chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: A report was received from a healthcare professional on 10/20/2003 concerning a 52 year old female vaccinee who experienced swelling and redness 2 days after receiving Fluvirin on 10/14/2003. On 10/16/2003, the vaccinee experienced swelling and redness after receiving Fluvirin on 10/14/2003.  At the time of the report the outcome of the event was unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pruritus
Clinical narrative: A report was received from a healthcare professional who was also the consumer on 10/20/2003 concerning a 48 year old female vaccinee who experienced local erythema and pruritis minutes after receiving Fluvirin on 10/16/2003. On 10/16/2003 the vaccinee experienced local erythema and pruritis extending from the injection site to her left underarm to under her left breast.  The vaccinee self treated with oetrizine hydrochloride, diphenhydramine hydrochloride and prednisone.  The local reaction resolved within half an hour.  The outcome of the pruritis was not reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/25/2003 Follow up information received from a healthcare professional indicated that the vaccinee experienced severe erythema and urticaria, localized to the left shoulder, left upper arm, left arm and left breast.  The event resolved on an unspecified date. The reporter has assessed the relationship of Fluvirin to the event as probably related.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/20/2003 concerning a 68 year old female vaccinee who received expired Fluvirin on 10/20/2003. On 20 October 2003 the vaccinee received expired Fluvirin.  The vaccinee did not complain of any adverse event. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1. 11/19/2003. A follow up report was received from a healthcare professional indicating that the vaccinee received 0.5ml of Fluvirin on 10/20/2003. No follow up pending.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/20/2003 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 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, 11/10/2003: A follow up report was received from a healthcare professional indicating that a 3 year old male vaccinee received Fluvirin on 10/07/2003.
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Medication error, Pain
Clinical narrative: A report was received from a consumer on 10/20/2003 concerning a male vaccinee of unknown age who experienced tiredness, and felt achy 1 day after receiving expired Fluvirin on 10/19/2003. On 10/19/2003 the vaccinee believes he received expired Fluvirin.  On 10/20/2003 the vaccinee felt tired and achy. No follow up.  Permission not granted to contact physician. Update 1, 12 December 2003 A follow up report was received from a consumer indicating that the vaccine he received had not expired.  The reporter stated that "Everything is OK'. Follow up pending.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: A report was received from a healthcare professional on 10/20/2003 concerning a female vaccinee in her 50's who experienced an injection site reaction with redness, pain, swelling, and itchiness 1 day after receiving Fluvirin on 10/17/2003. ON 10/18/2003 the vaccinee experienced an injection site reaction with redness, pain, swelling, and itchiness.  The swelling was 1.5cm by 1.5cm and the redness was 7cm by 7cm.  The vaccinee had not recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment. Update 1, 02 December 2003 Follow up information received from a healthcare professional indicated that the vaccinee who experienced severe swelling, redness and pain at the injection site, recovered within 1 week.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A report was received from a healthcare professional on 10/20/2003 concerning a 46 year old female vaccinee who experienced an injection site reaction with swelling, redness and pain 1 day after receiving Fluvirin on 10/10/2003. On 10/11/2003 the vaccinee experienced an injection site reaction with swelling, redness and pain.  The affected area was 5cm by 5cm.  The vaccinee recovered 1 week after onset. There was insufficient information to determine the reporter's causality assessment.   Follow up pending. Update 1, 02 December 2003: Follow up information received from a healthcare professional indicated that the vaccinee who experienced severe swelling, redness and pain at the injection site, recovered after 1 week.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: A report was received from a health car professional on 10/20/03 concerning an unspecified number of vaccinees who experienced erythema at the injection site an unspecified length of time after receiving Fluvirin on an unspecified date. There was insufficent information to determine the reporter's causality assessment. Follow up pending.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Lymphadenitis, Lymphadenopathy, Mastitis, Pleuritic pain
Clinical narrative: A report was received from a health care professional who was also the consumer on 10/21/2003 concerning a 46 year old male vaccinee who experienced swelling and discomfort  at the lymphatics 6 days after receiving Fluvirin on 10/14/2003. On 10/20/03 the vaccinee began to experience swelling and discomfort at the lympatics located at the left anterior axilla that also involved the left breast. The vaccine in the left deltoid. The out come of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 10/29/2003: A follow up was received from the effected and reporting health care professional indiciating that the lymphadenopathy under the axilla had slightly decreased. Swelling at the breast persists. Additionally the reporter reports pleuritic chest pain which has worsened and describes the pain like a costochondritis. A chest X-ray was performed on 10/28/2003 to rule out causes of chest pain. Update 2, 11/14/2003: Internal review indicated that these reactions were medically significant. Update 3, 11/17/2003: Further internal medical review indicated that  these reactions were not medically significant. Update 4, 12/22/2003: Follow up information received from the health care professional inidicated that the adverse events began on 10/21/03. The axillary lymph nodes clinically resolved three and a half weeks later. However the pleuritic chest pain remains on going with slight improvement. The health care professional has assessed the relationship of the vaccine to the lymphadenopathy as probable.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: A report was received from a health care professional on 10/21/03 concerning a 41 year old female vaccinee who experience nausea 6.5 hours after, and vomiting on day after receiving Fluvirin on 10/20/03. On 10/20/2003 the vaccinee experienced nausea 6.5 hours after vaccination. The nausea lasted until the following morning, during which time the vaccinee vomited every half hour up to a total of 6 to 8 times. The vaccinee claims to have an allergy to eggs and the last time she was exposed to eggs she experienced diarrhea, blotchy red rash, nausea and vomiting. The vaccinee was still nauseated at the time of the report and was to see her physician for treatment. There was insufficient information to determine the reporter's causality assessment.  Update 1, 11/27/2003: Follow up information received from a health care professional indicated that following treatment with diphenhydramine hydrochloride the nausea and vomiting resolved.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10/21/2003 concerning a vaccinee of unknown demography who was administered Fluvirin by an unlicensed route on 10/20 or 10/21/2003. On 10/20 or 10/21/2003, the vaccinee received one dose of fluvirin vaccine in the gluteal muscle instead of the deltoid muscle. At the time of the report the vaccinee had not experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error, Overdose
Clinical narrative: A report was received from a health care professional on 21 October 2003 concerning a 66-year-old male vaccinee who received an accidental overdose of Fluvirin on 21 October 2003. On 21 October 2003 the vaccinee received 0.5ml Fluvirin in each deltoid. No adverse symptoms were observed. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 14 November 2003: A follow up report was received form a health care professional indicating that the vaccinee was checked on 7 November 2003 and had experienced no adverse event.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 21 October 2003 concerning a 3-year-old vaccinee who received Fluvirin on 20 October 2003. On 20 October 2003 the 3 year-old vaccinee inadvertently received Fluvirin. No adverse symptoms were reported 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: Medication error
Clinical narrative: A report was received from a health care professional on 21 October 2003 concerning a female vaccinee of unknown age who inadvertently received Fluvirin subcutaneously on 21 October 2003. On 20 October 2003 the vaccinee inadvertently received Fluvirin subcutaneously. No adverse symptoms were reported in association with the event. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Medication error, Overdose
Clinical narrative: A report was received from a consumer on 21 October 2003 concerning a vaccinee of unknown demography who received 3ml of Fluvirin on 20 October 2003. On 20 October 2003 the vaccinee received 3ml of Fluvirin. The vaccinee denied experiencing any adverse symptoms at the time of the report. No follow-up. Permission not granted to contact physician.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 21 October 2003 concerning a 3-year-old vaccinee who received Fluvirin on 21 October 2003. On 21 October 2003 the vaccinee received 0.5ml Fluvirin. No adverse symptoms were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 21 October 2003 concerning a vaccinee of unknown demography who received expired Fluvirin on 20 October 2003. On 20 October 2003 the vaccinee received expired Fluvirin. No adverse symptoms were reported at the time of the event. There was insufficient information to determine the report's causality assessment. Update 1, 24 November 2003: Follow up information received from a health care professional indicated that the 87 year old female vaccinee did not experience any adverse reaction. The reporter stated that the vaccinee will receive the 2003-2004 vaccine in January 2004.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea
Clinical narrative: A report was received from a health care professional on 21 October 2003 concerning a 66-year-old female vaccinee who experienced breathing difficulty and chills 3 days after receiving Fluvirin on 17 October 2003. On 20 October 2003 the vaccinee experienced breathing difficulty and chills. 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: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Nausea, Vision blurred
Clinical narrative: A report was received from a health care professional on 22 October 2003 concerning a 65-year-old male vaccinee who experienced shortness of breath, dizziness, nausea and blurred vision 1 hour after receiving Fluvirin on 22 October 2003. On 22 October 2003 the vaccinee experienced shortness of breath, dizziness, nausea, and blurred vision. The vaccinee was taken to an emergency room for the management of events. It was unknown at the time of the report whether or not the vaccinee was admitted to hospital. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 10 December 2003: Following medical review on 10 December 2003, this case was considered to be medically significant (OMIC).
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received by a health care professional on 22 October 2003 concerning 80 adult vaccinees who received Fluvirin subcutaneously. A 27 gauge half-inch needle was used. Non of the vaccinees exhibited any adverse symptoms. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Medication error, Overdose
Clinical narrative: A report was received from a health care professional 22 October 2003 concerning a vaccinee of unknown demography who received two doses of Fluvirin on an unspecified date. On an unspecified date the vaccinee received two doses of Fluvirin. The reporter did not know if the vaccinee had experienced any adverse symptoms or if the vaccinee was given in a single 1ml dose or two 0.5ml doses. There was insufficient information to determine the reporter's causality assessment. Update1, 17 November 2003: Follow-up information received from a health care professional indicated that the vaccinee inadvertently received 1 dose of Fluvirin subcutaneously on 03 October 2003. The vaccinee was monitored adverse effects but none were reported.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 22OCT2003 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 21OCT2003. On 21OCT2003 the 2 year old vaccinee received Fluvirin . The vaccinee did not exhibit any adverse reaction as a result. There was insufficient information to determine the reporter's causality assessment. Update 1 12NOV2003: follow up information received from a health care professional indicated that the vaccinee experienced no adverse reaction.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: A report was received from a health care professional on 22OCT2003, concerning a 23 year old male vaccinee who experienced hives on his abdomen, thighs and arms and a red, swollen and hot injection site two days after receiving the Fluvirin vaccine on 20OCT2003. On 22OCT2003, the vaccinee woke up with hives on his abdomen, thighs and arms. His Fluvirin injection site was red, swollen and hot to touch. Following administration of Diphenhydramine the hives improved slightly. Update 1, 16FEB2004. A follow up report was received from a health care professional indicating that the 24 year old vaccinee's hives have now resolved. The vaccinee is allergic to sulphonamindes drugs and had mixed Amoxicillin Suspension the night prior to the development of the hives. The hives were persistent and re-flared for one week. The vaccinee was treated with prednisone and cetirizine hydrochloride. The reporter has assessed the relationship of Fluvirin to the event as probable. No follow up pending, all information received.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: A report was received from a health care professional on 22OCT2003 concerning a 3 year old male vaccinee who received Fluvirin on 22OCT2003. On 22OCT2003 the three year old vaccinee received Fluvirin. The vaccinee 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: 1DEC2003. Follow up information received from a health care professional indicated that the vaccinee received Fluvirin on 21OCT2003 and not on 22OCT2003 as was previously stated. No follow up pending,all information received.
Age: 0.79
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: A report was received from a health care professional on 22OCT2003 concerning a 9 month old female vaccinee who received Fluvirin on 22OCT2003. On 22OCT2003 the 9 month old vaccinee received Fluvirin. The vaccinee had not experienced any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1 17NOV2003: Follow up information received from a health care professional indicated that the vaccinee did not experience any adverse effects.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Diarrhoea, Pain, Pyrexia
Clinical narrative: A report was received from a health care professional on 22OCT2003 concerning a 57 year old male vaccinee who experienced low grade temperature, general body aches, joint pains and mild diarrhea 12 hours after receiving Fluvirin on 20OCT2003. On an unspecified date, 12 hours after receiving Fluvirin in OCT 2003 the vaccinee experienced low grade temperature, general body aches, joint pains and mild diarrhea. 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 . Cross reference with PJP200300868.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: A report was received from a health care professional on 22OCT2003 concerning a 45 year old male vaccinee who experienced low grade temperature and general body aches 12 hours after receiving Fluvirin on 17OCT2003. On an unspecified date , 12 hours after receiving Fluvirin, the vaccinee experienced low grade temperature and general body aches. The vaccinee recovered 12 hours later. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with PJP200300876.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: A report was received from a health care professional on 22OCT2003 concerning a 61 year old female vaccinee who developed a protruding , pin pong ball sized swelling immediately after receiving Fluvirin vaccine on 8OCT2003. On 8OCT2003, the vaccinee developed a protruding, ping pong ball sized swelling immediately after receiving Fluvirin vaccine. The reporter stated that the adverse event is most likely resolved. There was insufficient information to determine the investigator's causality assessment. Reference: PJP200300870, PJP200301318.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: A report was received from a health care professional on 22OCT2003 concerning a 69 year old female vaccine who developed a protruding, ping pong ball sized swelling immediately after receiving Fluvirin vaccine on 14OCT2003. On 14OCT2003, the vaccinee developed a protruding , ping pong ball sized swelling immediately after receiving Fluvirin vaccine. The reporter stated that the adverse event is most likely resolved. There was insufficient information to determine the investigator's causality assessment. Reference : PJP200300869, PJP200301318.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A report was received from a health care professional on 22OCT2003 concerning a 30 year old female vaccinee who experienced redness and swelling at the site of injection one day after receiving Fluvirin on 20OCT2003. On 21OCT2003 the vaccinee experienced redness and swelling at the injection site. The swelling was also reported to be warm to the touch. The vaccinee had not recovered at the time of the report. The was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1 10NOV2003: A follow up report was received from a health care professional indicating that a 31 year old female vaccinee experienced a 50 cents size red sore local reaction one day after receiving Fluvirin on 21OCT2003. The vaccinee recovered on 25OCT2003.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: A report was received from a health care professional on 22OCT2003 concerning a 30 year old female vaccinee who experienced injection site swelling and redness on an unspecified length of time after receiving Fluvirin on 17OCT2003. On an unspecified date in OCT2003 the vaccinee experienced injection site swelling and redness. The swelling was also reported to be warm to touch. 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 1 , 10NOV2003: A follow up report was received from a health care professional indicating that the reaction was the size of a 50 cents piece. The vaccine was administered on 16OCT2003 as previously reported. The onset date was reported as 17OCT2003. The vaccinee was 32 years old and not 30 years old as previously reported. The vaccinee recovered on 20OCT2003. Cross reference with PJP200300871.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site induration, Injection site swelling, Pain, Tenderness
Clinical narrative: A report was received from a health care professional on 22OCT2003 concerning a 41 year old female vaccinee who experiened tenderness, swelling and hardness at the site of injection approximately 1 to 2 hours after receiving Fluvirin SC on 21OCT2003. On 21OCT2003 the vaccinee received Fluvirin SC, 1-2 hours after receiving Fluvirin the vaccinee experienced some tenderness , swelling and hardness at the site of injection. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 3FEB2004: Further information was received from a health care professional on 3FEB2004 indicating that the vaccinee experienced local pain, swelling and redness 2-3 days following vaccination . The local pain, swelling and redness lasted 1.5 months. There was no further sequelae. Follow up pending. Cross reference with PJP200300874.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Pain, Tenderness
Clinical narrative: A report was received from a health care professional on 22OCT2003 concerning a 45 year old female vaccinee who experienced tenderness at the site of injection an unspecified length of time after receiving Fluvirin SC on 21OCT2003. On 21OCT2003 the vaccinee received Fluvirin SC. An unspecified length of time after receiving Fluvirin the vaccinee experienced some tenderness at the site of injection. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 3FEB2004: Further information was received from a health care professional on 3FEB2004 indicating that the vaccinee also experienced local pain which started 2 days following vaccination. The local pain lasted for 2-3 days and the vaccinee is reported to be doing well. Cross reference with PJP200300873.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: A report was received from an office manager on 20OCT2003 and validated by a health care professional on 21OCT2003 concerning a 2 year old male vaccinee who received Fluvirin on 20OCT2003. On 20OCT2003 the two year old vaccinee received Fluvirin. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: A report was received form a health care professional on 23OCT2003 concerning a vaccinee less than 4 years of age who received Fluvirin on 22OCT2003. On 22OCT2003 the vaccinee received Fluvirin wen less than 4 years of age. The reporter did not know whether or not the vaccinee exhibited any signs or symptoms of an adverse reaction. 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 10/23/2003 concerning approximately 10 pediatric vaccinees less than 4 years old, of unknown sex, who were inadvertently administered Flurvirin vaccine between 10/08/03 and approximately 10/22/03. No adverse reactions were recorded at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/9/2003: A follow up report was received from a health care professional indicating that a 2 year old male vaccinee inadvertently received Fluvirin on 10/15/2003. On 10/15/2003 a 2 year old vaccinee inadvertently received 0.25ml Fluvirin. At the time of reporting the vaccinee did not exhibit any adverse symptoms. Cross reference with: PJP-2003-01263, PJP-2003-01264, PJP-2003-1265, PJP-2003-01266, PJP-2003-01267, PJP-2003-01268, PJP-2003-01269. No follow up pending. A information received.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10/23/2003 concerning 6 pediatric vaccinees less than 4 years old, of unknown sex, who were inadvertently administered Fluvirin vaccine from 10/13/2003 until approximately 10/23/2003. It was unknown if there were any adverse events associated with the inadvertent administrations. There was insufficient information to determine the reporter's causality assessment. Update 1, 2/13/04: A follow up report was received from a health care professional indicating that 2 vaccinees under 4 years of age inadvertently received Fluvirin. The reporter was unaware of any adverse events at the time of reporting. No follow up pending, all information received.
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a consumer on 10/23/2003 concerning a male vaccinee of unspecified age who believes he received half the recommended dosage of Fluvirin on an unspecified date. The vaccinee indicated that while the nurse was administering Fluvirin, he saw a bubble in the syringe and the amount in the syringe was 0.25ml. The vaccinee did not report any adverse events in association with the incident. No follow up. The reporter declined to give permission to contact his physician.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10/23/2003 concerning 39 adult vaccinees of unknown gender who inadvertently received Fluvirin subcutaneously on 10/23/03. On 10/23/2003, 39 adult vaccinees inadvertently received Fluvirin subcutaneously with a 26 gauge half inch needle. No vaccinees had exhibited any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. No follow up. The reporter declined to provide any further information.
Age: 0.84
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10/22/2003 concerning a 22 month old female vaccinee who inadvertently received Fluvirin on 10/15/2003. The vaccinee did not exhibit any signs or symptoms of an adverse reaction at the time of the report. There was insufficent information to determine the reporter's Causality assessment. Update 1, 11/27/2003: Follow up information was received from a health care professional on 11/27/2003 indicating that the vaccinee was 10 months old. No sequela was noted at the time of the report. No follow up pending. Cross reference with PJP-2003-00913.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error, Overdose
Clinical narrative: A report was received from a health care professional on 10/23/2003 concerning a 56 year old male vaccinee who inadvertently received 2 doses of Fluvirin on 10/22/2003. On 10/22/2003 the vaccinee inadvertently received 2 doses of Fluvirin, one in each deltoid. It was unknown at the time of the report whether or not the vaccinee had experienced an adverse event. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update report, 1/19/2004: Follow up information received from a health care professional indicated the vaccinee did not experience any adverse event following inadvertent administration of Fluvirin.  No follow up pending, all information received.
Age: 0.7
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/23/2003 concerning an 8 month old female vaccinee who inadvertently received Fluvirin on 10/07/2003.On 10/07/2003 the vaccinee who was less than 4 years of age inadvertently received Fluvirin. 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: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/23/2003, concerning a 2 year old female vaccinee who inadvertently received the Fluvirin vaccine on 10/14/2003. On 10/14/2003 the vaccinee inadvertently received the Fluvirin vaccination.  At the time of the report no adverse event had occurred. There was insufficient information to determine the reporter's causality assessment. Update 1, 16 March 2004: Further information was received from a healthcare professional indicating that the vaccinee experienced no adverse events.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site reaction, Pruritus, Swelling
Clinical narrative: A report was received from a healthcare professional on 10/24/2003 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 10/24/2003. On 10/24/2003 the vaccinees experienced redness and wheals at the injection site with itching.  The vaccinees recovered on 10/24/2003. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 11/17/2003: A follow up report was received indicating that a 35 year old female vaccinee experienced a large red wheal with redness, swelling and warmth within 20 minutes of receiving Fluvirin on 10/22/2003.  The vaccinee was treated with antihistamines.  The vaccinee recovered on 10/25/2003.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: A report was received from a healthcare professional on 10/24/2003 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 10/24/2003. On 10/24/2003 the vaccinees experienced redness and wheals at the injection site with itching.  The vaccinees recovered on 10/24/2003. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 11/17/2003: A follow up report was received indicating that a 35 year old female vaccinee experienced a large red wheal with redness, swelling and warmth within 20 minutes of receiving Fluvirin on 10/22/2003.  The vaccinee was treated with antihistamines.  The vaccinee recovered on 10/25/2003.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Injection site erythema, Injection site pain, Medication error, Pyrexia
Clinical narrative: A report was received from a healthcare professional on 10/24/2003 concerning 3 vaccinees of unknown gender less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date 3 vaccinees less than 4 years of age inadvertently received Fluvirin.  It was unknown at the time of the report whether or not the vaccinees had exhibited any signs or symptoms of an adverse reaction. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/24/2003: Follow up information was received from a healthcare professional on 11/24/2003 indicating that the vaccinee was a 2 year old male.  The vaccinee experienced local redness at the site of injection an unspecified length of time after receiving 0.25ml Fluvirin on 10/17/2003.  The vaccinee also experienced fever, local swelling, bruising, soreness and redness on 10/18/2003.  The fever lasted for 2 days.  The local swelling, bruising, soreness and redness resolved 1 week later. Follow up pending.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: A report was received from a healthcare professional on 10/24/2003 concerning 3 vaccinees of unknown gender less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date 3 vaccinees less than 4 years of age inadvertently received Fluvirin.  It was unknown at the time of the report whether or not the vaccinees had exhibited any signs or symptoms of an adverse reaction. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/24/2003: Follow up information was received from a healthcare professional on 11/24/2003 indicating that the vaccinee was a 2 year old male.  The vaccinee experienced local redness at the site of injection an unspecified length of time after receiving 0.25ml Fluvirin on 10/17/2003.  The vaccinee also experienced fever, local swelling, bruising, soreness and redness on 10/18/2003.  The fever lasted for 2 days.  The local swelling, bruising, soreness and redness resolved 1 week later. Follow up pending.
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Medication error, Pyrexia
Clinical narrative: A report was received from a health care professional on 24 October 2003 concerning 3 vacciness of unknown gender less than 4 years of age who inadvertentl received Fluvirin on an unspecified date. On an unspecified date, 3 vacciness less than 4 years of age inadvertently received Fluvirin.  It was unknown at the time of the report whether or not the vacciness had exhibited my signs or symptoms of an adverse reaction. There was insufficiant information to determine the reporter's causality assesment. Update 1, 24 November 2003: Follow up information was received from a health care professional on 24 November 2003 indicating that the vaccinee was a 6 month old female. the vaccinee experienced fever on 23 October 2003 after receiving 0.25 ml Fluvirin vaccine on 22 October 2003. The fever resolved 2 days later. Follow up pending. Cross reference with: PJP200300889,PJP200301210, PJP200301211, PJP200301212, PJP200301213.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Skin discolouration
Clinical narrative: ADMINISTRATION BY UNLICENSED ROUTE (MEDICATION ERROR, MEDICATION ERROR) (MED ERROR) - Not Reported SWELLING AT THE SITE OF INJECTION (INJECTION SITE EDEMA, INJECTION SITE EDEMA) (EDEMA INJECTSITE) - recovered/resolved discoloration at the injection site (injection site reaction, injection site reaction ) (inject site react ) - recovered/ resolved INDURATION AT THE SITE OF INJECTION (INJECTION ISTE REACTION, INJECTION SITE REACTION ) (INJECT SITE REACT ) - recovered/ resolved  A report was received from a health care professional on 24 October 2003 concerning a 48 year old female vaccine who experienced swelling a discoloration at the site of injection an unspecified length of time after inadvertently receiving Fluvirin by subcutaneous injection on 24 October 2003.  On 24 October 203 the vaccine received Fluvirin by subcutaneous injection.  An unspecified length of time after receiving fluvirin the vaccine experienced swelling and discoloration at the injection site.  The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment.  Update 1, 12 January 2004.  A follow up letter was received from  a health care professional indication that the swelling and in duration at the site of injection began on 24 October 2003 and had completely subsided after 3 days.  No residual effects were noted accourding to the reporter.  No follow up pending, all information received.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error, Overdose
Clinical narrative: A report was received from a health care professional on 27 October 2003 concerning a 72 year old male vaccine who received a dose of Fluvirin vaccine on 13 October 2003 and inadvertently received a second dose on 27 October 2003. On 13 October 2003, the vaccine was administered Fluvirin and he inadvertently received a second dose of Fluvirin and he inadvertently received a second dose of fluvirin two weeks later on 27 October 2003.  No adverse events were reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 01 December 2003: Follow up information was received from a health care professional on 01 December 2003 indicating the vaccine was 65 years old. No follow up pending.
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: VACCINE RECEIVED 2 DOSES (ACCIDENTAL OVERDOSE, ACCIDENTAL OVERDOSE) (OVERDOSE ACCID) - Not reported  A report was received from a health care professional on 27 October 2003 concerning a vaccine of unknown demography who received 2 doses of Fluvirin vaccine 2 weeks apart on unknown dates.  On unknown dates, the vaccine received 2 doses of Fluvirin 2 weeks apart.  The outcome was not reported.  There was insufficient information to determine the reporter's causality assessments.  Update 1, 01 December 2003: Further information received from a health care professional on 01 December 2003 indicated theat the vaccine was male and received Fluvirin intramiscularly.  Follow up pending.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10/27/2003 concerning a 36 year old female vaccinee who inadvertently received expired Fluvirin vaccine on 10/27/2003. On 10/27/03, the vaccinee was inadvertently administered Fluvirin vaccine for the 2002-2003 flu season.  The vaccinee received 0.5 ml fluvirin intramuscularly in her deltoid. No adverse events were reported. There was insufficient information to determine the reporter's causality assessment. Update report, 1/13/04: Follow up information received from a health care professional indicated the Fluvirin vaccine administered on 10/27/03 had not expired. The vaccinee did not experince any adverse reaction following administration. 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 27 October 2003 concerning a 3 year old male vaccinee who inadvertently received Fluvirin vaccine on 21 October 2003. On 21 October 2003, the vaccinee was inadvertently administered Fluvirin. No adverse event was reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Feeling hot, Rash
Clinical narrative: A report was received from a health care professional on 27 October 2003 concerning a vaccinee of unknown demography who experienced a red, hot arm with a rash, neck redness and difficulty breathing an unspecified length of time after receiving Fluvirin vaccine on an unknown date. On an unknown date, the vaccinee's arm became red and hot with a rash. The redness extended from the arm to the vaccinee's neck. The vaccinee also experienced difficulty in breathing. 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 PJP-2003-01009.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Dyspnoea, Hallucination, Headache, Lymphadenopathy
Clinical narrative: A report was received from a health care professional on 27 October 2003 concerning a 57 year old female vaccinee who experienced fever, myalgia, a sore throat and shortness of breath on 24 October 2003 and swollen glands, headache, fever and hallucinations one day later, and elevated blood pressure and a temperature of 100 degrees Fahrenheit three days later after receiving Fluvirin vaccine on 24 October 2003. On 24 October 2003 in the evening, the vaccinee developed fever, myalgia, a sore throat and shortness of breath. On 25 October 2003 the vaccinee experienced hallucinations and continued to have muscle aches, swollen glands, headache and fever for which the vaccinee did not seek medical care. On 27 October 2003, the vaccinee attended her doctor's office with a temperature of 100 degrees Fahrenheit, and continuing headache, myalgia and had an elevated blood pressure of 160/90 mmHg. the outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1: 05 December 2003. Follow-up information received from a health care professional on 05 December 2003 indicated that the vaccinee received Pneumovax on the same day the Fluvirin was administered. The adverse events occurred 10 hours after administration of Fluvirin and Pneumovax on the same day and experienced no adverse events. The vaccinee recovered on 27 October 2003 following treatment with methylprednisone dose pack. The reporter has assessed the relationship of the Fluvirin to the fever, myalgia, sore throat, swollen glands, headache, hallucinations, elevated blood pressure and nausea as probable. Follow-up pending.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Nausea, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: A report was received from a health care professional on 27 October 2003 concerning a 57 year old female vaccinee who experienced fever, myalgia, a sore throat and shortness of breath on 24 October 2003 and swollen glands, headache, fever and hallucinations one day later, and elevated blood pressure and a temperature of 100 degrees Fahrenheit three days later after receiving Fluvirin vaccine on 24 October 2003. On 24 October 2003 in the evening, the vaccinee developed fever, myalgia, a sore throat and shortness of breath. On 25 October 2003 the vaccinee experienced hallucinations and continued to have muscle aches, swollen glands, headache and fever for which the vaccinee did not seek medical care. On 27 October 2003, the vaccinee attended her doctor's office with a temperature of 100 degrees Fahrenheit, and continuing headache, myalgia and had an elevated blood pressure of 160/90 mmHg. the outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1: 05 December 2003. Follow-up information received from a health care professional on 05 December 2003 indicated that the vaccinee received Pneumovax on the same day the Fluvirin was administered. The adverse events occurred 10 hours after administration of Fluvirin and Pneumovax on the same day and experienced no adverse events. The vaccinee recovered on 27 October 2003 following treatment with methylprednisone dose pack. The reporter has assessed the relationship of the Fluvirin to the fever, myalgia, sore throat, swollen glands, headache, hallucinations, elevated blood pressure and nausea as probable. Follow-up pending.
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 27 October 2003 concerning a female vaccinee of unknown age who inadvertently received a partial dose of Fluvirin vaccine on 27 October 2003. On 27 October 2003, the vaccinee inadvertently received a partial dose of Fluvirin as the needle became loose from the syringe. No adverse event was 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 27 October 2003 concerning approximately 100 vaccinees who inadvertently received Fluvirin vaccine subcutaneously during the week of 20 October 2003. During the week of 20 October 2003, approximately 100 vaccinees were administered Fluvirin subcutaneously. No adverse effects were reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Eczema, Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: A report was received by a health care professional on 27 October 2003, concerning a vaccinee of unknown demography who experienced hives and total body itching on the same day as receiving Fluvirin on 16 October 2003. on 16 October 2003 the vaccinee experienced hives and total body itching. the symptoms had not resolved at the time of the report, so the vaccinee's physician planned to treat the symptoms with unspecified corticosteroid therapy. Update 1, 09 Feb 2004. A follow-up report was received from a health care professional concerning a 68 year old female vaccinee who developed a rash and intense itching on an unreported area the same evening as she received Fluvirin in her left deltoid on 15 October 2004. The rash appeared the following day on the left deltoid. A biopsy from this site was reported as probable urticarial reaction. The reporter reported this as possibly related to drug reaction. At the time of the follow-up report the vaccinee's itching had resolved, but the rash had not resolved. The vaccinee was treated with oral prednisone. The reporter assessed the causality of the rash as probably related to Fluvirin, and the causality of the itching also probably related to Fluvirin. Update 2, 15 March 2004: Further information received from a health care professional indicated that the vaccinee's rash and itching have now become a chronic problem. The vaccinee is now under the care of an allergist who reports that the vaccinee's symptoms were probably not from the flu injection. The vaccinee has commenced treatment with allergy medication and continues to use topical steroids. Update 3, 19 April 2004: A follow-up report was received from a health care professional indicating that the vaccinee continues to have rashes and itching which was diagnosed as allergies and eczema. The vaccinee continues to have treatment and is currently on unspecified oral antihistamines and unspecified topical steroids. The vaccinee was reported to have a history of eczema and an unspecified allergy. Follow up pending.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error, Overdose
Clinical narrative: A report was received from a health care professional who was also the consumer on 27 October 2003 concerning a 41 year old female vaccinee who received 1.5 milliliters of Fluvirin on 27 October 2003. On 27 October 2003 the vaccinee self administered 1.5 milliliters. No adverse effects were noted at the time of the report. There was insufficient information to determine reporter's causality assessment. Follow up pending.