chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: A report was received from a health care professional on 11Dec03 concerning a 34 year old female vaccinee who experienced hypersensitivity with a feeling of itching in the throat and tightening, redness and a feeling of itching all over her body and difficulty breathing, which was considered medically significant, on 15Oct03 at 21:25 hours after receiving Fluvirin vaccine on 15Oct03 at 21:00 hours. The vaccinee has a history of several environmental allergies and comedications included cetirizine hydrochloride, citalogram and another drug to be confirmed. On 15Oct03 at 21:25 hours the vaccinee experienced a feeling of itching in the throat and tightening and took 50mg oral diphenhydramine hydrochloride. By 22:00 hours the attending physician referred the vaccinee to the ER for additional treatment as the vaccinees entire body had become red and itchy. The vaccinee received additional treatment with IV diphenhydramine hydrochloride and IV methylprednisolone sodium succinate in the ER and was discharged home on 16Oct03 at approximately 00:30 hours on 40mg oral prednisolone sodium phosphate for 15 days, 20mg cetirizine hydrochloride and 200mg oral diphenhydramine hydrochloride daily. The vaccinee was seen by a physician on the 16Oct03 and due to continued, itching and difficulty breathing was given 125mg IM methylprednisolone sodium succinate. The outcome was not reported at the time of this report. There was insufficient information to determine the reporters causality assessment. Follow up pending. Follow up received 18Jun04: follow up information received from an occupational health nurse on 18Jun04. The vaccinee was diagnosed as having an anaphylactic reaction to flu vaccine. Her symptoms included itchiness and swollen tongue. The symptoms started on 15Oct03 following vaccination and resolved on 16Oct03 (swollen tongue) and on 17Oct03 (itchiness). She had received flu vaccine for the previous two years without reaction. Her last influenza vaccination was given on 20Oct02. The anaphylactic reaction was treated with 125mg SoluMedrol, 50mg Benadryl and 40mg Prednisone for 5 days. Her concomitant medications included Zyrtec 10mg, Albuterol Inhaler, Esgic and Benadryl. Her past medications included Keflex and Vicodin. The reporter considers the event serious as medical intervention was required. The reporter has submitted a report on this case.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Erythema, Pruritus, Urticaria
Clinical narrative: A report was received from a healthcare professional on 10/23/2003, concerning a 49 year old female vaccinee who experienced hives, itching, diarrhea, red spots and red patches the evening after receiving the Fluvirin vaccinee on 10/23/2003. On the evening of 10/22/2003, the vaccinee experienced itching over her entire body and hives were visible on her right shoulder and back.  The vaccinee did not experience fever but had 9 episodes of diarrhea over a 6 hour period.  Diphenhydramine was administered three times during a 4 and a half hour period.  On 10/23/2003 the vaccinee woke up with 'red spots' and patches on her back and right shoulder.   There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Skin burning sensation
Clinical narrative: A report was received from a consumer on 30 October 2003 who was a 46 year old female vaccinee who experienced itching 6 hours after vaccination and burning 2 days after vaccination with Fluvirin on 28 October 2003. Approximately 6 hours after vaccination the vaccinee experienced itching in her arms and legs which spread to her hands and feet.  The vaccinee was self-treating with diphenhydramine hydrochloride but was unable to take it around the clock for complete relief.  On 30 October 2003, at 3:00AM, the vaccinee experienced intense itching and burning of her hands and soles of her feet.  The vaccinee was using terbinafine hydrochloride on her feet.  It was the vaccinee's first influenza vaccine.  The vaccinee planned to discuss her symptoms with her physician. Follow up pending.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: A report was received from a healthcare professional on 04 November 2003 concerning a 30 year old female vaccinee who experienced chest tightness and difficulty in breathing which was considered to be medically significant 15 to 20 minutes after receiving Fluvirin vaccine on 04 November 2003. On 04 November 2003 the vaccinee developed chest tightness and difficulty in breathing within 15 to 20 minutes of receiving Fluvirin.  The vaccinee was administered one dose of diphenhydramine hydrochloride and her symptoms resolved on 04 November 2003. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site reaction, Pain
Clinical narrative: A report was received from a health care professional on 11/07/03, concerning a 58 year old female vaccinee who developed a hard knot at the site of injection and skin discoloration around injection site 4 to 5 hours later, also pain later that night. A swollen and red arm with ecchymosis a day after receiving Fluvirin on 10/20/03. On 10/20/03, the vaccinee developed a hard knot at the site of injection. The skin around the injection site appeared red/blue in color. Later that night, the vaccinee experienced pain and could not move her arm. On the morning of 10/21/03 the red/blue color spread from the injection site down her elbow. The vaccinee's are was severely swollen and red. On 10/24/2003, the vaccinee was seen by the reporter for dialysis who described the condition as a red blue ecchymosis, which covered the entire upper arm. The vaccinee was seen in the emergency room and instructed to apply warm pads to the affected area and was prescribed hydrocodone acetaminophen for the pain. At the time of the report, the vaccinee's are was less swollen and painful but the red/blue color remained and there was no change in the size of the ecchymosis. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration, Swelling
Clinical narrative: A report was received from a health care professional on 11/07/03, concerning a 58 year old female vaccinee who developed a hard knot at the site of injection and skin discoloration around injection site 4 to 5 hours later, also pain later that night. A swollen and red arm with ecchymosis a day after receiving Fluvirin on 10/20/03. On 10/20/03, the vaccinee developed a hard knot at the site of injection. The skin around the injection site appeared red/blue in color. Later that night, the vaccinee experienced pain and could not move her arm. On the morning of 10/21/03 the red/blue color spread from the injection site down her elbow. The vaccinee's are was severely swollen and red. On 10/24/2003, the vaccinee was seen by the reporter for dialysis who described the condition as a red blue ecchymosis, which covered the entire upper arm. The vaccinee was seen in the emergency room and instructed to apply warm pads to the affected area and was prescribed hydrocodone acetaminophen for the pain. At the time of the report, the vaccinee's are was less swollen and painful but the red/blue color remained and there was no change in the size of the ecchymosis. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 56.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Back pain, CSF test abnormal, Dysphonia, Guillain-Barre syndrome
Clinical narrative: A report was received from a non-health care professional on behalf of the vaccinee who is a physician on 11/21/03 concerning a 56 year old male vaccinee who experienced weakness in his arms and legs which progressed to weakness all over his body, and was diagnosed with Guillain Barre Syndrome, which was considered to be medically significant (OMIC), approximately 2 weeks after receiving Fluvirin vaccine on 10/16/03. Approximately 2 weeks after receiving Fluvirin the vaccinee complained of weakness in his arms, which progressed to his legs and currently the vaccinee complains of feeling weak all over his body. The weakness in his hands has improved. The vaccinee sought medical attention and was subsequently diagnosed with Guillain Barre Syndrome. Treatment for the event included IV immunoglobulin (5 doses). The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 12/16/03: Further information received from a health care professional, who is the vaccinee, indicated that he experienced Guillain Barre Syndrome with a typical clinical presentation from 11/6/03, which was considered disabling and resulted in hospitalization on 11/21/03. CSF laboratory findings were confirmatory. An MRI of the cervical and thoracic spine was negative. The vaccinee was treated with IV immunoglobulin for 5 days. The vaccinee was discharged from hospital on 11/23/03. The vaccinee had not recovered at the time of the report. The vaccinee has a relevant medical history of hypertension and co-medications included Ramipril, Esomeprazole, Azithromycin from 10/20/03 to 10/24/03 for bronchitis and levofloxacin from 10/25/03 to 11/5/03 for bronchitis. The vaccinee had previous exposure to Fluvirin and did not experience similar events. The reporter as assessed the relationship of the vaccine to the Guillain Barre Syndrome as probable. Update 1/21/04: Further information was received from a health care professional on 1/21/04 indicating that the vaccinee experienced Guillain Barre Syndrome on 11/7/03 with classic clinical presentation. The vaccinee was treated with IV immunoglobulin from 11/14/03 to 11/18/03 and gabepentin from 12/03 and ongoing. The vaccinee had no previous episodes of Guillain Barre Syndrome. The vaccinee continues to have generalized muscle weakness, paresthesia and numbness. The vaccinee was treated with uvulopharyngopalato-plasty for sleep apnea in April 2003 and cefalexin monohydrate, azithromycin and doxycycline for an upper respiratory infection in October 2003. Follow up pending.
Age: 56.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Hypotension, Muscle atrophy
Clinical narrative: A report was received from a non-health care professional on behalf of the vaccinee who is a physician on 11/21/03 concerning a 56 year old male vaccinee who experienced weakness in his arms and legs which progressed to weakness all over his body, and was diagnosed with Guillain Barre Syndrome, which was considered to be medically significant (OMIC), approximately 2 weeks after receiving Fluvirin vaccine on 10/16/03. Approximately 2 weeks after receiving Fluvirin the vaccinee complained of weakness in his arms, which progressed to his legs and currently the vaccinee complains of feeling weak all over his body. The weakness in his hands has improved. The vaccinee sought medical attention and was subsequently diagnosed with Guillain Barre Syndrome. Treatment for the event included IV immunoglobulin (5 doses). The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 12/16/03: Further information received from a health care professional, who is the vaccinee, indicated that he experienced Guillain Barre Syndrome with a typical clinical presentation from 11/6/03, which was considered disabling and resulted in hospitalization on 11/21/03. CSF laboratory findings were confirmatory. An MRI of the cervical and thoracic spine was negative. The vaccinee was treated with IV immunoglobulin for 5 days. The vaccinee was discharged from hospital on 11/23/03. The vaccinee had not recovered at the time of the report. The vaccinee has a relevant medical history of hypertension and co-medications included Ramipril, Esomeprazole, Azithromycin from 10/20/03 to 10/24/03 for bronchitis and levofloxacin from 10/25/03 to 11/5/03 for bronchitis. The vaccinee had previous exposure to Fluvirin and did not experience similar events. The reporter as assessed the relationship of the vaccine to the Guillain Barre Syndrome as probable. Update 1/21/04: Further information was received from a health care professional on 1/21/04 indicating that the vaccinee experienced Guillain Barre Syndrome on 11/7/03 with classic clinical presentation. The vaccinee was treated with IV immunoglobulin from 11/14/03 to 11/18/03 and gabepentin from 12/03 and ongoing. The vaccinee had no previous episodes of Guillain Barre Syndrome. The vaccinee continues to have generalized muscle weakness, paresthesia and numbness. The vaccinee was treated with uvulopharyngopalato-plasty for sleep apnea in April 2003 and cefalexin monohydrate, azithromycin and doxycycline for an upper respiratory infection in October 2003. Follow up pending.
Age: 56.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: A report was received from a non-health care professional on behalf of the vaccinee who is a physician on 11/21/03 concerning a 56 year old male vaccinee who experienced weakness in his arms and legs which progressed to weakness all over his body, and was diagnosed with Guillain Barre Syndrome, which was considered to be medically significant (OMIC), approximately 2 weeks after receiving Fluvirin vaccine on 10/16/03. Approximately 2 weeks after receiving Fluvirin the vaccinee complained of weakness in his arms, which progressed to his legs and currently the vaccinee complains of feeling weak all over his body. The weakness in his hands has improved. The vaccinee sought medical attention and was subsequently diagnosed with Guillain Barre Syndrome. Treatment for the event included IV immunoglobulin (5 doses). The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 12/16/03: Further information received from a health care professional, who is the vaccinee, indicated that he experienced Guillain Barre Syndrome with a typical clinical presentation from 11/6/03, which was considered disabling and resulted in hospitalization on 11/21/03. CSF laboratory findings were confirmatory. An MRI of the cervical and thoracic spine was negative. The vaccinee was treated with IV immunoglobulin for 5 days. The vaccinee was discharged from hospital on 11/23/03. The vaccinee had not recovered at the time of the report. The vaccinee has a relevant medical history of hypertension and co-medications included Ramipril, Esomeprazole, Azithromycin from 10/20/03 to 10/24/03 for bronchitis and levofloxacin from 10/25/03 to 11/5/03 for bronchitis. The vaccinee had previous exposure to Fluvirin and did not experience similar events. The reporter as assessed the relationship of the vaccine to the Guillain Barre Syndrome as probable. Update 1/21/04: Further information was received from a health care professional on 1/21/04 indicating that the vaccinee experienced Guillain Barre Syndrome on 11/7/03 with classic clinical presentation. The vaccinee was treated with IV immunoglobulin from 11/14/03 to 11/18/03 and gabepentin from 12/03 and ongoing. The vaccinee had no previous episodes of Guillain Barre Syndrome. The vaccinee continues to have generalized muscle weakness, paresthesia and numbness. The vaccinee was treated with uvulopharyngopalato-plasty for sleep apnea in April 2003 and cefalexin monohydrate, azithromycin and doxycycline for an upper respiratory infection in October 2003. Follow up pending.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site necrosis, Injection site pain
Clinical narrative: A report was received from another pharmaceutical company on 15Jan04 concerning a 59 year old female vaccinee who experienced redness and pain at the injection site and a 2"x 2 1/2" necrotic area at the injection site on 18Nov02, which was considered medically significant and required surgical intervention, after receiving influenza vaccine (brand unspecified) and Pneumovax 23 on 13Nov02 at 13:30 hours. The vaccinee has a medical history of allergy (comatose) to codeine. On 13No02 the vaccinee was administered influenza vaccine (brand unspecified) and pneumococcal 23v polysaccharide vaccine in the same site. The vaccinee experienced redness and pain at the injection site an unspecified length of time following vaccination. Unspecified medical attention was sought. On 18Nov02 the vaccinee had developed a 2"x 2 1/2" necrotic area at the injection site, which was surgically removed 2 weeks later. The outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 7.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Cough, Erythema multiforme, Pyrexia, Rhinorrhoea, Urticaria
Clinical narrative: This is a non serious case from a medical assistant in the USA who reports a patient experienced a red, raised rash after receiving FluMist. This case is submitted according to the safety surveillance accelerated reporting agreement for FluMist. The reporter did not provide causality between events and FluMist. Within 48 hours of receiving FluMist on 10/26/04, a 7 year old male experienced a red, raised rash and itching. He was treated with Benadryl and recovered after four or five days. 10Feb05 additional informatin received: Pt's date of birth, exact onset time and time of Flumist administration was not recorded.
Age: 7.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: This is a non serious case from a medical assistant in the USA who reports a patient experienced a red, raised rash after receiving FluMist. This case is submitted according to the safety surveillance accelerated reporting agreement for FluMist. The reporter did not provide causality between events and FluMist. Within 48 hours of receiving FluMist on 10/26/04, a 7 year old male experienced a red, raised rash and itching. He was treated with Benadryl and recovered after four or five days. 10Feb05 additional informatin received: Pt's date of birth, exact onset time and time of Flumist administration was not recorded.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis, Blood uric acid increased
Clinical narrative: A report was received from a health care professional on 01Oct03 concerning a male vaccinee of unk age who developed arthritis and joint pain on his ankle an unspecified length of time after receiving Fluvirin vaccine on an unk date. On an unk date the vaccinee received a dose of Fluvirin vaccine and developed arthritis and joint pain on his ankle. The vaccinees symptoms had been resolving gradually at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up information received from a health care professional indicated that the vaccinee experienced inflammation of the right ankle joint on 30Sep03 following vaccination the previous day. Uric acid crystals were seen in the fluid but serum uric acid was 5.4. The vaccinees symptoms resolved in a week following treatment with NSAIDS. The reporter has assessed the relationship of the vaccine to the event as possible. All information received, no follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Confusional state, Encephalopathy
Clinical narrative: A report was received from a health care professional on 21 October 2003 concerning a vaccinee of unknown demography who experienced confusion and encephalopathy and was hospitalized an unspecified length of time after receiving Fluvirin on an unspecified date. On an unspecified date the vaccinee experienced confusion and encephalopathy. The vaccinee was admitted to hospital on an unspecified date. The outcome of the events were not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Dyspnoea, Flushing, Heart rate increased
Clinical narrative: A report was received from a health care professional on 07 November 2003 concerning a 33 year old male vaccinee who experienced sweating, shortness of breath, flushing, and later developed redness and swelling at the injection site, which was considered to be medically significant, on 06 November 2003 after receiving Fluvirin vaccine on the same day. On 06 November 2003 the vaccinee immediately experienced sweating, shortness of breath and flushing after vaccination and was admitted to the local emergency department where the attending physician informed the nursing staff that the vaccinee had a localized reaction. Later during the hospital visit, the vaccinee developed redness and swelling at the injection site. The vaccinee's symptoms resolved on the same day and he was discharged from the hospital. There was insufficient information to determine the reporter's causality assessment. Update 1, 12 December 2003: Further information was received from a health care professional indicating that the vaccinee experienced itching and swelling of his right arm, a sensation of throat swelling but no physical evidence of the neck or throat , with difficulty speaking, dizziness, cold chills and sweats within 20 minutes of receiving Fluvirin on 06 November 2003. The vaccinee's symptoms resolved on the same day. The vaccinee has a medical history of non-insulin dependent diabetes mellitus. Medications included fenofibrate, rosiglitance maleate, clomifene citrate and multivitamins. It was noted that the vaccinee became anxious  and nervous prior to Fluvirin administration and kept "clearing his throat". The ER report confirmed that the vaccinee experienced a local reaction to a flu vaccine.. The vaccinee was treated with hydroxyzine embonate and triamcinolone acetonide. The vaccine had previously received flu vaccine several years ago and had soreness of the arm but no noticeable reaction. Update 2, 02 April 2004: Further information was received from a health care professional indicating that the vaccinee experienced an allergic reaction to the Flu vaccine with symptoms of nausea, extreme pain in his right arm and neck pain on 06 November 2003. The vaccinee was also treated with hydroxyzine hydrochloride 25mg as required. On 06 November 2003 at 15:35, the vaccinee's blood pressure was 151/92mmHg, pulse rate was 72 bpm and respiratory rate was 20/min. The vaccinee was discharged at 17:04 and advised to return to the emergency room if he experienced any further problems. The vaccinee has a further medical history of heart murmur and high cholesterol. The vaccinee had no known allergies and no swelling of larynx was seen. No follow up pending, no further information available.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Hypersensitivity, Hypertension, Injection site erythema, Injection site reaction
Clinical narrative: A report was received from a health care professional on 07 November 2003 concerning a 33 year old male vaccinee who experienced sweating, shortness of breath, flushing, and later developed redness and swelling at the injection site, which was considered to be medically significant, on 06 November 2003 after receiving Fluvirin vaccine on the same day. On 06 November 2003 the vaccinee immediately experienced sweating, shortness of breath and flushing after vaccination and was admitted to the local emergency department where the attending physician informed the nursing staff that the vaccinee had a localized reaction. Later during the hospital visit, the vaccinee developed redness and swelling at the injection site. The vaccinee's symptoms resolved on the same day and he was discharged from the hospital. There was insufficient information to determine the reporter's causality assessment. Update 1, 12 December 2003: Further information was received from a health care professional indicating that the vaccinee experienced itching and swelling of his right arm, a sensation of throat swelling but no physical evidence of the neck or throat , with difficulty speaking, dizziness, cold chills and sweats within 20 minutes of receiving Fluvirin on 06 November 2003. The vaccinee's symptoms resolved on the same day. The vaccinee has a medical history of non-insulin dependent diabetes mellitus. Medications included fenofibrate, rosiglitance maleate, clomifene citrate and multivitamins. It was noted that the vaccinee became anxious  and nervous prior to Fluvirin administration and kept "clearing his throat". The ER report confirmed that the vaccinee experienced a local reaction to a flu vaccine.. The vaccinee was treated with hydroxyzine embonate and triamcinolone acetonide. The vaccine had previously received flu vaccine several years ago and had soreness of the arm but no noticeable reaction. Update 2, 02 April 2004: Further information was received from a health care professional indicating that the vaccinee experienced an allergic reaction to the Flu vaccine with symptoms of nausea, extreme pain in his right arm and neck pain on 06 November 2003. The vaccinee was also treated with hydroxyzine hydrochloride 25mg as required. On 06 November 2003 at 15:35, the vaccinee's blood pressure was 151/92mmHg, pulse rate was 72 bpm and respiratory rate was 20/min. The vaccinee was discharged at 17:04 and advised to return to the emergency room if he experienced any further problems. The vaccinee has a further medical history of heart murmur and high cholesterol. The vaccinee had no known allergies and no swelling of larynx was seen. No follow up pending, no further information available.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Nausea, Pain, Pruritus, Respiratory rate increased
Clinical narrative: A report was received from a health care professional on 07 November 2003 concerning a 33 year old male vaccinee who experienced sweating, shortness of breath, flushing, and later developed redness and swelling at the injection site, which was considered to be medically significant, on 06 November 2003 after receiving Fluvirin vaccine on the same day. On 06 November 2003 the vaccinee immediately experienced sweating, shortness of breath and flushing after vaccination and was admitted to the local emergency department where the attending physician informed the nursing staff that the vaccinee had a localized reaction. Later during the hospital visit, the vaccinee developed redness and swelling at the injection site. The vaccinee's symptoms resolved on the same day and he was discharged from the hospital. There was insufficient information to determine the reporter's causality assessment. Update 1, 12 December 2003: Further information was received from a health care professional indicating that the vaccinee experienced itching and swelling of his right arm, a sensation of throat swelling but no physical evidence of the neck or throat , with difficulty speaking, dizziness, cold chills and sweats within 20 minutes of receiving Fluvirin on 06 November 2003. The vaccinee's symptoms resolved on the same day. The vaccinee has a medical history of non-insulin dependent diabetes mellitus. Medications included fenofibrate, rosiglitance maleate, clomifene citrate and multivitamins. It was noted that the vaccinee became anxious  and nervous prior to Fluvirin administration and kept "clearing his throat". The ER report confirmed that the vaccinee experienced a local reaction to a flu vaccine.. The vaccinee was treated with hydroxyzine embonate and triamcinolone acetonide. The vaccine had previously received flu vaccine several years ago and had soreness of the arm but no noticeable reaction. Update 2, 02 April 2004: Further information was received from a health care professional indicating that the vaccinee experienced an allergic reaction to the Flu vaccine with symptoms of nausea, extreme pain in his right arm and neck pain on 06 November 2003. The vaccinee was also treated with hydroxyzine hydrochloride 25mg as required. On 06 November 2003 at 15:35, the vaccinee's blood pressure was 151/92mmHg, pulse rate was 72 bpm and respiratory rate was 20/min. The vaccinee was discharged at 17:04 and advised to return to the emergency room if he experienced any further problems. The vaccinee has a further medical history of heart murmur and high cholesterol. The vaccinee had no known allergies and no swelling of larynx was seen. No follow up pending, no further information available.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Speech disorder, Vaccine positive rechallenge
Clinical narrative: A report was received from a health care professional on 07 November 2003 concerning a 33 year old male vaccinee who experienced sweating, shortness of breath, flushing, and later developed redness and swelling at the injection site, which was considered to be medically significant, on 06 November 2003 after receiving Fluvirin vaccine on the same day. On 06 November 2003 the vaccinee immediately experienced sweating, shortness of breath and flushing after vaccination and was admitted to the local emergency department where the attending physician informed the nursing staff that the vaccinee had a localized reaction. Later during the hospital visit, the vaccinee developed redness and swelling at the injection site. The vaccinee's symptoms resolved on the same day and he was discharged from the hospital. There was insufficient information to determine the reporter's causality assessment. Update 1, 12 December 2003: Further information was received from a health care professional indicating that the vaccinee experienced itching and swelling of his right arm, a sensation of throat swelling but no physical evidence of the neck or throat , with difficulty speaking, dizziness, cold chills and sweats within 20 minutes of receiving Fluvirin on 06 November 2003. The vaccinee's symptoms resolved on the same day. The vaccinee has a medical history of non-insulin dependent diabetes mellitus. Medications included fenofibrate, rosiglitance maleate, clomifene citrate and multivitamins. It was noted that the vaccinee became anxious  and nervous prior to Fluvirin administration and kept "clearing his throat". The ER report confirmed that the vaccinee experienced a local reaction to a flu vaccine.. The vaccinee was treated with hydroxyzine embonate and triamcinolone acetonide. The vaccine had previously received flu vaccine several years ago and had soreness of the arm but no noticeable reaction. Update 2, 02 April 2004: Further information was received from a health care professional indicating that the vaccinee experienced an allergic reaction to the Flu vaccine with symptoms of nausea, extreme pain in his right arm and neck pain on 06 November 2003. The vaccinee was also treated with hydroxyzine hydrochloride 25mg as required. On 06 November 2003 at 15:35, the vaccinee's blood pressure was 151/92mmHg, pulse rate was 72 bpm and respiratory rate was 20/min. The vaccinee was discharged at 17:04 and advised to return to the emergency room if he experienced any further problems. The vaccinee has a further medical history of heart murmur and high cholesterol. The vaccinee had no known allergies and no swelling of larynx was seen. No follow up pending, no further information available.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Angioneurotic oedema, Face oedema, Medication error, Tongue oedema, Urticaria
Clinical narrative: A report was received from a health care professional on 19 November 2003, concerning a 49 year old female vaccinee who experienced angioedema which was considered to be medically significant (OMIC) the day after inadvertently receiving Fluvirin intradermally on 14 November 2003. The vaccinee had an allergy to co-trimoxazole and has no concomitant medications. On 15 November 2003 the vaccinee experienced angioedema with generalized urticaria and swelling of the lips and tongue after inadvertently receiving Fluvirin intradermally. The vaccinee was treated with diphenhydramine. At the time of the report the angioedema was improved nut continuing. There was insufficient information to determine the reporter's causality assessment. Follow-up pending. See ref: PJP-2003-01116.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Angioneurotic oedema, Medication error, Oedema, Pruritus, Rash macular
Clinical narrative: A report was received from health care professional on 19 November 2003, concerning a 54 year old male vaccinee who experienced angioedema which was considered to be medically significant (OMIC) the day after inadvertently receiving Fluvirin intradermally on 14 November 2003. On 15 November 2003 the vaccinee experienced angioedema with generalized blotchy edema and pruritus after inadvertently receiving Fluvirin intradermally. The vaccinee was treated with cetirizine hydrochloride. At the time of the report the angioedema was improved but continuing. There was insufficient information to determine the reporter's causality assessment. Follow-up pending. See ref: PJP-2003-0115.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: A report was received from a health care professional on 25 November 2003 concerning a 69 year old male vaccinee who experienced Guillain-Barre Syndrome, requiring hospitalization an unspecified length of time after receiving Fluvirin on an unspecified date. On unspecified date the vaccinee experienced GBS. The vaccinee was hospitalized on an unspecified date. The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: A report was received from a health care professional on 6 January 2003, concerning a male vaccine of approximately 30 years of age who experienced Guillain-Barre Syndrome, and was hospitalized approximately 2-3 weeks after receiving Fluvirin on 20 November 2003. On an unspecified date in 2003, 2-3 weeks after receiving Fluvirin the vaccinee experienced symptoms of GBS. The vaccinee was hospitalized on an unspecified date. The vaccinee experienced symptoms of GBS primarily in the lower extremities. The symptoms had not resolved at the time of the report. The vaccinee had received influenza vaccine (brand unspecified) in the past without any adverse events occurring. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 9/2/03, concerning a 52 year old female vaccinee who inadvertently received expired Fluvirin vaccine on 9/2/03. On 9/2/03, the vaccinee inadvertently received Fluvirin vaccine. No adverse event was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Update 2/16/04: A follow up report was received from a health care professional indicating that no adverse event had occurred at the time of reporting. No follow up pending, all information received. See PJP200300722 and PJP200300723.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 9/2/03 concerning a 52 year old male vaccinee who inadvertently received expired Fluvirin vaccine on 9/2/03. On 9/2/03, the vaccinee inadvertently received 2002-2003 Fluvirin vaccine. No adverse event was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Update 2/16/04: A follow up report was received from a health care professional indicating that no adverse event had occurred at the time of reporting. No follow up pending, all information received. See PJP200300721 and PJP200300722.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 9/15/03 concerning a 86 year old female vaccinee who inadvertently received 2 doses of Fluvirin vaccine, one on 9/4/03 and one on 9/15/03. On 9/4/03 and 9/15/03, the vaccinee inadvertently received 2 doses of Fluvirin (one on 9/4/03 and one on 9/15/03). At the time of the report the vaccinee had not experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Hypoaesthesia, Throat tightness
Clinical narrative: A report was received from a health care professional on 9/26/03 concerning a 33 year old female vaccinee who experienced metallic taste in her mouth, tightness in her throat, left arm numbness, left hand numbness and numbness of the fingers on her left hand two hours after receiving Fluvirin on 9/25/03. On 9/25/03, the vaccinee experienced metallic taste in her mouth, tightness in her throat and left arm numbness radiating to the hands and fingers. There was no wheezing or shortness of breath. The vaccinee received the injection to her left deltoid muscle. The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 0.59
Sex: F
Vaccine: DTP, FLU3, HEP, HIBV
Symptoms: Medication error, Rash
Clinical narrative: A report was received from a health care professional on 9/29/03 concerning a 7 month old female vaccinee who inadvertently received Fluvirin on 9/29/03. On 9/29/03, the vaccinee inadvertently received Fluvirin IM in the right thigh. There was insufficient information to determine the reporter's causality assessment. Update 10/20/03: Further information received from a health care professional on 10/20/03 indicated that the vaccinee developed a slight chest rash on day two which resolved following treatment with topical Benadryl and hydrocortisone cream. No follow up pending, all information received.
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Injection site erythema, Injection site swelling, Malaise, Pyrexia
Clinical narrative: A report was received from a healthcare professional on 9/29/03 concerning a female vaccinee in her mid 40's who experienced injection site reaction with redness, swelling, fever, malaise, and loss of voice one day after receiving Fluvirin on 9/26/03. On 9/27/03, the vaccinee experienced injection site reaction with redness, swelling, fever, malaise, and loss of voice. The swelling had resolved at the time of the report, but the other symptoms continued. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200300731 and PJP200300732. Follow up pending.
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Injection site erythema, Injection site pain, Injection site reaction, Pain
Clinical narrative: A report was received from a health care professional on 9/29/03 concerning a female vaccinee in her 30's who experienced injection site reaction with redness and soreness, decreased appetite and mild total body ache one day after receiving Fluvirin on 9/26/03. On 9/27/03, the vaccinee experienced injection site reaction with redness and soreness, decreased appetite and mild total body ache. The events resolved on an unspecified date. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200300732, PJP200300730. Follow up pending.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: A report was received from a health care professional on 9/29/03 concerning a 36 year old female vaccinee who experienced arm pain within 2 hours of receiving Fluvirin on 9/26/03. On 9/26/03, the vaccinee's entire arm, from the injection site to the fingertips hurt. The event resolved on 9/27/03. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200300731 and PJP200300730. Follow up pending.
Age: 1.0
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 09/19/2003 concerning an 18 month old vaccinee of unknown sex who inadvertently received Fluvirin on an unspecified date.  On an unspecified date the vaccinee inadvertently received Fluvirin.  There was insufficient information to determine the reporter's causality assessment.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Pruritus, Swelling
Clinical narrative: A report was received from a healthcare professional on 09/30/2003 concerning a 75 year old female vaccinee who experienced itching of both feet 3 days after, and swelling of the feet, blistering of the feet and weeping of the feet 4 days after receiving Fluvirin on 09/25/2003.  On 09/28/2003 the vaccinee developed itching of both feet, which progressed to swelling, blistering and weeping on 09/29/2003.  There was a mild improvement on 09/30/2003.  The vaccinee was self-treating with warm soaks.  The reaction involved the distal portion of both feet, (tarsals/metartals) and dorsal and plantar surfaces of both feet.  The vaccinee had not recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment.   Update 1, 10/07/2003: Follow up information was received from a healthcare professional on 10/07/2003, indicating that the vaccinee's feet had improved but were still itchy.  On 09/30/2003, the vaccinee was prescribed one Methylprednisone dose pack.  The vaccinee is currently taking Levothyroxine, Atorvastatine, Amlodipine besilate and Estradiol oral therapy.  The vaccinee has no drug allergies and no significant past medical history. Update 2, 10/20/2003: Further information recieved from a healthcare professional on 10/20/2003 indicated that the vaccinee experienced itching and blistering of both feet on 09/27/2003.  Additionally, the vaccinee was currently taking Omeprazole oral therapy.  No follow up pending, all information received.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: A report was received from a healthcare professional on 09/30/2003 concerning a female vaccinee in her mid thirties who experienced an injection site wheal with redness, swelling and warmth when receiving Fluvirin on 09/30/2003.  The vaccinee also received less than the recommended dosage.  On 09/30/2003 the vaccinee experienced welting of the injection site during Fluvirin administration.  The vaccinee received Fluvirin intramuscularly in the left deltoid.  Approximately half way through administration the injection site because red and swollen.  The administration was stopped.  The vaccinee received approximately 0.25ml Fluvirin.  The area around the injection site felt warm and looked like a "mosquito bite".  The vaccinee recovered on 09/30/2003.  There was insufficient information to determine the reporter's causality assessment.   Follow up pending. Update 1, 10/13/2003: A follow up report was received from a healthcare professional indicating that the 32 year old female vaccinee experienced an injection site wheal, eryhtema, and warmth.  The vaccinee was administered the second half of the dose on 10/01/2003 when it was certain that the redness and skin reaction had regressed.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/02/2003 concerning an unspecified number of vaccinees under the age of 4 years who were inadvertently administered Fluvirin between 09/26/2003 and 10/01/2003.  Between 09/26/2003 and 10/01/2003 an unspecified number of vaccinees under the age of four years inadvertently received Fluvirin.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/02/2003 concerning a group of 40 vaccinees who inadvertently received 1.5ml Fluvirin instead of the recommended 0.5ml from 10/01/2003 onwards. From 10/01/2003 onwards 40 vaccinees inadvertently received 1.5ml Fluvirin. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 10/10/2003: A follow up report received from a healthcare professional indicated that the vaccinees were aged between 61 and 95 years of age.  There were 31 females and 9 males.  No adverse events were reported in association with the incident.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Medication error, Pain
Clinical narrative: A report was received from a healthcare professional on 10/02/2003 concerning a 35 year old female vaccinee who experienced malaise, soreness at the injection site and developed mild to moderate total body ache after inadvertently receiving expired Fluvirin vaccine on 09/30/2003. On 09/30/2003, the vaccinee felt ill, had mild to moderate total body ache on 10/01/2003 and had soreness at the injection site a couple of hours following vaccination.  The body ache had improved at the time of the report, however the soreness was continuing at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/02/2003: Further information was received from a healthcare professional on 01/02/2004 indicating that the vaccinee received Fluvirin on approximately 10/01/2003.  The vaccinee experienced redness on her arm and soreness the following day 10/02/2003.  The redness on the arm and the soreness resolved 2-3 days later.   Follow up pending.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/02/2003 concerning a 55 year old female vaccinee who experienced redness at the injection site an unspecified length of time after inadvertently receiving expired Fluvirin vaccine on 09/30/2003. On 09/30/2003 the vaccinee inadvertently received expired Fluvirin vaccine and an unspecified time later the vaccinee experienced redness at the injection site.  The outcome was unknown at the time of the report. There was insufficient information to determine the reporter's causality assessment.
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/02/2003 concerning a male vaccinee in his 50's who inadvertently received expired Fluvirin vaccine on 09/30/2003. On 09/30/2003 the vaccinee inadvertently received expired Fluvirin vaccine.  No adverse reaction had occurred at the time of the report. There was insufficient information to determine the reporter's causality assessment.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperglycaemia
Clinical narrative: A report was received from a healthcare professional on 10/03/2003 concerning a 73 year old female vaccinee who experienced hyperglycemia in the evening of 10/02/2003 after receiving Fluvirin vaccine in the afternoon of 10/02/2003. On 10/02/2003, the vaccinee was administered Fluvirin vaccine in the afternoon and later that evening the vaccinee noted that her finger stick blood sugar tests were reading 400mg/dl.  The tests were repeated twice and they all yielded a result in the 400mg/dl range.  The vaccinee self administered an extra 10 units of insulin subcutaneously as a result of her hyperglycemia.  The vaccinee did not exhibit any outward signs or symptoms of hyperglycemia.  The vaccinee did not exhibit any outward signs or symptoms hyperglycemia.  On the morning of 10/03/2003, the vaccinee's fasting blood glucose was approximately 50mg/dl.  Her normal fasting blood glucose is between 50mg/dl to 80mg/dl.  The vaccinee's normal dose of insulin of 40 units subcutaneously every morning was resumed.  The vaccinee has had perfect control of her diabetes for 5 years.  The outcome of the event was not reported.   There was insufficient information to determine the reporter's causality assessment. Update 1, 11/10/2003: Further information received from a healthcare professional on 11/10/2003 indicated that the vaccinee developed a fasting blood glucose of 400mg/dl on 10/03/2003, which resolved the following morning on 10/04/2003 following an extra insulin dose. No follow up pending.