chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: A report was received from a health care professional on 10/29/03 concerning an unspecified number of vaccinees of unspecified demography who experienced localized hives, swelling, redness and itching an unspecified length of time after receiving Fluvirin on an unknown date. On an unknown date an unspecified number of vaccinees experienced localized hives, swelling, redness and itching on an unspecified length of time after receiving Fluvirin. The reporter noted many more local adverse effects than usual with the 2003-2004 Fluvirin. It was not reported if the vaccinee's had recovered at the time of the report. There was insufficient information to determine the reporter's causality. Update 2/16/04: A follow up report was received from a health care professional concerning a 39 year old female vaccinee who developed an injection site that was warm to touch. The vaccinee also experienced redness and itching after receiving Fluvirin on 10/14/03. The outcome of the adverse events was not reported at the time of reporting. Update 4/16/04: Further follow up information received from a health care professional indicated that the vaccinee's symptoms resolved and no further symptoms were reported as of 4/04. No follow up pending. All information received.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: A report was received from a health care professional on 10/29/03 concerning an unspecified number of vaccinees of unspecified demography who experienced localized hives, swelling, redness and itching an unspecified length of time after receiving Fluvirin on an unknown date. On an unknown date an unspecified number of vaccinees experienced localized hives, swelling, redness and itching on an unspecified length of time after receiving Fluvirin. The reporter noted many more local adverse effects than usual with the 2003-2004 Fluvirin. It was not reported if the vaccinee's had recovered at the time of the report. There was insufficient information to determine the reporter's causality. Update 2/16/04: A follow up report was received from a health care professional concerning a 39 year old female vaccinee who developed an injection site that was warm to touch. The vaccinee also experienced redness and itching after receiving Fluvirin on 10/14/03. The outcome of the adverse events was not reported at the time of reporting. Update 4/16/04: Further follow up information received from a health care professional indicated that the vaccinee's symptoms resolved and no further symptoms were reported as of 4/04. No follow up pending. All information received.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 2/24/04 concerning a 61 year old male vaccinee who inadvertently received expired Fluvirin on an unspecified date in September 2003. On an unspecified date in September 2003, the vaccinee was inadvertently administered a dose of 2002-2003 Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 2/24/04 concerning a 16 year old female vaccinee who inadvertently received expired Fluvirin on an unspecified date in September 2003. On an unspecified date in September 2003, the vaccinee was inadvertently administered a dose of 2002-2003 Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 2/24/04 concerning a 46 year old female vaccinee who inadvertently received expired Fluvirin on an unspecified date in September 2003. On an unspecified date in September 2003, the vaccinee was inadvertently administered a dose of 2002-2003 Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was 47 month old female who inadvertently received 0.5ml Fluvirin on 12/10/03. No adverse events were reported at the time of the event. No follow up pending. All information received.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12/8/03 concerning five children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information received from a health care professional indicated that a 3 year old male vaccinee inadvertently received Fluvirin on 12/6/03. No adverse reactions have been reported to date. No follow up pending. All information received.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12/8/03 concerning 5 children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information received from a health care professional indicated that a 3.5 year old female vaccinee inadvertently received Fluvirin on 12/6/03. No adverse events have been reported to date. No follow up pending. All information received.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12/8/03 concerning 5 children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report, no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information received from a health care professional indicated that a 2.5 year old female vaccinee inadvertently received Fluvirin on 12/6/03. No adverse events have been reported to date. No follow up pending. All information received.
Age: 1.56
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12/8/03 concerning 5 children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information received from a health care professional indicated that a 1.5 year old male vaccinee inadvertently received Fluvirin on 12/6/03. No adverse events have been reported to date. No follow up pending. All information received.
Age: 1.6
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12/8/03 concerning 5 children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information was received from a health care professional indicated that a 1.5 year old male vaccinee inadvertently received Fluvirin on 12/6/03. No adverse events have been reported to date. No follow up pending. All information received.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12/8/03 concerning 5 children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information received from a health care professional indicated that a 2.5 year old male vaccinee inadvertently received Fluvirin on 12/6/03. No adverse events have been reported to date. No follow up pending. All information received.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 3/1/04 concerning a 2.5 year old female vaccinee who inadvertently received Fluvirin on 12/4/03. On 12/4/03, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending. All information received.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 3 and half year old male who inadvertently received 0.5ml Fluvirin on 12/30/03. No adverse events were reported at the time of the event. No follow up pending. All information received.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 39.5 month old male who inadvertently received 0.5ml Fluvirin on 1/23/04. No adverse events were reported at the time of the event. No follow up pending. All information received.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 40 month old male who inadvertently received 0.5ml Fluvirin on 12/24/03. No adverse events were reported at the time of the event. No follow up pending. All information received.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 40 month old female who inadvertently received 0.5ml Fluvirin on 1/15/04. No adverse events were reported at the time of the event. No follow up pending. All information received.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 39 month old female who inadvertently received 0.5ml Fluvirin on 12/15/03. No adverse events were reported at the time of the event. No follow up pending. All information received.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 45 month old female who inadvertently received 0.5ml Fluvirin on 1/12/04. No adverse events were reported at the time of the event. No follow up pending. All information received.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 47 month old male who inadvertently received 0.5ml Fluvirin on 12/18/03. No adverse event were reported at the time of the event. No follow up pending. All information received.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: A report was received from a health care professional on 3/22/04 concerning a 65 year old female vaccinee who experienced on 11/21/03 a sore throat, productive cough, and nasal drainage after receiving Fluvirin on 11/12/03. On 11/21/03, the vaccinee experienced a sore throat, productive cough and nasal drainage. The vaccinee recovered from all events on 11/26/03. There was insufficient information to determine the reporter's causality assessment. No follow up pending. All information received.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 2 year old female vaccinee inadvertently received 0.25ml Fluvirin on 10/30/03. The vaccinee did not experience any adverse symptoms as a result. Follow up pending.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 3 year old male vaccinee inadvertently received 0.5ml Fluvirin on 11/12/03. The vaccinee did not experience any adverse symptoms as a result. Follow up pending.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 2 year old male vaccinee inadvertently received 0.25ml Fluvirin on 12/2/03. The vaccinee did not experience any adverse symptoms as a result. Follow up pending.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 2 year old female vaccinee inadvertently received 0.25ml Fluvirin on 12/3/03. The vaccinee did not experience any adverse symptoms as a result. Follow up pending.
Age: 1.31
Sex: F
Vaccine: FLU3
Symptoms: Medication error, Pharyngitis, Pyrexia, Rhinitis
Clinical narrative: A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 1 year old female vaccinee experienced fever and cold symptoms one week after inadvertently receiving 0.25ml Fluvirin on 12/2/03. The vaccinee recovered after approximately 4 days. Follow up pending.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Rash
Clinical narrative: A report was received from a health care professional on 3/26/04 concerning an 81 year old female vaccinee who developed an all over body rash except for her face and legs on 11/5/03 after receiving Fluvirin on 11/1/03. On 11/5/03, the vaccinee developed an all over body rash except for her face and legs after receiving Fluvirin on 11/1/03. The patient scratched at the rash creating sores. The patient was treated for scabies and her detergent was changed. At the time of the report the patient had not recovered. There was insufficient information to determine the reporter's causality assessment. Follow up received 8/30/04: Further information was received via our distributor. The vaccinee was treated with hydroxyzine, Lotrisone, and Eucerin. As at 8/11/04, the rash continues. She has an appointment with a dermatologist scheduled for 8/13/04. No additional information is available at this time.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Arthritis, Feeling hot, Hyperhidrosis, Pharyngitis
Clinical narrative: A report was received from a 67 year old female vaccinee on 6/9/04. The vaccinee's past medical history includes atrial fibrillation, for which she is taking Coumadin 5mg alternating with 7.5mg (start date May 2003) and Calan 240mg (start date unknown). On 12/17/03, the vaccinee received one dose of Fluvirin into the left upper arm. About two days later, she developed cold symptoms with fever and sweating that lasted approximately two weeks. Within four to five days of the cold symptoms developing, she also experienced joint pain with inflammation and warmth on her hand. As the pain gradually subsided, soreness appeared at the same site. The vaccinee stated that the cycle of pain and soreness occurred at one particular part of the body at a time (i.e. one arm then the other arm, but not together) and rotated around different parts of the body. The vaccinee took Tylenol for the pain attacks, but this did not have any effect. The attacks stopped at the end of May 2004. The vaccinee stated that recent laboratory test results of an unknown blood test specific for arthritis showed high levels. She will consult a rheumatologist in the near future. The vaccinee stated that she had previously received influenza vaccines for many years without any problem. The vaccinee consulted a physician regarding the events. The physician did not think the events were related to the Fluvirin injection. Follow up received 7/13/04: Report received from a health care professional stating that this 67 year old female received an influenza vaccination (brand not specified) on 12/17/03 into the left deltoid. The vaccinee developed arthritis pain and soreness in the muscles starting on 1/5/04. The event has not resolved. The vaccinee's history includes allergies to Antivert, Zocor, and Baycol. The vaccinee has not been seen by the reporter in the past 3 months. No further information is expected.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Rhinitis
Clinical narrative: A report was received from a 67 year old female vaccinee on 6/9/04. The vaccinee's past medical history includes atrial fibrillation, for which she is taking Coumadin 5mg alternating with 7.5mg (start date May 2003) and Calan 240mg (start date unknown). On 12/17/03, the vaccinee received one dose of Fluvirin into the left upper arm. About two days later, she developed cold symptoms with fever and sweating that lasted approximately two weeks. Within four to five days of the cold symptoms developing, she also experienced joint pain with inflammation and warmth on her hand. As the pain gradually subsided, soreness appeared at the same site. The vaccinee stated that the cycle of pain and soreness occurred at one particular part of the body at a time (i.e. one arm then the other arm, but not together) and rotated around different parts of the body. The vaccinee took Tylenol for the pain attacks, but this did not have any effect. The attacks stopped at the end of May 2004. The vaccinee stated that recent laboratory test results of an unknown blood test specific for arthritis showed high levels. She will consult a rheumatologist in the near future. The vaccinee stated that she had previously received influenza vaccines for many years without any problem. The vaccinee consulted a physician regarding the events. The physician did not think the events were related to the Fluvirin injection. Follow up received 7/13/04: Report received from a health care professional stating that this 67 year old female received an influenza vaccination (brand not specified) on 12/17/03 into the left deltoid. The vaccinee developed arthritis pain and soreness in the muscles starting on 1/5/04. The event has not resolved. The vaccinee's history includes allergies to Antivert, Zocor, and Baycol. The vaccinee has not been seen by the reporter in the past 3 months. No further information is expected.
Age: 0.8
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional in the USA on 7/5/04 concerning a 10 month old male vaccinee who inadvertently received Fluvirin on 11/6/03. This report was received as follow up and involves a group of 10 children under the age of 4 years who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional in the USA on 7/5/04 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 11/11/03. This report was received as follow up and involves a group of 10 children under the age of 4 who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional in the USA on 7/5/04 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 10/28/03. This report was received as follow up and involves a group of 10 children under the age of 4 who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional in the USA on 7/5/04 concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 10/29/03. This report was received as follow up and involves a group of 10 children under the age of 4 years who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional in the USA on 7/5/04 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 10/29/03. This report was received as follow up and involves a group of 10 children under the age of 4 years who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.
Age: 1.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional in the USA on 7/5/04 concerning a 1 year old female vaccinee who inadvertently received Fluvirin on 10/29/03. This report was received as follow up and involves a group of 10 children under the age of 4 years who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.
Age: 1.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional in the USA on 7/5/04 concerning a 1 year old male vaccinee who inadvertently received Fluvirin on 11/3/03. This report was received as follow up and involves a group of 10 children under the age of 4 years who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.
Age: 0.99
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: From initial information received on 12/9/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 11 month old female patient received her first dose of FLUZONE, lot number U1468AA, administered in the left thigh, a dose of MMR, lot number 0313P, administered in the right thigh and a dose of VARIVAX, lot number 1350N, administered in the left thigh on 12/3/04. The routes of administration were not reported. Two days later, on 12/5/04, the patient experienced a febrile seizure. The patient's body temperature at the time of the seizure was unknown as per the reporter. The patient was hospitalized for three days and discharged on 12/8/04. The patient has recovered from this event.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Cerebral ischaemia, Delirium, Hypersensitivity, Hypokinesia
Clinical narrative: Left arm sore at point of vaccination. Swelling, tenderness, and pain in under left arm lymph nodes. Left teeth very sensitive to cold drinks. During night (3 AM 12/12/03) when awakened to go to bathroom, lost balance, all faculties quit, legs folded. I fell into wall, then regained equilibrium and returned to bed. After in bed, tried to sit up and reach for drink of water; could not. Tried to sit up. Could not. Called 911 and taken to emergency center. 3 episodes after returning home. Discharge Summary received on 1/25/2005 arachnoid cyst and ischemic changes.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injury, Lymphadenopathy
Clinical narrative: Left arm sore at point of vaccination. Swelling, tenderness, and pain in under left arm lymph nodes. Left teeth very sensitive to cold drinks. During night (3 AM 12/12/03) when awakened to go to bathroom, lost balance, all faculties quit, legs folded. I fell into wall, then regained equilibrium and returned to bed. After in bed, tried to sit up and reach for drink of water; could not. Tried to sit up. Could not. Called 911 and taken to emergency center. 3 episodes after returning home. Discharge Summary received on 1/25/2005 arachnoid cyst and ischemic changes.
Age: 38.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Asthenia, Chest pain, Condition aggravated, Dyspnoea, Guillain-Barre syndrome
Clinical narrative: Progressive numbness, tingling, weakness to functional impairment. Started about month after first vaccinations. Multiple hospitalizations, outpatient treatment with Plasmaphoresis and physical therapy. Follow Up: Diagnosis was GBS. Medical Records received on 12/29/2004 states pt experienced demyelineating neuropathy.  Discharge Summary reviewed states patient experienced SOB, hypertension and chest pain. Per annual follow up: she has primarily recovered, except for residual sensory and motor difficulty.
Age: 38.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Hypoaesthesia, Hypokinesia, Neuropathy, Paraesthesia, Sensory disturbance
Clinical narrative: Progressive numbness, tingling, weakness to functional impairment. Started about month after first vaccinations. Multiple hospitalizations, outpatient treatment with Plasmaphoresis and physical therapy. Follow Up: Diagnosis was GBS. Medical Records received on 12/29/2004 states pt experienced demyelineating neuropathy.  Discharge Summary reviewed states patient experienced SOB, hypertension and chest pain. Per annual follow up: she has primarily recovered, except for residual sensory and motor difficulty.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Developed per pt report, low grade fever, body aches and chills, evening of Dec 1 flu shot remained ill for several days. Did see PCP no influenza testing, given no dx per pt. No meds for this. No dehydration. No hospital visit. X 3days.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: As per pt she received an influenza vaccination at a public clinic on 11/16/2004. She received the shot in her right arm and immediately felt pain. Pain has been constant to date and she has been unable to use her arm for any length of time. No redness or swelling. Follow up 01/25/05: To see physician 02/17/05. Still cannot use arm due to pain.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Influenza administered at head start school by RN on 11/12/04. On 11/13/04, client observed left deltoid swollen and red (where the injection was administered) and had rashes all over trunk. Was treated by doctor 11/29/04.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Shot given 1PM Wednesday, arm and neck sore Wed. Thursday Left arm shoulder neck stiff and sore. Fri whole neck and shoulder stiff
Age: 1.03
Sex: F
Vaccine: FLU3, HIBV, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Swelling and redness at injection site almost immediately after immunizations (MMR)
Age: 1.01
Sex: F
Vaccine: FLU3, PNC, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Pyrexia, Rash papular, Skin ulcer
Clinical narrative: Varicella vaccine given SQ left thigh on 11/27/2004. Fever to 101.5 began 12/07/04. Also noted redness and swelling at inj site, non tender, no warmth. 12/08/04 developed 3 erythematous papular lesions on abdomen. Remainder of exam 12/08/04 was normal.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Softball size red, raised, itching, local reaction below injection site starting next day after injection and lasting 3 days, no intervention necessary.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Evening of flu inj given c/o sore throat and temp 103 x 1 day.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oedema
Clinical narrative: x12 hours edema in right arm
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Screaming
Clinical narrative: Mother reports child had high pitched screaming immediately following injections 4-5 hours later after sleeping he awoke and again had high pitched screaming lasting 30-45 min.
Sex: M
Vaccine: IPV
Symptoms: Crying, Headache, Injection site erythema, Screaming, Vomiting
Clinical narrative: Dtap administered at well visit #5 Left deltoid, within 30 min of vaccine child screamed, lots of head pain, vomited x1 afebrile, within 12 hrs Left deltoid large red area 15x20cm tender.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Feeling cold, Feeling hot, Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: Broke out in hives, face wash itchy and hot, arms were numb and tingly and cold
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Broke out in hives, face wash itchy and hot, arms were numb and tingly and cold
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Tenderness
Clinical narrative: Erythematous, warm and tender area measuring 1 1/2 inch x 2 inch left upper arm below injection site
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cold sweat, Hyperhidrosis, Hypotonia, Pallor, Pyrexia
Clinical narrative: Mother reports baby had become limb, pale, sleepy, clammy, and sweaty after 1 hour after receiving vaccines. Stated the episode lasted 16-18 hours, his resp seemed slower also. All symptoms lasted 16-18 hours. Low grade fever noted but responded to Tylenol. No loss of consciousness, no seizure like activity.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Respiratory rate decreased, Somnolence
Clinical narrative: Mother reports baby had become limb, pale, sleepy, clammy, and sweaty after 1 hour after receiving vaccines. Stated the episode lasted 16-18 hours, his resp seemed slower also. All symptoms lasted 16-18 hours. Low grade fever noted but responded to Tylenol. No loss of consciousness, no seizure like activity.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Mother noticed on 10/29/2004 left thigh red swollen
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying, Injection site mass, Irritability
Clinical narrative: Inconsolable crying 7PM-7AM, fussy during day. Lump on right thigh around 4cm, no redness, no warmth and tenderness.
Age: 13.0
Sex: F
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Diagnosed with Varicella after receiving the vaccine on 8/12/1996.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability
Clinical narrative: Fussy: irritable within two hours of vaccine lasted around 12 hours. No fever. No V/D. CBC checked WNL. No treatment.
Age: 1.05
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Blister, Dermatitis bullous, Drug ineffective, Erythema, Infection
Clinical narrative: Mother called and report a "spot" on child lower leg that progressed to a blister on 9/22/04 and 9/23/04 and then dried up. Low grade fever also accompanied that. Report also follow up October that vaccination site in RUA continued off and on to be red and itchy. This continued through November 20th when out of state the child broke out with "pimple looking rash" and a fever that would come and go until 11/27/04. Saw a doctor with this on 11/23/04 who reported this to be chickenpox "an odd case". Child now without rash, but continues to be itchy along waist line, arms, legs and injection site and run low grade fever off and on. Mother concerned.
Age: 1.05
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Mother called and report a "spot" on child lower leg that progressed to a blister on 9/22/04 and 9/23/04 and then dried up. Low grade fever also accompanied that. Report also follow up October that vaccination site in RUA continued off and on to be red and itchy. This continued through November 20th when out of state the child broke out with "pimple looking rash" and a fever that would come and go until 11/27/04. Saw a doctor with this on 11/23/04 who reported this to be chickenpox "an odd case". Child now without rash, but continues to be itchy along waist line, arms, legs and injection site and run low grade fever off and on. Mother concerned.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Vomiting, White blood cell disorder
Clinical narrative: Fever to 102.3F. Vomited x 1 yesterday. No diarrhea.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Mtr called to report child c/o left arm pain ( 3AM 12/7/04) vomiting, leg pain, temp 102, medicated with Tylenol, cool compress to arm, seen by pediatrician 10:30 AM, steroid and antibiotic rx'd, couns. on cool compress to left arm.
Age: 7.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective
Clinical narrative: Pt developed varicella like rash after exposure to active case of varicella at school.
Age: 66.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: 11/19/04 c/o red, painful, lump left arm at site Td, noted 11/18/04 when lying in bed. Pt tx Aleve. MD to Biacin x 500mg 2 qdx10d; warm soak, f/u 11/20/04 s/s improving.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying
Clinical narrative: Persist crying for 4 hours after vaccination.
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Varicella vaccine given 01/30/2002 at 12 month check up. Diagnosed with post vaccine. Varicella 12/02/04 age 3 years.
Age: 2.0
Sex: F
Vaccine: DTAP, PNC
Symptoms: Crying, Erythema, Hyperhidrosis, Pyrexia, Screaming
Clinical narrative: T/C from mother, child has small lump with erythema in size of quarter; low grade fever (states sweating, hasn't taken temp) and has been crying since this AM.
Age: 2.0
Sex: F
Vaccine: DTAP, PNC
Symptoms: Skin nodule
Clinical narrative: T/C from mother, child has small lump with erythema in size of quarter; low grade fever (states sweating, hasn't taken temp) and has been crying since this AM.
Age: 5.0
Sex: M
Vaccine: MMR, TD
Symptoms: Anorexia, Erythema, Fatigue, Hallucination, Headache
Clinical narrative: Fever staying between 103-104. Tylenol and Motrin and baths bring fever down some. Hearing voices with high fever, loss of appetite and lying around, tired, nausea, headache. Arm (right) swollen , red, hot below shot site. Right arm stiff to move.
Age: 5.0
Sex: M
Vaccine: MMR, TD
Symptoms: Injection site warmth, Musculoskeletal stiffness, Nausea, Pyrexia, Sluggishness
Clinical narrative: Fever staying between 103-104. Tylenol and Motrin and baths bring fever down some. Hearing voices with high fever, loss of appetite and lying around, tired, nausea, headache. Arm (right) swollen , red, hot below shot site. Right arm stiff to move.
Age: 5.0
Sex: M
Vaccine: MMR, TD
Symptoms: Swelling, White blood cell disorder
Clinical narrative: Fever staying between 103-104. Tylenol and Motrin and baths bring fever down some. Hearing voices with high fever, loss of appetite and lying around, tired, nausea, headache. Arm (right) swollen , red, hot below shot site. Right arm stiff to move.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 2 year old female vaccinee inadvertently received 0.25 Fluvirin on 11/5/03. The vaccinee did not experience any adverse symptoms as a result. Follow up pending.
Age: 1.03
Sex: M
Vaccine: HIBV
Symptoms: High-pitched crying, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: red and swollen at site, hard and warm to touch, child screams when you touch site.
Age: 2.0
Sex: F
Vaccine: MEA
Symptoms: Nasal congestion, Otitis media, Pyrexia
Clinical narrative: Patient received monovalent measles vaccine on 11-08-04. Within 24 hours, she bagan a low grade fever (~101) and clear nasal discharge. The low grade fever continued for about 1 week. However, the nasal drainage became greenish yellow and thick 5 days after the vaccine. The child was taken to the pediatrician - her ears were fine and she was given a flu shot at that time. She returned to the pediatrician at 9 days after the vaccine with a temperature of 103 and was diagnosed with otitis media. She was prescribed a Z-pack. Her symptoms did not resolve and she was prescribed a second Z-pack with good results.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia
Clinical narrative: When she received vaccine, felt it was a different shot than before.  Started to hurt and progressed to pain in several hours.  Four days later, feels "needles" in upper arm & pain "deep inside", more toward shoulder.  Orthopedic specialist consulted.  He will do MRI if no improvement.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Pain
Clinical narrative: Within a few hours of shots, he began crying and cried almost non-stop for 4 hours.  Was given po codeine for pain from ER
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Severe Hives.... Prednisone 6 days.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles Right torso, no pain or fever, 4 spots.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: RASH ON LEFT SIDE OF NECK GOING DOWN TO CHEST.
Age: 1.28
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever 103-104 in 24 hours. Treated with Motrin. Febrile seizure 24 hours later (twice) with hospitalization. Follow up 02/07/05: Fever of 102.5, body shaking, no prior history of seizures.
Age: 1.01
Sex: F
Vaccine: FLU3, PNC, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: 2 small vesicles at vaccination site. Rx arm site
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Hypokinesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 2 hours post injection, pain at site. Progressively worsened with small area of redness and more pain next morning. 24 hours after injection, I could not move arm; swollen, red, and hot. Called MD and told to go to ER. Admitted 12/12/04 with cellultiis. Need IV antibiotics and pain medicines in hospital.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain, White blood cell count increased
Clinical narrative: 2 hours post injection, pain at site. Progressively worsened with small area of redness and more pain next morning. 24 hours after injection, I could not move arm; swollen, red, and hot. Called MD and told to go to ER. Admitted 12/12/04 with cellultiis. Need IV antibiotics and pain medicines in hospital.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Injection site induration, Swelling
Clinical narrative: Redness, swelling, induration 4x4 in right thigh site of DTaP administration 24 hours after the vaccine was given.
Age: 1.08
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Crying, Erythema, Face oedema, Insomnia, Irritability
Clinical narrative: No SOB,Red at neck area, did not sleep, 2 hours crying x 3 days, no sleep 2 days. No fever, no nausea, no diarrhea. Swelling at face noticed by mother night after vaccine given. Seen by PMD never. 5th day after vaccines still red, no crying, not fussy, and sleeping less than normal, increased fussiness.
Age: 1.08
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Screaming
Clinical narrative: No SOB,Red at neck area, did not sleep, 2 hours crying x 3 days, no sleep 2 days. No fever, no nausea, no diarrhea. Swelling at face noticed by mother night after vaccine given. Seen by PMD never. 5th day after vaccines still red, no crying, not fussy, and sleeping less than normal, increased fussiness.
Sex: M
Vaccine: DTP, HIBV
Symptoms: Autism, Erythema, Pyrexia, Rash papular, Speech disorder
Clinical narrative: Pink papular rash on trunk with temp 102.1 week after MMR, speech regression. Diagnosed with autism/LKS at 2 years of age.