chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site pain
Clinical narrative: It was reported that a 42 year old female received Fluzone SV '99-'00 on 10/22/99. The pt stated that on the same day, post vax, her "right arm was so sore to the point it felt as if it were paralyzed". She was not evaluated by a physician. The reporter also mentioned that the pt is on chemotherapy. No further information is available at this time. When additional information was provided on 12/23/99, it is stated that the symptoms were gone by the morning. From correspondence received on 2/1/00, it was reported, "reviewed, no additional information at this time".
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema multiforme, Rash, Skin necrosis
Clinical narrative: It was reported that a 65 year old female received Fluzone SV '99-'00 on 10/19/99. She "developed generalized rash the next day, post vax." No further information is available at this time. According to information received on 11/23/99, the pt cleared with a prednisone taper. A skin biopsy was performed and revealed vacuoles interlaced with dermatitis with necrotic keratinocytes, consistent with erythema multiforme. The physician intends to check a patch test to formaldehyde and tumisol in 3 to 4 months.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urticaria
Clinical narrative: It was reported that a 65 year old female received Fluzone SV '99-'00 on 10/19/99. She "developed generalized rash the next day, post vax." No further information is available at this time. According to information received on 11/23/99, the pt cleared with a prednisone taper. A skin biopsy was performed and revealed vacuoles interlaced with dermatitis with necrotic keratinocytes, consistent with erythema multiforme. The physician intends to check a patch test to formaldehyde and tumisol in 3 to 4 months.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema multiforme, Rash, Skin necrosis
Clinical narrative: It was reported that a 65 year old female received a Fluzone SV '99-'00 vaccination on 10/19/99. On 10/20/99, the pt experienced "generalized hives". She was evaluated by an ER physician and treated with Benadryl and Solu-Medrol and given oral Benadryl to take every 4 hours. She was then evaluated by her own physician who gave her a Medrol pack. Compazine for nausea and additional Benadryl.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urticaria
Clinical narrative: It was reported that a 65 year old female received a Fluzone SV '99-'00 vaccination on 10/19/99. On 10/20/99, the pt experienced "generalized hives". She was evaluated by an ER physician and treated with Benadryl and Solu-Medrol and given oral Benadryl to take every 4 hours. She was then evaluated by her own physician who gave her a Medrol pack. Compazine for nausea and additional Benadryl.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Ocular hyperaemia, Pain, Pharyngolaryngeal pain
Clinical narrative: It was reported that a 61 year old female received Fluzone SV '99-'00 on 10/26/99. On the same day, the pt experienced "general body aches, sore throat, and red swollen eye". She was not evaluated by a physician. She was given antibiotic eye drops by the clinic. No further information is available at this time. From correspondence received on 2/1/00, it was reported, "reviewed, no additional information at this time".
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Injection site erythema, Injection site swelling, Lacrimal disorder
Clinical narrative: It was reported that a 53 year old female received a Fluzone SV '99-'00 vaccination on 10/7/99. Reportedly the next day, the pt developed a local reaction of redness and swelling, lasting 1 week. On 10/12/99, the pt developed burning and tearing of the eyes, lasting 1 week. On 10/25/99, the pt developed chills, congestion and a cough. The pt is being evaluated today, 11/2/99. From additional information received on 11/2/99, it was reported that the pt is recovering. Additional information dated 11/23/99: "Pt is still congested but recovering on her own. Did not come in for evaluation." Follow up #1 06/14/02; During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added rhinitis)
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinitis
Clinical narrative: It was reported that a 53 year old female received a Fluzone SV '99-'00 vaccination on 10/7/99. Reportedly the next day, the pt developed a local reaction of redness and swelling, lasting 1 week. On 10/12/99, the pt developed burning and tearing of the eyes, lasting 1 week. On 10/25/99, the pt developed chills, congestion and a cough. The pt is being evaluated today, 11/2/99. From additional information received on 11/2/99, it was reported that the pt is recovering. Additional information dated 11/23/99: "Pt is still congested but recovering on her own. Did not come in for evaluation." Follow up #1 06/14/02; During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added rhinitis)
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: It was reported that a 51 year old female received a Fluzone SV '99-'00 vaccination on 10/31/99. Reportedly on 11/1/99, the pt experienced a large local reaction of redness (15cm X 18cm), induration and pain at the injection site. From additional information received on 11/5/99, it was reported that the pt was given Benadryl for treatment. Two days later, the local reaction was better (8.5cm X 9.5cm). The pt is still recovering.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Tremor
Clinical narrative: It was reported that a 9 year old male received a Fluzone SV '99-'00 vaccination on 11/4/99, at 11:30. At approx. 12:00 that same day, the pt reported not feeling well. Pt was shaking uncontrollably, temperature 97.6F, pulse 96, resp. 18, and BP 80/60. The pt's mom phoned and she came at 12:20 to take pt to the doctor. At 12:20, the pt's pulse was 92. Reportedly, the pt recovered from this experience. No additional information was provided from correspondence on 12/15/99. Follow up #1 06/19/02:During internal auditing of all files, it was deemed necessary to amend the report the report by updating the Adverse Event coding (added Malaise)
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle twitching
Clinical narrative: It was reported that a male pt received a Fluzone SV '99-'00 vaccination on 10/25/99. Reportedly, on 10/27/99, the pt developed muscle twitching. Pt plans to see neurologist if persists. The physician reporting is the pt. From correspondence received on 11/22/99, additional pt, physician and vaccine information was provided.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Dysphonia, Pharyngeal oedema
Clinical narrative: It was reported that a 51 year old female received a Fluzone SV '99-'00 vaccination on 11/3/99. Reportedly a few minutes, post vax, the pt complained of a funny taste in her mouth. A few minutes later, the pt was getting hoarse and stated her throat felt like it was swelling. The pt was given 2 Benadryl 25mg caps and sent to the ER. Reportedly, the pt recovered from this experience. From additional information received on 12/8/99, an amendment in the vaccine administrator's name was made.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Erythema, Injection site erythema
Clinical narrative: It was reported that a 50 year old female received a Fluzone SV '99-'00 vaccination on 11/15/99. Reportedly, on 11/16/99, the pt developed a local reaction of redness and erythema with a blister formation of 2cm oblong. From additional information received on 11/18/99, it was reported that the local reaction occurred on the pt's left deltoid with 3cm erythema and induration. From additional information received on 12/20/99, it was reported, "Reviewed, no other information at present time."
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: It was reported that a 47 year old female was vaccinated with Fluzone SV '99-'00 on 10/20/99. Reportedly, a few hours later, the pt had a 45mm area of redness around the left deltoid at the injection site. The site was also warm, red and painful. No additional information was provided from correspondence received on 2/1/00.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site mass
Clinical narrative: It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl 25mg per oral every 4 hours was prescribed. Reportedly, the pt recovered from this experience. No additional information was provided from correspondence returned on 12/15/1999.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Urticaria
Clinical narrative: It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl 25mg per oral every 4 hours was prescribed. Reportedly, the pt recovered from this experience. No additional information was provided from correspondence returned on 12/15/1999.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site mass, Pyrexia
Clinical narrative: It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/5/99, the pt developed redness at the injection site 8cm to 10cm, fever, urticaria, erythema and an induration. Benadryl 25mg per oral, every 4 hours, was prescribed. The symptoms resolved between 11/6/99 and 11/9/99. No additional information was provided from follow-up correspondence returned on 12/8/99.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site induration, Pyrexia, Urticaria
Clinical narrative: It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/5/99, the pt developed redness at the injection site 8cm to 10cm, fever, urticaria, erythema and an induration. Benadryl 25mg per oral, every 4 hours, was prescribed. The symptoms resolved between 11/6/99 and 11/9/99. No additional information was provided from follow-up correspondence returned on 12/8/99.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site mass, Urticaria
Clinical narrative: It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl was given as treatment. Reportedly, the pt recovered from this experience. No addition information was provided from follow-up correspondence returned on 12/8/99.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Urticaria
Clinical narrative: It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl was given as treatment. Reportedly, the pt recovered from this experience. No addition information was provided from follow-up correspondence returned on 12/8/99.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: It was reported that a 63 year old male received a Fluzone SV '99-'00 vaccination on 11/3/99. On 11/6/99, the pt went rifle shooting with strap for rifle secured around left arm. On 11/7/99, in the evening, the pt stated his left upper arm was sore. On 11/8/99, in the evening, the pt developed a slight fever and generalized discomfort. On 11/9/99, the pt stated every bone in his body hurt. On 11/10/99, the pt took Advil and used a heating pad. The pt reportedly, recovered from this experience. From additional information received on 12/6/99, it was reported that the pt returned to work on 11/10/99. From additional correspondence received on 1/28/00, it was reported, "Reviewed with no additional information. Employee is at work with no problems."
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site mass
Clinical narrative: It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl 25mg per oral every 4 hours was prescribed. Reportedly, the pt recovered from this experience. No additional information was provided from follow-up correspondence returned on 12/8/99.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Urticaria
Clinical narrative: It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl 25mg per oral every 4 hours was prescribed. Reportedly, the pt recovered from this experience. No additional information was provided from follow-up correspondence returned on 12/8/99.
Age: 93.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site mass, Urticaria
Clinical narrative: It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl 25mg per oral every 4 hours was prescribed. Reportedly, the symptoms resolved on 11/7/99. No additional information was provided from follow-up correspondence returned on 12/8/99.
Age: 93.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Urticaria
Clinical narrative: It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl 25mg per oral every 4 hours was prescribed. Reportedly, the symptoms resolved on 11/7/99. No additional information was provided from follow-up correspondence returned on 12/8/99.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site mass, Pruritus, Urticaria
Clinical narrative: It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly on 11/4/99, the pt developed redness at and around the injection site 6cm-8cm, itching, urticaria, erythema and an induration. Benadryl 25mg per oral every 4 hours was prescribed. The symptoms resolved between 11/6/99 and 11/9/99. No additional information was provided from correspondence returned on 12/15/99.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site induration, Pruritus, Urticaria
Clinical narrative: It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly on 11/4/99, the pt developed redness at and around the injection site 6cm-8cm, itching, urticaria, erythema and an induration. Benadryl 25mg per oral every 4 hours was prescribed. The symptoms resolved between 11/6/99 and 11/9/99. No additional information was provided from correspondence returned on 12/15/99.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: It was reported that a 34 year old female received a Fluzone SV '99-'00 vaccination on 10/20/99. Reportedly, on 10/21/99, the pt's left deltoid was red, sore and warm at the injection site. The reaction site was approx. 3" by 2" in diameter and was sore for 3 days. The pt reportedly, recovered from this experience. No additional information was provided from correspondence received on 2/1/00.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Pruritus, Rash
Clinical narrative: It was reported that a 43 year old male received a Fluzone SV '99-'00 vaccination on 10/13/99. Reportedly, approx. 48 hours, post vax, the pt was awakened in the middle of the night due to itching. The pt reports that he had masses of very small, red "dots" over his buttocks, mid-thigh to mid-abdomen, arms, hands and ankles. He reports a pronounced red rectangular area over the injection site. These symptoms abated approx. 1 week later. The pt recovered fully. No additional information was provided from correspondence returned on 3/7/00.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Back pain, Hypertonia, Hypokinesia, Lymphadenopathy, Pain
Clinical narrative: It was reported that a 44 year old female was vaccinated with Fluzone UNSP '99-'00 on 10/23/99. Reportedly, on 10/24/99, the pt developed tenderness "deep in my arm pit," almost in the chest area of her left side (the injection side). She reported this area as being extremely tender and hurting and aching all of the time. It hurt the pt to raise her arm over her head for 4 days. The pt also reported a tightness in her left lower back like spasms. On 11/2/99, the pt had an appointment to see doctor and on 11/4/99, labs were drawn.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Flank pain, Hypokinesia, Muscle spasms, Musculoskeletal discomfort, Pain
Clinical narrative: It was reported that a 44 year old female was vaccinated with Fluzone UNSP '99-'00 on 10/23/99. Reportedly, on 10/24/99, the pt developed tenderness "deep in my arm pit," almost in the chest area of her left side (the injection side). She reported this area as being extremely tender and hurting and aching all of the time. It hurt the pt to raise her arm over her head for 4 days. The pt also reported a tightness in her left lower back like spasms. On 11/2/99, the pt had an appointment to see doctor and on 11/4/99, labs were drawn.
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Nausea
Clinical narrative: It was reported that a 51 year old female received the Fluzone SV '99-'00 vaccine on 11/14/99. On 11/15/99, reportedly, the pt awoke with severe dizziness and nausea. The pt was able to go to work. It is stated that the pt has never had dizziness with nausea in the past. She also states that she has a "sensation" (warm flush) with reaction. The pt recovered in 2 days. From correspondence received on 1/21/00, amendments for the responsible physician and the name and address of the initial reporter were provided.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: It was reported that a 36 year old male received a Fluzone SV '99-'00 vaccination on 11/17/99. Reportedly on 11/18/99, the pt developed swelling of wrists of both arms, "actually 2" from the wrist". The pt was evaluated by the medical service doctor on 11/19/99; there were no physical impairments. From additional information received on 11/23/99, it was learned that the pt recovered. From correspondence received on 1/28/00, it war reported, "1/25/00, reviewed, no additional information at this time."
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Hypokinesia, Injection site pain
Clinical narrative: It was reported that a 48 year old male received a Fluzone SV '99-'00 vaccination on 11/4/99. Reportedly, that same day, the pt complained of pain at the site of the injection and inability to lift left arm. The vaccination was administered with biojecter. From additional information received on 1/19/00, it was reported that as of 12/1/99, the pt continued to have soreness in left arm, rendering him to sleep on his right side. Pt was unable to lift arm over head.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypokinesia, Pain
Clinical narrative: It was reported that a 60 year old male received a Fluzone SV '99-'00 vaccination on 11/17/99. Reportedly, on 11/19/99, the pt complained of pain when lifting arms, which has yet to subside. From additional correspondence received on 1/24/00, it was reported that 2 days, post vax, the pt was unable to lift arm to brush teeth. Within 1 week, pt experienced difficulty lifting both arms, which reoccurs every 2 to 3 days. Tylenol or Advil relieves the pain. The pt was referred to a doctor. The pt was seen and he felt the arm difficulties were not due to Fluzone shot. The pt was given "cortisone type" shot and told to come back in 2 weeks if not better.
Age: 2.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Diarrhoea, Rash maculo-papular
Clinical narrative: It was reported that a 2 year old male received Fluzone SV '99-'00 on 10/25/99. "Approx. 3 hours, post vax, he developed a papular rash head to toe". He had no respiratory distress and was treated symptomatically. No further information is available at this time.
Age: 2.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash papular
Clinical narrative: It was reported that a 2 year old male received Fluzone SV '99-'00 on 10/25/99. "Approx. 3 hours, post vax, he developed a papular rash head to toe". He had no respiratory distress and was treated symptomatically. No further information is available at this time.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site hypersensitivity, Pruritus, Rash maculo-papular
Clinical narrative: On 1/18/00, the pt developed itching and a rash described as a 1-22mm raised papules with red centers on upper back, chest, arms, left thigh and abdomen. Reportedly the pt recovered from this experience.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus, Rash papular
Clinical narrative: On 1/18/00, the pt developed itching and a rash described as a 1-22mm raised papules with red centers on upper back, chest, arms, left thigh and abdomen. Reportedly the pt recovered from this experience.
Age: 8.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Angioneurotic oedema, Dyspnoea, Headache, Myalgia
Clinical narrative: It was reported that an 8 year old male was vaccinated with Fluzone DSP on 10/18/99. The child presented at the doctor's office on 10/31/99, with urticaria, angioedema, difficulty breathing, fever, headache, myalgia and stomachache. It is reported that this child had never received the flu vaccine prior to this 10/18/99 dose. The pt has a history of asthma. To date, there has been no reaction to the 2nd dose of vaccine given on 11/16/99.
Age: 8.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Urticaria
Clinical narrative: It was reported that an 8 year old male was vaccinated with Fluzone DSP on 10/18/99. The child presented at the doctor's office on 10/31/99, with urticaria, angioedema, difficulty breathing, fever, headache, myalgia and stomachache. It is reported that this child had never received the flu vaccine prior to this 10/18/99 dose. The pt has a history of asthma. To date, there has been no reaction to the 2nd dose of vaccine given on 11/16/99.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: Approximately 5 days post vax, the pt noticed his head falls to his left, shoulder droops to the left. The pt states he experienced difficulty walking, turning head to the right and eating. These symptoms are still persisting.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Difficulty in walking, Muscular weakness, Paralysis
Clinical narrative: Approximately 5 days post vax, the pt noticed his head falls to his left, shoulder droops to the left. The pt states he experienced difficulty walking, turning head to the right and eating. These symptoms are still persisting.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bone disorder, Injection site pain, Joint range of motion decreased, Neck pain, Pain
Clinical narrative: It was reported that a female pt received a Fluzone '99-'00 vaccination on 10/20/99. Reportedly, on 10/21/99, the pt developed pain at the injection site that radiated to the neck and arm. The pt also had a decreased range of motion.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Neck pain
Clinical narrative: It was reported that a female pt received a Fluzone '99-'00 vaccination on 10/20/99. Reportedly, on 10/21/99, the pt developed pain at the injection site that radiated to the neck and arm. The pt also had a decreased range of motion.
Age: 40.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: It was reported that a 40 year old male received Fluzone SV '99-'00 and Pneumovax on 10/11/99. The pt experienced a low-grade fever, 12 hours, post vax. He also, experienced a fever of 102, the same night. Two days later, he experienced a low-grade fever again, along with a headache and general malaise. No further information is available at this time. From additional information received on 12/1/99, it was reported that the illness continued for 10 days.
Age: 2.0
Sex: F
Vaccine: PNC, PNC
Symptoms: Convulsion, Cyanosis, Eye movement disorder, Musculoskeletal stiffness, Pallor
Clinical narrative: This 2 year old had a seizure involving generalized shaking, pallor, whimpering and decreased respiratory rate. This occurred approx. 5 minutes, post vax. Child was standing and talking normally to mother but then became very pale fist and backed up by mother. Child was very post-ictal afterwards. Follow-up exam was normal.
Age: 2.0
Sex: F
Vaccine: PNC, PNC
Symptoms: Convulsion, Pallor, Postictal state, Respiratory rate decreased, Tremor
Clinical narrative: This 2 year old had a seizure involving generalized shaking, pallor, whimpering and decreased respiratory rate. This occurred approx. 5 minutes, post vax. Child was standing and talking normally to mother but then became very pale fist and backed up by mother. Child was very post-ictal afterwards. Follow-up exam was normal.
Age: 1.0
Sex: M
Vaccine: DTP, HEP, HIBV
Symptoms: Hypersensitivity, Similar reaction on previous exposure to drug, White blood cell count increased
Clinical narrative: The vaccinee received his 2nd dose of vax even though the adverse reactions from the first dose had not resolved. Blood work was performed the day of the vax. The pediatrician called the vaccinee's family 1-2 days later and notified them that the vaccinee's white blood cell count was elevated. The vaccinee was admitted to the hospital. It was thought that the pt had some rare form of leukemia, specifically juvenile monocytic leukemia. Tests were evaluated by several specialists but the dx was not confirmed. An allergist and immunologist identified something problematic with the antibodies. The pt was taken home and resumed breast feeding. The parents decided not to further immunize their child as symptoms started after immunizations began. All symptoms reported resolved over the next 3-4 months. Hypersensitivity reactions continue.
Sex: U
Vaccine: PNC
Symptoms: Angioneurotic oedema, Rash
Clinical narrative: Within 48 to 72 hours post vax, the pt developed angioedema and a generalized rash. The pt recovered within 3 to 5 days. This event is considered medically important.
Sex: U
Vaccine: PNC
Symptoms: Angioneurotic oedema, Rash, Vaccine positive rechallenge
Clinical narrative: Within 48 to 72 hours post 2nd dose of vax, the pt developed angioedema and a generalized rash. The pt recovered within 3-5 days. The reporter indicated that this event is definitely related to IZ. This event is considered medically important.
Age: 73.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Arthralgia, Bacterial infection, Headache, Hypoaesthesia, Myalgia
Clinical narrative: 8 days after a flu-like illness and 2 days, post vax, pt had numbness in his feet, progressing to GBS, arresting at waist and then descending. Still complaint of tingling in one foot. A letter from his neurologist, stated that he never told the pt that the "combination of kidney infection and influenza vaccine caused the GBS. In fact, after review of the records, it is not clear to me that the pt had a kidney infection at all (review of the records indicated that he presented with fever, generalized joint aches, headache, drowsiness and chills and no urinary symptoms, but generalized myalgias. He had a normal white count and although he did have some bacteria on urinalysis, he had no WBCs, negative leukocyte esterase activity and negative nitrates). My discussion with the pt was that in all likelihood he had a viral illness on 10/2/99 and that this was more likely the cause of his GBS than his flu vaccine. The onset of the numbness in his feet occurred on 10/10/00, 8 days after the flu-like illness but only 2 days after the flu shot, too short a time to have been related to the flu vaccine itself.
Age: 73.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Pyrexia, Somnolence, Viral infection
Clinical narrative: 8 days after a flu-like illness and 2 days, post vax, pt had numbness in his feet, progressing to GBS, arresting at waist and then descending. Still complaint of tingling in one foot. A letter from his neurologist, stated that he never told the pt that the "combination of kidney infection and influenza vaccine caused the GBS. In fact, after review of the records, it is not clear to me that the pt had a kidney infection at all (review of the records indicated that he presented with fever, generalized joint aches, headache, drowsiness and chills and no urinary symptoms, but generalized myalgias. He had a normal white count and although he did have some bacteria on urinalysis, he had no WBCs, negative leukocyte esterase activity and negative nitrates). My discussion with the pt was that in all likelihood he had a viral illness on 10/2/99 and that this was more likely the cause of his GBS than his flu vaccine. The onset of the numbness in his feet occurred on 10/10/00, 8 days after the flu-like illness but only 2 days after the flu shot, too short a time to have been related to the flu vaccine itself.
Age: 73.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Arthralgia, Bacterial infection, Guillain-Barre syndrome, Headache, Hypoaesthesia
Clinical narrative: 8 days after a flu-like illness and 2 days, post vax, pt had numbness in his feet, progressing to GBS, arresting at waist and then descending. Still complaint of tingling in one foot. A letter from his neurologist, stated that he never told the pt that the "combination of kidney infection and influenza vaccine caused the GBS. In fact, after review of the records, it is not clear to me that the pt had a kidney infection at all (review of the records indicated that he presented with fever, generalized joint aches, headache, drowsiness and chills and no urinary symptoms, but generalized myalgias. He had a normal white count and although he did have some bacteria on urinalysis, he had no WBCs, negative leukocyte esterase activity and negative nitrates). My discussion with the pt was that in all likelihood he had a viral illness on 10/2/99 and that this was more likely the cause of his GBS than his flu vaccine. The onset of the numbness in his feet occurred on 10/10/00, 8 days after the flu-like illness but only 2 days after the flu shot, too short a time to have been related to the flu vaccine itself.
Age: 73.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Kidney infection, Myalgia, Pyrexia, Somnolence, Viral infection
Clinical narrative: 8 days after a flu-like illness and 2 days, post vax, pt had numbness in his feet, progressing to GBS, arresting at waist and then descending. Still complaint of tingling in one foot. A letter from his neurologist, stated that he never told the pt that the "combination of kidney infection and influenza vaccine caused the GBS. In fact, after review of the records, it is not clear to me that the pt had a kidney infection at all (review of the records indicated that he presented with fever, generalized joint aches, headache, drowsiness and chills and no urinary symptoms, but generalized myalgias. He had a normal white count and although he did have some bacteria on urinalysis, he had no WBCs, negative leukocyte esterase activity and negative nitrates). My discussion with the pt was that in all likelihood he had a viral illness on 10/2/99 and that this was more likely the cause of his GBS than his flu vaccine. The onset of the numbness in his feet occurred on 10/10/00, 8 days after the flu-like illness but only 2 days after the flu shot, too short a time to have been related to the flu vaccine itself.
Age: 18.0
Sex: F
Vaccine: LYME
Symptoms: Dizziness, Peripheral coldness, Peripheral vascular disorder, Tremor
Clinical narrative: Shaking, dizzy, cold arm and loss of circulation. Pt took Advil and symptoms were better.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Disturbance in attention, Dizziness, Fatigue, Gastrointestinal disorder, Headache
Clinical narrative: Headaches, loss of concentration, dizziness, vertigo, ringing in my ear, severe fatigue and various intestinal problems. The doctors were unable to determine cause.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Tinnitus, Vertigo
Clinical narrative: Headaches, loss of concentration, dizziness, vertigo, ringing in my ear, severe fatigue and various intestinal problems. The doctors were unable to determine cause.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Asthenia, Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Red, slightly swollen arm where the shot was given. Strength loss in arm and fingers felt numb.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site nodule, Swelling, Tremor
Clinical narrative: Left arm swelling above the elbow. Large nodule at the injection site. Experienced tremoring in left hand. Pt was put on Keflex by civilian provider and also pt alternated warm and cold packs for swelling. After swelling subsided, pt has had no other problems.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Cough, Dizziness, Dyspnoea, Gastroenteritis
Clinical narrative: Pt claims reaction to Anthrax #5, nausea, cough, weakness, dizziness, fever, shortness of breath X 1 day, headache, with sore throat. 10 days, post vax, dx of AGE. Pt had another Anthrax on 6/6/00, with no problems. Again, pt requested Vaers form.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Nausea, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Pt claims reaction to Anthrax #5, nausea, cough, weakness, dizziness, fever, shortness of breath X 1 day, headache, with sore throat. 10 days, post vax, dx of AGE. Pt had another Anthrax on 6/6/00, with no problems. Again, pt requested Vaers form.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Listless, Pallor, Respiratory disorder, Tremor, Vomiting
Clinical narrative: Child became listless, vomited, color "gray-blue" and appeared to have tremors; shallow respiration. EMS transported to ER. Exam was normal on arrival. Re-evaluation in office on 9/16/00; had no further symptoms. No sequelae.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion
Clinical narrative: Pt had a 5 minute generalized seizure. Brought to ER with no fever or signs of infection. No focal findings. Given boost of phenobarbital and discharged from ER. Pt known to have seizure disorder and had therapeutic level of phenobarbital (20) on 8/20/2000.
Age: 4.0
Sex: F
Vaccine: MMR, PNC
Symptoms: Injection site erythema, Injection site induration, Pruritus
Clinical narrative: Redness, pruritus and induration 8cm X 7cm. Treated with Prelone and Augmentin.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC
Symptoms: Gait disturbance, Tremor
Clinical narrative: Shaking, after waking from sleep. Mother feels gait is not normal and despite no redness, swelling or tenderness in leg.
Age: 1.5
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Urticaria
Clinical narrative: Hives on both lower extremities that began within 24 hours of vaccination.
Age: 0.75
Sex: M
Vaccine: HEP, PNC
Symptoms: Agitation, Pyrexia
Clinical narrative: Pt experienced fever of 102-104 and extreme irritability for 4-5 days, post vax. Mom instructed to give Tylenol and Motrin during these times.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Arthralgia, Heart rate increased, Injection site reaction, Injection site warmth, Pain
Clinical narrative: The same day as the pt developed warmth at the site of injection described as "extremely hot", arthralgia, body aches and an increased heart rate. The pt recovered.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Arthralgia, Heart rate increased, Injection site warmth, Pain
Clinical narrative: The same day as the pt developed warmth at the site of injection described as "extremely hot", arthralgia, body aches and an increased heart rate. The pt recovered.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: It was reported that a pt received Fluzone SV '99-'00 and Pnu-Imune 23 vaccines mixed in 1 syringe, on 11/4/99. Reportedly, on 11/7/99, at 04:00, the pt's temperature was 98.8F, the pt complained of generalized pain. At 12:00 noon, the pt's temperature was 101.6F and took 2 Tylenol. On 11/8/99, at 12:24, the pt's temperature was 99.4F. At 15:30, the pt complained of severe headache and body ache, temperature was 99.3F and was given DCN twice a day per oral. At 16:25, the pt complained of headache being worse and body ache and was given DCN 100, 2 X a day. No additional information was received from follow-up correspondence returned on 12/6/99.  Follow up on 10/28/2002: "During internal review of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added medication error).  Case was upgraded to a 15-Day-Alert Report.  This case is closed."
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Difficulty in walking, Guillain-Barre syndrome, Muscular weakness, Nerve injury, Night sweats
Clinical narrative: Guillain Barre Syndrome, paralysis. Two days post vax, this pt developed Guillain Barre Syndrome and paralysis one week post vax. From additional information received on 09/23/99, the pt currently suffers from tingling in fingers and toes, weakness to hip flexors, due to nerve damage, and also suffers from night sweat. The pt stated that, "she suffered 3 months of paralysis post vax and recovered enough to walk without any help, but was unable to work more than 20 hours per week. Now the pt is to a point whereas she cannot walk at all." Pt stated that she has seen several doctors about her condition, but none could pinpoint or diagnosis her problem. Laboratory and diagnostic tests were done, but nothing significant was found. All values were within nml limits. The pt could not or would not provide physician information for follow-up with doctors whom she had seen. Pt also stated that the physicians that had seen feel as though her condition is related to the vax that she was given but this information could not be verified.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Paralysis, White blood cell count increased
Clinical narrative: Guillain Barre Syndrome, paralysis. Two days post vax, this pt developed Guillain Barre Syndrome and paralysis one week post vax. From additional information received on 09/23/99, the pt currently suffers from tingling in fingers and toes, weakness to hip flexors, due to nerve damage, and also suffers from night sweat. The pt stated that, "she suffered 3 months of paralysis post vax and recovered enough to walk without any help, but was unable to work more than 20 hours per week. Now the pt is to a point whereas she cannot walk at all." Pt stated that she has seen several doctors about her condition, but none could pinpoint or diagnosis her problem. Laboratory and diagnostic tests were done, but nothing significant was found. All values were within nml limits. The pt could not or would not provide physician information for follow-up with doctors whom she had seen. Pt also stated that the physicians that had seen feel as though her condition is related to the vax that she was given but this information could not be verified.
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site mass
Clinical narrative: It was reported that a female pt received vax on 09/16/99. Reportedly sometime post vax, the pt experienced a red bump at the injection site. From correspondence received on 03/20/00, it was reported that the pt recovered from this event.
Sex: M
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site pain, Pruritus
Clinical narrative: Injection site reaction, pruritus. It was reported that a male pt received vax on 09/16/1999. Reportedly sometime after the vax, the pt experienced a red raised bump at the injection site accompanied by itching and tenderness. From additional information received on 09/20/99, it was reported that the pt recovered from this experience.
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Urticaria, rash. It was reported that a female pt received vax on 09/02/99. Reportedly sometime after the vax, the pt experienced hives and rash over entire body.
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site pain
Clinical narrative: Pain, injection site reaction. It was reported that a female pt received vax on 09/09/1999. Reportedly sometime post vax, the pt experienced redness and pain down arm at the injection site. From additional information received on 09/20/99, it was reported that the pt recovered from the experience.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Lymphadenopathy, Lymphoma
Clinical narrative: Face edema, lymphedema.  It was reported that a female pt received vax in 10/1999. Reportedly 4 days post vax, the pt experienced facial swelling and swollen lymph nodes. The pt was seen by an infectious disease doctor and had a biopsy done on one of the lymph nodes, the report was lymphoma. The pt was seen by an oncologist and went through chemotherapy. From additional information received on 10/04/99, it was reported that the pt recovered from the experience. As of 04/10/00, reported, 'Reviewed, no additional information at this time...' per physician.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dysphonia, Dyspnoea, Pharyngeal oedema, Swelling face
Clinical narrative: Duplicate report in system is U19990799. It was reported that a 40-year-old female received vax on 09/29/1999. Approximately 10 minutes post vax, the pt experienced an acute anaphylactic reaction. She was treated in the office and went home. Additional information received 10/04/99 includes pt information, timing of events, illness at time of vax and responsible physician information. It was reported that she received vax and within 20 minutes experienced 'throat swelling, swelling lips, horse voice, shaky (shakiness) and shortness of breath.' Pt received 9% NS IV, Benadryl 50mg, oxygen, Epi .4, breathing treatment of Albuterol and Solu-Medrol 125mg. Pt recovered completely.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Duplicate report in system is U19990799. It was reported that a 40-year-old female received vax on 09/29/1999. Approximately 10 minutes post vax, the pt experienced an acute anaphylactic reaction. She was treated in the office and went home. Additional information received 10/04/99 includes pt information, timing of events, illness at time of vax and responsible physician information. It was reported that she received vax and within 20 minutes experienced 'throat swelling, swelling lips, horse voice, shaky (shakiness) and shortness of breath.' Pt received 9% NS IV, Benadryl 50mg, oxygen, Epi .4, breathing treatment of Albuterol and Solu-Medrol 125mg. Pt recovered completely.
Age: 38.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Chest discomfort, Cough, Dysphonia, Pharyngeal oedema
Clinical narrative: Laryngismus. A duplicate report is in system: U1999-00797. This report is the original. It was reported that a 38-year-old female received vaxs on 09/30/99. Reportedly 2 hours post vax, the pt felt as though her throat was closing. She reported was seen in the office and was treated with steroids. Information received states that 5 hours post vax, this pt experienced a 'hoarse voice, swelling of the throat and coughing. Pt was given Solu-Medrol 125mg and breathing treatment of Albuterol and Atrovent.' She also  experienced chest tightness. The pt recovered completely.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever, chills, myalgia. This pt received vax in an unspecified deltoid and within 4 hours post vax, experienced low-grade fever, chills and myalgia. The pt recovered.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever, Chills, Myalgia. It was reported that this female pt received vax in an unspecified deltoid and within 4 hours post vax, experienced a low-grade fever, chills and myalgia. She recovered.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: It was reported that a 54 year old female received Fluzone SV '99-'00 on 9/29/99. Three days later, the pt developed a severe headache. No further information is available at this time. From additional information received on 11/10/99, it was reported that the "pt denied consent". Additional pt and responsible physician information was also provided.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: It was reported that a 26 year old female received a Fluzone SV '99-'00 vaccination on 10/4/99. Reportedly, sometime after the vaccination, the pt experienced a local reaction of redness and swelling along with itching at the injection site.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Paraesthesia
Clinical narrative: It was reported that a female received Fluzone WV (U0067AA) on 10/06/99. The same day, she experienced "a large local reaction consisting of redness, swelling, inflammation and tingling ins her arm". The pt was evaluated on 10/7/00. No further information at this time. Additional information received on 11/8/99, includes the pt's information, medication, medical history and vaccine administrator's information. It was also reported that the pt has recovered.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: It was reported that a 70 year old female received Fluzone SV '99-'00 vaccination on 10/6/99. On 10/8/99, the pt experienced a "local reaction of redness, swelling and soreness". No further information is available at this time. From correspondence received on 5/2/00, it was reported that the pt recovered from this experience. No further information available regarding this pt or this case. This case is closed.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypersensitivity, Injection site pain, Pleuritic pain
Clinical narrative: It was reported that a 47 year old female received Fluzone SV '99-'00 vaccination on 10/4/99, at 07:30. "Four hours after she began to experience pain at her left deltoid, which radiated over cap of shoulder and down axilla. It felt like a fractured rib with deep breathing and was difficult to breathe for 72 hours." On 10/8/99, the pt was "feeling 100 % recovered". No treatment was given. No additional information was provided from follow-up correspondence request.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Dizziness, Fatigue, Flushing, Headache
Clinical narrative: It was reported that a 54 year old female pt received a Fluzone UNSP '99-'00 vaccination on 10/15/99. Reportedly, within 2 hours, post vax, the pt experienced headache, achiness, fatigue and nausea. Placed on Phenergan for nausea. Pt was out of work and in bed. One week later, still feeling nausea, lightheaded and loss of appetite. Also experienced flushing across chest and up neck. Pt is on Premarin from hysterectomy but has not had this flushing before. (**A lot number was provided (4928136415) was determined to be an Aventis Pasteur, Inc. Fluzone product code.)