chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: A report was received from a health care professional on 11/7/04, concerning a 47 year old female vaccinee who experienced lymphadenopathy, malaise and a feeling of warmth, 18 hours following the inadvertent administration of expired Fluvirin vaccine on 11/3/03. On 11/5/03, the vaccinee experienced lymphadenopathy, malaise and a feeling of warmth. A description on the clinical symptoms given included swollen and tender lymph nodes behind the ear, under the clavicle, on the left side of the neck and in the vaccinee's left hip. The vaccinee also had constitutional symptoms of malaise and a feeling of warmth. The reporter thinks the vaccinee's symptoms have worsened slightly. An ER physician examined her and stated she was OK. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/23/2003: A follow up report was received from a health care professional indicating that the vaccinee had developed the following adverse experiences on 11/5/2003: Lymph node swelling and left neck swelling that had not resolved at the time of the follow up report. Left arm swelling and pain which were slowly resolving at the time of the follow up report. Left arm pain and left hip pain, which had both resolved at the time of the follow up report. An ER physician checked the vaccinee and said he wasn't sure but felt it probably was due to the influenza vaccine. Update 2, 02/03/04: A follow up report was received from a health care professional indicating that the vaccinee's left lymphadenopathy subsided total on 01/20/04. The reporter reported that the vaccinee has not experienced any further sequelae. 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 11/10/03 concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 10/20/03. On 10/20/03 , the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference: PJP200301187, PJP200301185, PJP200301184, PJP200301182, PJP200301180, PJP200301179, PJP200301177, PJP200301176, PJP200301175, PJP200301174, PJP200301172.
Sex: U
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health care professional on 11/10/03, concerning a vaccinee of unspecified demography who received a second dose of Fluvirin 3 weeks after receiving the first dose on an unspecified date. On an unspecified date, the vaccinee was inadvertently administered a second dose of Fluvirin. No adverse events were reported at the time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health care professional on 11/10/03, concerning an 88 year old female vaccinee who received a dose of Fluvirin on 10/16/03 and inadvertently received a second dose on 11/10/03. No adverse events were reported at the time of report. 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 health care professional on 11/10/03, concerning a vaccinee who was less than 4 years of age and of unknown gender, that inadvertently received Fluvirin on an unknown date. The reporter did not have information on whether an adverse event had occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: A report was received from a health care professional on 10 November 2003, concerning a 54 year old female vaccinee who experienced Labyrinth's disease one day after receiving Fluvirin on 29 October 2003. On the morning of 30 October 2003, the vaccinee experienced dizziness. Her physician diagnosed Labyrinth's Disease. The vaccinee has never previously experienced episodes of dizziness. The vaccinee was treated with fexofenadine, 180mg daily. On 07 November 2003, the vaccinee's condition had improved. However, she was continuing to have short periods of vertigo several time a day, with positions changes. The reporter has assessed the relationship of the Fluvirin to the event as unrelated. Follow up pending.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10 November 2003 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee inadvertently received 0.5 ml Fluvirin. It was not reported whether or not an adverse event had occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301040. Update 1, 06 January 2004. A follow up report was received form a health care professional indicating that no adverse effects were experienced by the vaccine at the time of the follow up report. No 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 10 November 2003 concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee inadvertently received 0.5 ml Fluvirin. It was not reported whether or not an adverse event had occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301039. Update 1, 06 January 2004. A follow up report was received from a health care professional indicating that no adverse effects were experienced by the vaccinee at the time of the follow up report. No follow up pending.
Age: 1.19
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10 November 2003 concerning a male vaccinee less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date the vaccinee inadvertently received 0.25 ml Fluvirin. The vaccine had not experienced any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update report: 13 January 2004. Follow up information received from a health care professional indicated that a 14 month old male vaccinee inadvertently received Fluvirin on 27 October 2003 and had not experienced any adverse reaction. Follow up pending. Cross reference with PJP200301042.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10 November 2003 concerning a male vaccinee less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date the vaccinee inadvertently received 0.25 ml Fluvirin. The vaccine had not experienced any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update report: 13 January 2003. Follow up information received from a health care professional indicated that a 28 month old male vaccinee inadvertently received Fluvirin on 27 October 2003 and had not experienced no adverse event as a result. Follow up pending. Cross reference with PJP200301041.
Age: 1.94
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 20 October 2003 concerning an unspecified number of vaccinees less than 4 years of age who received Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received Fluvirin. The reporter was not aware of any of adverse symptoms occurring at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 10 November 2003: A follow up report was received from a health care professional indicating that a 2 year old male vaccinee received Fluvirin on 7 October 2003. Cross reference with PJP200300839.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: A report was received from a health care professional on 07 November 2003, concerning several vaccinees who experienced soreness, redness, swelling and itching at the site of injection after an unspecified length of time after receiving Fluvirin on unspecified dates in October and November 2003. On unspecified dates in October and November 2003 the vaccinees experienced soreness, redness, swelling and itching at the injection site. The swelling was described as the size of a small orange, raised, red and hard. The outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Injection site swelling, Pruritus
Clinical narrative: A report was received from a health care professional on 07 November 2003, concerning several vaccinees who experienced soreness, redness, swelling and itching at the site of injection after an unspecified length of time after receiving Fluvirin on unspecified dates in October and November 2003. On unspecified dates in October and November 2003 the vaccinees experienced soreness, redness, swelling and itching at the injection site. The swelling was described as the size of a small orange, raised, red and hard. The outcome of the events was not reported. 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 health care professional on 11 November 2003 concerning 2 vaccinees of unknown demography who were inadvertently administered frozen Fluvirin vaccine on 11 November 2003. On 11 November 2003 2 vaccinees inadvertently received Fluvirin which had been frozen. At the time of the report the outcome was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health care professional on 11 November 2003, concerning an unspecified number of vaccinees who inadvertently received 1 ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1 ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 4 December 2003. An update report was received from a health care professional concerning a 94 year old female vaccinee who inadvertently received 1 ml of Fluvirin subcutaneously on 31 October 2003. No adverse symptoms were exhibited at the time of reporting. Follow up pending. Cross reference with: PJP200301345, PJP200301332, PJP200301333, PJP200301334, PJP200301335, PJP200301336, PJP200301337, PJP200301338, PJP200301339, PJP200301340, PJP200301341, PJP200301342, PJP200301343, and PJP200301344.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Medication error, Tenderness
Clinical narrative: A report was received from a health care professional on 11 November 2003 concerning a 52 year old female vaccinee who experienced localized redness an unspecified length of time after inadvertently receiving a sub-optimal dose of Fluvirin intradermally on 11 November 2003. On 11 November 2003 the vaccinee received 0.1 ml Fluvirin intradermally. The vaccinee experienced injection site redness shortly after vaccination. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 25 November 2003: Follow up information received from a health care professional indicated that the vaccinee also experienced localized tenderness on 11 November 2003. The vaccinee recovered on 18 November 2003. Cross reference with: PJP200301050, PJP200301051.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Medication error
Clinical narrative: A report was received from a health care professional on 11/11/03 concerning a 47 year old female vaccinee who experienced localized redness an unspecified time after inadvertently receiving a sub optimal dose of Fluvirin intradermally on 11/11/03. On 11/11/03 the vaccinee received 0.1ml Fluvirin intradermally. The vaccinee experienced injection site redness shortly after vaccination. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/25/03: Follow up information received from a health care professional indicated that the vaccinee also experienced localized tenderness. The vaccinee recovered 6 days after the onset of the event. Cross reference with: PJP200301051 amd PJP200301049.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Medication error, Tenderness
Clinical narrative: Localized redness (Injection site reaction, injection site reaction)(Inject site react) - recovered/resolved Localized tenderness (Injection site pain, Injection site pain)(pain inject site) - recovered/resolved Received sub-optimal dose (Medication error, medication error)(Med error) - not reported Administration by an unlicensed route (Medication error, medication error) (Med error) - not reported A report was received from a health care professional on 11 November 2003 concerning a 35 year old male vaccinee who experienced localized redness an unspecified length of time after inadvertently receiving a sub-optimal dose of Fluvirin intradermally on 11 November 2003. On 11 November 2003 the vacinee received 0.1ml Fluvirin intradermally. The vaccinee experinced injection site redness shortly after vaccination. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1 25 November 2003 Follow-up information recieved from a health care professional indicated that the vacinee also experienced localized tenderness on 11 November 2003. The vacinee recovered on 17 November 2003.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Oedema, Pain, Rash
Clinical narrative: Swelling (Edema, edema)(Edema) - recovered/resolved Redness (Rash, rash)(Rash) - recovered/resolved Warmth (Vasodilatation, Vasodilatation)(Vasodilat) - recovered/resolved Pain (Pain, Pain)(Pain) - recovered/resolved A report was received from an office manager on 11 November 2003 concerning a female vaccinee in her 30's who experienced swelling, redness, warmth and pain on the same day as receiving Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee experienced swelling, redness, warmth and pain. The pain had been becoming milder at the time of the report. The vaccinee had not recovered at the time of the report. Update 1. 25 November 2003: Further information was recevied from an office manager on 25 November 2003 indicating that the swelling, redness, warmth and pain experienced by the 39 year old female vaccinee resolved 3 days after onset, on 13 November 2003. There was insufficient information to determine the reporter's causalty assessment. No follow-up pending.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Vasodilatation
Clinical narrative: Swelling (Edema, edema)(Edema) - recovered/resolved Redness (Rash, rash)(Rash) - recovered/resolved Warmth (Vasodilatation, Vasodilatation)(Vasodilat) - recovered/resolved Pain (Pain, Pain)(Pain) - recovered/resolved A report was received from an office manager on 11 November 2003 concerning a female vaccinee in her 30's who experienced swelling, redness, warmth and pain on the same day as receiving Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee experienced swelling, redness, warmth and pain. The pain had been becoming milder at the time of the report. The vaccinee had not recovered at the time of the report. Update 1. 25 November 2003: Further information was recevied from an office manager on 25 November 2003 indicating that the swelling, redness, warmth and pain experienced by the 39 year old female vaccinee resolved 3 days after onset, on 13 November 2003. There was insufficient information to determine the reporter's causalty assessment. No follow-up pending.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Oedema, Pain, Rash
Clinical narrative: Swelling (Edema, Edema)(Edema) - recovered/resolved Redness (Rash, rash)(Rash) - recovered/resolved Warmth (Vasodilatation, vasodilatation)( Vasodilat) - recovered/resolved Pain (Pain, pain)(Pain) - recovered/resolved A report was received from an office manager on 11 November 2003 concerning a female vaccinee in her 20's who experienced swelling, redness, warmth and pain on the same day as receiving Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee experienced swelling, redness, warmth and pain. The pain had been becoming milder at the time of the report. The vaccinee had not recovered at the time of the report. Update 1, 25 November 2003: Further information was received from an office manager on 25 November 2003 indicating that the swelling, redness, warmth and pain experienced by the 23 year old female vaccinee resolved 2 days after onset, on 12 November 2003. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Vasodilatation
Clinical narrative: Swelling (Edema, Edema)(Edema) - recovered/resolved Redness (Rash, rash)(Rash) - recovered/resolved Warmth (Vasodilatation, vasodilatation)( Vasodilat) - recovered/resolved Pain (Pain, pain)(Pain) - recovered/resolved A report was received from an office manager on 11 November 2003 concerning a female vaccinee in her 20's who experienced swelling, redness, warmth and pain on the same day as receiving Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee experienced swelling, redness, warmth and pain. The pain had been becoming milder at the time of the report. The vaccinee had not recovered at the time of the report. Update 1, 25 November 2003: Further information was received from an office manager on 25 November 2003 indicating that the swelling, redness, warmth and pain experienced by the 23 year old female vaccinee resolved 2 days after onset, on 12 November 2003. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Oedema, Pain, Rash
Clinical narrative: Swelling (Edema, edema)(Edema) - recovered/resolved Redness (rash, rash)(Rash) - recovered/resolved Warmth (Vasodilatation, vasodilatation)(Vasodilat) - recovered/resolved Pain (Pain, pain)(Pain) - recovered/resolved A report was received from an office manager on 11 November 2003 concerning a female vaccinee in the 30's who experienced swelling, redness, warmth and pain on the same day as receiving Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee experienced swelling, redness, warmth and pain. The pain had been becoming milder at the time of the report. The vaccinee had not recovered at the time of the report.  Update 1, 25 November 2003: Further information was received from an office manager on 25 November 2003 indicating that the swelling, redness, warmth and pain experienced by the 46 year old female vaccinee resolved 3 days after onset, on 13 November 2003. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Vasodilatation
Clinical narrative: Swelling (Edema, edema)(Edema) - recovered/resolved Redness (rash, rash)(Rash) - recovered/resolved Warmth (Vasodilatation, vasodilatation)(Vasodilat) - recovered/resolved Pain (Pain, pain)(Pain) - recovered/resolved A report was received from an office manager on 11 November 2003 concerning a female vaccinee in the 30's who experienced swelling, redness, warmth and pain on the same day as receiving Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee experienced swelling, redness, warmth and pain. The pain had been becoming milder at the time of the report. The vaccinee had not recovered at the time of the report.  Update 1, 25 November 2003: Further information was received from an office manager on 25 November 2003 indicating that the swelling, redness, warmth and pain experienced by the 46 year old female vaccinee resolved 3 days after onset, on 13 November 2003. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Oedema, Pain, Rash
Clinical narrative: Swelling (Edema, edema)(Edema) - recovered/resolved Redness (Rash, rash)(Rash) - recovered/resolved Warmth (Vasodilatation, vasodilatation)(Vasodilat) - recovered/resolved Pain (Pain, pain)(Pain) - recovered/resolved A report was received from an office manager on 11 November 2003 concerning a female vaccinee in her 30's who experienced swelling, redness, warmth and pain on the same day as receiving Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee experoenced swelling, redness, warmth and pain. The pain had been becoming milder at the time of the report. The vaccinee had not recovered at the time of the report. Update 1, 25 November 2003: Further information was received from an office manager on 25 November 2003 indicating that the swelling, redness, warmth and pain experienced by the 33 year old female vaccinee resolved 4 days after onset, on 14 November 2003. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Vasodilatation
Clinical narrative: Swelling (Edema, edema)(Edema) - recovered/resolved Redness (Rash, rash)(Rash) - recovered/resolved Warmth (Vasodilatation, vasodilatation)(Vasodilat) - recovered/resolved Pain (Pain, pain)(Pain) - recovered/resolved A report was received from an office manager on 11 November 2003 concerning a female vaccinee in her 30's who experienced swelling, redness, warmth and pain on the same day as receiving Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee experoenced swelling, redness, warmth and pain. The pain had been becoming milder at the time of the report. The vaccinee had not recovered at the time of the report. Update 1, 25 November 2003: Further information was received from an office manager on 25 November 2003 indicating that the swelling, redness, warmth and pain experienced by the 33 year old female vaccinee resolved 4 days after onset, on 14 November 2003. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
Age: 0.82
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12 November 2003, concerning a 9-month-old male vaccine who inadvertently received a second dose of Fluvirin on 12 November 2003.  On 12 November 2003, a 9-month-old male vaccine received a second dose of 0.25mls Fluvirin intramuscularly.  The dates of administration and dosage of the first dose were unspecified.  At the time of reporting the vaccine did not exhibit any adverse symptoms.  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 health care professional on 12 November 2003, concerning a number of vaccine who inadvertently received 2 doses of Fluvirin on unspecified date.  On unspecified dates, within approximately a one-month period the vaccine received 2 doses of Fluvirin.  No adverse symptoms were exhibited at the time of reporting.  There was insufficient information to determine the reporter's causality assessment.  Follow-up pending.
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: A report was received from a health care professional on 12 November 2003, concerning a male vaccine of unspecified age who experienced a sharp pain under his left shoulder blade on the evening of administration, and numbness in his entire left arm the following day after receiving Fluvirin on 11 November 2003.  On 11 November 2003, the vaccine received Fluvirin 0.5ml intramuscularly to left deltoid.  The vaccine developed a sharp pain under his left shoulder blade.  On 12 November 2003, the vaccine experienced numbness in his entire left arm.  According to the reporter the pain under the shoulder blade has subsided currently but the numbness is still ongoing.  There was insufficient information to determine the reporter's causality assessment.  Follow-up pending.
Age: 1.5
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12 November 2003, concerning a 17-month-old female vaccine who inadvertently received Fluvirin on 11 November 2003.  On 11 November 2003, the vaccine inadvertently received Fluvirin 0.25ml intramuscularly.  The vaccine did not experience any adverse symptoms at the time of reporting.  There was insufficient information to determine the reporter's causality assessment.  Update 1, 23 February 2004.  A follow-up report was received from a health care professional indicating that the vaccine inadvertently received 0.5ml Fluvirin.  No adverse event had occurred at the time of reporting.  No follow-up pending, all information received.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12 November 2003, concerning a 23-month-old female vaccine who inadvertently received Fluvirin on 12 November 2003.  On 12 November 2003, the vaccine inadvertently received Fluvirin intramuscularly.  The vaccine did not experience any adverse symptoms at the time of reporting.  There was insufficient information to determine the reporter's causality assessment.  Follow-up pending.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12 November 2003, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on an unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin intramuscularly. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 07 January 2004. A follow up report was received from a health care professional concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 12 November 2003. On 12 November 2003, the vaccinee inadvertently received Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report master file. Cross reference with: PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.
Sex: U
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health care professional on 12 November 2003, concerning an unspecified number (approximately 12-24) of vaccinees who inadvertently received 1 ml Fluvirin on an unspecified date. On an unspecified date, an unspecified number of vaccinees inadvertently received 1 ml Fluvirin intramuscularly. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment.  Update 1, 02 January 2004. A follow up report was received from a health care professional concerning a 22 vaccinees who inadvertently received 1ml Fluvirin on 13 November 2003. No adverse effects were experienced at the time of reporting. No follow up pending.
Sex: U
Vaccine: FLUX
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12 November 2003, concerning approximately 60 vaccinees who may have inadvertently received an expired influenza vaccine (brand unspecified) on an unspecified date. On an unspecified date approximately 60 vaccinees may have inadvertently received expired influenza vaccines. There was no information regarding adverse symptoms exhibited by the vaccines at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 1.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12 November 2003, concerning an unknown number of vaccinees under 4 years of age who have inadvertently received Fluvirin on an unspecified date. On an unspecified date, an unspecified number of vaccinees under 4 years of age inadvertently received Fluvirin. No information was available at the time of reporting regarding the exhibition of adverse symptoms by the vaccinees. There was insufficient information to determine the reporter's causality assessment. Follow up received on 05 July 2004 confirming 10 children under the age of 4 years of age had been inadvertently administered Fluvirin instead of the product approved for pediatric use in the USA. This case involves a 22 month old female who inadvertently received Fluvirin on 04/Nov/2003. The vaccinee did not experience any adverse effects. No further information is expected. X-ref: CVOX200400231 to 00239.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 12 November 2003, concerning a 51 year old female vaccinee who inadvertently received expired Fluvirin on 11 November 2003. On 11 November 2003, the vaccinee inadvertently received 0.5 ml of expired Fluvirin. The vaccinee did not exhibit any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 0.94
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 14 October 2003 concerning an unspecified number of vaccinees less than 4 years of age who received Fluvirin subcutaneously on an unspecified date. On an unspecified date an unspecified number of vaccinees under 4 years of age received Fluvirin subcutaneously. The reporter indicated the the exact number of vaccinees was unknown but was believed to be less than 20 vaccinees. Vaccinees aged between 6 and 35 months were given 0.25 ml and 0.5 ml was given to vaccinees greater than 35 months. No adverse symptoms had been noted. Update 1, 07 November 2003. A follow up report was received from a consumer indicating that an 11 month old male vaccinee inadvertently received Fluvirin on 10 October 2003. No adverse reaction had occurred at the time of the report. Cross reference with: PJP200300808.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Visual field defect
Clinical narrative: A report was received from a health care professional on 12 November 2003 concerning a 52 year old female vaccinee who experienced loss of peripheral vision after receiving Fluvirin on 06 November 2003. On 06 November 2003 a female vaccinee received a single dose of Fluvirin, and that night the vaccinee experienced loss of peripheral vision. the loss of vision was due to a choked optic nerve as per an ophthalmologist and an eye care specialist. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health care professional on 13 November 2003 concerning a vaccinee who inadvertently received 2 doses of Fluvirin on an unspecified date. On an unspecified date the vaccinee inadvertently received 2 doses of Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting.  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 health care professional on 13 November 2003, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date, the vaccinees inadvertently received 0.25 ml of Fluvirin. The vaccinees did not experience any adverse symptoms at the time of reporting. 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 health care professional on 13 November 2003, concerning three vaccinees of unknown demography who inadvertently received expired Fluvirin on an unspecified date. On an unspecified date the vaccinees inadvertently received expired Fluvirin. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health care professional on 13 November 2003 concerning an 87 year old female vaccinee who inadvertently received 2 doses of Fluvirin on unspecified dated, over a period of a couple of days. On unspecified dates, the vaccinee inadvertently received 2 doses of Fluvirin over a period of a couple of days. No adverse symptoms were reported at the time of reporting. 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 health care professional on 13 November 2003 concerning an unspecified number of vaccinees less than 4 years who inadvertently received Fluvirin on an unspecified date. On an unspecified date the vaccinees inadvertently received Fluvirin. No adverse symptoms were reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: M
Vaccine: FLUX
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 13 November 2003 concerning a male vaccinee in his 40s who inadvertently received influenza vaccine (brand not specified) subcutaneously on 12 November 2003. On 12 November 2003, the vaccinee received influenza vaccine (brand unspecified) subcutaneously. At the time of the report no adverse event had occurred. There was insufficient information to determine the reporter's causality assessment. Update, 01 March 2004: Follow up information received from a health care professional indicated that there is no additional information forthcoming from the vaccinee. No follow up pending.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/13/03 concerning a 84 year old female vaccinee who inadvertently received 2 doses of Fluvirin, one on 11/13/03 and the other on an unspecified date. On 11/13/03, the vaccinee received Fluvirin, on another unspecified date another nurse administered Fluvirin to the vaccinee. The vaccinee had not experienced any adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: A report was received from a health care professional on 11/13/03 concerning a 28 year old female vaccinee who experienced tingling in her upper and lower extremities 2 days after receiving Fluvirin on 11/8/03. On 11/10/03 the vaccinee experienced tingling in her upper and lower extremities. The symptoms went away and then returned. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 2/10/04: A follow up report was received from a health care professional indicating that the vaccinee experienced upper and lower extremity paraesthesia 2 days after receiving Fluvirin on 10/30/03. The vaccinee recovered after two days. No follow up, all information received.
Sex: U
Vaccine: FLU3
Symptoms: Neck pain
Clinical narrative: A report was received from a health care professional on 10/3/03 concerning a vaccinee of unspecified demography who experienced a sore neck 2 to 3 days after receiving Fluvirin on an unknown date in 2003. On an unspecified date a vaccinee experienced a sore neck. It was not reported if the vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Ear pain, Neck pain, Pain, Pyrexia
Clinical narrative: A report was received from a health care professional on 10/3/03 concerning a vaccinee of unspecified demography who experienced pain in the arm, neck and ear, and a fever 2 to 3 days after receiving Fluvirin on an unknown date in 2003. On an unspecified date the vaccinee experienced pain in the arm, neck and ear, and felt feverish. It was not reported if the vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Paraesthesia
Clinical narrative: A report was received from a health care professional on 10/3/03 concerning a female vaccinee of unspecified age who experienced confusion and a tingling sensation 1 day after receiving Fluvirin on an unknown date in 2003. On an unspecified date the vaccinee experienced confusion and a tingling sensation all over her body. The confusion and tingling resolved within 24 hours. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Muscular weakness, Myalgia
Clinical narrative: A report was received from a health care professional on 11/14/03 concerning a female vaccinee in her 40s who experienced muscle soreness around the injection site, limitation of motion, and muscle weakness within one week of receiving Fluvirin on 10/14/03. Within one week of receiving Fluvirin, the vaccinee experienced muscle soreness around the injection site, limitation of motion, and muscle weakness. The vaccinee had not recovered at the time of the report. The vaccinee had no previous medical history. 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 health care professional on 11/14/03 concerning 6 vaccinees of unknown demography who inadvertently received two 0.5ml doses of Fluvirin, one on 11/07/03 and another on 11/10/03. On 11/07/03 and on 11/10/03, 6 unidentified vaccinees inadvertently received a 0.5ml dose of Fluvirin. The vaccinees had not experienced any adverse reactions at the time of the report. 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 health care professional on 11/14/03 concerning a vaccinee of unspecified demography who inadvertently received Fluvirin via the SC route on an unspecified date. On an unspecified date, the vaccinee received Fluvirin via the SC route. The reporter did not know whether or not the vaccinee experienced any adverse symptoms after the event. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/14/03, concerning a 56 year old female vaccinee who inadvertently received expired Fluvirin SC on 11/10/03. On 11/10/03, the vaccinee inadvertently received expired Fluvirin SC. The vaccinee had not experienced any adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 1.2
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/14/03 concerning a 14 month old vaccinee of unknown sex, who inadvertently received Fluvirin on an unknown date. On an unknown date a child under 4 years of age inadvertently received Fluvirin. At the time of the report no adverse events had occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 36.0
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 10/24/03 concerning 4 vaccinees of unspecified demography who experienced redness and wheals at the injection site with itching on the same day as receiving Fluvirin on 10/24/03. On 10/24/03 the vaccinees experienced redness and wheals at the injection site with itching. The vaccinees recovered on 10/24/03. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 11/17/03: A follow up report was received indicating that a 36 year old female vaccinee experienced a large red wheal with redness, swelling and warmth within 20 minutes of receiving Fluvirin on 10/20/03. The vaccinee was treated with antihistamine. The vaccine recovered after 3-4 days.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: A report was received from a health care professional on 10/24/03 concerning 4 vaccinees of unspecified demography who experienced redness and wheals at the injection site with itching on the same day as receiving Fluvirin on 10/24/03. On 10/24/03 the vaccinees experienced redness and wheals at the injection site with itching. The vaccinees recovered on 10/24/03. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 11/17/03: A follow up report was received indicating that a 36 year old female vaccinee experienced a large red wheal with redness, swelling and warmth within 20 minutes of receiving Fluvirin on 10/20/03. The vaccinee was treated with antihistamine. The vaccine recovered after 3-4 days.
Age: 34.0
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 10/24/03 concerning 4 vaccinees of unspecified demography who experienced redness and wheals at the injection site with itching on the same day as receiving Fluvirin on 10/24/03. On 10/24/03 the vaccinees experienced redness and wheals at the injection site with itching. The vaccinees recovered on 10/24/03. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 11/17/03: A follow up report was received indicating that a 34 year old female vaccinee experienced a local red wheal with redness, swelling, hives, and warmth within 20 minutes of receiving Fluvirin on 10/15/03. The vaccinee was treated with antihistamines. The vaccinee recovered after 3-5 days.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: A report was received from a health care professional on 10/24/03 concerning 4 vaccinees of unspecified demography who experienced redness and wheals at the injection site with itching on the same day as receiving Fluvirin on 10/24/03. On 10/24/03 the vaccinees experienced redness and wheals at the injection site with itching. The vaccinees recovered on 10/24/03. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 11/17/03: A follow up report was received indicating that a 34 year old female vaccinee experienced a local red wheal with redness, swelling, hives, and warmth within 20 minutes of receiving Fluvirin on 10/15/03. The vaccinee was treated with antihistamines. The vaccinee recovered after 3-5 days.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/17/03 concerning multiple vaccinees less than 4 years of age who inadvertently received Fluvirin vaccine between early October 2003 to the time of the report. Between early October 2003 and the time of the report, multiple vaccinees under 4 years of age received Fluvirin. It was not reported if the vaccinees had experienced any adverse reactions. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/17/03 concerning a female vaccinee less than 4 years of age who inadvertently received 0.25ml Fluvirin vaccine on an unspecified day in November 2003. On an unspecified day in November 2003, the vaccinee received Fluvirin. It was not reported if the vaccinee had experienced any adverse reaction. 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 on 11/17/03 from a health care professional concerning an unspecified number (approximately 20) of vaccinees who inadvertently received 1ml Fluvirin on 11/17/03. On 11/17/03, an unspecified number (approximately 20) of vaccinees inadvertently received 1ml Fluvirin. The vaccinees did not exhibit any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 92.0
Sex: F
Vaccine: FLUX
Symptoms: Decreased appetite, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: A report was received from a consumer on 11/17/03 whom is a 92 year old female vaccinee who developed severe flu like symptoms after receiving influenza vaccine on an unknown date in 2002. On an unspecified date in 2002, the patient developed severe flu like symptoms consisting of fevers, decreased appetite, tiredness, and body aches. At the time of the report the consumer did not know when these symptoms began relative to administration of the influenza vaccine however the vaccinees symptoms lasted approximately 2 weeks. The vaccinee had a similar experience 14 years ago following administration of influenza vaccine. Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/17/03 concerning an unspecified number of vaccinees less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees under 4 years of age received Fluvirin. None of the vaccinees had experienced any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.