chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Neuritis, Pain
Clinical narrative: A report was received from a healthcare professional on 31Oct02, concerning a 48 year old female vaccinee who experienced back pain, lethargy, loss of appetite, insomnia, feet pain, hand pain and arm pain, approximately 72 hours after receiving Fluvirin on 25Oct02. On 28Oct02, the vaccinee experienced left arm pain (the injection arm) and then right arm pain. The pain continued in her arms and later included the palms of her hands. As a result of the pain, the vaccinee sought medical care at a local ER on 27Oct02 at 11:00PM. The feet, hand and arm pain resolved on an unspecified date. The vaccinee continued to experience back pain, lethargy, loss of appetite and insomnia up to 31Oct02. The vaccinee was scheduled for a follow up visit with her physician on 31Oct02. The reporter has assessed the relationship of the vaccine to the event as possible. Update 1, 22Jan03, A report received from a health care professional indicated that the vaccinee also experienced flu-like muscular aches and chills on 25Oct02, neuritis or nerve pains on 27Oct02, fatigue, muscle weakness, aches and stiffness on 29Oct02 and an upper respiratory infection on approx 09Nov02. The flu-like muscular aches and chills resolved on 26Oct02. The vaccinee was treated with an anti-inflammatory Naprosyn and amoxicillin, salbutamol, loratadine and fluticasone propionate for the respiratory infection. The neuritis or nerve pains, fatigue, muscle weakness, aches and stiffness had not resolved at the time of the report but had much improved. The upper respiratory infection had not resolved at the time of the report. The reporter has assessed the relationship of the vaccine to the flu-like muscle aches and chills, neuritis or nerve pains, fatigue, muscle weakness, aches and stiffness as probable and the upper respiratory infection to be presumed secondary to the compromised immune status of the vaccinee.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 17Oct02, concerning a 72 year old male vaccinee who inadvertently received the Fluvirin vaccine on 17Oct02. The vaccinee inadvertently received 0.1ml of Fluvirin ID instead of Tuberculin PPD. The vaccinee has not developed or reported any untoward or adverse reactions. There was insufficient information to determine the reporters causality assessment.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Pruritus, Pyrexia, Urticaria, Vaccine positive rechallenge
Clinical narrative: A report was received from a health professional on 17Oct02, concerning a 52 year old female vaccinee who experienced an injection site reaction, fever and itchiness which started after receiving Fluvirin on 14Oct02. On 14Oct02, the vaccinee received her yearly vaccination. Thirty minutes after the injection, the vaccinee noticed a small welt at the injection site that was itchy and that evening the welt had grown to the size of a baseball and was red, hard, and itchy. She was treated with diphenhydramine hydrochloride cream and capsules with some relief of the itching. She has not yet recovered. The reporter has assessed the relationship of the vaccine to the event as probable.
Age: 0.51
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 18Oct02, concerning a 6 month old female vaccinee who inadvertently received the Fluvirin vaccine on 17Oct02. On 17Oct02 a 6 month old vaccinee received 0.5ml of the Fluvirin vaccine. There was insufficient information to determine the reporters causality assessment.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Skin irritation
Clinical narrative: A report was received from a health professional on 18Oct02, concerning 60 year old female vaccinee who experienced redness and irritation about 3 hours after receiving the Fluvirin vaccine on 10Oct02. On 10Oct02 the vaccinee was administered the Fluvirin vaccine ID. She experienced some redness (about 5cm) and irritation at the injection site about 3 hours after receiving the vaccine. No treatment was given. It was unk if the pt had recovered. The reporter has assessed the relationship of the vaccine to the events as possible.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Hypokinesia, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: A report received from a 42 year old female vaccinee who is a health care professional on 15Oct02, who experienced a red swollen hot arm and soreness, minutes after receiving Fluvirin vaccine on 15Oct02. The vaccinee had received the Flu injection for 14 years with no problems. She received 0.5ml to the left arm and within minutes she developed swelling of the entire arm, which also became bright red and hot. Ice packs were applied with no relief. Three hours later the same symptoms and soreness were present. The vaccinee stated that the events were resolving at the time of the report. The reporter has assessed the relationship of the vaccine to the events as probable. Update1 05Dec02: A report was received from a health care professional who was also the vaccinee. The vaccinee also experienced an inability to move her arm on 15Oct02. The vaccinee was given the Fluvirin vaccine at 8:45AM and by 9:00AM the vaccinees arm was red and warm to touch at the injection site. By 9:30AM the vaccinees arm was swollen and the red inflamed area was getting larger and painful. By the end of the day the vaccinee was unable to move her arm without pain radiating from the injection site to the wrist. It interfered with the vaccinees ability to perform her job requirements. The events resolved on an unspecified date. There was insufficient information to determine the reporter's causality assessment.
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report received from a health professional on 15Oct02, concerning a 72 year old female vaccinee who was inadvertently administered partially frozen Fluvirin on 14Oct02. On 14Oct02, the vaccinee was inadvertently administered partially frozen Fluvirin into the left deltoid. The vaccinee has not displayed any signs of symptoms of an adverse reaction. No treatment was administered to the vaccinee. The physician plans to revaccinate the vaccinee in three weeks and will monitor the pt closely for adverse reactions. There is insufficient information to determine the reporters causality assessment.
Age: 1.11
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 16Oct02, concerning 13 month old male vaccinee who was inadvertently administered Fluvirin on 16Oct02. On 16Oct02 a 13 month old male vaccinee was inadvertently administered 0.25ml of Fluvirin vaccine in the right anterior thigh. The vaccinee has not received a previous influenza vaccination. The vaccinee has not exhibited any signs of symptoms of an adverse event and will be closely monitored by the vaccinees mother for adverse reactions. There was insufficient information to determine the reporters causality assessment. Update 1 31Dec02: A report was received from a health care professional which indicated that the vaccinee experienced no adverse event and the physician felt that no treatment was necessary.
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 16Oct02, concerning a 6 month old male vaccinee who was inadvertently administered the Fluvirin vaccine on 16Oct02. On 16Oct02 the vaccinee was inadvertently administered 0.25ml of the Fluvirin vaccine in the thigh. The vaccinee had not received a previous influenza vaccine. The vaccinee has not exhibited any signs or symptoms of an adverse event. The vaccinee will be closely monitored for adverse reaction. There was insufficient information to determine the reporter's causality assessment.
Sex: U
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: A report was received from a health professional on 17Oct02, concerning a 2 vaccinees of unk demography who experienced shortness of breath after receiving Fluvirin on an unk date. On the unreported date, the vaccinees experienced shortness of breath after receiving Fluvirin. No  other information was available from the reporter. The reporter has assessed the relationship of the vaccine to the event as probable. Ref: PJP200200572, PJP200200573.
Sex: U
Vaccine: FLU3
Symptoms: Cough, Headache, Panic reaction
Clinical narrative: A report was received from a health professional on 17Oct02 concerning a vaccinee of unk demography who experienced panic attack, productive cough, and a headache after receiving Fluvirin on an unk date. On an unreported date, the vaccinee experienced a panic attack, headache and a productive cough after receiving Fluvirin. No other information was available from the reporter. The reporter has assessed the relationship of the vaccine to the event as probable. Ref: PJP200200573, PJP200200571.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Medication error
Clinical narrative: A report was received from a health professional on 17Oct02 concerning a group of 10 vaccinees of unk demography who experienced a 4.5 inch wide area of redness at the injection site after receiving Fluvirin on an unk date. On an unreported date, the vaccinees experienced a 4.5 inch wide area of redness around the site of injection.  The reporter has assessed the relationship of the vaccine to the event as probable. The reporter felt that the adverse events were due to a product defect.  Ref: PJP200200572, PJP200200571.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health  professional on 17Oct02, concerning 8 adult vaccinees who inadvertently received last years Fluvirin vaccine formulation on 16Oct02. Eight vaccinees inadvertently received last years Fluvirin vaccine formulation. The vaccinees have not developed or reported any untoward or adverse reactions. There was insufficient information to determine the reporter's causality assessment.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 07Oct02, concerning a number of vaccinees who experienced a medication error after receiving out of date Fluvirin on 07Oct02. On 07Oct02, an unreported number of vaccinees were inadvertently administered last years Fluvirin. No clinical presentation was reported. There was insufficient information to determine the reporter's causality assessment.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: A report was received from a health care professional on 10/18/2002, concerning a 39 year old female vaccinee who experienced pruritus 12 hours after receiving Fluvirin vaccine on 10/15/2002. On 10/15/2002, the patient experienced pruritus on her arm and abdomen. She self-medicated with Benadryl and the pruritus eventually resolved. The reporter has assessed the relationship of the vaccine to the event as probable. Update1. 04/01/2003: A report was received from a health care professional who indicated that the pruritus resolved on 10/16/2002. The vaccinee received the recomendation that she should not receive further vaccinations containing chicken, egg, or thiomersal. The reporter has assessed the relationship of the vaccine to the event as possible.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/13/2002 concerning a group of approximately 30-40 vaccinees between the ages of 70-80 years who inadvertently received subtherapeutic dose of Fluvirin between 10/20/2002-11/06/2002. Between 10/20/2002-11/06/2002 a group of approximately 30-40 vaccinees inadvertently received a sub-therapeutic dose of Fluvirin when the black line that encircles the syringe was utilized to expel air and prime the needle. There was insufficient information to determine the reporters causality assessment.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error, Overdose
Clinical narrative: A report received from a health care professional on 10/25/2002, concerning a 2 year old vaccinee of unknown sex who inadvertently received 0.25ml  of Fluvirin vaccine on 10/25/2002/. The vaccinee experienced no adverse reaction. There was insufficient information to determine the reporters causality assessment. Update1. 12/10/2002: A report was received from a health care professional which indicated that the vaccinee was a 32 month old male when he received Fluvirin vaccine.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: A report was received from a health care professional on 10/25/2002, concerning approximately 100 vaccinees of unknown demography who experienced injection site reaction an unknown time after receiving the Fluviring vaccine during October 2002. During October 2002, the reporter observed anecdotally a higher than ususal incidence of local reactions(warmth and redness) at the injection site. The clinic has administered Fluvirin vaccine to approximately 2000 adult patients since 10/01/2002. The reporter suspected that approximately 100 vaccinees were affected with the adverse event. The events were reported as resolved. The reporter has assessed the relationship of the vaccine to the events as probable.
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10/23/2002, concerning a female vaccinee of unknown age who inadvertently received frozen Fluvirin vaccine on 10/23/2002. The vaccinee did not experience any adverse event. There was insufficient information to determine the reporters causality assessment. Cross Reference with: PJP200200629, PJP20020774, PJP200200775. Update1. 12/23/2002: A report from a health care professional which indicated that the event was reported to be resolved on an unspecified date.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report received from a health care professional concerning 70 vaccinees who received Fluvirin on 10/23/2002. On 10/23/2002, 70 vaccinees in a nursing home were administered Fluvirin which was defrosted from frozen. No adverse effects were noted uo to 2 days. The reporter has assessed the relationship of vaccinees to the event unclassifiable.
Sex: U
Vaccine: FLU3
Symptoms: Medication error, Overdose
Clinical narrative: A report received from a health care professional on 10/26/2002, concerning 12 vaccinees of unknown demography who inadvertently received an accidental overdose (1ml) of the Fluvirin vaccine on either 10/25/2002 or 10/26/2002. There were no adverse reactions at the time of the report. There was insufficient information to determine the reporters causality assessment.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Medication error
Clinical narrative: A report received from a health care professional on 10/28/2002, concerning a 40 year old female vaccinee who inadvertently received the Fluvirin vaccine subcutaneously on 10/25/2002 and experienced an injection site reaction. On 10/25/2002, the patient complained of warmth, redness and pain at the injection site. On 10/28/2002, the vaccinee stated that the symptoms were relieved, but not completely resolved. The reporter has assessed the relationship of the vaccine to the warmth, redness, and pain as possible, and the inadvertent subcutaneous administration as unclassigied.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site swelling, Lymphoedema
Clinical narrative: A report was received from a health care professional on 10/28/2002, concerning a 40 year old female vaccinee who experienced an injection site reaction, and swelling of the clavicular and axillary lymph nodes after receiving the 0.1ml  of Fluvirin vaccine subcutaneously on 10/24/2002. On 10/25/2002, the vaccinee noticed a swelling at the site of administration as well as swelling of her axillary and clavicular lymph The local swelling resolved on 10/26/2002 and the swelling of the axillary lymph nodes resolved on 10/27/2002. The clavicular lymph node swelling has improved greatly but has not completely resolved. The reporter has assessed the relationship of the vaccine to the events as possible. Update1./ 01/02/2003: A report was received from a health care professional which indicated that the vaccinee experienced supraclavicular lymph node swelling on 10/26/2002. No action was taken for the swelling which resolved. The vaccinee recovered on 11/02/2002. The reporter has assessed the relationship of the vaccine to the supraclavicular lymph node swelling as probable.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site warmth
Clinical narrative: A report was received from a health care professional on 10/21/2002, concerning a 46 year old female vaccinee who experienced a large welt over the deltoid region of her arm which was described as red, hot and swollen after receiving 0.5ml Fluvirin on 10/15/2002. On 10/15/2002, the vaccinee received 0.5ml Fluvirin intramuscularly. On 10/16/2002 she had developed a large welt described as the size of the vaccinees bicep, which was red, swollen and hot. The vaccinee recovered on 10/18/2002 There was insufficient information to determine the reporters causality assessment. Reference: PJP200200602, PJP200200601, PJP200300598, PJP200200597.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: A report was received from a health care professional on 10/21/02 concerning a 38 year old female vaccinee who developed a welt over the deltoid region of her arm which was described as red, swollen, hot and painful after receiving 0.5 ml Fluvirin on 10/15/02. On 10/15/2002 the vaccinee received 0.5 ml Fluvirin intramuscularly. On 10/16/02 she had developed a welt over the deltoid region of her arm, which was also described as red, swollen, hand and painful. The vaccinee was reported as recovered since 10/18/02. There was insufficient information to determine the reporter's causality assessment. Ref: PJP200200596, PJP200200601, PJP200200602 and PJP200200598.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: A report was received from a health care professional on 10/21/02 concerning a 46 year old female vaccinee who developed a welt over the deltoid region of her arm on 10/16/02,  which was described as red, swollen, painful and warm after receiving 0.5 ml Fluvirin on 10/15/02. The vaccinee was reported as recovered since 10/18/2002. There was insufficient information to determine the reporter's causality assessment. Ref: PJP200200596, PJP200200601, PJP200200602 and PJP200200597.
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 10/23/02, concerning a male vaccinee of unknown age who was inadvertently administered the Fluvirin vaccine subcutaneously on 10/23/02. The vaccinee did not experienced any adverse event. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200200611.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 10/23/02, concerning a 2 year old male vaccine who was inadvertently administered Fluvirin vaccine on 10/23/02. The vaccinee experienced no adverse reaction. There was insufficient information to determine the reporter's causality assessment.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: A report was received from a health care professional on 10/21/2002 concerning a 50 year old female vaccinee who developed diarrhea and experienced a large welt over the deltoid region of her arm which was described as red, swollen, painful, warm and itching on 10/16/02,  after receiving 0.5 ml of Fluvirin on 10/15/02. The vaccine was administered intramuscularly. The welt was treated with ice and paracetamol. The vaccinee was reported as recovered since 10/18/02. There was insufficient information to determine the reporter's causality assessment. Ref: PJP200200602, PJP200200598, PJP200200597 and PJP200200596.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: A report was received from a health care professional on 10/21/2002 concerning a 50 year old female vaccinee who developed diarrhea and experienced a large welt over the deltoid region of her arm which was described as red, swollen, painful, warm and itching on 10/16/02,  after receiving 0.5 ml of Fluvirin on 10/15/02. The vaccine was administered intramuscularly. The welt was treated with ice and paracetamol. The vaccinee was reported as recovered since 10/18/02. There was insufficient information to determine the reporter's causality assessment. Ref: PJP200200602, PJP200200598, PJP200200597 and PJP200200596.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Lymph node pain, Urticaria
Clinical narrative: A report was received from a health care professional on 10/21/2002, concerning a 38 year old female vaccinee who experienced a large welt over the deltoid region of her arm which was described as red and swollen, and the armpit gland was reported as sore on 10/16/02, after receiving 0.5 ml Fluvirin on 10/15/02. The vaccinee was reported as recovered since 10/18/02. There was insufficient information to determine the reporter's causality assessment. Ref: PJP200200601, PJP200200598, PJP200200597, PJP200200596.
Age: 52.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report received from a health professional on 10/28/2002, concerning a 52 year old female vaccinee who received 2 doses of the influenza vaccine (one Fluvirin, one Brand unknown) on 10/26/02. On 10/26/2002, the vaccinee went to 2 separate clinics and received 2 separate doses of the Fluvirin vaccination with the intent of receiving greater immunogenic protection from the vaccine. No adverse reaction was reported. There was insufficient information to determine the reporter's causality assessment.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A report was received from a health professional on 10/25/02, concerning as unknown number of vaccinees of unknown demography who experienced injection site reactions after receiving the Fluvirin vaccine on 10/11/02. On 10/11/02, an unspecified number of vaccines experienced redness, swelling and soreness at the injection site. There was insufficient information to determine the reporter's causality assessment.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 10/21/02, concerning a 69 year old female vaccinee who was administered expired Fluvirin vaccine on 10/21/02. The vaccinee did not experienced any adverse effects. The reporter has assessed the relationship of the vaccine to the event as unclassifiable. Update (1) 12/12/02: A follow up report was received from a health care professional. The vaccinee received Fluvirin subcutaneously on 10/21/02. The vaccinee received the 2002-2003 formulation of influenza vaccine (brand unspecified) on 11/15/02.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoacusis
Clinical narrative: A report was received from a health professional on 10/21/02, concerning a 46 year old male vaccinee who experienced worsening hearing loss right after receiving the flu vaccine (brand unspecified) in September 2002. The patient was diagnosed with mild to moderate hearing loss in his right ear and moderate to severe hearing loss in his left ear in June 2002. On 10/16/02, the vaccinee was evaluated at an audiology clinic different from the one he was evaluated at in June 2002. It was noted that he had worsening hearing loss in his right ear. The vaccinee had received previous influenza vaccines in the past 4-5 years, without a similar adverse reaction. The reporter has assessed the relationship of the vaccine to the event as unrelated.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/29/2002, concerning a 70 year old male vaccinee who received last years batch of Fluvirin intramuscularly on 10/23/2002. ON 10/23/2002, the vaccinee was inadvertently administered last years batch of Fluvirin (dated 30 June 2002) intramuscularly.  It was reported that the vaccinee did not experience any adverse event in relation to the incident. The reporter has assessed the relationship of the vaccine to the event as related.
Age: 1.19
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/16/2002, concerning a 14 month old female vaccine who was inadvertently administered 0.25ml intramuscularly in the vastus lateralis on the 15 October 2002. On 10/15/2002, the vaccinee suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis.  The vaccinee had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 10/21/2002, concerning a 24 month old female vaccinee who inadvertently received the Fluvirin vaccine on 10/21/2002. On 10/21/2002, a 24 month old female vaccinee was inadvertently administered the Fluvirin vaccine.  The vaccinee had not received a previous influenza vaccination.  The vaccinee had not showed any signs or symptoms of an adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1 01/06/2003 The reporter stated that the vaccinee was given the incorrect dose, the vaccinee was less than 8 years old and was given the dose for vaccinees greater than 8 years old.  The parent was notified, but the vaccinee had experienced no adverse reaction 72 hours after the vaccination.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 10/23/2002, concerning a 30 year old female vaccinee who was inadvertently administered the Fluvirin vaccine subcutaneously on 10/23/2002.  The vaccinee did not experience any adverse event. There was insufficient information to determine the reporters causality assessment.
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report received from a health professional on 10/29/2002, concerning a female vaccinee who received Fluvirin on 10/29/2002. On 10/29/2002, the vaccinee was inadvertently administered 2001-2002 Fluvirin.  The vaccinee did not experience any adverse event. There was insufficient information to determine the reporter's causality assessment.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Raynaud's phenomenon
Clinical narrative: A report was received from a health professional on 10/21/02, concerning a female vaccinee in her early 30's who experienced finger tingling after receiving Fluvirin vaccine on approximately 10/15/02. On approximately 10/15/02, on the evening of the same day that she received her Fluvirin vaccination the vaccinee experienced finger tingling in her ring and little fingers. The finger tingling had not resolved at the time of this report. The reporter has assess the relationship of the vaccine to the event as unclassifiable. Update (1) 01/02/03: The 22 year old vaccinee experienced Raynaud's disease a few hours after receiving the Fluvirin vaccine in the left deltoid muscle. The vaccinee experienced tingling in the left ring and pinky finger on 10/15/02, which lasted for several days. The attending nurse recommended ibuprofen. The vaccinee has recovered.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Medication error, Pruritus
Clinical narrative: A report was received from a health care professional on 10/29/02, concerning a 38 year old male vaccinee who experienced an injection site reaction after receiving Fluvirin on 10/23/02. On 10/24/02, the vaccinee developed a 8"x' area of redness, swelling, tenderness and itching near the injection site. The vaccinee has not yet recovered. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/13/02:A follow up report received from a health care professional indicated that the vaccinee received Fluvirin via subcutaneous injection inferior to the deltoid muscle. Symptoms of the adverse event also included redness, induration and itching around the injection site. The vaccinee recovered after 8 days.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 10/21/02, concerning 12 adult vaccinee's who were inadvertently administered frozen Fluvirin vaccine on 10/18/02. They will be re-vaccinated in approximately 4 weeks. The vaccinee's have not experienced any adverse effects. The reporter has assessed the relationship of the vaccine to the event as unclassifiable.
Sex: U
Vaccine: FLU3
Symptoms: Drug ineffective, Infection, Pain
Clinical narrative: A report was received from a health care professional on 11/13/02, concerning a group of 46 vaccinees of unknown demography who experienced sore arms and developed the flu 2-3 weeks after administration of Fluvirin on an unreported date. There was insufficent information to determine the reporter's causality assessment.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Medication error
Clinical narrative: A report was received from a health care professional on 10/29/02, concerning a 40 year old female vaccinee who experienced an injection site reaction 1 day after receiving fluvirin vaccine on 10/23/2002. On 10/24/02, the vaccinee developed a 8"x 6" area of redness, swelling, tenderness and itching near the injection site. The vaccinee has not yet recovered. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/13/02: A follow up report received from a health care professional indicated that the vaccinee received Fluvirin via subcutaneous injection inferior to the deltoid muscle. Symptoms of the event included induration around the injection site. The vaccinee recovered after 7 days. Ref: PJP200200614 and PJP200200619.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: A report was received from a health care professional on 10/29/02, concerning a 40 year old female vaccinee who experienced an injection site reaction 1 day after receiving fluvirin vaccine on 10/23/2002. On 10/24/02, the vaccinee developed a 8"x 6" area of redness, swelling, tenderness and itching near the injection site. The vaccinee has not yet recovered. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/13/02: A follow up report received from a health care professional indicated that the vaccinee received Fluvirin via subcutaneous injection inferior to the deltoid muscle. Symptoms of the event included induration around the injection site. The vaccinee recovered after 7 days. Ref: PJP200200614 and PJP200200619.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: A report was received from a customer on 10/24/2002, concerning a 60 year old female vaccinee who experienced injection site redness, swelling and hardness 1 day after, and flu-like symptoms 2 days after receiving the Fluvirin vaccine on 10/21/2002. On 10/21/2002, the patient received her flu vaccination in the left arm. One day later, the arm became red, swollen and was very hard at the injection site. On 10/23/2002, the vaccinee experienced flu-like symptoms including chills and coldness. The vaccinee last received flu vaccination several years ago with no allergic reactions.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: A report was received from a customer on 10/24/2002, concerning a 60 year old female vaccinee who experienced injection site redness, swelling and hardness 1 day after, and flu-like symptoms 2 days after receiving the Fluvirin vaccine on 10/21/2002. On 10/21/2002, the patient received her flu vaccination in the left arm. One day later, the arm became red, swollen and was very hard at the injection site. On 10/23/2002, the vaccinee experienced flu-like symptoms including chills and coldness. The vaccinee last received flu vaccination several years ago with no allergic reactions.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Ecchymosis, Injection site erythema, Injection site swelling, Swelling, Tenderness
Clinical narrative: A report received from a health care professional on 10/29/2002, concerning a 25 year old female vaccinee who experienced an injection site reaction after receiving Fluvirin on 10/23/2002. On 10/24/2002, the vaccinee developed a 3" X 3" area of redness, swelling, tenderness and itching near the injection site. The vaccinee has not yet recovered. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/11/2002,  A follow-up report received from a health care professional indicated that other symptoms of the event included swelling and ecchymosis superior to the injection site. The vaccinee recovered after 3 days.
Age: 1.05
Sex: M
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health care professional on 10/24/2002, concerning a 12 month old male vaccinee who inadvertently received 0.25 ml Fluvirin intramuscularly on 10/23/2002. On 10/23/2002, the vaccinee experienced a medication error following inadvertent administration of 0.25 ml Fluvirin intramuscularly. No adverse event was reported. There was insufficient information to determine the reporter's causality assessment. Update 1 12/09/2002: A follow up report was received from a health care professional on 12/09/2002. It was reported that the vaccinee received 0.5 ml Fluvirin subcutaneously on 10/23/2002. No adverse reaction was reported.
Age: 0.45
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report received from a health professional on 10/22/2002, concerning a 5 month old male vaccinee who inadvertently received the Fluvirin vaccine on 10/18/2001. The vaccinee experienced no adverse event. There was insufficient information to determine the reporter's causality assessment.
Age: 0.98
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report received from a health professional on 10/22/2002, concerning an 11 month old female vaccinee who inadvertently received the Fluvirin vaccine on 10/11/2002. The vaccinee experienced no adverse event. There was insufficient information to determine the reporter's causality assessment.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: A report was received from a health care professional on 10/15/02, concerning a vaccinee who experienced a red, hot swollen arm after receiving Fluvirin on 10/5/02. On 10/15/02, the vaccine received 0.5ml Fluvirin to the left arm and within minutes developed swelling of the entire arm which was also red and hot. Ice packs were applied with no relief. The vaccinee had not recovered at the time of the report. The reporter has assessed the relationship of the vaccine to the event as probable.
Age: 0.57
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 0/22/02, concerning a 6 month old male vaccinee who inadvertently received the Fluvirin vaccine on 10/11/02. The vaccinee experienced no adverse event. There was insufficient information to determine the reporter's causality assessment. Cross referenced with PJP200200621 and PJP200200622.
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: A report received from a health professional on 10/22/02, concerning a male vaccinee in his 70's who experienced diarrhea on 10/18/02, after receiving the Fluvirin vaccine on 10/18/02. That evening he developed "watery stools" every 2 hours which was persisting at the time of the report. The vaccinee has not recovered. The reporter has assessed the relationship of the medication to the event as unknown. Cross reference with PJP20020537.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a consumer concerning a 53 year old male vaccine who inadvertently received 1ml Fluvirin on 10/30/02. The vaccinee experienced no adverse reaction.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10/24/2002, concerning a 37 year old female vaccinee and approximately 10 other staff who inadvertently received Fluvirin subcutaneously in 10/2002. In October 2002, the vaccinee and approximately 10 others experienced inadvertent administration of Fluvirin receiving 0.5ml of Fluvirin Subcutaneously with 5/16 inch needles. No adverse event was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Injection site mass, Pain, Paraesthesia
Clinical narrative: A report was received from a healthcare professional on 10/24/2002, concerning a 26 year old female vaccinee who experienced warmth, tingling, redness and soreness and developed a softball-sized lump at the injection site after receiving Fluvirin intramuscularly on 10/23/2002. On 10/23/2002, the vaccinee experienced warmth, tingling, redness, soreness and a lump at the injection site after receiving 0.5ml Fluvirin intramuscularly on 10/23/2002.  It was reported that the attending physician suspected that the vaccinee may be allergic to the drug.  The vaccinee has received an influenza vaccine for the past 6 years without any problems.  Symptoms had not resolved at the time of the reporting. There was insufficient information to determine the reporter's causality assessment.
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 10/23/2002, concerning a female vaccinee of unknown age who inadvertently received frozen Fluvirin vaccine on 10/23/2002.  The vaccinee did not experience any adverse event. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP-2002-00585, PJP-2002-00775. Update 1 12/23/2002 A report was received from a healthcare professional which indicated that the event resolved on an unspecified date.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 10/30/2002, concerning a vaccinee of unknown demography, who was inadvertently administered expired Fluvirin on an unknown date in September 2002. On an unknown date in September 2002, the vaccinee was administered with 2001-2002 Fluvirin formulation. There was insufficient information to determine the reporter's causality assessment. Update 1, January 9, 2003: A follow up report was received from a healthcare professional indicating that a 74 year old female vaccinee did not experience an adverse event after inadvertent administration of expired Fluvirin on an unreported date in September 2002.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 10/23/2002, concerning 70 children under 4 years of age who were inadvertently administered Fluvirin vaccine between approximately 10/01/2002 and 10/23/2002. Between approximately 10/01/2002 and 10/23/2002, 70 children under 4 years of age were inadvertently administered Fluvirin 0.25ml intramuscularly.  None of the vaccinees have exhibited any signs or symptoms of an adverse event but will be closely monitored. There was insufficient information to determine the reporters causality assessment.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A report received from a health professional on 10/29/2002, concerning approximately 25 vaccinees of unknown demography who experienced swelling, redness and soreness at the injection site an unknown time after receiving the Fluvirin vaccine between 10/14/2002 and 10/29/2002. Between 10/14/2002 and 10/29/2002, approximately 25 patients reported having swelling, redness and soreness at the injection site after receiving the Fluvirin vaccine.  The reporter stated that she has been administering the influenza vaccine for many years and that she has seen now an exceptionally high incidence of local reactions in her vaccinees.  Her estimation was that approximately 50% of the vaccinees experienced local reactions.  The reporter has assessed the relationship of the vaccine to the events as probable.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a pharmacy student on 10/24/2002, concerning a 25 year old male vaccinee who received 0.5ml Fluvirin intramuscularly.  However half the dose spilled while being administered. On 10/24/2002, the vaccinee experienced a medication error when half of the Fluvirin vaccine he was receiving spilled onto his arm.  It was reported that the vaccinee did not experience any adverse effects. The reporter has assess the relationship of the event to the medication as unclassifiable.
Age: 1.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report received from a health professional on 10/10/2002, concerning an 18 month old female vaccinee who inadvertently received Fluvirin on 10/30/2002. On 10/30/2002, the vaccinee was inadvertently administered Fluvirin.  The vaccinee was less than 4 years old.  The vaccinee did not experience any adverse event. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/03/2002. A report was received from a healthcare professional which confirmed that the vaccinee had still not experience any adverse effects at the time of the report.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 10/30/2002, concerning approximately 10 vaccinees who inadvertently received last year's Fluvirin.  From 10/28/2002 to 10/30/2002, approximately 10 vaccinees were inadvertently vaccinated with expired Fluvirin. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/27/2003. A report was received from a healthcare professional concerning a 50 year old female vaccinee who received expired influenza vaccine (brand unspecified) on an unspecified date.  The vaccinee was subsequently re-vaccinated with this years influenza vaccination and experienced no adverse reaction.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report received from a health professional on 10/24/2002, concerning a 2 year old male vaccinee who inadvertently received Fluvirin vaccine on 10/17/2002.  The vaccinee experienced no adverse reaction. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/11/2002. One dose of Fluvirin was administered a second dose due one month later was withheld.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 10/31/2002, concerning a group of vaccinees less than 4 years old who had been vaccinated with Fluvirin from 10/21/2002 to 10/31/2002. Between 10/21/2002 and 10/31/2002, an unreported number of vaccinees less than 4 years old inadvertently received 0.25ml Fluvirin intramuscularly.  No adverse events were reported. There was insufficient information to determine the reporter's causality assessment.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 23Oct02, concerning a 39 year old female health professional who was inadvertently administered Fluvirin vaccine in Oct 2002. The vaccinee did not experience any adverse event. The event resolved. There was insufficient information to determine the reporters causality assessment. Cross-reference with PJP 2002 00640. Update 1 09Dec02: A report was received from a health care professional which indicated that the 40 year old vaccinee received the Fluvirin vaccine on 23Oct02.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 23Oct02, concerning a 39 year old female health professional who was inadvertently administered Fluvirin vaccine in Oct 2002. The health professional did not experience any adverse event. The event resolved. There was insufficient information to determine the reporters causality assessment. Cross-reference with PJP 2002 00638. Update 1 09Dec02: The vaccinee received the Fluvirin vaccine on 23Oct02.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: A report was received from a health professional on 23Oct02, concerning a 52 year old male vaccinee who experienced large (about the size of an apple), red, hot patches at and around the site of injection and pain under the arm after receiving the Fluvirin vaccine on 21Oct02. On 21Oct02, the vaccinee developed large (about the size of an apple), red, hot patches at and around the site of injection and pain under the arm. There were no signs of fever or illness. The reporter has assessed the relationship of the vaccine to the event as probably related particularly due to the needle length.
Sex: U
Vaccine: FLU3
Symptoms: Upper respiratory tract infection
Clinical narrative: A report was received from a health professional on 22Oct02, concerning a female vaccinee who developed upper respiratory symptoms after receiving Fluvirin on an unk date.  On an unk date, the vaccinee received an unknown dose of Fluvirin through a route unk. She developed upper respiratory symptoms and the outcome was reported as unk. The vaccinee has received annual flu vaccinations for 10 years without any adverse reaction.  There was insufficient information to determine the reporters causality assessment. Cross-reference with PJP 2002 00638. Update 1 09Dec02: The vaccinee received the Fluvirin vaccine on 23Oct02. Ref: PJP200200647; PJP200200649.
Sex: M
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: A report was received from a health professional on 22Oct02, concerning a vaccinee of unk demography who experienced nausea after receiving Fluvirin on an unk date. The vaccinee developed  nausea on an unk date. The vaccinee received a previous Flu vaccine with no adverse effects.  It was unk if the vaccinee had recovered.  There was insufficient information to determine the reporters causality assessment. Ref: PJP200200645; PJP200200649.
Sex: U
Vaccine: FLU3
Symptoms: Asthma
Clinical narrative: A report was received from a health professional on 22Oct02, concerning a vaccinee of unk demography who developed an asthmatic reaction after receiving Fluvirin on an unk date. On an unk date, the vaccinee received an unknown dose of Fluvirin via an unk route. She developed an asthmatic reaction. The vaccinee had received annual flu vaccination for 10 years without any adverse reaction. There was insufficient information to determine the reporters causality assessment.  Ref: PJP200200647; PJP200200645.