chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: A report was received from a healthcare professional on 10/03/2003 concerning a female vaccinee of approximately 30 years of age who experienced an injection site.  The area was not itchy.  The swelling resolved on 10/02/2003.  The redness covered an area of approximately 3 inches by 2 inches.  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.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 3OCT2003 concerning 9 vaccinees of unknown demography who inadvertently received expired Fluvarin vaccine on an unknown date. On an unknown date, 9 vaccinees inadvertently received expired Fluvirin vaccine. No adverse events wee reported 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: Unevaluable event
Clinical narrative: A report was received from a health care professional on 3OCT2003 concerning 4 vaccinees of unspecified demography who experienced unspecified adverse events 2 to 3 days after receiving fluvirin on an unknown date in 2003. Since 18SEPT2003 the reporter had received 4 adverse event reports associated with Fluvirin administration. It was not reported if the vaccinees had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending: See Ref: PJP200301080,  RJP200301081, RJP200301082
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site reaction, Joint range of motion decreased
Clinical narrative: A repot was received from a health care professional on 6OCT2003 concerning a female vaccine in her late thirties who experienced local sensitivity at the injection site on the same day as receiving Fluvirin vaccine on 3OCT2003 and shoulder joint pain which made it difficult to raise her arm an unspecified number of days after vaccination. On 3OCT2003 the vaccinee experienced local sensitivity at the injection site. An unspecified number of days later the vaccinee developed a shoulder joint pain that made it difficult for her to raise her arm. The vaccinee was to seek treatment from her physician. There was insufficient information to determine the reporter's causality assessment. Update 1 23DEC2003: A follow up report received from a health care professional which indicated that the 48 year old female vaccinee experienced shoulder joint ache on 4OCT2003. The shoulder joint ache resolved on 6OCT2003. no action was taken to treat this reaction. It was not reported if local sensitivity at the site of injection had resolved. Follow up pending.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: A report was received from a health care professional on 6OCT2003 concerning a 63 year old male vaccinee who inadvertently expired Fluvirin vaccine on 30SEPT2003. On 30SEPT2003, the vaccinee inadvertently received 2002-2003 Fluvirin vaccine. No adverse effect was reported. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200300760.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 6OCT2003 concerning a 39 year old female vaccinee who inadvertently received expired Fluvirin vaccine on 30SEPT2003. On 30SEPT2003, the vaccinee inadvertently received 2002-2003 Fluvirin vaccine. No adverse effect was reported. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200300759.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: A repot was received from a health care professional on 3OCT2003 concerning a 34 year old male vaccinee who inadvertently received expired Fluvirin vaccine on 3OCT2003. On 3OCT2003, the vaccine inadvertently received 2002 Fluvirin vaccine. No adverse effect was reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 2January 2004: Further information was received from a health care professional on 2JAN2004 indicating the vaccinee experienced no adverse reaction. No follow up pending, all information received. Cross reference PJP200300762.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A repot was received from a health care professional on 3OCT2003 concerning a 44 year old female vaccinee who inadvertently received expired Fluvirin vaccine on 3OCT2003. On 3OCT2003, the vaccine inadvertently received 2002 Fluvirin vaccine. No adverse effect was reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 2January 2004: Further information was received from a health care professional on 2JAN2004 indicating the vaccinee experienced no adverse reaction. No follow up pending, all information received. Cross reference PJP200300761.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A repot was received from a health care professional on 7OCT2003 concerning a 39 year old male vaccinee who experienced an accidental overdose, after inadvertently receiving Fluvirin vaccine on 29SEPT2003 and again on 3OCT2003. On 3OCT2003, the vaccinee experienced an accidental overdose after inadvertently receiving a second Fluvirin vaccination 4 days after the first vaccination. No adverse effects were reported at time of report. There was insufficient information to determine the reporter's causality assessment. Update 1 28OCT2003: Follow up information received from a health care professional indicated that the vaccinee had still not experienced any adverse reaction at the time of this report. No follow up pending.
Age: 1.93
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 7OCT2003 concerning a two year old female vaccinee who inadvertantly administered Fluvirin 0.25ml vaccine IM on 7OCT2003. On 7OCT2003, one does of Fluvirin 0.25ml was administered IM to a two year ld vaccine. No adverse event was noted or reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 7OCT2003, concerning a female vaccinee who inadvertantly received Fluvirin vaccine SC on 6OCT2003. On 6OCT2003, an obese female vaccinee inadvertantly received a 0.51 Fluvirin dose SC instead of IMwith the use of a 5/8 inch needle. No adverse signs or symptoms were noted at the time of the report. There was insufficient information to determine the reporter's causality assessment. Further information was received from a health care professional on 2JAN2004 indicating that no adverse outcome was reported. No follow up pending as no further information is available.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: A report was received form a health care professional on 7OCT2003 concerning 50 vacinees of less than 4 years of age who inadvertently received 0.5ml fluvirin vaccine on an unspecified date. On an unspecified date 50 vaccinees inadvertently received Fluvirin 0.5ml. 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: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Pain, Pharyngolaryngeal pain, Swelling
Clinical narrative: A report was received from a healthcare professional on 10/07/2003 concerning a 28 year old female vaccinee who developed a swollen, aching arm, flu-like symptoms including body aches and a sore throat on 10/03/2003 after receiving Fluvirin vaccine on 10/03/2003. The vaccinee's arm became swollen and ached following vaccination.  That evening the vaccinee experienced flu-like symptoms including body aches and a sore throat.  The practice doctor and a co-worker who administered the vaccine were also given the same vaccination and both experienced the same symptoms.  The vaccinee had recovered at the time of the report. There was insuffcient information to determine the reporter's causality assessment. Follow up pending.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia, Pyrexia, Rash
Clinical narrative: A report was received from a healthcare professional on 10/08/2003 concerning a 40 year old female vaccinee who experienced fever, chills and joint ache and developed an edematous rash following vaccination with 0.5ml Fluvirin vaccine on 10/06/2003. On 10/06/2003, the vaccinee was administered 0.5 ml Fluvirin vaccine in her deltoid muscle.  The vaccinee self-administered ibuprofen and her symptoms improved.  On the morning of 10/08/2003, approximiately 36 hours after Fluvirin administration, the vaccinee developed an edematous rash (not maculopapular) which appeared as patches on her trunk, shoulder and back.  The rash was not described as pruritic but is currently progressing and worsening. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/07/2003: Further information received from a healthcare professional on 11/07/2003 indicated that the vaccinee's rash was probably due to an allergy to neomycin.  The vaccinee also experienced myalgias within 12 hours of receiving Fluvirin.  The rash resolved within 48 hours and the fever and chills and the myalgias resolved following treatment with ibuprofen. No follow up pending, all information received.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Amnesia, Hallucination, Myalgia, Pyrexia, Tremor
Clinical narrative: A report was received from a healthcare professional on 10/08/2003 concerning a 41 year old male vaccinee who experienced shaking, chills, fever and memory loss on 10/07/2003 after receiving 0.5ml Fluvirin on 10/06/2003. On 10/06/2003, in the afternoon, the vaccinee received Fluvirin 0.5ml intramuscularly in his left deltoid muscle.  On the morning of 10/07/2003, the vaccinee developed shaking, chills and fever.  Furthermore, the vaccinee did not recall what occurred that morning including conversations with his family members.  All of the symptoms have completely self-resolved within 12 hours of onset. There was insufficient information to determin the reporter's causality assessment. Update 1, 11/03/2003: Further information received from a healthcare professional on 11/03/2003 indicated that the vaccinee woke at 05:00 hours on 10/07/2003 after receiving Fluvirin 12-13 hours previously.  He developed uncontrollable shaking chills, myalgias and he was hallucinating.  The vaccinee stated that he did not recognize his own father.  The hallucinations resolved on 10/07/2003 and the shaking chills, myalgias and fever resolved on 10/08/2003.  The vaccinee was advised not to take the Flu vaccine again. The reporter has assessed the relationship of the vaccine to the shaking chills, hallucinations, myalgias and fever as probable. No follow up pending, all information received.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/09/2003 concerning a group of 8 vaccinees aged less than 4 years of age, who were inadvertently administered Fluvirin vaccine between 10/06/2003 to 10/08/2003. During 10/06/2003 to 10/08/2003, a group of 8 vaccinees aged less than 4 years of age received Fluvirin vaccine.  No adverse symptoms occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: A report was received from a health care professional on 10/09/03 concerning a (approximately 50 year old female vaccinee who experienced swelling in her arm on 10/8/03 and developed a red rash on 10/9/03 after receiving Fluvirin vaccine on 10/8/03. On 10/08/03 the vaccinee was administered Fluvirin and later that evening she developed swelling in her arm. On the morning of 10/09/03, the vaccinee had a 1"x2" red rash. The vaccine has no medical conditions, has no allergies (specifically no allergies to eggs or thiomersal) and is not taking any medication. The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Update1, 11/4/2003, Follow up information received from a health care professional indicated that the vaccinee was 55 years old. The vaccinee experienced swelling at the injection site on 10/7/03 and a 1"x2" rash at the injection site on 10/08/2003 after receiving Fluvirin on 10/7/2003. The vaccinees symptoms abated two days after the injection. The reporter has assessed the relationship of the vaccine to the events as probable. No follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: A report was received from a health care professional on 9OCT2003 concerning 2 vaccinees of unknown demography who inadvertently received expired Fluvarin vaccine on an unknown date. On an unknown date, 2 vaccinees received a dose of Fluvirin which expired on 30June2003. No adverse events were 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 10/10/2003 concerning 5 vaccinees of unknown demography who inadvertently received expired Fluvirin vaccine on 10/03/2003. No adverse reactions were reported. There was insufficient information to determine the reporter's causality assessement. Follow up pending.
Age: 1.69
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10/10/2003 concerning a 20 month old female vaccinee who inadvertently received Fluvirin vaccine on 10/10/03. On 10/10/03, the vaccinee inadvertently received Fluvirin 0.25ml intramuscularly in the thigh. This was the vaccinee's first dose. No adverse reaction was reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 11/7/03: Further information received from a health care professional on 11/07/03 indicated that the reported telephoned the vacinees' home two days after vaccination and no adverse reaction was reported. No follow up pending.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site mass, Injection site warmth, Pruritus
Clinical narrative: A report was received from an health care professional on 10/09/2003 concerning a 42 year old female vaccinee who experienced redness, warmth, itching and developed a quarter-sized knot at the injection site on 10/09/03 after receiving Fluvirin vaccine on 10/09/2003.  The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update1, 11/4/2003: Further information received from a health care professional on 11/4/2003 indicated that the vaccinee received Fluvirin vaccine on 10/08/2003.  The event duration was 4 days, resolving on 11/13/2003. No follow up pending, all information received.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site mass, Injection site warmth, Pruritus
Clinical narrative: A report was received from a health care professional on 10/092003 concerning a 41 year old female vaccinee who experienced redness, warmth and itching at the injection site on 10/09/03 after receiving Fluvirin vaccine on 10/09/03. 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, 11/4/2003: Further information received from a health care professional on 11/4/03 indicated that the vaccinee received Fluvirin vaccine on 10/7/03. The event duration was 4 to 5 days. the vaccinee also experienced a grapefruit sized knot an unspecified length of time after receiving Fluvirin. No follow up pending, all information received. Cross reference with: PjP-2003-00785, PJP-2003-00987, PJP-2003-00988.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: A report was received from a health care professional on 10OCT2003 concerning an unspecified number of children of unspecified age who received Fluvirin from an unspecified date to 10OCT2003. From an unspecified date to 10OCT2003 an unspecified number of vaccinees of unspecified age received Fluvirin. To the reporter's knowledge no adverse reactions had occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Headache, Hyperhidrosis, Joint stiffness, Pain, Pyrexia
Clinical narrative: A report was received from a health care professional on 9OCT2003 concerning two vaccinees of unknown demography who experienced fever, night sweats, stiff joints and headache on 7OCT2003 after receiving Fluvirin vaccine on 7OCT2003. on 7OCT2003, two vaccinees received Fuvirin and later that evening they both experienced fever of 101-102 degrees Fahrenheit, night sweats, stiff joints and headache. The vaccinees' symptoms improved on 9OCT2003. There was insufficient information to determine the reporter's causality assessment. No follow up pending as the reporter will not collect any further information. Update 1. 17DEC2003.  A follow up report was received form a health care professional concerning a male vaccinee, of unspecified age who experienced fever, night sweats, stiff joints, headache and achiness all over on 7OCT2003 after receiving Fluvirin vaccine on the same day. On 7OCT2003 the vaccine experienced fever, night sweats, stiff joints, headache and achiness all over following Fluvirin vaccination. No follow up pending as the reporter will not collect any further information. Master file. Cross Reference with PJP200400060.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Lymphoedema, Neck pain, Pain
Clinical narrative: A report was received from a health care professional on 8OCT2003 concerning a vaccinee of unknown demography who experienced pain at the injection site and supraclavicular lymph node sweling and pain an unspecified length of time after receiving Fluvirin vaccine on an unspecified day in October 2003. On an unspecified day in October 2003 the vaccinee experienced pain at the injection site that radiated up tot he shoulder and neck area, and supraclavicular lymph node sweling and pain after receiving Fluvirin. The pain occurred on the same side of the body as the injection site. The outcome of the event was not reported. The reporter had administered approximately 80 Fluvirin injections to date this flu season. There was insufficient information to determine the reporter's causality assessment. Update 1, 10NOV2003: Further information received from a health care professional on 10NOV2003 indicated that the vaccinee was a 24 year old male. The vaccinee experienced supraventricular lymphadenopathy approximately 1 to 2 days after receiving Fluvirin on 3OCT2003. The vaccinee previously received a flu vaccination without any adverse effect. The supraventricular lymphadenopathy was assumed to have resolved 5 to 7 days following vaccination. The reporter had assessed the relationship of the vaccine  to thesupraventricular lymphadenopathy as probable. No follow up pending . Cross reference with : RJP200300827.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: On 9OCT2003 at 12:00 the vaccinee developed erythema at the injection site after receiving Fluvirin in her left deltoid muscle on 8OCT2003. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 10NOV2003: Further information received from a health care professional on 10NOV2003 indicated that the vaccinee received Fluvirin on 9OCT2003. The vaccinee experienced erythema at the injection site on 10OCT2003 and recovered three days later. No follow up pending. Cross reference with : PJP200300792, PJP200300793, PJP200301113
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: On 9OCT2003 at 12:00 the vaccinee developed large erythema at the injection site after receiving Fluvirin in her left deltoid muscle on 8OCT2003. The vaccinee had not recovered at  the time of the report. There was insufficient information to determine the reporter's causality assessment. Further information received from a health care professional on 10NOV2003 indicated that the vaccinee received Fluvirin on 9OCT2003. The erythema at the injection site began on 10OCT2003 and resolved 3 days later. The vaccine is pregnant and in her first trimester. Follow up pending. Cross reference with: PJP200300791, PJP200300793, PJP200301113. Follow up received 29JUNE2004. Vaccinee had a positive pregnancy test on 9OCT2003 (day of vaccination). The vaccines gave birth to a normal healthy baby girl on 2JUNE2004; the baby was delivered by repeat Caesarean Section with no complications. Concomitant medications during pregnancy included, prenatal vitamins, nitrofurantoin for urinary tract infection and amoxicillin for bronchitis.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Injection site erythema, Pyrexia, Vomiting
Clinical narrative: A report was received from a healthcare professional on 10/09/2003, concerning a 30 year old female vaccinee who developed large erythema at the injection site and experienced fever, headache, and joint pain on 10/09/2003 after receiving Fluvirin vaccine on 10/08/2003. On 10/09/2003 at 9:00 the vaccinee developed large erythema at the injection site and experienced fever, headache and joint pain after receiving Fluvirin in her left deltoid muscle on 10/08/2003.  The vaccinee was administered diphenhydramine hydrochloride and ibuprofen for her symptoms.  The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/10/2003: Further information received from a healthcare professional on 11/10/2003 indicated that the vaccinee received Fluvirin on 10/09/2003.  The vaccinee also experienced vomiting on the night of 10/09/2003.  The vaccinee was out of work for 2 days.  The fever, joint pain and vomiting resolved 2 days later. No follow up pending.
Age: 57.0
Sex: U
Vaccine: FLU3
Symptoms: Cough, Nasal congestion, Pain, Pharyngolaryngeal pain
Clinical narrative: A report was received from a consumer on 10OCT2003 concerning a 57 year old female vaccinee who experienced aches 2 days after receiving Fluvirin on 2OCT20036, and sore throat, congestion and cough three days after vaccination. On 4OCT2003 the vaccinee experienced aches and then on 5OCT2003 the vaccinee experienced flu symptoms including aches, congestion, sore throat and coughing but no fever. The vaccinee contacted a hospital and was advised to take ibuprofen. She also took saline nasal drugs for nasal congestion, menthol and camphor applied topically at bedtime and zinc salts every six hours for symptoms relief. The vaccinee had not recovered at the time of the report. No follow up. Permission not granted to contact treating physician. Cross reference with PJP200300794.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 13OCT2003 concerning a 2 year old female vaccinee who inadvertantly received one dose of Fluvirin on 10OCT2003. The vaccinee had experienced no adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 13OCT2003 concerning a 58 year old male vaccinee who inadvertently received expired 2002-2003 formulation of Fluvirin on 13OCT2003. The vaccinee had experienced no adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia, Pain, Pyrexia
Clinical narrative: A report was received from a health care professional on 13OCT2003 who is a 43 year old female vaccinee who experienced severe body aches, myalgias, arthralgias and fever on the same day as receiving Fluvirin vaccine on 9SEPT2003. On 9SEPT2003, the vaccine experienced severe body aches, myalgias, arthralgias and fever with temperature spikes as high as 103 degrees Fahrenheit. The vaccinee was administered 800 mg ibuprofen every 6 hours and 325 mg acetaminophen every 4 hours. The vaccinees symptoms persisted through most of 10SEPT2003 until 22:00 hours, at which time her fever and other associated symptoms resolved. Since 10 SEPT2003, and up to the time of the report the vaccinees symptoms have not returned. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: A report received from a health care professional on 14OCT2003 concerning a 25 year old female vaccinee who experienced a red, hot, sore injection site the day after receiving Fluvirin vaccine on 10OCT2003. On 11OCT2003, the vaccinee experienced a red, raised, hot to touch, sore area about 1.5 inches in diameter at the site of injection after receiving Fluvirin vaccine on 10OCT2003. The adverse reaction was not yet resolved at the time of reporting but the vaccinee is currently improving. There was insufficient information to determine the reporter's causality assessment. Update 1, 18MAR2004: A follow up report was received from a health care professional indicating that the vaccinee experienced a red raised heated area 24 hours after receiving Fluvirin. The vaccinee recovered from the red, raised heated area in 48 hours. The outcomes of the events reported initially were not reported. No follow up pending, all information received. Reference PJP200300802. PJP20300803
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: A report was received from a health care professional on 13OCT2003, concerning a 28 yar old female vaccinee who developed a red,hot, painful injection site, and a rash on her left leg on the same day as receiving Fluvirin on 10OCT2003. On 10OCT2003 the vaccinee developed a red, raised , hot to touch, painful area about 1-1.5 inches in diameter at the site of injection, and a rash on her left leg after receiving Fluvirin on the same day. The vaccinee was improving at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 18MAR2004: A follow up report was received from a health care professional indicating that the vaccinee also experienced itching and flu-like symptoms. The time to onset was reported as 8 hours. The vaccinee recovered after 72 hours. The outcome of the events reported initially was not reported except for the rash which was reported as resolved. No follow up pending, all information received. References: PJP200300801, PJP200300803.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: A report was received from a health care professional on 13OCT2003, concerning a 28 yar old female vaccinee who developed a red,hot, painful injection site, and a rash on her left leg on the same day as receiving Fluvirin on 10OCT2003. On 10OCT2003 the vaccinee developed a red, raised , hot to touch, painful area about 1-1.5 inches in diameter at the site of injection, and a rash on her left leg after receiving Fluvirin on the same day. The vaccinee was improving at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 18MAR2004: A follow up report was received from a health care professional indicating that the vaccinee also experienced itching and flu-like symptoms. The time to onset was reported as 8 hours. The vaccinee recovered after 72 hours. The outcome of the events reported initially was not reported except for the rash which was reported as resolved. No follow up pending, all information received. References: PJP200300801, PJP200300803.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Agitation, Flushing, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A report was received from a healthcare professional on 10/13/2003 concerning a 49 year old female vaccinee who developed a red, hot, painful, itchy injection site, a bumpy rash on her thighs, and she felt agitated and flushed on the day after receiving Fluvirin on 10/10/2003. On 10/11/2003, the vaccinee developed a red, raised, hot to touch, painful, itchy 4-5 inch area at the site of injection, a bumpy rash on her thighs, and she felt agitated and flushed after receiving Fluvirin on 10/10/2003.  The vaccinee was improving at the time of reporting. There was insufficient information to determine the reporter's causality assessmen. Update 1, 03/18/2004: A follow up report was received from a healthcare professional indicating that the vaccinee experienced a raised rash, itching and was warm to touch 12 hours after receiving Fluvirin.  The reporter indicated that the affected arm looked like a burn.  The vaccinee recovered 84 hours later.  The outcome of the events reported initially was not reported. No follow up pending, all information received.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Pruritus, Rash
Clinical narrative: A report was received from a healthcare professional on 10/13/2003 concerning a 49 year old female vaccinee who developed a red, hot, painful, itchy injection site, a bumpy rash on her thighs, and she felt agitated and flushed on the day after receiving Fluvirin on 10/10/2003. On 10/11/2003, the vaccinee developed a red, raised, hot to touch, painful, itchy 4-5 inch area at the site of injection, a bumpy rash on her thighs, and she felt agitated and flushed after receiving Fluvirin on 10/10/2003.  The vaccinee was improving at the time of reporting. There was insufficient information to determine the reporter's causality assessmen. Update 1, 03/18/2004: A follow up report was received from a healthcare professional indicating that the vaccinee experienced a raised rash, itching and was warm to touch 12 hours after receiving Fluvirin.  The reporter indicated that the affected arm looked like a burn.  The vaccinee recovered 84 hours later.  The outcome of the events reported initially was not reported. No follow up pending, all information received.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/14/2003 concerning a vaccinee of unknown demography who received expired Fluvirin on an unspecified date. On an unspecified date the vaccinee received expired Fluvirin.  The vaccinee did not experience any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1. 22 December 2003. The expired Fluvirin was administered to three vaccinees.  No specific information was available on the vaccinees.  No adverse effects had occurred as a result, as the time of this report.  No follow-up pending.
Sex: U
Vaccine: FLU3
Symptoms: Medication error, Overdose
Clinical narrative: A report was received from a healthcare professional on 10/14/2003 concerning an unspecified number of vaccinees of unknown demography who received double the recommended dose of Fluvirin on 10/14/2003. On 10/14/2003 an unspecified number of vaccinees received double the recommended dose of Fluvirin.  The reporter did not have vaccinee demographics or specifics on any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 20 February 2004. A follow-up report was received from a healthcare professional indicating that 96 females, 29 males and 23 vaccinees of unspecified gender and all of unknown age received Fluvirin.  No adverse events were reported. No follow-up pending, all information received.
Sex: M
Vaccine: FLU3
Symptoms: Nonspecific reaction
Clinical narrative: A report was received from a consumer on 10/14/2003 concerning an unspecified number of vaccinees less than 4 years of age who received Fluvirin subcutaneously on an unspecified date. On an unspecified date an unspecified number of vaccinees less than 4 years of age received Fluvirin subcutaneously.  The reporter indicated that the exact number was unknown but was believed to involve less than 20 vaccinees.  Vaccinees aged between 6 and 35 months were given 0.25ml and 0.5ml was given to vaccinees greater than 35 months.  No adverse symptoms had been noted. Follow up pending. Update 1, 7 November 2003: A follow up report was received from a consumer indicating that a male vaccinee less than 4 years of age received Fluvirin intramuscularly on 10/13/2003.  No adverse reaction had occurred at the time of the report.
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/14/2003 concerning an 8 month old male vaccinee who received Fluvirin on 10/14/2003.  On 10/14/2003 the vaccinee inadvertently received 0.25ml Fluvirin intramuscularly.  No adverse effects were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 24 November 2003  Follow-up information received from a healthcare professional indicated that the vaccinee did not experience any adverse reaction.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pruritus
Clinical narrative: A report was received from a healthcare professional on 10/15/2003 concerning a group of approximately 15 vaccinees who experienced injection site reaction, with redness, swelling and itching a few minutes after receiving Fluvirin on an unspecified date. On an unspecified date the vaccinees experienced injection site reactions with redness, swelling, and itching.  The vaccinees recovered on an unspecified date without treatment. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 22 December 2003. A follow up report was received from a healthcare professional concerning a 27 year old female vaccinee who experienced redness, swelling and severe itching at the injection site on the same day as  receiving Fluvirin on 10/10/2003. On 10/10/2003, the vaccinee experienced redness, swelling and severe itching at the injection site after receiving Fluvirin 0.5ml.  The symptoms lasted for a duration of 24 hours, and had resolved at the time of follow up report. No follow up pending.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Mental impairment, Neuropathy, Tremor
Clinical narrative: A report was received from a consumer on 10/15/2003 concerning a 50 year old male vaccinee who experienced neurological symptoms with shaking at the back of the head and alteration of mental status approximately 5 hours after vaccination on an unspecified date. On an unspecified date the vaccinee experienced neurological symptoms with shaking at the back of the head and alteration of mental status described as a dream-like or fog-like state.  The vaccinee recovered on an unspecified date without sequalae or treatment.  The vaccinee developed similar neurological symptoms (though not as marked) in the past after receiving antibiotics and unspecified pain medications. Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Medication error, Overdose
Clinical narrative: A report was received from a healthcare professional on 10/15/2003 concerning a group of vaccinees of unknown demography who received an accidental overdose of Fluvirin on approximately 8 October 2003. On approximately 8 October 2003 a group of vaccinees were inadvertently administered 1ml Fluvirin instead of the recommended dose of 0.5ml.  No adverse events were reported in relation to the overdosing. There was insufficient information to determine the reporter's causality assessment. Update 1, 17 November 2003 Follow up information received from a healthcare professional indicated that possibly 19 vaccinees inadvertently received 1ml Fluvirin. Follow up pending.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health care professional on 10/16/2003 concerning a 92 year old female vaccine who inadvertently received a accidental overdose of Fluvirin on 10/16/2003. On 10/16/2003 the vaccinee had previously been vaccinated with Fluvirin on 10/03/2003. There was insufficient information to determine the reporter's causality assessment.
Sex: U
Vaccine: FLU3
Symptoms: Contusion, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A report was received from a health care professional concerning 4 vaccinees of unspecified demography who experienced injection site bruising, swelling, warmth and erythema of an unspecified length of time after receiving Fluvirin between 10/10/2003 and 10/16/2003. It was not reported if the vaccinees had recovered. There was insufficient information to determine the reporters Causality assessment. Follow up pending.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/17/2003 concerning a 51 year old male vaccinee who received Fluvirin intravenously on 10/17/2003. On 10/17/2003 Fluvirin was administered via an intravenous push when the vaccinee was undergoing dialysis.  The vaccinee did not complain of any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 20 February 2004. A follow up report was received from a healthcare professional reporting no adverse event. No follow up pending, all information received.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/16/2003 concerning a 57 year old female vaccinee who received Fluvirin subcutaneously on 10/16/2003. On 10/16/2003 the vaccinee received Fluvirin subcutaneously.  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: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/16/2003 concerning a 2 year old vaccinee of unknown sex who received Fluvirin on 10/16/2003. On 10/16/2003 the vaccinee received Fluvirin.  The vaccinee did not experience any adverse symptoms. There was insufficient information to determine the reporter's causality assessment. Update 2, 10 February 2004: Further information was received from a healthcare professional on 02/10/2004 indicating that the vaccinee was male and experienced no sequalae of any type in the six weeks post vaccination. No follow up pending, all information received.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10/17/03 concerning a group of vaccinees less than 4 years of age, of unknown sex who received Fluvirin on an unknown date. The reporter did not have vaccinee details or details of how many vaccinees were involved. At the time of the report there were no adverse events associated with Fluvirin. There was insufficient information to determine the reporter's causality assessment. Following up pending.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: A report was received from a healthcare professional on 10/17/2003 concerning a 33 year olf female vaccinee who experienced a reticular, blanching rash over the entire body on the same day as receiving Fluvirin on 10/16/2003. ON 10/16/2003 the vaccinee experienced a reticular, blanching rash over the entire body sparing only the face and the palms of the hands.  The vaccinee did not report any fever, shortness of breath or itch in relation to the rash.  It was the vaccinee's first exposure to the influenza vaccine.  The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/24/2003 Follow up information received from a healthcare professional indicated that the vaccinee also experienced epigastric pain and joint aches.  The event resolved on an unspecified dated. The reporter considered there to be a temporal relationship between the Fluvirin and the adverse events.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10/17/2003 concerning a 3 year old female vaccinee who received Fluvirin on 10/17/03 The vaccinee experienced no adverse symptoms. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1 11/14/2003: the follow up report received from a health care professional indicating that the vaccinee had not experienced any adverse events.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Swelling
Clinical narrative: A report was received from a health care professional on 10/17/2003 concerning a 63 year old female vaccinee who experienced a red swollen rash on the same day as receiving expired Fluvirin on 10/15/2003. The rash was approximately 30 mm wide. The rash appeared to have stabilized on 10/16/2003. The out come was not reported. Update 1, 2/5/2004: A follow up report was received from a health care professional indicating that the vaccinee's red, swollen rash developed on 10/16/2003 and had completely resolved on 10/27/2003. The reporter assessed the causality as unrelated. No follow up pending all information received.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10/17/2003 concerning a 3 year old vaccinee of unknown sex, who received Fluvirin on 10/17/2003. 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: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10/17/2003 concerning an unspecified number of vaccinees of unspecified sex who received Fluvirin subcutaneously on an unspecified date. The vaccinees 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, 2/16/2004: A follow up report was received from a health care professional indicating that the 43 year old female vaccinee had no adverse event at the time of reporting. Follow up pending.
Sex: U
Vaccine: FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: A report was received from a health care professional concerning three vaccinees of unknown demography who experienced pain at the injection site an unspecified length of time after receiving Fluvirin vaccine on an unspecified day in October 2003. On an unspecified day in October 2003, three vaccinees experienced pain at the injection site that radiated up to the shoulder and neck after receiving Fluvirin.  The pain occurred on the same side of the body as the injection site. The outcome of the event was not reported. The reporter had administered approximately 80 Fluvirin injections to date this flu season. There was insufficient information to determine the reporter's causality assessment.  Update1, 11/10/2003: Further information received from a health care professional on 11/10/2003 indicated that 3 to 4 vaccinees experienced pain in their deltoid radiation into the trapezius 1 to 2 days after receiving Fluvirin on 10/03/03. No follow up pending. Cross reference with PJP-2003-00790.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dermatitis contact, Rash maculo-papular
Clinical narrative: A reported was received from a health care professional who was also the consumer on 10/20/2003 concerning a 29 year old female vaccinee who experienced a maculo-papular, non-itchy rash 2 days after receiving Fluvirin on 10/16/2003. On 10/18/2003 the vaccinee experienced a maculo-papular, non-itchy rash that began and was most concentrated in the abdominal area. By 10/19/2003 the rash had spread to the chest and arms. At the time of reporting the original site of the rash (upper abdoment) was unchanged and continued to spread. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update1, 03/01/2003: Follow up information received from a health care professional indicated that the maculo-papular, non-itchy rash was not due to the Fluvirin vaccination but was due to contact dermatitis with soap. No follow up pending.
Age: 1.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10/20/2003, concerning an unknown number of children under 4 years of age who inadvertently received the Fluvirin vaccine on 10/15/2003. The reporter was uncertain how many children were vaccinated. At the time of th report no adverse events had occurred. There was insufficient information to determine the reporter's causality assessment. Update1, 11/25/2003: Follow up information received from a health care professional indicated that a 1 year old male vaccinee had been inadvertently administered a dose of Fluvirin instead of Fluzone between 10/06/2003 and 10/16/2003. No adverse event as reported at the time of report.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: A report was received from a health care professional on 10/20/2003 concerning a 54 year old female vaccinee who experienced a red, hard, swollen area on day after receiving Fluvirin on 10/15/2003. On 10/16/2003, the vaccinee experienced a red, hard, swollen area about 2 inches in diameter after receiving Fluvirin on 10/15/2003. the event resolved after 2 days. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Reference: PJP-2003-00833, PJP-2003-00834, PJP-2003-00836
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A report was received from a health care professional on 10/20/2003 concerning a 57 year old female vaccinee who experienced a red and swollen are on day after receiving Fluvirin on 10/15/2003. On 10/16/2003, the vaccinee experienced a red and swollen area about 3 inches in diameter after receiving Fluvirin on 10/15/2003. The outcome of the events were unknown at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Reference PJP-2003-00832, PJP-2003-00834, PJP-2003-00836.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: A report was received from a health care professional on 10/20/2003 concerning a 49 year old female vaccinee who experienced redness and swelling on 10/13/2003 after receiving Fluvirin on the same day. The event was resolved at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Reference PJP -2003-00832, PJP-2003-00833, PJP-2003-00836