chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash erythematous
Clinical narrative: A report was received from a consumer on 10/31/03, who is a female vaccinee of unspecified age, who developed approximately 20 raised red itchy spots on her torso, arms and neck 6 days after receiving an unspecified brand of Influenza vaccine on 10/23/03. The vaccinee reported that her husband has poison ivy and that the vaccinee used the same bathtub, which her husband had used the previous day and 24 hours later, the vaccinee developed the spots. The vaccinee has tolerated Flu vaccines in the past without any difficulties. At the time of the report the vaccinee had not recovered. There was insufficient information to determine the reporter's causality assessment. 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 10/31/03 concerning a 30 month old male vaccinee who was inadvertently administered Fluvirin on 10/31/03. The vaccinee had not experienced any adverse effects at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/19/04: A follow up report was received from a health care professional indicating that the vaccinee was two years old and received Fluvirin on 10/22/03. No adverse events had occurred at the time of reporting. No follow up pending, all information received.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health care professional on 10/31/03, concerning a 67 year old female vaccinee who inadvertently received 2 doses of Fluvirin, on on 10/28/03 and another on 10/31/03. The vaccinee did not experience any adverse reaction at the time of the report.  There was insufficient information to determine the reporter's causality assessment. Update 1, 12/10/2003: A follow up report was received from a health care professional which indicated that the vaccinee's vital signs were monitored every 8 hours for 2 days after she inadvertently received 2 doses of Fluvirin. There were no problems, changes or adverse reactions noted. No follow up pending.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health care professional on 11/02/03 concerning a 55 year old female vaccinee who inadvertently received expired Fluvirin on 11/1/03. the vaccinee had experienced no adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/02/2004: A follow up report was received from a health care professional indicating that the vaccinee inadvertently received 1 ml of expired Fluvirin on 11/01/03. No adverse events were reported at the time of the follow up report. No follow up pending, all information received. See ref.: PJP200300969 and PJP200300970.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health care professional on 11/02/03 concerning a 50 year old female vaccinee who inadvertently received expired Fluvirin on 11/01/03. The vaccinee had experienced no adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/02/04: A follow up report was received from a health care professional indicating that the vaccinee inadvertently received 1ml of expired Fluvirin on 11/01/03. No adverse events were reported at the time of the follow up report. No follow up pending, all information received. See ref>: PJP200300968 and PJP20030970>
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health care professional on 11/02/03 concerning a 30 year old male vaccinee who inadvertently received expired Fluvirin on 11/1/03. The vaccinee had experienced no adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/02/04: A follow up report was received from a health care professional indicating that the vaccinee inadvertently received 1ml of expired Fluvirin on 11/01/03. No adverse events were reported at the time of the follow up report. No follow up pending, all information received. See ref.: PJP200300968 and PJP200300969.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Joint swelling
Clinical narrative: A report was received from a health care professional on 11/03/03 concerning a female vaccinee of unknown age who experienced swelling, pain, warmth and tenderness at the injection site 1 day after receiving Fluvirin on 10/30/03. The reporter recommended symptomatic treatment with an ice pack at the affected area. On 11/03/03 the vaccinee had not yet recovered and indicated using a heat pack instead of an ice pack. The vaccinee is to attend her physician for further follow up. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/23/04: Further information was received from a health care professional indicating that the vaccinee was 48 years old and experienced extreme pain in her arm which had spread from the injection site 6 hours following vaccination and resolved on 11/30/03. The vaccinee also experienced pain and swelling in her shoulder. The vaccinee visited her physician twice and her symptoms were treated with antibiotic and anti-inflammatory agents. 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 healthcare professional on 11/03/2003 concerning a 3 year old vaccinee of unspecified gender who inadvertently received Fluvirin on an unspecified date. On an unspecified date the vaccinee, who was less than 4 years of age inadvertently received Fluvirin.  The vaccinee had not experienced any adverse effects at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 02 January 2004: Follow up information received from a healthcare professional indicated that a 2 year old male vaccinee inadvertently received Fluvirin.  The vaccinee did not experience any adverse events, as a result. Update 2, 10 February 2004: Further information received from a healthcare professional on 10 February 2004 indicated that the vaccinee received Fluvirin on 01 November 2003.  The vaccinee did not get re-vaccinated and did not develop the Flu. No follow up pending, all information received.
Sex: U
Vaccine: FLU3
Symptoms: Fatigue, Headache, Pain
Clinical narrative: A report was received from a healthcare professional on 3 November 2003 concerning two vaccinees of unspecified demography who experienced fatigue, achiness and headache the day after receiving Influenza vaccine (brand unspecified) on an unspecified date. On an unspecified date two vaccinees experienced fatigue, achiness and headache.  Both vaccinees had received influenza vaccine in previous years without any side effects.  The outcome of the events were not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: A report was received from a healthcare professional on 3 November 2003 concerning an unspecified number of vaccinees who experienced mild headache an unspecified length of time after receiving Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees experienced mild headache.  The vaccinees recovered 2 to 3 days later. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Headache, Malaise, Pain
Clinical narrative: A report was received from a healthcare professional on 3 November 2003 concerning a vaccinee of unspecified demography who experienced severe headache, malaise and bodyache an unspecified length of time after receiving Fluvirin on an unspecified date. On an unspecified date the vaccinee experienced severe headache, malaise and bodyache.  The vaccinee was negative for influenza virus in serum.  The symptoms were relieved with naproxen sodium and ibuprofen.  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.
Age: 99.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health care professional on 11/04/03 concerning a 98 year old female vaccinee who was inadvertently administered 2 doses of Fluvirin, the first on 10/20/03 and the second on 11/04/03. On 10/20/03 and 11/04/03 respectively, the vaccinee was inadvertently administered 2doses of Fluvirin, the first into the left deltoid and the second into the right deltoid. There was no adverse events at the time of the report. There insufficient information to determine the reporter's causality assessment.  Update 1, 12/12/03: Follow up information received from a health care professional indicated that the vaccinee did not experience any adverse reaction. No follow up pending.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/04/03 concerning a unspecified number of vaccinees who inadvertently received expired Fluvirin on an unspecified date. It was unknown whether or not any vaccinees had experienced any adverse events. There was insufficient information to determine the reporter causality assessment. Follow up pending. Update 1, 12/10/03: A follow up report received from a health care professional indicated that a 62 year old female vaccinee inadvertently received expired Fluvirin on 11/03/03. No side effects were observed at the time of the report. Follow up pending.
Sex: M
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health care professional on 11/04/03, concerning a male vaccinee of unknown age who received 2 doses of Fluvirin, the first on 10/23/03 and the second on 11/04/03. On 10/23/03, the vaccinee received 035ml Fluvirin. Subsequently on 11/04/03 the vaccinee was inadvertently administered 0.5ml Fluvirin instead of the pneumococcal vaccine. The vaccinee had not exhibited any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/10/03: Follow up information received from a health care professional on 12/10/03 indicated that the reporter had followed up with the patient on 12/02/03 and the patient was feeling well and had no adverse events. No follow up pending.
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/04/2003 concerning a 6 month old male vaccinee who inadvertently received Fluvirin on 10/10/2003. 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. See Ref.: PJP200300984 and PJP200300985.
Age: 0.9
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/04/2003 concerning a 9 month old male vaccinee who inadvertently received Fluvirin on 10/29/2003. 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. Update 1, 11/25/2003: A follow up report was received from a health care professional which indicated that the vaccinee was 11 months old when he received Fluvirin on 10/28/2003. The vaccinee had still not experienced any adverse reaction at the time of the report. No follow up pending. See Ref.: PJP200300983 and PJP200300985.
Age: 3.5
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/04/03 concerning a 24 month old male vaccinee who inadvertently received Fluvirin on 10/29/03. 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. Update 1, 11/25/03: A follow up report was received from a health care professional which indicated that the vaccinee was 31 months old when he received Fluvirin on 10/28/03. The vaccinee had still not experienced any adverse reaction at the time of the report. No follow up pending. See Ref.: PJP200300983 and PJP200300984.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Swelling
Clinical narrative: A report was received from a health care professional on 11/05/03, concerning a 25 year old male vaccinee who experienced swelling and pain the same day of receiving Fluvirin in his left deltoid on 11/3/03. On 11/3/03, the vaccinee experienced swelling in the left upper area and pain. the vaccinee had not yet recovered at the time of reporting. There was insufficient information to determin the reporter's causality assessment. Follow up pending.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: A report was received from a health care professional on 11/04/03, concerning a female vaccinee of unknown age who developed a quarter sized knot which was red and hot an unspecified length of time after receiving Fluvirin vaccine on 10/07/2003. The outcome was unknown at the time of the report. There was insufficient information to determine the reporter's causality assessment. No follow up pending. Cross reference with: PJP20030785, PJP200300786 and PJP200300988.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Pain
Clinical narrative: A report was received from a health care professional on 11/04/2003, concerning a female vaccinee of unknown age who developed a quarter sized knot which was red and a very sore arm an unspecified length of time after receiving Fluvirin on 10/16/2003. The outcome was unknown at the time of the report. There was insufficient information to determine the reporter's causality assessment. No follow up pending. Cross reference with: PJP20030785, PJP200300786 and PJP200300987.
Sex: M
Vaccine: FLU3
Symptoms: Respiratory disorder
Clinical narrative: A report was received from a health care professional on 11/05/2003, concerning a male vaccinee of unknown age who developed oculorespiratory syndrome an unspecified length of time after receiving Fluvirin on an unknown date. The vaccinee is HIV positive. The outcome of the oculorespiratory syndrome was not reported. The reporter has assessed the relationship of the vaccinee to the event as unrelated. Follow up pending.
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Medication error
Clinical narrative: Injection site swelling (Injection site edema, injection site edema) (Edema inject site) - recovered/resolved Injection site redness (injection site reaction, injection site reaction)(inject site react) - recovered/resolved Injection site warmth (Injection site reaction, injection site reaction) (Inject site react)- recovered/resolved Administration by an unlicensed route (Medication error, medication error) (Med error) - recovered/resolved     A report was received from a health professional on 05 November 2003, concerning approximately 20 vaccines who experienced local swelling, warmth and redness at the injection site an unspecified length of time after inadvertently receiving Fluvirin subcutaneously between 03 November - 04 November 2003. Between 03 November - 04 November 2003, the vaccines experienced local swelling, warmth and redness at the injection site. No other information was available. There was insufficient information to determine the reporter's causality assessment. Update 1, 09 March 2004 Follow-up information received from a health care professional indicated that approximately 18-20 female vaccines received Fluviron on 05 November 2003 subcutaneously and within 1 hour of administration experienced local swelling and redness at injection site. The adverse reactions resolved approximately 12-24 hours later. No long term complications were reported. No follow-up pending, all information recevied.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Injection site redness (Injection site reaction, injection site reaction)(Inject site react) not recovered/not resolved  Injection site raised (Injection site edema, injection site edema)(Edema inject site) - not recovered/not resolved Injection site sore (Injection site pain)(Pain inject site) - not recovered/not resolved Injection site hot (Injection site reaction, Injection site reaction)(Inject site react) - not recovered/not resolved Diarrhea (Diarrhea, Diarrhea) (Diarrhea) - not recovered/not resolved A report was received from a consumer on 05 November 2003, concerning a 44 year old female vaccinee who developed a red, raised, hot to touch spot at the site of injection approximately 3 and a half hours after receiving Fluvirin on 03 November 2003 and also experienced 3 episodes of diarrhea on 04 November 2003. On 03 November 2003, the vaccinee developed a red, raised, hot to touch spot at the site of injection. The vaccinee did not experience any fever. The spot on the vaccinee's arm increased in size to approximately 3 inches in diameter and the soreness worsened. On 04 November 2003, the vaccinee experienced 3 episodes of diarrhea. Follow-up pending.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Injection site redness (Injection site reaction, injection site reaction)(Inject site react) not recovered/not resolved  Injection site raised (Injection site edema, injection site edema)(Edema inject site) - not recovered/not resolved Injection site sore (Injection site pain)(Pain inject site) - not recovered/not resolved Injection site hot (Injection site reaction, Injection site reaction)(Inject site react) - not recovered/not resolved Diarrhea (Diarrhea, Diarrhea) (Diarrhea) - not recovered/not resolved A report was received from a consumer on 05 November 2003, concerning a 44 year old female vaccinee who developed a red, raised, hot to touch spot at the site of injection approximately 3 and a half hours after receiving Fluvirin on 03 November 2003 and also experienced 3 episodes of diarrhea on 04 November 2003. On 03 November 2003, the vaccinee developed a red, raised, hot to touch spot at the site of injection. The vaccinee did not experience any fever. The spot on the vaccinee's arm increased in size to approximately 3 inches in diameter and the soreness worsened. On 04 November 2003, the vaccinee experienced 3 episodes of diarrhea. Follow-up pending.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Local pain (Injection site pain, injecton site pain)(Pain inject site) - recovered/resolved Local swelling (Injection site inflammation, injection site inflammation)(Inflam inject site) - recovered/resolved Local redness (Injection site reaction, injection site reaction)(Inject site react) - recovered/resolved A report was received from a health professional on 05 November 2003, concerning 44 vaccinees who all experienced local reactions at the injection site a day after receiving Fluvirin on 03 November 2003. On 04 November 2003, the vaccinees experienced local reactions at the injection site. No other information was available. There was insufficient information to determine the reporter's causality assessment. Update 1, 20 January 2004. A follow-up report was received from a health care professional concerning 20 to 30 vaccinees who developed local pain, local swelling and local redness after they received Fluvirin. The reporter indicated that all symtoms had resolved within 48 hours and there are no ongoing complaints.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Hypersensitivity, Injection site erythema, Pruritus, Rash
Clinical narrative: Red patch at injection site- recovered/resolved Hot patch at injection site- recovered/resolved Itchy patch at injection site- recovered/resolved  A report was received from a health professional on 05 November 2003, concerning a 59 year old female vaccinee who developed a 6cm x 3cm red, hot and itchy patch at the site of injection the same evening after receiving Fluvirin vaccine on 04 November 2003. On 04 November 2003 the vaccinee developed a 6cm x 3cm red, hot and itchy patch at the site of injection. It was reported as being similar to an allergic reaction such as that observed during an allergy test. The rash was treated with a topical corticostaroid cream and the patient recovered on 05 November 2003. There was insufficient information to determine the reporter's causality assessment. Follow-up pending.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema, Pain, Pruritus, Rash
Clinical narrative: Red area (Rash, Rash) - not recovered/not resolved Itchy area (Pruritus, Pruritus)(Pruritus) - not recovered/not resolved Swollen (edema, Edema) (Edema) - not recovered/not resolved Tender (Pain, Pain) (Pain) - not recovered/ not resolved. A report was recieved from a health care professional on 5 November 2003 concerning a 41 year old female vaccinee who experienced a red, itchy area that was swollen and tender on the same day as receiving Fluvirin on 3 November 2003. On 3 November 2003 the vaccinee experienced a red, itchy area (40 x 60 mm) that was swollen and tender. 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.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Tenderness
Clinical narrative: Red area (Rash, Rash) - not recovered/not resolved Itchy area (Pruritus, Pruritus)(Pruritus) - not recovered/not resolved Swollen (edema, Edema) (Edema) - not recovered/not resolved Tender (Pain, Pain) (Pain) - not recovered/ not resolved. A report was recieved from a health care professional on 5 November 2003 concerning a 41 year old female vaccinee who experienced a red, itchy area that was swollen and tender on the same day as receiving Fluvirin on 3 November 2003. On 3 November 2003 the vaccinee experienced a red, itchy area (40 x 60 mm) that was swollen and tender. 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.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: A report was received from a health care professional on 5 November 2003 concerning a 37 year-old female vaccine who experienced a red, swollen area with hot spots on the same day as receiving Fluvirin on 4 November 2003.  On 4 November 2003 the vaccine experienced a red, swollen area with hot spots from shoulder to elbow.  the area was 10 x 10mm.  The vaccine had not recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain
Clinical narrative: A report was received from a health care professional on 5 November 2003 concerning a 31 year old female vaccine who experienced a large red painful area on the same day as receiving Fluvirin on 4 November 2003.  On 4 November 2003 the vaccine experienced a experienced a large red painful area.  The vaccine had not recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: A report was received from a health care professional on 5 November 2003 concerning a 36-year-old female vaccine who experienced a red, itchy area that was mildly painful on the same day as receiving Fluvirin on 4 November 2033.  On 4 November 2003 the vaccine experienced a red, itchy area that was mildly painful.  The vaccine had not recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 5 November 2003 concerning a 65-year-old male vaccine who received expired Fluvirin on 1 October 2003.  On 1October 2003 the vaccine received expired Fluvirin.  There was insufficient information to determine the reporter's causality assessment.  Update 1, 16 February 2004.  A follow-up report was received from a health care professional indicating that the vaccine received Fluvirin on 02 October 2003.  No adverse event had occurred at the time of reporting.  No follow-up pending.  All information received.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 5 November 2003 concerning a vaccine of unspecified demography who received expired Fluvirin on 1 October 2003.  On 1 October 2003 the vaccine received expired Fluvirin.  There was insufficient information to determine the reporter's causality assessment.  Update 1, 16 February 2004.  A follow-up report was received from a health care professional indicating that a 45 year old female vaccine received expired Fluvirin on 02 October 2003. No adverse event had occurred at the time of reporting.  No follow-up pending, all informaiton received.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 5 November 2003 concerning a vaccinee of unspecified demography who received expired Fluvirin on 1 October 2003. On 1 October 2003 the vaccinee received expired Fluvirin. There was insufficient information to determine the reporter's causality assessment. Update 1, 16 February 2004. A follow up report was received from a healthcare professional indicating that a 52 year old male vaccinee received expired Fluvirin on 02 October 2003.  No adverse event had occurred at the time reporting. No follow up pending, all information received.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: A report was received from a healthcare professional on 5 November 2003 concerning a 56 year old female vaccinee who experienced a 3-4 inch red area around the injection site and itches on the same day as receiving Fluvirin on 4 November 2003. On 4 November 2003 the vaccinee experienced a 3-4 inch red area around the injection site and itches.  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.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pain, Pruritus
Clinical narrative: A report was received from a healthcare professional on 5 November 2003 concerning a 50 year old female vaccinee who experienced a 3-4 inch red area which was itchy, painful and hot on the same day as receiving Fluvirin on a 4 November 2003. On 4 November 2003 the vaccinee experienced a 3-4 inch red area which was itchy, painful and hot.  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.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 6 November 2003 concerning a 73 year old female vaccinee who received expired Fluvirin on 4 November 2003. On 4 November 2003 the vaccinee received expired vaccine.  No adverse event had occurred at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 6 November 2003 concerning a 71 year old male vaccinee who received expired Fluvirin on 4 November 2003. On 4 November 2003 the vaccinee received expired vaccine.  No adverse event had occurred 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: Erythema, Oedema
Clinical narrative: A report was received from a health care professional on 27 October 2003 concerning 3 vaccinees of unknown demography who experienced red, swollen arms an unspecified length of time after receiving Fluvirin vaccine on an unknown date. On an unknown date, the vaccinee's arms became red and swollen. The swelling ranged from the size of a golf ball to the size of a tennis ball. The outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200300897.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 6 November 2003 concerning a 77 year old male vaccinee who received expired Fluvirin on 5 November 2003. On 5 November 2003 the vaccinee received expired vaccine. No adverse event had occurred at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301007, PJP200301008,PJP200301011.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 6 November 2003 concerning a 71year old male vaccinee who received expired Fluvirin on 5 November 2003. On 5 November 2003 the vaccinee received expired vaccine. No adverse event had occurred at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301007, PJP200301008,PJP200301010.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: A report was received from a health care professional on 6 November 2003 concerning a 24 year old female vaccinee who experienced redness and warmth at the injection site 2 days after receiving Fluvirin on 3 November 2003. On 5 November 2003 the vaccinee experienced redness and warmth at the injection site. The vaccinee had not recovered at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301013.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: A report was received from a health care professional on 6 November 2003 concerning a 25 year old female vaccinee who experienced redness and warmth at the injection site 1 day after receiving Fluvirin on 5 November 2003. On 6 November 2003 the vaccinee experienced redness and warmth at the injection site. The vaccinee had not recovered at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301012.
Sex: U
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health professional on 11/06/03, concerning a vaccinee of unspecified demography who received an unspecified brand of flu vaccine on 10/20/03 and inadvertently received Fluvirin on 11/06/2003. At the time of the repot the vaccinee had not experienced any adverse reactions. No other information was available 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 professional on 11/06/03, concerning approximately 30 elderly vaccinees who inadvertently received Fluvirin subcutaneously on 11/06/03. No other information was available 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 professional on 11/06/2003, concerning approximately 20-30 vaccinees who developed a warm, red and sore spot at the site of injection. This occurred approximately 24-48 hours after they received Fluvirin on 11/04/03 or 11/05/03. On 11/06/03 the vaccinees developed a warm, red sore spot about the size of a silver dollar at the site of injection. The reporter described the reaction as cellulitis and attributed it to the short needle length of the prefilled syringe. There was insufficient information to determine the reporter's causality. Follow up pending.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Skin irritation
Clinical narrative: A report was received from a health professional on 11/06/03, concerning a 66 year old vaccinee who experienced localized redness at the injection site two days after receiving Fluvirin on 10/30/03. On 11/01/03, the vaccinee experienced localized redness about 10mm in diameter at the injection site. There was no other symptoms. The event had not resolved at the time of report and the vaccinee is seeing his physician for a follow up visit. The vaccinee has previously had the flu vaccine without any such reaction. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/08/2003: Follow up information received from a health care professional indicated that on 11/06/03, the vaccinee experienced irritation and redness at the injection site and appeared to have a large scab. The vaccinee was admitted into the monitoring area. On 11/10/03, the vaccinee informed his doctor that the large scab was in fact a tick. The tick was removed on the same day and there were no further problems. The redness resolved on 11/10/03. No follow up pending.
Age: 1.92
Sex: M
Vaccine: FLU3
Symptoms: Drug ineffective, Hypertrophy, Influenza, Medication error, Pyrexia
Clinical narrative: A report was received from a health care professional on 11/06/03, concerning a 2 year old male vaccinee who received Fluvirin on 11/06/03. On 11/06/03, the vaccinee received a single of dose of Fluvirin intramuscularly. At the time of reporting the vaccinee did not exhibit any adverse symptoms from the vaccination. There was insufficient information to determine the reporter's causality assessment. Update 1, 05/10/04: Follow up information received from a health care professional indicated that the 2 year old vaccinee developed emesis and a temperature of 100.9 several hours after receiving Fluvirin on 11/06/03. Both events resolved on an unspecified date. The reporter indicated that the emesis and elevated temperature were possibly unrelated as when the patient was later examined he did have tonsillar hypertrophy without a high temperature. On 12/29/03, the patient tested positive for Influenza A. It was not reported if the vaccinee had recovered from the tonsillar hypertrophy and the Influenza A at the time of the report. There was insufficient information to determine the causality of the tonsillar hypertrophy and the Influenza A. Follow up pending.
Age: 1.92
Sex: M
Vaccine: FLU3
Symptoms: Respiratory disorder, Vomiting
Clinical narrative: A report was received from a health care professional on 11/06/03, concerning a 2 year old male vaccinee who received Fluvirin on 11/06/03. On 11/06/03, the vaccinee received a single of dose of Fluvirin intramuscularly. At the time of reporting the vaccinee did not exhibit any adverse symptoms from the vaccination. There was insufficient information to determine the reporter's causality assessment. Update 1, 05/10/04: Follow up information received from a health care professional indicated that the 2 year old vaccinee developed emesis and a temperature of 100.9 several hours after receiving Fluvirin on 11/06/03. Both events resolved on an unspecified date. The reporter indicated that the emesis and elevated temperature were possibly unrelated as when the patient was later examined he did have tonsillar hypertrophy without a high temperature. On 12/29/03, the patient tested positive for Influenza A. It was not reported if the vaccinee had recovered from the tonsillar hypertrophy and the Influenza A at the time of the report. There was insufficient information to determine the causality of the tonsillar hypertrophy and the Influenza A. Follow up pending.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Contusion, Erythema, Feeling hot, Hypersensitivity
Clinical narrative: A report was received from a health care professional on 11/06/03, concerning a 74 year old female who experienced cellulitis with erythema, bruising and warmth on the same day as possibly receiving Fluvirin subcutaneously on 10/27/03. On 10/27/03 the vaccinee experienced erythema and bruising, (10x12 cm) on the affected upper extremity from shoulder to elbow. No rash was present, but the area was warm to touch. This event was labeled by the treating physician as possible cellulitis versus possible allergic reaction. The vaccinee was treated with cephalexin and cetirizine hydrochloride. The event was much improved but not completely resolved at the time of reporting. It was believed that the vaccinee had been administered subcutaneously. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/06/03, concerning a 74 year old female who experienced cellulitis with erythema, bruising and warmth on the same day as possibly receiving Fluvirin subcutaneously on 10/27/03. On 10/27/03 the vaccinee experienced erythema and bruising, (10x12 cm) on the affected upper extremity from shoulder to elbow. No rash was present, but the area was warm to touch. This event was labeled by the treating physician as possible cellulitis versus possible allergic reaction. The vaccinee was treated with cephalexin and cetirizine hydrochloride. The event was much improved but not completely resolved at the time of reporting. It was believed that the vaccinee had been administered subcutaneously. 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 received from a health care professional on 11/06/03, concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 11/04/03. No adverse event was reported at the time of the report. There was insufficient information to determine the reporters causality assessment. Follow up pending.
Age: 1.57
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/07/03, concerning an 18 month old male vaccinee who inadvertently received Fluvirin on 11/07/03. On 11/07/03 the vaccinee received a single dose of Fluvirin, 0.25ml. At the time of reporting the vaccinee did not exhibit any adverse symptoms. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/07/04: Further information was received from a health care professional on 01/07/04 indicating that the vaccinee did not experience any adverse reaction. No follow up pending, all information received.
Sex: U
Vaccine: FLUX
Symptoms: Injection site erythema
Clinical narrative: A report was received from a health care professional on 11/07/03, concerning two vaccinees who developed local skin reactions at the site of injection, involving a red patch 3-4 inches wide, after receiving an unspecified brand of influenza vaccine on an unspecified date. On an unspecified date, the vaccinees developed a red patch 3-4 inches wide at the site of injection. No other information was available at the time of the report and the outcome was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: A report was received from a health care professional on 11/07/03, concerning a vaccinee of unknown demography who experienced pain at the injection site for more than 2 days after receiving Fluvirin vaccine on 11/03/03. The outcome of the event was not reported. There was insufficient information to determine the reporters causality assessment. Follow up pending.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Feeling hot
Clinical narrative: A report was received from a health care professional on 11/07/2003, concerning a 25 year old female vaccinee who developed a metallic taste in her mouth approximately 20 minutes after receiving Fluvirin vaccine on 11/7/03. The vaccinee recovered on 11/07/03. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/09/04: Further information was received from a health care professional on 01/09/04 indicating that the vaccinee developed a metallic taste 10 minutes following vaccination and experienced a feeling of warmth 5-10 minutes following vaccination. The vaccinee's symptoms have resolved. Follow up pending.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Drug ineffective, Headache, Influenza like illness, Lethargy
Clinical narrative: A report was received from a health care professional on 11/07/03, concerning a 37 year old female vaccinee who experienced flu like symptoms consisting of general achiness, lethargy, headache, low grade fevers, congestion and coughing approximately two weeks after receiving Fluvirin vaccine on an unknown day in October 2003. The vaccinee was seen in a physicians office on 11/07/03 and she appeared to be doing well. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/24/2004: Follow up information received from a health care professional indicated that an influenza test revealed a positive result. The patient was treated with Amantadine and recovered with conservative treatment. No follow up pending.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Pain, Pyrexia
Clinical narrative: A report was received from a health care professional on 11/07/03, concerning a 37 year old female vaccinee who experienced flu like symptoms consisting of general achiness, lethargy, headache, low grade fevers, congestion and coughing approximately two weeks after receiving Fluvirin vaccine on an unknown day in October 2003. The vaccinee was seen in a physicians office on 11/07/03 and she appeared to be doing well. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/24/2004: Follow up information received from a health care professional indicated that an influenza test revealed a positive result. The patient was treated with Amantadine and recovered with conservative treatment. No follow up pending.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health care professional on 11/07/2003, concerning a vaccinee of unspecified demography who received Fluvirin on 11/06/03. After receiving the influenza vaccine (brand unspecified) approximately two weeks earlier on an unknown date. No adverse effects were reported from the initial vaccination. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/26/04: A follow up report was received from a health care professional who confirmed that the vaccinee was 62 year old female who did not experience any adverse event. Update 2, 04/06/04: Further information was received from a health care professional providing the batch of the Fluvirin administered. 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 11/07/03, concerning a 33 month old female vaccinee who advertently received Fluvirin on 11/7/03. On 11/7/03 the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting the vaccinee did not exhibit any adverse symptoms. There was insufficient information to determine the reporters causality assessment. Update 1, 01/24/04: A follow up report was received from a health care professional indicating that no adverse reactions were reported, at the time of reporting. No follow up pending, all information received.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health care professional on 11/08/03, concerning an 88 year old female vaccinee who inadvertently received a second dose of Fluvirin on 11/07/03. On 11/04/03, an 88 year old female vaccinee was administered 0.5mls Fluvirin. Subsequently on 11/7/03, the vaccinee received a further dose of 0.5mls of Fluvirin. The vaccinee did not exhibit any untoward sings or symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/16/04: A follow up report was received from a health care professional indicating that there was no adverse events experienced by the vaccinee. No follow up pending, all information received.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Lymphadenopathy, Malaise, Medication error, Pain
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.