly, the patient recovered from this event.
Age: 10.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Injection site pain, Loss of consciousness, Medication error
Clinical narrative: From initial information received on 03/30/04 from a medical clinic, regarding an adverse event occurring in the USA, it was reported that a 10 year old male patient received Daptacel, lot number C1527AA, administered in the right deltoid, and Fluzone SV '2003-'2004 USP, lot number U1129AA, administered in the left deltoid on 03/30/04. The dose of Daptacel was given in error. After the vaccinations, the patient felt ok, went to school, and passed out while waiting in the lunch line. Soreness was noted at the injection site of the Fluzone vaccination. The patient reportedly did recover from this event.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, Injection site pain, Pain
Clinical narrative: From initial information received on 06/11/04 from an registered nurse regarding an adverse event occurring in the USA, it was reported that a 72 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1270AA, administered intramuscularly in the left deltoid on 10/14/03 at 11:00 AM. One week later, on 10/21/03, the patient developed a sore left arm at the site of injection. He was unable to lift the arm over his head and internal rotation of the arm was painful. Treatment included Vioxx 25mg daily, which reportedly helped initially, but the patient is never pain free. The patient has not recovered from these events. From additional information received on 09/07/04 from the initial reporter, it was reported that the number of previous Fluzone doses the patient received is not known. It was also stated that this report was " reviewed, no additional information at this time. "
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Myalgia, Pain
Clinical narrative: From initial information received on 06/21/04 from the patient regarding an adverse event occurring in the USA, it was reported that the 57 year old female patient received a Fluzone SV '2003-'2004 vaccination, lot number U1269AA, administered intra muscularly in the left arm on 10/11/03. The patient stated that within 24 hours post vaccination, on 10/12/03, she developed muscle aches and pain in her arms, thighs and lower back. She was seen by an orthopedic physician, a chiropractor and a rheumatologist and was diagnosed with polymyalgia. Treatment included oral prednisone and cortisone injections into her left shoulder. The patient had not recovered from these events at the time of this report. From additional information received on 08/04/04 from the responsible physician, it was reported that there is no additional information at this time. It was not reported whether the patient recovered from these events.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Lethargy, Pyrexia
Clinical narrative: From initial information received on 09/03/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 18 month old male patient received Fluzone SV '2003-'2004 USP pediatric dose vaccination and a Tripedia vaccination on 08/31/04. The lot numbers, route and site of administration are unknown. Reportedly the next day the patient developed a fever and was lethargic. The patient's recovery status is currently unknown.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Myalgia, Night sweats, Pyrexia
Clinical narrative: From initial information received on 10/28/03 from the patient regarding an adverse event occurring in the USA, it was reported that the 62 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1090AA, administered in the left deltoid ( route of administration not reported) on 10/04/03. Within 24 hours, the patient developed fever, night sweats, chills, muscle aches and persisting weakness. The patient had lymphocytic leukemia at the time of vaccination. The patient's recovery status is unknown.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: From initial information received on 11/03/03 from a consumer, regarding an adverse event occurring in the USA, it was reported that the 70 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1069AA, administered intramuscularly in the right deltoid on 10/22/03. Within one hour of vaccination, the patient noticed soreness underneath her arm. She reported that the pain was fairly close to the axillary area. The patient denied any redness, lumps, numbness or tingling. She stated that she had no limitations in mobility. The patient recovered from this event on an unspecified date.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Laryngitis, Nasal congestion, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: From initial information received on 11/19/03 from the patient regarding an adverse event occurring in the USA, it was reported that the 54 year old female patient received a dose of Fluzone SV '2003-2004 USP, lot number U1139AA, administered intramuscularly in her deltoid on 10/09/03. Three to four days after vaccination, the patient developed a severe sore throat, congestion, laryngitis and a temperature of 101 degrees Fahrenheit. She was seen by a physician and treated with antibiotics. The symptoms lasted two weeks and the patient recovered.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Penis disorder, Pruritus, Urticaria
Clinical narrative: From initial information received on November 21, 2003 from a consumer regarding an adverse event occurring in USA, it was reported that a 74 year old male patient received Fluzone SV '2003-2004' USP, lot number U12699AA, administered intramuscularly in the left arm on October 13, 2003.  The next morning on October 14, 2003, the patient stated that he had developed hives on his torso, itching and his penis was "full of fluid".  He was seen by a physician on an unspecified date.  The recovery status of the patient is unknown.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Dyspnoea, Lacrimation increased, Malaise, Nasal congestion
Clinical narrative: From initial information received on 11/03/03 from the patient regarding and adverse event occurring in the USA, it was reported that the 71 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number not reported, administered intramuscularly in the left deltoid and a dose of Pneumovax administered in the right are ( lot number and route of administration not reported), on 11/28/03 at approximately 9:00 AM. Two hours later, the patient developed itching throughout her body, but denied rash or hives. She was also afraid that she "wasn't going to be able to take another breath" and developed respiratory symptoms such as nasal congestion and watering eyes. The patient also felt weak and lousy. She still complains of symptoms and has not recovered. On 12/09/03 the lot number for the product was provided via e-mail. The lot number for Fluzone SV '2003-'2004 USP was U1133AA and for Pneumovax 0986N. No other information was provided at this time.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus
Clinical narrative: From initial information received on 11/03/03 from the patient regarding and adverse event occurring in the USA, it was reported that the 71 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number not reported, administered intramuscularly in the left deltoid and a dose of Pneumovax administered in the right are ( lot number and route of administration not reported), on 11/28/03 at approximately 9:00 AM. Two hours later, the patient developed itching throughout her body, but denied rash or hives. She was also afraid that she "wasn't going to be able to take another breath" and developed respiratory symptoms such as nasal congestion and watering eyes. The patient also felt weak and lousy. She still complains of symptoms and has not recovered. On 12/09/03 the lot number for the product was provided via e-mail. The lot number for Fluzone SV '2003-'2004 USP was U1133AA and for Pneumovax 0986N. No other information was provided at this time.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site vesicles
Clinical narrative: From initial information received on 12/05/2003 from the patient regarding an adverse event occurring in the U.S.A., it was reported that the 32 year old female patient received a dose of the FLUZONE SV '2003-'2004 USP, lot number U1087AA administered at 5:00 PM on 11/25/2003. Expiration date of the product is 01/30/2004. The route and site of administration were not reported. 21 hours later, the patient developed blisters at the site of injection. The patient's pre-existing medical conditions include allergies to codeine. Her concomitant medications include Eskalith, Lamictal, Tri-Norinyl and Wellbutrin. Reportedly, the patient recovered from this event.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Skin discolouration
Clinical narrative: From initial information received on 12/16/2003 from the patient regarding an adverse event occurring in the USA, it was reported that 66 year old female patient received a dose of FLUZONE SV '2002-'2003 USP, no other vaccine information provided, in November of 2002. Almost immediately after receiving the shot, the patient experienced intense itching and redness at the site of injection lasting two weeks. The patient also reported that the site was hot and there was some induration. Reportedly, the redness faded to a pink area and the discoloration continued for at least another week. The patient treated the symptoms with antihistamine tablets, Lanacane and Allegra. She has received the flu shot for many years ("probably more than 40") and has no recollection of ever having a reaction. The patient also stated that she has eaten eggs many times before and since receiving the shot and she has had no adverse reaction. Reportedly, the patient recovered from these events.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Myalgia, Pain
Clinical narrative: From initial information received on 2/9/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 50 year old female patient received her first dose of FLUZONE, lot number U1253AA, administered IM in the right arm on an unspecified day in November of 2003. That evening, the patient experienced soreness in her arm, which she described as a consistent ache that is sharp upon movement. Reportedly, the soreness persists. The patient also claimed to have a limited range of motion, but denied numbness or tingling. At the time of vaccination, the patient also took Premarin. Reportedly, the patient did not recover from this event.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Ear pain, Feeling cold, Headache, Nausea
Clinical narrative: From initial information received on 2/24/04 from the patient's parent regarding an adverse event occurring in the USA, it was reported that a nine year old female patient received a Fluzone vaccination, lot number and route and site of administration unknown, on 12/3/03. Two days later, on 12/5/03, the patient experienced constant nausea, lightheadedness when standing, feeling of being cold all the time, ear pain, throat pain, and headaches. At the time of this report, the patient had not recovered from these events.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngolaryngeal pain
Clinical narrative: From initial information received on 2/24/04 from the patient's parent regarding an adverse event occurring in the USA, it was reported that a nine year old female patient received a Fluzone vaccination, lot number and route and site of administration unknown, on 12/3/03. Two days later, on 12/5/03, the patient experienced constant nausea, lightheadedness when standing, feeling of being cold all the time, ear pain, throat pain, and headaches. At the time of this report, the patient had not recovered from these events.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Diabetes mellitus, Polyuria, Thirst, Weight decreased
Clinical narrative: From initial information received on 3/3/04 from the patient, regarding an adverse event occurring in the USA, it was reported that a 23 year old male patient received FLUZONE, lot number U1143AA, administered on 11/4/03. By 11/11/03, the patient developed polyuria and extreme thirst. Not recognizing these symptoms, the patient slowly lost 20-25 pounds before seeing a physician on 2/3/04. The physician diagnosed him as a diabetic and on 2/12/04 it was verified he has Type I Diabetes. He now requires insulin shots and continual blood glucose monitoring. This was the first flu shot that the patient ever received. He had no concurrent vaccinations, and he was not taking any medications at the time. He reports that he was not ill at the time of vaccination, or anytime near 11/4/03. The patient reportedly has not recovered from this event.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Difficulty in walking, Injection site swelling, Pyrexia
Clinical narrative: From initial information received on 4/15/04 from the patient's mother regarding an adverse event occurring in the USA, it was reported that a three year old female patient received a dose of FLUZONE, lot number U0904CA, administered in the thigh on 10/16/02 in the AM. Later that day, the patient experienced swelling at the injection site, difficulty walking and a fever of 101 degrees F. Her past medical history is significant for autoimmune hemolytic anemia, juvenile arthritis and many food allergies, including an allergy to eggs. Her concomitant medications included steroids. Reportedly, the patient recovered from these events.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: From initial information received on 11/12/03 from the patient's parent regarding an adverse event occurring in the USA, it was reported that a 12 year old female patient received a dose of FLUZONE, lot number not reported, administered on 11/10/03 at 6:00 PM (route and site of administration not reported). The next morning, the patient developed pain and swelling around the site of injection. The child missed school on 11/12/03. The patient's recovery status was not reported. No additional information was not received at this time.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Myalgia
Clinical narrative: Form initial information received on 18NOV2003 form the patient's wife regarding an adverse event occurring in the USA , it was reported that a 64 year old male patient received a dose of FLUZONE SV 2003-2004 USP and a dose of Pneumococcal Vaccine on 9OCT2003. The following day, the patient developed muscle aches and pains that have gotten progressively worse since the onset date. The patient was evaluated by six doctors including an internist, pulmonologist, gastroenterologist, neurologist, cardiologist, and rheumatologist. There is no confirmed diagnosis. The patient's blood work revealed elevated WBC and elevated CPK. An echocardiogram, muscle function testing, chest x ray, EMG and autoimmune tests were all normal. At the time of this report, the patient had nor recovered.
Age: 46.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Anxiety, Restlessness, Urticaria
Clinical narrative: This is a non-serious spontaneous case from a physician in the USA reporting a patient developed HIVES. The reporter causality between events and FluMist is not provided. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. A 46 year old female developed hives under arms, abdominal pain, became restless and felt anxious after receiving FluMist. On 10DEC04, the patient received FluMist along with three allergy shots. She left the doctor's office and after five minutes became anxious and drove back to the physician's office. Her vital signs were within normal limits but she was restless with abdominal pain. She also had hives under her arms, which were not diffuse, within one hour of Flumist vaccination. There were no respiratory symptoms or swelling. The patient took benadryl before going to the ER. She as treated at the ER with solumedrol and IV fluids after which she was released. The patient has recovered from all events. The patient has a history of allergies but not to eggs and receives allergy desensitization shots in the reporting physician's office. The reporting physician feels that in the future, vaccine and allergy shots should be separated. The reporter determined the events to be unrelated to FluMist due to administation of concurrent allergy shots with the FluMist vaccination. 09Feb05 Additional information received: Pt's date of birth, confirmatin that the time of vaccine admin and onset of events were not recorded.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac arrest, Respiratory arrest
Clinical narrative: Patient brought to ED on 12/19/04 in full arrest and could not be resuscitated. That ED notified our hospital that patient had died. Our hospital does not have further details at this time.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: S/P Flu vaccine 3 days earlier. Found expired in morning.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Dysarthria, Facial palsy, Laboratory test abnormal, Transient ischaemic attack
Clinical narrative: Symptoms of stroke (facial paralysis and slurred speech) developed next day. Admitted to hospital; symptoms cleared in 24 hours. Diagnosis: TIA. Medical records state 7th nerve palsy. msv
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous
Clinical narrative: Miscarriage at six weeks gestation one week after flu vaccination.
Age: 1.33
Sex: F
Vaccine: FLU3
Symptoms: Personality disorder, Psychomotor hyperactivity
Clinical narrative: Drastic personality change overnight. Attention span decreased, hyperactive. Will visit the doctor today to start testing for ADD.
Age: 44.0
Sex: M
Vaccine: FLUN3
Symptoms: Eye pain, Pharyngolaryngeal pain, Rhinitis, Rhinorrhoea, Sinusitis
Clinical narrative: Pt suffers from acute sinusitis two to three times a year, usually occurring after the start of a viral infection. Where pt lives has low humidity 20-30% RH most of the year. And air pollution especially particulate. He works in an office environment where the humidity is usually slightly lower than outside air, it can be raining outside, but humidity inside would be about 35 to 40% RH inside. Office RH not uncommon below 30%, even down to 18% at times. Pt sleeps at home in humidity above 35% and increases humidity to about 60% when nasal irritation is detected. On 27Nov04 at Noon I received FluMist influenza virus vaccine lives, IN. At about 12 hours later I started to get a runny nose and slightly sore throat. Each of the following days it got worse. I stayed home from work for December 1st to December 6th and rested. Felt better Dec 7 but still had a slight sore throat and post nasal drip of thick white phlegm. During the whole time no significant cough or breathing or chest problems. On December 14th started to get worse again on Dec 16th say my Ear Nose and Throat Doctor and he prescribed Ketek Pak, the 400mg tablet taken two at a time for five days; started taking the Ketek on Dec 16th at 11:00AM. Took the next two days off from work and on Dec 18th at 1:00PM started to get worse. By Dec 18th at 7:00PM was bad enough sinus pain and pressure; facial pressure; eye orb pressure; fever of 99.9F called the doctor on call and got a prescription for Augmentin for a 15 day period. Started feeling better on Dec 19th at about 10:00AM when yellow phlegm started to come out left nostril. Still recovering as of Dec 20th 3:30PM but feeling much better with thick sinus mucus and left eye pain when looking to extreme left, right, up and down.
Age: 85.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Rash
Age: 0.58
Sex: M
Vaccine: DTAP, FLU3, HIBV, IPV, PNC
Symptoms: Injection site reaction, Rash maculo-papular
Clinical narrative: Maculopapular rash left thigh, onset within hours of immunizations.
Age: 28.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Rash papular, Rash pustular
Clinical narrative: 3 raised papules and pustules on chest and shoulders
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Hypokinesia, Injection site erythema, Injection site mass, Pain
Clinical narrative: Local reaction in left deltoid 2 days after vaccination 2 in induration with redness, heat, feverish all over. 2-3 weeks later, intense heat on  shoulder, elbow,wrist joints, decreases ROM, pain.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Local reaction in left deltoid 2 days after vaccination 2 in induration with redness, heat, feverish all over. 2-3 weeks later, intense heat on  shoulder, elbow,wrist joints, decreases ROM, pain.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Feeling hot, Headache, Pallor, Rash
Clinical narrative: 1 day after Flumist, headache, pale, warm to touch, 2nd day rash on forehead and right side of forehead, seen in office (12/10/04) at pediatricians. Observe.
Age: 14.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site mass, Injection site oedema, Pyrexia
Clinical narrative: 12 hrs after vaccine developed red, swollen area 10cm in diameter. Indurated tender. Fever, chills.
Age: 14.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: 12 hrs after vaccine developed red, swollen area 10cm in diameter. Indurated tender. Fever, chills.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Severe dizziness, lasted two days no treatment
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Musculoskeletal stiffness, Pharyngitis, Pyrexia, Rhinitis
Clinical narrative: Fever 101 stiff neck, cold like symptoms, 10 days after Flumist. No treatment 48hrs.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash macular
Clinical narrative: Pt was given 0.25ml of flu vaccine on 12/06/04. Reaction began 12/7/04. Red blotches from waist down on 12/8/04. Progressed to entire body by 12/9/04. Benadryl was started on 12/8/04. On 12/9/04, child went to med ctr and started Atarax.
Age: 44.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Facial palsy
Clinical narrative: Bells Palsy occurred 1 days after receiving flu vax and hep B vax
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: Alopicia, generalized (head and body) Hair started falling out 4 days after administration hep B 1
Age: 40.0
Sex: M
Vaccine: HEPA, MMR, TD, TYP
Symptoms: Erythema, Injection site reaction, Myalgia, Oral pain, Pyrexia
Clinical narrative: 2 days after 10/25/04 MMR, Td, Typhoid and Hep A, developed severe mouth pain which led to inability to chew-bilateral masseter muscle tenderness which resolved improved by 10/29/04. Resolved first on L sides, then at right side. Temp 99.2. No oral pathology (acute). Also had severe local Left arm injection tenderness, erythema.
Age: 40.0
Sex: M
Vaccine: HEPA, MMR, TD, TYP
Symptoms: Tenderness
Clinical narrative: 2 days after 10/25/04 MMR, Td, Typhoid and Hep A, developed severe mouth pain which led to inability to chew-bilateral masseter muscle tenderness which resolved improved by 10/29/04. Resolved first on L sides, then at right side. Temp 99.2. No oral pathology (acute). Also had severe local Left arm injection tenderness, erythema.
Age: 0.38
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Rash
Clinical narrative: Mom presented to an office visit for follow up to an ER visit, and then states that when pt had his vaccines 12/15/04 within 20 minutes he had a rash to the area but no other signs and symptoms, then went away after awhile they was not difficulty breathing didn't call because all resolved.
Age: 3.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash papular
Clinical narrative: Vaccine given 7 days later, rash at site of vaccine, papular.
Age: 3.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dermatitis bullous, Injection site reaction, Rash erythematous
Clinical narrative: Vaccine given 7 days later, rash at site of vaccine, papular.
Age: 3.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash papular
Clinical narrative: Vaccine given raised red bumpy rash area of vaccine, face, neck, 7 days after vaccine
Age: 3.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dermatitis bullous, Injection site reaction, Rash erythematous
Clinical narrative: Vaccine given raised red bumpy rash area of vaccine, face, neck, 7 days after vaccine
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site mass
Clinical narrative: 11cm x 8 cm area of erythema/induration to right upper arm after IPV, DTaP placed 2 days prior in this arm.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Lethargy, Respiratory disorder, Vomiting
Clinical narrative: 12/21/2004 patient returned 4 hours after immunizations given. He vomited twice, had irregualr respirations, was pale and lethargic.( RR 15-20 gasping respirations, HR 124, Pulse Ox 96-97) He was observed in the office for 2 hours with no further vomiting, the baby became more alert, color and breathing normal except for occasional gasps.
Age: 0.75
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Injection site erythema
Clinical narrative: red mottled skin .5 cm at area where DTaP was administered, area has continues but has faded.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Contusion, Crying, Erythema, Oedema
Clinical narrative: About 2 hours after being vaccinated the patient cried, had swollen (red edema) of the left thigh that expanded. She also had bruising after the edema decreased.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot
Clinical narrative: Client presented to clinic with a large reddened area, warm to touch that was 6 cm in diameter on today,12/22/04. Client stated the area had been approximately 12 cm on the left deltoid. NO lesions or broken tissue noted or induration.