chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Vomiting
Clinical narrative: From initial information received on 02/25/04 from a county health service regarding an adverse event occurring in the USA, it was reported that a 49 year old female patient received a Fluzone SV '2003-'2004 USP vaccination, lot number U194AA, administered intramuscularly in the left deltoid, and a Pneumovax 23 vaccination, lot number 0029N, administered intramuscularly in the right deltoid on 11/10/03 at 5:00 PM. Thirty minutes later the patient noted dizziness at home. At 8:00 PM, the patient went to bed with soreness of both arms with the left on being worse that the right. She experienced absolute fatigue, headache and sinus feeling pressure. She took Tylenol, Ibuprofen and another medication for relief. The patient " had a rough night up six times to get relief of pain, aches in knees in the night". On 11/12/03, the symptoms "kind of lifted". Her left arm was still sore, shoulder joint to knuckles stiff and could not be used, muscles felt sore and injection site was hot. Her right arm had minimal soreness. She felt miserable and had no appetite. Her sinus headache went to a migraine in the afternoon. She took a long nap, couldn't quite put her knees together and she ached. In the afternoon, she felt chilled. At 6:00 Pm she began shivering under three quilts, vomited and diarrhea started. She was taking a lot of Ibuprofen. On 11/13/03, the headache resolved, but she couldn't bend her elbow. She slept in the afternoon and felt better so she went to work. As she was driving she became hot and could no longer drive. She felt like " I had run a marathon". She went to the doctor for another reason and the doctor noted a fast heart rate. On 11/14/03, her arm began to bend. Her stomach was upset and she didn't want to eat. She began to have a sinus headache, more diarrhea and noted dark stools. She experienced a nosebleed and dizziness at intervals. It was at this time the patient called the county health service and was encouraged to seek medical attention and to report the above events at which time she refused. On 11/15/03, the patient did not eat breakfast, did not have an appetite and had a nervous stomach. She denied any headache and migraine and can now move her fingers. Her knee aches and elbow aches have subsided. On 11/20/03, her shoulder to elbow was stiff. On 11/30/03, she experienced stiffness and aches. The patient has stated "I have had 4 bouts of flu like symptoms about every 10 days following my shot". The patient did not seek medical evaluation from her medical provider because she has had reactions in the past and reportedly physician thinks she is somewhat of a hypochondriac. The patient has completely recovered from these events. From additional information received on 09/13/04 from the initial reporter, the patient was not on any other medications at the time of vaccination. The patient refused to go to a medical provider. The reporter stated that the case was reviewed and that there is no additional information at this time. No further information is anticipated, this cause is considered closed.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Migraine, Myalgia, Pain, Sinus headache, Vomiting
Clinical narrative: From initial information received on 02/25/04 from a county health service regarding an adverse event occurring in the USA, it was reported that a 49 year old female patient received a Fluzone SV '2003-'2004 USP vaccination, lot number U194AA, administered intramuscularly in the left deltoid, and a Pneumovax 23 vaccination, lot number 0029N, administered intramuscularly in the right deltoid on 11/10/03 at 5:00 PM. Thirty minutes later the patient noted dizziness at home. At 8:00 PM, the patient went to bed with soreness of both arms with the left on being worse that the right. She experienced absolute fatigue, headache and sinus feeling pressure. She took Tylenol, Ibuprofen and another medication for relief. The patient " had a rough night up six times to get relief of pain, aches in knees in the night". On 11/12/03, the symptoms "kind of lifted". Her left arm was still sore, shoulder joint to knuckles stiff and could not be used, muscles felt sore and injection site was hot. Her right arm had minimal soreness. She felt miserable and had no appetite. Her sinus headache went to a migraine in the afternoon. She took a long nap, couldn't quite put her knees together and she ached. In the afternoon, she felt chilled. At 6:00 Pm she began shivering under three quilts, vomited and diarrhea started. She was taking a lot of Ibuprofen. On 11/13/03, the headache resolved, but she couldn't bend her elbow. She slept in the afternoon and felt better so she went to work. As she was driving she became hot and could no longer drive. She felt like " I had run a marathon". She went to the doctor for another reason and the doctor noted a fast heart rate. On 11/14/03, her arm began to bend. Her stomach was upset and she didn't want to eat. She began to have a sinus headache, more diarrhea and noted dark stools. She experienced a nosebleed and dizziness at intervals. It was at this time the patient called the county health service and was encouraged to seek medical attention and to report the above events at which time she refused. On 11/15/03, the patient did not eat breakfast, did not have an appetite and had a nervous stomach. She denied any headache and migraine and can now move her fingers. Her knee aches and elbow aches have subsided. On 11/20/03, her shoulder to elbow was stiff. On 11/30/03, she experienced stiffness and aches. The patient has stated "I have had 4 bouts of flu like symptoms about every 10 days following my shot". The patient did not seek medical evaluation from her medical provider because she has had reactions in the past and reportedly physician thinks she is somewhat of a hypochondriac. The patient has completely recovered from these events. From additional information received on 09/13/04 from the initial reporter, the patient was not on any other medications at the time of vaccination. The patient refused to go to a medical provider. The reporter stated that the case was reviewed and that there is no additional information at this time. No further information is anticipated, this cause is considered closed.
Age: 1.75
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Alopecia, Speech disorder
Clinical narrative: From initial information received on 08/19/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 21 month old female patient received a 0.25 cc dose of Fluzone SV '2003-'2004 USP, lot number U1128AA, administered intramuscularly in the left deltoid on 11/07/03. Two weeks later, on 11/21/03, the mother stated that the child's hair started falling out. No lab work was done. Reportedly, the patient recovered from this event. From additional information received on 08/31/04 from a registered nurse, it was reported that the patient's mother stated within tow weeks after receiving Fluzone on 11/03, the patient's hair started falling out. the patient also developed trouble with her language use. One to two weeks post vaccination, the patient could only speak the beginning syllable of a word and not finish it.  All MRI test were normal. Reportedly, the patient's hair has grown back, but her language use has not returned. A follow up telephone call was placed on 09/07/04 to the reporting nurse. She stated that the patient has not been tested fro autism. She was last seen at the office for her two year physical, , at which time physical therapy had been discussed. At the time of the visit, the patient had recovered from the hair loss, but was still having issues with her speech. The reporter stated that the patient had documented sensory integration issues and that there were multiple concerns about her speech and hearing prior to receiving the vaccine on 11/07/03. The reporter was unable to provide any additional information at this time and stated tat the physician who last saw the patient in their office is currently out on long term medical leave.
Age: 24.0
Sex: M
Vaccine: FLU3, SMALL, TYP
Symptoms: Cellulitis, Erythema, Feeling hot, Pain
Clinical narrative: Erythematous ring around injection site approx 7/5 cm by 10 cm in diameter.  No signs of infection (blood or exudates) from injection site.  Erythematous ring warm to touch and elicited some minor pain.  Left arm.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP
Symptoms: Abdominal pain upper, Dizziness, Feeling cold, Injection site reaction, Pruritus
Clinical narrative: Patient is 22-year-old male who received the smallpox vaccine on 17 Dec 2004 who presents with complaints of distal lesions from the vaccination site.  Patient reports having an itchy area on his elbow and when he looked at his elbow he saw that he had a rash.  He reports two or three new little papules at the site.  He reports feeling lightheaded yesterday.  He was reportedly pale.  No fevers but he did complain of being chilled.  No nausea or vomiting.  He does say that his "stomach felt weird".  He reports it was a sharp pain but it went away on its own.  No headaches.  No chest pain.  Due to deploy on the 12th of this next month.   No history of skin problems or history of psoriasis.   MEDICATIONS: 1. None  PMH: 1. None  MED ALLERGIES: 1. NKDA  Family History: No allergies or problems with medications  Social History: Non-smoker  Infectious History:  no history of recurrent infections or bad infections a/ generalized vaccinia
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP
Symptoms: Rash, Vaccination complication
Clinical narrative: Patient is 22-year-old male who received the smallpox vaccine on 17 Dec 2004 who presents with complaints of distal lesions from the vaccination site.  Patient reports having an itchy area on his elbow and when he looked at his elbow he saw that he had a rash.  He reports two or three new little papules at the site.  He reports feeling lightheaded yesterday.  He was reportedly pale.  No fevers but he did complain of being chilled.  No nausea or vomiting.  He does say that his "stomach felt weird".  He reports it was a sharp pain but it went away on its own.  No headaches.  No chest pain.  Due to deploy on the 12th of this next month.   No history of skin problems or history of psoriasis.   MEDICATIONS: 1. None  PMH: 1. None  MED ALLERGIES: 1. NKDA  Family History: No allergies or problems with medications  Social History: Non-smoker  Infectious History:  no history of recurrent infections or bad infections a/ generalized vaccinia
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Atelectasis, Atherosclerosis, Difficulty in walking, Extensor plantar response
Clinical narrative: From initial information received on 16Mar04 from a physician's office, regarding an adverse event occurring, it was reported that an 85 year old male pt received Fluzone SV 2003-2/4 USP, lot number U1131AA, administered IM in the left deltoid on 10Nov03.The pt had no reaction at the time of vaccination. He visited his physician for a regular office visit on 31Dec03 and had no complaints. On 02Jan04, he was seen in the ER for bilateral leg and arm weakness. This was his second visit to the ER, but no details were provided regarding his first visit. He was admitted to the hospital on 02Jan04 and was diagnosed with Guillain Barre Syndrome. The pt's recovery status is unk. From additional information received on 28May04 from a physician, the pt's hospital records were provided. The pt was admitted to the hospital on 02Jan04 with a three to four day history of progressive arm and leg weakness to the point where he had to walk with a cane and felt like he could fall when he was ambulating. Vital signs were stable on admission. Upon initial exam, the pt appeared weak and had difficulty getting out of bed. He was unable to push himself into a sitting position using his arms. His lower extremities appeared to be areflexic. He had a slightly positive Babinski. Romberg testing was negative. Pronator drift testing was also negative. His gait was watched without ataxia. Cerebellar testing of the lower extremities was normal. The pt denied concurrent fever, shortness of breath, coughing, muscle fasciculations or numbness or tingling of the hands or feet. He also denied exposure to botulism. Reportedly, the pt had not had any tick bites or traveled recently. A CAT scan of the brain on 02Jan04 revealed chronic findings with no acute anomaly identified. The pt's recovery status was not reported.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypokinesia, Laboratory test abnormal
Clinical narrative: From initial information received on 16Mar04 from a physician's office, regarding an adverse event occurring, it was reported that an 85 year old male pt received Fluzone SV 2003-2/4 USP, lot number U1131AA, administered IM in the left deltoid on 10Nov03.The pt had no reaction at the time of vaccination. He visited his physician for a regular office visit on 31Dec03 and had no complaints. On 02Jan04, he was seen in the ER for bilateral leg and arm weakness. This was his second visit to the ER, but no details were provided regarding his first visit. He was admitted to the hospital on 02Jan04 and was diagnosed with Guillain Barre Syndrome. The pt's recovery status is unk. From additional information received on 28May04 from a physician, the pt's hospital records were provided. The pt was admitted to the hospital on 02Jan04 with a three to four day history of progressive arm and leg weakness to the point where he had to walk with a cane and felt like he could fall when he was ambulating. Vital signs were stable on admission. Upon initial exam, the pt appeared weak and had difficulty getting out of bed. He was unable to push himself into a sitting position using his arms. His lower extremities appeared to be areflexic. He had a slightly positive Babinski. Romberg testing was negative. Pronator drift testing was also negative. His gait was watched without ataxia. Cerebellar testing of the lower extremities was normal. The pt denied concurrent fever, shortness of breath, coughing, muscle fasciculations or numbness or tingling of the hands or feet. He also denied exposure to botulism. Reportedly, the pt had not had any tick bites or traveled recently. A CAT scan of the brain on 02Jan04 revealed chronic findings with no acute anomaly identified. The pt's recovery status was not reported.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: From initial information received on 22Oct03 from a health care professional regarding an adverse event occurring, it was reported that a 61 year old female pt received a dose of Fluzone SV 2003-2004 USP, lot number U1137HA, administered IM in the left deltoid on 10Oct03 at 11:30AM. Eight days later, on 18Oct03, the pt developed pain in both axillary areas. The areas were sensitive to touch. Reportedly the pt recovered from this event. From additional information received on 05Feb04 from a health care professional, it was reported that no additional information was available for this case at this time. No further information is anticipated, this case is considered closed.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: From initial information received on 25Sep03 from a health care professional regarding an adverse event occurring, it was reported that a 46 year old female pt received a dose of Fluzone, lot number U1139AA, expiration date 30Jun04, administered in the right deltoid on 22Sep03. On the same day, the pt's arm became red and swollen. The pt was seen by a physician and it was noted that the area of redness and swelling measured 6.5 inches in diameter. The pt was treated with Benadryl and ice packs to treat the reaction and reportedly the area has decreased in size. The pt's recovery status is currently unk. From additional information received on 19Nov03 from a health care professional, it was reported that the vaccine was administered IM. No other medical information was provided at this time. No further information is anticipated, this case is considered closed.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site erythema, Injection site pain, Pruritus, Somnolence
Clinical narrative: From initial information received on 10/01/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 40 year old female patient received her first dose of Fluzone, lot number U1141AA, expiration date 06/30/04, administered in the left deltoid on 9/29/03. 24 hours later, the patient developed a 3.5 x 6 cm oval red area, which was sore and had mild itching. She was prescribed Atarax for the itching and cool soaks. Reportedly, the patient stated that she was light headed and felt groggy. The patient's recovery status was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: From initial information received on 10/06/03 from a health care professional regarding an adverse event occurring in the U.S.A, it was reported that a female patient (age and birth date not reported) received Fluzone SV '2003-'2004 USP, lot number U1260AA, administered intra-muscularly (site of administration not reported) on 10/03/03. The following day, the patient developed pain, edema, redness, and itching at the injection site, as well as pain and swelling in her joints. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302255, 200302256, and 200302258.
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site erythema, Injection site oedema, Joint swelling, Pain
Clinical narrative: From initial information received on 10/06/03 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a female patient (age and birth date not reported) received Fluzone SV '2003-'2004 USP, lot number U1260AA, administered intra-muscularly in the right arm on 10/03/2003. The following day the patient developed redness and edema at the injection site, as well as itching, fever, aching, nausea, and pain and swelling in her joints. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302253, 200302256, 200302257 and 200302258.
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia
Clinical narrative: From initial information received on 10/06/03 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a female patient (age and birth date not reported) received Fluzone SV '2003-'2004 USP, lot number U1260AA, administered intra-muscularly in the right arm on 10/03/2003. The following day the patient developed redness and edema at the injection site, as well as itching, fever, aching, nausea, and pain and swelling in her joints. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302253, 200302256, 200302257 and 200302258.
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Injection site erythema, Injection site oedema, Joint swelling, Pain
Clinical narrative: From initial information received on 10/06/03, from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a female patient (age and date of birth not reported) received Fluzone SV '2003-'2004 USP, Lot number U1260AA, administered intra-muscularly (site of administration not reported) on 10/03/03. One day later, the patient developed redness, edema, and itching at the injection site, as well as fever, aching, joint pain and joint swelling. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302253, 200302255, 200302257 and 200302258.
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia
Clinical narrative: From initial information received on 10/06/03, from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a female patient (age and date of birth not reported) received Fluzone SV '2003-'2004 USP, Lot number U1260AA, administered intra-muscularly (site of administration not reported) on 10/03/03. One day later, the patient developed redness, edema, and itching at the injection site, as well as fever, aching, joint pain and joint swelling. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302253, 200302255, 200302257 and 200302258.
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site erythema, Injection site oedema, Injection site pain, Joint swelling
Clinical narrative: From initial information received on 10/06/03 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a female patient (age and birth date not reported) received Fluzone SV '200-'2004 USP, lot number U1260AA, administered intra-muscularly (route and site not reported) on 10/03/03. The following day, the patient developed pain, edema, redness, and itching at injection site, as well as fever, achiness, and pain and swelling in her joints. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302253, 200302255, 200302256, and 200302258.
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: From initial information received on 10/06/03 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a female patient (age and birth date not reported) received Fluzone SV '200-'2004 USP, lot number U1260AA, administered intra-muscularly (route and site not reported) on 10/03/03. The following day, the patient developed pain, edema, redness, and itching at injection site, as well as fever, achiness, and pain and swelling in her joints. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302253, 200302255, 200302256, and 200302258.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site erythema, Injection site oedema, Joint swelling, Nausea
Clinical narrative: From initial information received on 10/06/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 48 year old female patient received her first does of Influenza Virus Vaccine, lot number U1260AA, administered intra-muscularly in the right arm on 10/03/03.The following day, the patient developed redness and edema at injection site, itching, pain and swelling in joints, as well as fever, aching, and nausea. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302253, 200302255, 200302256 and 200302257.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: From initial information received on 10/06/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 48 year old female patient received her first does of Influenza Virus Vaccine, lot number U1260AA, administered intra-muscularly in the right arm on 10/03/03.The following day, the patient developed redness and edema at injection site, itching, pain and swelling in joints, as well as fever, aching, and nausea. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302253, 200302255, 200302256 and 200302257.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash
Clinical narrative: From initial information received on 10/09/03, from a health care professional, regarding an adverse event occurring in the U.S.A., it was reported that a 55 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1089AA, given intra muscularly in the left arm on 10/04/03. The following day, 10/05/03, the patient developed a rash at the injection site as well as on both legs. The recovery status was reported as unknown. This is the same reporter as case 200302313. From additional information received on 11/18/03, from a health care professional, it was reported that the patient also developed a rash on her stomach, legs and chest. The rash was not itchy and the patient was fine otherwise and she did not seek medical care. The rash cleared after one week and the patient recovered. No further information is anticipated, this case is considered closed.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster, Infection, Rash
Clinical narrative: From initial information received on 10/09/03, from a health care professional, regarding an adverse event occurring in the U.S.A., it was reported that a 55 year old male patient received Fluzone SV '200-'2004, lot number U1089AA, given intra muscularly in the left arm on 10/03/03. The following day, on 10/04/03, the patient developed a rash on his back, buttocks and on both legs. the recovery status was reported as unknown. The reporter of this case is the same reporter for case 200302312. From additional information received on 11/18/03 from a health care professional, the patient had been taking prednisone 50 mg two weeks before immunization. The patient was seen by his primary care physician on 10/09/03 who prescribed Allegra and Hydrocortisone for the rash, which was all over the patient's body. The patient was feeling a little better at the time. On 11/13/03, the health care provider spoke with the patient, who stated that his primary physician had diagnosed him with shingles. It is unknown if the patient recovered. No further information is anticipated, this case is considered closed.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea, Pyrexia
Clinical narrative: From initial information received on 10/10/03, from a health care professional regarding an adverse event occurring in the USA, it was reported that a 42 year old female patient received a dose of Fluzone, lot number U1139AA, administered intra-muscularly in the left arm on 10/07/03. Two days later, the patient developed a 2 inch red area, swollen and warm at the administration site as well as fever, nausea and vomiting. During this event, the patient was also taking Glucophage, Acupril and HCTZ. The patient's recovery status is unknown.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: From initial information received on 10/10/03, from a health care professional regarding an adverse event occurring in the USA, it was reported that a 42 year old female patient received a dose of Fluzone, lot number U1139AA, administered intra-muscularly in the left arm on 10/07/03. Two days later, the patient developed a 2 inch red area, swollen and warm at the administration site as well as fever, nausea and vomiting. During this event, the patient was also taking Glucophage, Acupril and HCTZ. The patient's recovery status is unknown.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Feeling hot, Pruritus, Rash, Respiratory disorder
Clinical narrative: From initial information received on 10/13/03, from a health care professional regarding an adverse event occurring in the USA, it was reported that a 44 year old female patient received her first dose of Influenza Virus vaccine, lot number U1137HA, administered intra-muscularly in the left deltoid on 10/10/03 at 3:45 pm. Twenty two  minutes later, the patient developed rash on the upper body, warm and clammy skin, generalized itching, and an itchy throat. The patient received Benadryl and Prednisone, after which she immediately recovered. The patient is allergic to pollen, pet dander and PCN. From additional information received on 11/24/03, from a health care professional, it was reported that the patient had not previously received any influenza vaccine. Following the adverse events the patient was referred to her private physician. No other information was provided at this time. Further information is not anticipated, this case is considered closed.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: From initial information received on 10/15/03, from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 66 year old female patient received Fluzone SV '2003-'2004 USP, lot number U1266AA, administered intra-muscularly in the left deltoid on 10/10/03. Four days later, the patient developed radiating pain in the left arm and shoulder. She was seen in the emergency room and treatment included Celebrex and a heart attack was ruled out as per the reporter. Reportedly, the patient's recovery status is currently unknown.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Immune system disorder, Influenza like illness, Malaise, Pyrexia
Clinical narrative: From initial information received on October 15,2003 from the patient regarding an adverse event occurring in the USA, it was reported that a female patient (age and birth not reported) received Fluzone SV '2003-2004' UPS, lot number U1097AA, administered intra-muscularly in the left deltoid on October 09,2003.  One day later, the patient developed a fever, chills, general malaise, and "flu-like symptoms".  The patient was prescribed Tylenol and advised to force fluids.  The patient's medical conditions include immunosuppression and at the time of vaccination the patient had a compromised immune system.  Reportedly, the patient recovered from this event. From additional information received on 01/14/2004 from the responsible physician, it was reported that the patient received the Fluzone SV '2003-2004' vaccination on October 02,2003, not October 09,2003 as previously reported.  Additionally, the adverse event onset date was updated to October 03,2003, not October 10,2003 as previously reported.  The patient's date of birth and contact information were also provided.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Pain
Clinical narrative: From initial information received on October 20,2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a female patient (age and birth date not reported) received a dose of Fluzone SV '2003-'2004 USP, lot number U1137HA, on October 02,2003 at 4:15PM (route and site of administration not reported). On October 03,2003 at 9:00AM, the patient developed left shoulder pain with movement.  The patient's recovery status is currently unknown. From additional information received on 11/17/2003 from the initial reporter, it was reported that the vaccine was administered intra-muscularly in the left deltoid.  Treatment included Aleve three times a day as occasion as needed and Icy Hot to the shoulder.  No relevant diagnostic tests were performed at this time.  The patient is still under a doctor's care and is being treated for possible mild to moderate subacromial bursitis.  No other information reported at this time. Further information is not anticipated, this case is considered closed.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Oedema
Clinical narrative: From initial information received on October 10,2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 37 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1253AA, expiration date June 30,2004, administered in the right deltoid (route of administration not reported) on October 17,2003 at 9:00AM.  At 11:00AM of the following day, the patient developed soreness in the right axilla down to the chest wall with edema.  The patient was recommended to use ice packs.  The patient's recovery status is currently unknown.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Breast pain, Chest pain, Ear pain, Neck pain
Clinical narrative: From initial information received on October 17,2003 from a patient, who is a physician, regarding an adverse event occurring in the USA.  It was reported that he received a dose of Fluzone SV '2003-'2004 USP on October 2, 2003, route and site of administration not reported.  An unspecified time after vaccination, the patient developed brachial plexus neuropathy and skin pain in the chest, neck, and back area. From additional information received on 11/20/2003 through a telephone call to the patient, who is a physician, it was reported that the onset of the symptoms began with a left sided sore throat, ear ache, and tenderness of the skin over the left clavicle and left breast.  The patient developed a "bump" on his left shoulder and was treated with acyclovir.  He was seen by a neurologist and the neurological work-up was within normal limits.  A C-spine and MRI of the spine were performed and were within normal limits for a 60 year old male.  The patient also stated that he fully recovered from these events on 11/11/2003.  No other information was provided. No further information is anticipated, this case is considered closed.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Neuropathy, Pharyngolaryngeal pain, Skin nodule
Clinical narrative: From initial information received on October 17,2003 from a patient, who is a physician, regarding an adverse event occurring in the USA.  It was reported that he received a dose of Fluzone SV '2003-'2004 USP on October 2, 2003, route and site of administration not reported.  An unspecified time after vaccination, the patient developed brachial plexus neuropathy and skin pain in the chest, neck, and back area. From additional information received on 11/20/2003 through a telephone call to the patient, who is a physician, it was reported that the onset of the symptoms began with a left sided sore throat, ear ache, and tenderness of the skin over the left clavicle and left breast.  The patient developed a "bump" on his left shoulder and was treated with acyclovir.  He was seen by a neurologist and the neurological work-up was within normal limits.  A C-spine and MRI of the spine were performed and were within normal limits for a 60 year old male.  The patient also stated that he fully recovered from these events on 11/11/2003.  No other information was provided. No further information is anticipated, this case is considered closed.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Angioneurotic oedema, Ear pain, Pharyngolaryngeal pain
Clinical narrative: From initial information received on 22OCT2003 from a health care professional regarding an adverse event occuring in the USA, it was reported that a 44 year old female patient received a dose of FLUZONE 2003-2004, administered IM in the left deltoid on 20OCT2003. The following day, the patient developed left eye angioedema, left earache and a sore throuat. The patient was treated with Benadryl 25mg orally , two doses given. Reportedly,t the events fully resolved.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: From initial information received on 24OCT2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 47 year old male patient received a dose of FLUZONE administered IM in the left deltoid on 22OCT2003 at 4:00pm. The next day, at 6PM , the patient developed a pruritic rash on his trunk , arms and neck. No respiratory or neurologic symptoms were present. The patient was prescribed Benadryl 25mg one to two every six hours as necessary for itching. It is not known whether the patient recovered.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Pruritus, Rash macular
Clinical narrative: From initial information received on 24OCT2003 from a physician regarding an adverse event occurring in the USA it was reported that a 57 year old female received a dose of FLUZONE, administered IM in the right deltoid on 21OCT2003. The following day, the patient developed a local reddened area at the injection site. She was seen by a physician the next day. At that time, the patient had a 15cm x 15cm indurated area at the site and a red macular rash on her upper extremities and torso. She also reported slight pruritus. The patient had not recovered from these events at the time of this report.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Generalized rash From initial information received on 10/27/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 40 year old female patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1267AA, administered in the right deltoid (route not reported) on 10/14/2003 at 01:30 PM. Half a hour later, the patient developed a rash on the right side of her body, leg, arm and face. She was treated with allerga and hydroxyzine 20mg. intra-muscularly. Reportedly, the patient recovered from this event. The reporting facility for this case is the same as for case 2003-02792.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash papular, Rash pruritic
Clinical narrative: Papular rash Pruritic rash Redness From initial information received on 10/28/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 64 year old female patient received a dose of FLUZONE SV '2003-'2004 USP,  lot number U1123AA, administered intra-muscularly in the left deltoid on 10/21/2003 at 12:15 PM. Within 2 hours of receiving the vaccination, the patient developed an itching rash. There was no swelling or breathing difficulty. The following day at 10:56 AM, the rash pruritic, scattered, raised and red. It was described as papular with a reddish border (about 20 papules in total). The affected areas were the upper body, arms, chest and back. There was no typical hives or urticaria. The patient was treated with benadryl and caladryl lotion for itching. The patient has had influenza shots in the past with no previous reactions. She has had similar rashes in the past, but only from oral medications including penicillin, sulfa and morphine and these were described as "blotches further apart - hives". Reportedly, the patient recovered from these events.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Dizziness From initial information received on 10/28/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 38 year old female patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1132AA, administered intra-muscularly in the left deltoid on 10/28/2003. Within three minutes of vaccination, the patient felt dizzy and light headed and fell to the floor. She was taken to the emergency room via wheelchair. The patient's recovery status is currently unknown.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Pruritus, Rash, Swelling face, Urticaria
Clinical narrative: Facial swelling - Swollen eyes Hives Rash Pruritis From initial information received on 10/29/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 51 year old female patient received a dose of FLUZONE SV '2003-'2004 at 10:40 AM. 19 hours later, the patient developed facial swelling, swollen eyes and a hive around her chin, neck and nose. The patient had no respiratory problems. She developed a rash on her chin after the hives resolved and also experienced itching. She took Benadryl and used hydrocortisone cream to treat the symptoms. The patient's physician prescribed Zyrtec. On 10/28/2003 the patient still had some facial swelling, but this symptom was resolving. The reporter of this case is the same reporter of case U1998-00297.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Nausea, Pain
Clinical narrative: From initial information received on 29OCT2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 36 year old female patient received a dose of FLUZONE administered in the left deltoid on 27OCT2003. The following day,the patient woke up with body aches, fatigue, a temperature of 101 degrees Fahrenheit, stomach cramps, nausea and diarrhea. The patient's recovery status is currently unknown. The reporter of this case is the same reporter of case U2001011283.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: From initial information received on 29OCT2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 36 year old female patient received a dose of FLUZONE administered in the left deltoid on 27OCT2003. The following day,the patient woke up with body aches, fatigue, a temperature of 101 degrees Fahrenheit, stomach cramps, nausea and diarrhea. The patient's recovery status is currently unknown. The reporter of this case is the same reporter of case U2001011283.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hyperhidrosis, Oedema peripheral, Swelling, Urticaria
Clinical narrative: From initial information received on 29OCT2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 39 year old female patient received a dose of FLUZONE administered IN on 27OCT2003. Bout 15 minutes later, the pt experienced swelling of the hands, weakness,hives and idaphoresis. The pt was given Benadryl IM and ice packs were applied to the injection stie. The patient rested for 45 minutes and the events fully resolved. The patient recovered from these events.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Headache
Clinical narrative: From initial information received on 30OCT2003 from an MD regarding an adverse event occurring in the USA, it was reported that a 78 year old female patient received a dose of FLUZONE on 18OCT2003. The route and site of administration were not reported. Three days later , on 21OCT2004. the patient developed a bitemporal, persistent , severe headache. She also had throbbing in her inner ears. A CAT scan was within normal limits. The pt's recovery status is unk.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: From initial information received on 10/30/2002 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a four year old male patient received FLUZONE SV '2003-'2004 USP, lot number U1268AA, administered intramuscularly in the left arm on 10/27/2003. Two days later, on 10/29/2003, the patient's entire left arm was swollen, red and itchy. The patient was seen by a physician. At the time of this report, the patient had not recovered from these adverse events. From additional information received on 02/12/2004 from the reporting physician, a correction to the patient's name was provided, as well as his address, birth weight and number of siblings. Per the physician there is no additional information for this case. No further information is anticipated, this case is considered closed.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pharyngolaryngeal pain, Postnasal drip, Pyrexia
Clinical narrative: Muscle ache Fever Sore throat Postnasal drip From initial information on 11/04/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 55 year old female patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1135FA, administrated in the left deltoid on 10/16/2003. The reporter stated that the vaccine was administered with a 5/8 inch needle and may have been given subcutaneously. The following day, the patient developed a sore throat and muscle aches in her shoulder and neck. She also experienced a temperature of 99.1 degrees fahrenheit which lasted for three days, as well as postnasal drip. The patient self-medicated with Ibuprofen and Tylenol and visited a chiropractor for the muscle aches. Reportedly, the symptoms resolved and returned on 10/30/2003. It was not reported whether the patient recovered. From information received on 04/23/2004 from a health care professional, it was reported that the information has been reviewed and no additional information is available. The recovery status was erroneously checked as yes in version 0 but was corrected in version 1. No further information is anticipated, this case is considered closed.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash papular, Swelling
Clinical narrative: From initial information received on 11/04/2003 from a physician regarding an adverse event occurring in the U.S.A., it was reported that a 47 year old female patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1123AA, administered intra-muscularly in the left deltoid on 11/03/2003 at 1:55 PM. The patient had received the influenza vaccine four times in the past. Two hours after receiving the vaccine on 11/03/2003, the patient developed body itching. The patient inspected her skin approximately a half hour later and found three red, raised, circular areas with white centers measuring about one inch in diameter. She took one dose of Benadryl 25 mg. and awoke the next morning at 6:00 AM with swollen hands and knees. She was seen by the reporting physician the following day at 9:00 AM and the hand swelling was gone. It was noted that she had three red papules measuring approximately 1.5 cm, which she treated with topical Benadryl. The papules were located on her medial thigh, left hip and left neck. The physician stated that the patient did not have any difficulty breathing or anaphylaxis with these events. Reportedly, the patient recovered from these events.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: From initial information received on 11/05/2003, from a health care professional regarding an adverse event occurring in the USA, it was reported that a 32 year old female patient received a dose of Fluzone SV '2003-'2004 USP (lot number U1102AA, expiration date 6/30/04) administered on 10/04/03. The route and site of administration were not reported. Within 24 hours, the patient developed a fever of 102 degrees Fahrenheit with malaise, fatigue and cervical lymphadenopathy. The next day, the patient still had a fever of 100 degrees Fahrenheit and was seen by a physician, who recommended Motrin 600mg, every 6 hours. the patient reportedly has received numerous influenza vaccines in the past. Her recovery status is unknown. From additional information received on 02/11/04 from a health care professional, the county of vaccination was reported. The vaccine was administered intra muscularly in the left deltoid on 11/04/03, not 10/04/03, as initially reported. The adverse event onset date was 11/05/03. the symptoms lasted for 72 hours. Reportedly, the patient purchased the vaccine with private funds. No relevant diagnostic tests were preformed. The patient did require a doctor's office visit due to the symptoms. She did not have any illnesses present at the time of vaccination. Reportedly, the patient recovered from these events. Her full address and telephone number were also provided. No further information is anticipated, this case is considered closed.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Headache, Laboratory test abnormal, Purpura, Pyrexia
Clinical narrative: From initial information received on 11/07/03, from a physician regarding an adverse event occurring in the USA, it was reported that a 77 year old male patient received a dose of Fluzone SV '200-'2004, lot number U1089AA, administered intra muscularly (site not reported) on 10/27/03. Three days late, on 10/30/03, the patient developed a headache, fever and fatigue. A purpuric rash was noted on his lower legs below his knees. The physician ordered blood tests, which showed a normal white blood cell count, decreased platelets and an increased sed rate. The patient contiues with the purpuric rash and complaints of headache, fatigue and low grade fever. Reportedly, the events have not resolved.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema multiforme
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 a 3 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1131AA, route and site of administration not reported, on 11/05/2003.  Two days later, the patient developed erythema mulitforme.  No other reactions were reported by the physician.  The patient's recovery status is unknown.