chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral
Clinical narrative: Within 20 minutes post vax the pt developed a golf ball sized swelling of his elbow. The swelling was reported to be an allergic reaction. As of 3 day post vax the swelling persisted. Pt is being seen by a specialist.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Muscular weakness
Clinical narrative: A few days post vax, pt developed weakness in her arms and legs, muscle aches and malaise. The pt felt slower with not much stamina.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site haemorrhage, Injection site oedema
Clinical narrative: Subsequent to inadvertently receiving Flu Shield subcutaneous, the pt developed swelling and bruising at the injection site. One day post vax a diagnosis of cellulitis was made and the pt was treated with Keflex.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia
Clinical narrative: Subsequent to receiving vaccine pt developed pain and tingling in the lower arm. Pt was seen in the ER and was told by the attending physician that it was probably due to the administration technique. He sated that the vax may have been administered into her bursa.
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Skin discolouration
Clinical narrative: Subsequent to receiving vax, pt developed an injection site reaction characterized by hypopigmentation, adipose changes, induration in which 2 fingers can fit and an area of swelling the size of an orange.
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Subsequent to receiving vax, pt developed numbness and tingling of her hands and feet lasting for 3 months.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Joint swelling, Pain
Clinical narrative: Approximately 4 months post vax, this pt experienced chills, aches, and swollen joints. Pt was seen in the ER and indicated that she had experienced those symptoms for "some time."
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Muscular weakness
Clinical narrative: Subsequent to receiving vax, pt developed muscle cramps and weakness.
Age: 1.8
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Dyspnoea
Clinical narrative: Subsequent to receiving second dose of influenza virus vaccine pt developed difficulty breathing and abdominal pain. Pt was treated with Benadryl and the symptoms resolved.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pneumonia, Red blood cell count decreased, White blood cell count increased
Clinical narrative: Subsequent to receiving flu vaccine, pt developed pneumonia. Laboratory tests revealed an elevated white blood cell count and a decreased red blood cell count. A chest x-ray revealed pneumonia.
Sex: U
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: Subsequent to receiving vax, the pt was diagnosed with influenza A virus infection confirmed by nasal swab.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Subsequent to receiving the vaccine, pt developed injection site pain described as tender, and she developed severely decreased range of motion in her arm. She was seen by the employee physician.
Age: 25.0
Sex: M
Vaccine: TD
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Pt inadvertently received a subcutaneous injection of Tetanus and Diptheria Toxoids Adsorbed, Purogenated instead of PPD. The pt developed an erythematous wheel at the injection site. The pt reportedly popped it like a pimple and then had a 3mm scab. The pt reported that the injection site was scarred.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Condition aggravated, Difficulty in walking, Gait disturbance, Muscular weakness, Pain
Clinical narrative: Within minutes of receiving vax pt experienced tingling in her left arm which then moved to her left leg. Pt stated that the tingling localized in her left leg at the site of a previous injury and that she experienced pain in this area. Pt was unable to walk for a couple of days due to pain and then needed a cane for a couple of weeks. She stated that her leg is now weaker and that experiences pain in the area of a previous injury and that her pre-existing limp is now more pronounced.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Paraesthesia
Clinical narrative: Within minutes of receiving vax pt experienced tingling in her left arm which then moved to her left leg. Pt stated that the tingling localized in her left leg at the site of a previous injury and that she experienced pain in this area. Pt was unable to walk for a couple of days due to pain and then needed a cane for a couple of weeks. She stated that her leg is now weaker and that experiences pain in the area of a previous injury and that her pre-existing limp is now more pronounced.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Injury, Malaise, Nausea, Vomiting
Clinical narrative: Pt was treated in the ER following abrasions and contusions sustained to her forehead. Pt received injection at that time. Two days post vax the pt developed nausea and vomiting and felt weird. She was diagnosed with a drug reaction and recovered.
Age: 54.0
Sex: M
Vaccine: TD
Symptoms: Agitation, Emotional disorder, Flushing, Lethargy, Pruritus
Clinical narrative: Two days post vax pt was found in his bed very lethargic and withdrawn. Pt developed a bright red flush covering entire body. Within one hour he experienced sever itching and agitation. Pt was seen in the ER and treated with Benadryl.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Cold sweat, Fatigue, Hyperhidrosis, Pain, Swelling face
Clinical narrative: Subsequent to receiving vax, pt experienced generalized achiness, projectile vomiting, clamminess, sweating, fatigue and generalized puffiness. Her face and hands were especially puffy. She was seen by her physician and treated with acetaminophen.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Vomiting
Clinical narrative: Subsequent to receiving vax, pt experienced generalized achiness, projectile vomiting, clamminess, sweating, fatigue and generalized puffiness. Her face and hands were especially puffy. She was seen by her physician and treated with acetaminophen.
Sex: U
Vaccine: TD
Symptoms: Injection site oedema
Clinical narrative: Within two days post vax, pt developed swelling at the injection site.
Sex: U
Vaccine: TD
Symptoms: Injection site oedema, Musculoskeletal stiffness
Clinical narrative: 4 days post vax pt developed swelling at the injection site and neck stiffness.
Sex: U
Vaccine: TD
Symptoms: Unevaluable event
Clinical narrative: Within days of receiving vax, the pt developed an adverse experience which was not stated.
Sex: U
Vaccine: TD
Symptoms: Nonspecific reaction
Clinical narrative: Pharmacist reported that subsequent to receiving vax pt had an unspecified adverse experience.
Age: 72.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Difficulty in walking, Neck pain, Pain
Clinical narrative: Subsequent to receiving vax, pt developed profound pain in her arm, posterior neck, lower back and experienced difficulty walking. Pt was treated with Lodine which brought intermittent relief, however she feels worse in the morning.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Chills, Headache, Nausea, Pyrexia, Tremor
Clinical narrative: Within 5 hours post vax pt began to feel nauseated and had a fever of 99F. Pt was treated with Tylenol. An hour later her temperature increased to 102.8F and within 15 minutes had increased to 103.4. The physician treated the pt with Motrin, Tylenol and a lukewarm bath. The pt began shivering and shaking severely. At midnight her temperature was 103F. She was given more Tylenol while also continuing to be sponged down. One hour later her temperature was down to 101F. The next morning it was down to 99F. The next night at midnight she developed a severe headache and was treated with Tylenol. An hour later she was soaked. Lab work, blood work and CBC were all negative.
Age: 76.0
Sex: F
Vaccine: TD
Symptoms: Agitation, Dyspnoea, Erythema, Faecal incontinence, Urinary incontinence
Clinical narrative: Within 45 minutes of receiving vax, the pt developed a reddened face, vomiting, shortness of breath, moaning and incontinence of bladder and bowel. The pt was taken to the ER and treated with IV normal saline and Benadryl.
Age: 76.0
Sex: F
Vaccine: TD
Symptoms: Vomiting
Clinical narrative: Within 45 minutes of receiving vax, the pt developed a reddened face, vomiting, shortness of breath, moaning and incontinence of bladder and bowel. The pt was taken to the ER and treated with IV normal saline and Benadryl.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Feeling cold, Hyperhidrosis, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Within 12 hours he developed vomiting, cold sweats, an injection site reaction characterized by redness, swelling and warmth and a fever which lasted 4 days.  The injection site reaction an 4 inch area in diameter remained reddened, swollen and hot to touch.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Pyrexia, Vomiting
Clinical narrative: Within 12 hours he developed vomiting, cold sweats, an injection site reaction characterized by redness, swelling and warmth and a fever which lasted 4 days.  The injection site reaction an 4 inch area in diameter remained reddened, swollen and hot to touch.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site oedema, Pain, Pruritus
Clinical narrative: Pt developed an injection site reaction characterized by redness, swelling and itching. She also experienced pain under that arm.
Age: 43.0
Sex: M
Vaccine: TD
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: One day post vax the pt developed a fever of 101F and swelling at the injection site which extended to the wrist and was described as pitting. The left arm was 1.5 times it usual size. The fever resolved within two days.
Age: 41.0
Sex: M
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site oedema, Pyrexia, Vasodilation procedure
Clinical narrative: One day post vax the pt developed a low grade fever and an injection site reaction characterized by redness, swelling and warmth.  Pt was treated with Benadryl and cold packs.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Pt developed an injection site reaction with pain radiating down the arm and weakness of the arm. Follow up states patient recovered.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site oedema, Pyrexia
Clinical narrative: Two days post vax the pt developed a low grade fever and an injection site reaction characterized by redness and swelling. Pt was treated with Benadryl and cold packs.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site oedema, Vasodilation procedure
Clinical narrative: One day post vax the pt developed an injection site reaction characterized by redness, swelling and warmth. Pt was treated with Benadryl and cold packs.
Sex: U
Vaccine: TD
Symptoms: Infection, Injection site reaction
Clinical narrative: Subsequent to receiving vax, pt developed a local reaction that appeared to be infected. Additional information has been requested.
Sex: U
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Subsequent to receiving vax, pt developed an injection site reaction characterized by an area of redness, pain and swelling ranging in size from a half dollar to a softball.
Age: 76.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain
Clinical narrative: Subsequent to receiving vax, pt developed pain at the injection site. After injecting the pt the reporter noticed very small white particular matter suspended within the solution. The reported indicated that it was the first time the vial was entered and that other vials from the same lot appeared to be fine. An attempt to resuspend the particles back into the solution was unsuccessful. The reporter does not believe the vial was ever frozen. Follow up information states the patient recovered.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Injection site rash, Pruritus
Clinical narrative: One day post vax the pt developed an injection site reaction characterized by itching, rash and a wheel. Pt refused medication for treatment and was slowly recovering. Follow up states the patient recovered.
Age: 49.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Within 30 minutes of vax, pt developed a headache with the sensation of increased pressure in his head, burning sensation on his tongue, joint pain and muscle pain. Pt was seen in the ER and treated with antihistamines. His symptoms persisted as of 10/01/1999.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Rash
Clinical narrative: Four days post vax pt developed an injection site reaction characterized by an itchy rash. Pt was treated with steroids, anti-inflammatories and a topical cortisone cream. Follow up states patient recovered.
Sex: F
Vaccine: TD
Symptoms: Chest discomfort, Headache, Pain, Pyrexia
Clinical narrative: 2 hours post vax pt developed a headache, fever of 102F, aches and pains and chest tightness. Pt was treated with Benadryl, Demoral and Phenergan.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Subsequent to receiving vax, pt developed an injection site reaction characterized by redness and swelling described as ranging from quarter size to golf ball size.
Age: 64.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: two days post vax pt developed an injection site reaction characterized by erythema and tenderness, and a fever. The reporter indicated that the vaccine was partially frozen at the time of administration.
Sex: F
Vaccine: TD
Symptoms: Injection site mass, Similar reaction on previous exposure to drug
Clinical narrative: Subsequent to receiving vax pt developed a large lump at the injection site. Additional information indicated that the pt had a very large injection site reaction characterized by redness, swelling and warmth with her previous tetanus and diphtheria toxoid vaccine.
Age: 62.0
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Skin discolouration
Clinical narrative: Pt developed an injection site reaction characterized by an area of redness, swelling and purple discoloration 2 inches in diameter.
Age: 61.0
Sex: M
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site reaction
Clinical narrative: Two days post vax pt developed cellulitis characterized by a large, red area at and around the injection site.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Pain
Clinical narrative: One day post vax pt developed pain in her shoulder of the arm where the vaccine was injected. The pain radiated down her arm. The physician indicated that the event resembles a tendonitis type reaction.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction, Skin discolouration
Clinical narrative: One day post vax the pt developed an injection site reaction characterized by swelling, redness and tenderness. Additional information indicated that the pt developed some skin discoloration at the injection site and was treated with unspecified oral steroids for 4 days. The discoloration resolved within 2 months.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Injection site inflammation, Injection site mass, Injection site warmth, Injury
Clinical narrative: Pt received a Tetanus and Diphtheria Toxoids Adsorbed Purogenated for management of a lacerated finger and developed an injection site reaction characterized by induration, inflammation and warmth. The symptoms persisted six days post vax and the physician prescribed Duracef.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Within 24 hours pt developed an injection site reaction characterized by a 2 inch area of redness and slight tenderness which resolved within 4 days without treatment.
Sex: M
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: Subsequent to receiving vax, pt developed a severe injection site reaction.
Sex: F
Vaccine: TD
Symptoms: Injection site mass
Clinical narrative: A pt inadvertently received a subcutaneous injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated instead of PPD. The pt developed a huge knot the size of a fifty cent piece at the site of administration. Pt is being referred to a physician.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: One day post vax the pt developed an injection site reaction reaction characterized by redness, swelling and pain.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: One day post vax pt developed an injection site reaction characterized by redness and pain.
Age: 49.0
Sex: U
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: Subsequent to receiving Tetanus and Diphtheria Toxoids Adsorbed Purogenated pt developed an injection site reaction.
Sex: F
Vaccine: TD
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Subsequent to receiving Tetanus and Diphtheria Toxoids Absorbed Purogenated the pt developed an injection site reaction characterized by a small area of induration, pain and a hard knot.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain
Clinical narrative: Two hours post vax pt developed a deep burning and radiating pain at the injection site. The pain woke her up at night. Pt also has rotator cuff pain not related to the vaccine. Follow up states as of 01/19/2000 patient recovered.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Injection site oedema, Injection site pain, Lymphadenopathy, Pharyngitis, Sinusitis
Clinical narrative: 10 days post vax pt was seen for the treatment of tracheopharyngitis and sinusitis and complained of pain and swelling at the injection site. Physical examination revealed that the pt was afebrile and developed swelling in his axillary nodes. Follow up information received 04/11/2000 indicated patient recovered.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: Approximately one month post vax pt developed injection site reaction.
Sex: U
Vaccine: TD
Symptoms: Erythema multiforme
Clinical narrative: Subsequent to receiving Tetanus and Diphtheria Toxoids Adsorbed Purogenated pt developed erythema multiforme.
Sex: U
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: Subsequent to receiving either Tetanus and Diphtheria Toxoids Adsorbed or Tetanus Toxoid Adsorbed an inmate developed a local reaction.
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Hypersensitivity, Injection site reaction
Clinical narrative: Subsequent to receiving Tetanus and Diphtheria Toxoids Adsorbed Purogenated pt developed a severe injection site reaction which was diagnosed as possible a hypersensitivity to the preservative thimerosal contained in the vaccine.
Sex: U
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: Subsequent to receiving Tetanus and Diphtheria Toxoids Adsorbed Purogenated pt developed an injection site reaction on week post vax.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: One week subsequent to receiving Tetanus and Diphtheria Toxoids Adsorbed Purogenated pt developed an injection site reaction.
Sex: F
Vaccine: PNC
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: A consumer reported that her niece received an injection of Prevnar and subsequently developed a fever which persisted for 1 week and redness and swelling of both hands. The reporter declined to provide additional information and declined to grant permission for follow-up investigation.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Rash
Clinical narrative: A physician reported that a 9 month old male received an injection of Prevnar on 5/20/00. Two days later, he developed an allergic rash. He was treated with diphenhydramine and recovered within 2 days. This is 1 of 2 pts from this facility who experienced this event following receipt of Prevnar.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Rash
Clinical narrative: A physician reported that a 35 month old male received an injection of Prevnar on 5/10/00. Three days later, he developed an allergic rash. He was treated with diphenhydramine and recovered within 3 days. This is 1 of 2 patients form this facility who experienced this event following receipt of Prevnar.
Age: 2.6
Sex: F
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: A nurse reported that a 31 month old female received her first injection of Prevnar on 3/3/00. The child was also started on antibiotic therapy for "red ears" the same day that Prevnar was administered. A "couple" of days later, the pt developed hives. As of 3/8/00, the pt's symptoms were worsening.
Age: 2.0
Sex: U
Vaccine: PNC
Symptoms: Rash
Clinical narrative: A sales representative reported that a 2 year old child received an injection of Prevnar on 3/9/00. Later that day, the child developed a rash. The rash worsened and became generalized on 3/10/00. No further information was available at the date of this report.
Age: 2.5
Sex: F
Vaccine: PNC
Symptoms: Injection site mass, Injection site warmth, Rash
Clinical narrative: A sales representative reported that a 30 month old received an injection of Prevnar. On 3/10/00, following the vax, the pt developed a body rash from "head to toe." On the following day, the pt developed an injection site reaction, characterized as a hard, hot knot. Follow-up information received from the physician on 4/11/00 indicated the pt had received one previous dose of Prevnar. The pt recovered.
Age: 0.6
Sex: M
Vaccine: PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: A pharmacist reported that a 7 month old male received an injection of Prevnar on 4/1/00 or 4/2/00. Later that day he developed a fever of 101 and was "very fussy". He was taken to the ER. Blood cultures were negative. The infant recovered within 36 hours. No further information was available at the date of this report.
Sex: U
Vaccine: PNC
Symptoms: Injection site mass
Clinical narrative: A sales representative reported that a pt received an injection of Prevnar and subsequently developed a "pen-sized" lump at the injection site. The lump resolved after approximately 24 hours. No further information was available at the date of this report.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC
Symptoms: Injection site oedema, Injection site rash, Pyrexia
Clinical narrative: A sales representative reported that a 15 month old child received the first dose of Prevnar along with Act-Hib on 4/4/00. The following day, the child developed an injection site reaction characterized by redness, swelling and rash and a "low-grade" fever. The child was seen by the physician on 4/5/00 who prescribed applications of ice to the affected thigh. Additional information received from the physician on 5/2/00 supplied pt information and lot number. The reporter noted a change in the date of vaccine administration and onset of adverse events. Both sides of administration were in the left thigh.
Age: 0.8
Sex: M
Vaccine: PNC
Symptoms: Rash
Clinical narrative: A physician reported that a 10 month old male received his first injection of Prevnar on 3/31/00. The next day, he developed a pinpoint rash. The reporter indicated that the infant had a viral upper respiratory tract infection at the time of vaccination. He recovered.
Age: 1.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Urticaria
Clinical narrative: A physician reported that an 18 month old male received his first injection of Prevnar, as well as Acel-Imune vaccines on 4/6/00. The next day, he developed hives. He was treated with Benadryl and recovered.
Age: 1.0
Sex: U
Vaccine: HIBV, IPV, MMR, PNC
Symptoms: Pyrexia
Clinical narrative: A 12 month old received Prevnar, Hib-Titer, MMR, and IPV on 4/11/00. On 4/12/00, the pt developed a fever of 102 and 103. The pt was treated with Motrin and Tylenol. The pt recovered. This is 1 of 2 pts from this facility who experienced an adverse event following receipt of Prevnar. Copies of this report have been forwarded to Merck and Aventis Pasteur, manufacturers of the concomitantly administered vaccines.
Age: 0.8
Sex: M
Vaccine: PNC
Symptoms: Rash
Clinical narrative: The mother of a 10-month old male reported that her son received his first injection of Prevnar on 3/17/00. The next day he developed a red rash on his torso. He was treated wit Benadryl and recovered.
Age: 7.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: A 7 year old male received an injection of Prevnar into his left thigh on 4/19/00. Approximately 48 hours later, the pt developed swelling, redness and tenderness at the injection site. Additional info recieved on 6/8/00, from the reporter indicated that the child had a chronic allergy/asthma hisotry, and that the child recovered from the events.
Age: 0.5
Sex: U
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: A 6 month old received Prevnar, Acel-Imune, Hib-Titer and Engerix on 3/24/00 and the next day, developed urticaria. The pt was treated with Benadryl. The pt recovered. This is 1 of 2 patients from this facility who experienced an adverse event following receipt of Prevnar. A copy of this report has been forwarded to SKB, manufacturer of Engerix.
Age: 1.08
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt developed an injection site reaction at the site of the Prevnar shot and was seen by the physician on 4/22/00. The physician noted an area of redness measuring 1.5cm in diameter and induration measuring 2cm in diameter at the Prevnar injection site. The infant's parents were instructed to apply warm and moist compresses to the Prevnar site. The infant recovered. Follow up info received on 7/5/00 provided the pt's full name.
Age: 2.9
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A physician reported that a 35 month old female received Prevnar on 4/28/2000. On 4/29/2000, the pt developed an injection site reaction characterized by swelling and redness. Additional info received from the physician on 6/28/00 indicated that the pt recovered.
Sex: U
Vaccine: PNC
Symptoms: Upper respiratory tract infection, Vomiting
Clinical narrative: A company representative reported that a child received an injection of Prevnar and subsequently, developed vomiting and symptoms of an URI. The vomiting persisted for 3 days. No further information was available at the time of this report.
Age: 0.25
Sex: M
Vaccine: IPV, PNC
Symptoms: Somnolence
Clinical narrative: A nurse reported that a 3 month old male received Prevnar and IPV vaccines on 5/3/00 and since then, the infant has been sleeping "a lot more than normal, but is arousable." Follow up info received 6/13/00 indicated that the infant recovered.
Sex: U
Vaccine: PNC
Symptoms: Injection site swelling
Clinical narrative: A pharmacist reported that a pt received Prevnar and subsequently developed swelling at the injection site. The pt was taken to ER. No further information was available at the date of this report.
Age: 0.2
Sex: U
Vaccine: PNC
Symptoms: Somnolence
Clinical narrative: A 2 month old child received their first dose of Prevnar in May, 2000. The grandmother described the child as being "very" sleepy. The child kept their eyes closed while drinking it's bottle. The child was taken to the physician's office where they were found to be arrousable and alert.
Age: 1.6
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: A nurse reported that a 19 month old male received his 1st dose of Prevnar on 4/26/2000 and that same day, developed an injection site reaction characterized by a 10.5cm by 9cm area of redness, induration and inflammation. Additional info received on 7/5/00 indicated that the pt was seen by the physician on 4/28/00 "when above measurements were taken. Child without limp." He recovered. The pt had a history of frequent otitis media with placement of PE tubes.
Age: 2.2
Sex: U
Vaccine: PNC
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: A physician reported that a 26 month old pt received Prevnar on 5/10/2000. On 5/12/2000, the pt developed an injection site reaction characterized by an area of redness and warmth "the size of a fist".
Sex: U
Vaccine: PNC
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A nurse reported that a child received Prevnar and within 24 hours, post vax, developed an injection site reaction characterized by redness, swelling, warmth and pain. No further information was available at the date of this report.
Sex: U
Vaccine: PNC
Symptoms: Injection site swelling
Clinical narrative: A nurse reported that 70% of children who received their 1st dose of Prevnar at this facility developed injection site reactions described as "ugly and the size of an egg." The children recovered after 1 week. No further information was available at the date of this report.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Diarrhoea, Febrile convulsion, Hypersensitivity
Clinical narrative: Post vax, that evening, child developed fever of 102.6F. He was seen in the ER and experienced a seizure. The pt was observed in the ER for several hours where a dx of "febrile seizure vs Prevnar reaction" was made. He was discharged from the ER; his diarrhea persisted and he was prescribed Tylenol for his fever. The reporter indicated that his brother developed fever and diarrhea; however, he was not immunized with Prevnar.
Age: 7.0
Sex: M
Vaccine: PNC
Symptoms: Injection site swelling
Clinical narrative: A company representative reported that a 7 year old male received Prevnar in April, 2000. The child, subsequently, developed swelling at the site of the Prevnar injection that extended from his shoulder to his elbow. The child was treated with diphenhydramine and recovered.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Pyrexia, Somnolence, Vomiting
Clinical narrative: A nurse reported that a 9 month old male received an injection of Prevnar on 5/20/00. "Soon after" immunization, the infant developed fever, vomiting, and drowsiness. These symptoms persisted as of 5/22/2000. Follow up info received 6/21/00 indicated that the infant was immunized on 5/19/00; fever, vomiting and drowsiness began approximately 4 hrs post-immunization. The infant recovered.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Diarrhoea, Gastroenteritis
Clinical narrative: A nurse reported that her 6 month old daughter received Prevnar, Hib-Titer and DTAP vaccines on 5/19/00. The next morning, the pt developed diarrhea which persisted and the pt was seen by the physician on 5/21/00. He reportedly dx'd "the stomach flu" and prescribed no treatment. Hourly episodes of diarrhea persisted on 5/22/00. Follow up info received from the vaccine provider on 6/13/00 indicated that a stool culture was negative. The infant recovered.
Age: 0.75
Sex: F
Vaccine: HEP, PNC
Symptoms: Convulsion, Pyrexia, White blood cell count increased
Clinical narrative: A physician reported that a 9 month old female received Prevnar and Hep-B vaccines on 5/22/00. Sixteen hours, post vax, the infant developed a fever up to 102.3F. Twenty hours, post vax, she developed a generalized tonic-clonic seizure lasting 1 to 2 minutes. The fever resolved within 2 hours of the seizure. The reporter noted that the infant was well within 24 hours and that the seizure did not reoccur.
Age: 31.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: starting 10NOV92 have had hives every evening (mod to severe cases); no resp involvement just itching;
Age: 0.2
Sex: F
Vaccine: DTPHIB, OPV, DTPHIB, OPV
Symptoms: Apnoea, Dysphagia, Gaze palsy, Hyperkinesia, Vomiting
Clinical narrative: 2hr post vax pt was noted to be choking & gagging, eyes rolled back, arms & legs were moving about;thought to be apneic (was nl);EEG in hosp w/in 24hr was nl;reflux & gagging requiring apnea monitor;
Age: 1.4
Sex: F
Vaccine: HIBV, HIBV, HIBV
Symptoms: Injection site hypersensitivity, Injection site inflammation, Vasodilatation
Clinical narrative: p/vax pt rt thigh red; inflamed; warm to touch; spread from mid thigh to knee; applied cold packs & given tylenol/advil
Age: 1.4
Sex: F
Vaccine: HIBV, HIBV, HIBV
Symptoms: Hypertonia, Injection site hypersensitivity, Injection site mass, Injection site reaction, Pyrexia
Clinical narrative: p/vax pt rt thigh red; inflamed; warm to touch; spread from mid thigh to knee; applied cold packs & given tylenol/advil
Age: 1.4
Sex: F
Vaccine: HIBV, HIBV, HIBV
Symptoms: Vasodilatation
Clinical narrative: p/vax pt rt thigh red; inflamed; warm to touch; spread from mid thigh to knee; applied cold packs & given tylenol/advil
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Apnoea, Cardiac arrest
Clinical narrative: p/vax in early morning 11/13/99 pt was found dead in crib;attempted resuscitation was unsuccessful;
Age: 1.25
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Anaphylactic reaction, Respiratory distress
Clinical narrative: Pt developed edema, urticaria and was treated with Benadryl.
Age: 1.25
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Oedema, Urticaria
Clinical narrative: Pt developed edema, urticaria and was treated with Benadryl.
Sex: M
Vaccine: LYME
Symptoms: Amnesia, Anorexia, Arthralgia, Asthenia, Dizziness
Clinical narrative: On 2/24/99, the pt received the first injection with Lymerix, with no untoward effects. On 3/24/99, he received the second dose, and for the next six months he felt achy and tired but was able to work. It was reported by 9/99 he was noted to walk with a limp and appeared fatigued. It was reported he missed work on "numerous occasions" due to pain which traveled from joint to joint. He had painful stiffness trying to get out of bed. It was reported other symptoms that were experienced included memory loss, extreme fatigue, lack of appetite, weakness, dizziness, and headaches. It was reported walking was painful, to run impossible and he was not able to perform routine tasks at work. The pt consulted a rheumatologist and had blood work which was positive for the Lyme antibody but was negative for rheumatoid factor. The rheumatology differential diagnosis included "polyarthritis in the absence of synovitis, symmetry, and a negative rheumatoid factor. The pt was treated with diclofanao which apparently was effective. "which if he forgets his symptom return. It is unclear if the pt has had a stomach and liver disorder side effects. The pt started sucralfate for his stomach.  The most recent information received on 7/12/00 inferred the symptoms are controlled by Voltaren but are ongoing. Additional information has been requested.  The pt has been persistently incapacitated as he can not perform routine tasks at work.
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Gait disturbance, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: On 2/24/99, the pt received the first injection with Lymerix, with no untoward effects. On 3/24/99, he received the second dose, and for the next six months he felt achy and tired but was able to work. It was reported by 9/99 he was noted to walk with a limp and appeared fatigued. It was reported he missed work on "numerous occasions" due to pain which traveled from joint to joint. He had painful stiffness trying to get out of bed. It was reported other symptoms that were experienced included memory loss, extreme fatigue, lack of appetite, weakness, dizziness, and headaches. It was reported walking was painful, to run impossible and he was not able to perform routine tasks at work. The pt consulted a rheumatologist and had blood work which was positive for the Lyme antibody but was negative for rheumatoid factor. The rheumatology differential diagnosis included "polyarthritis in the absence of synovitis, symmetry, and a negative rheumatoid factor. The pt was treated with diclofanao which apparently was effective. "which if he forgets his symptom return. It is unclear if the pt has had a stomach and liver disorder side effects. The pt started sucralfate for his stomach.  The most recent information received on 7/12/00 inferred the symptoms are controlled by Voltaren but are ongoing. Additional information has been requested.  The pt has been persistently incapacitated as he can not perform routine tasks at work.
Sex: M
Vaccine: LYME
Symptoms: Polyarthritis
Clinical narrative: On 2/24/99, the pt received the first injection with Lymerix, with no untoward effects. On 3/24/99, he received the second dose, and for the next six months he felt achy and tired but was able to work. It was reported by 9/99 he was noted to walk with a limp and appeared fatigued. It was reported he missed work on "numerous occasions" due to pain which traveled from joint to joint. He had painful stiffness trying to get out of bed. It was reported other symptoms that were experienced included memory loss, extreme fatigue, lack of appetite, weakness, dizziness, and headaches. It was reported walking was painful, to run impossible and he was not able to perform routine tasks at work. The pt consulted a rheumatologist and had blood work which was positive for the Lyme antibody but was negative for rheumatoid factor. The rheumatology differential diagnosis included "polyarthritis in the absence of synovitis, symmetry, and a negative rheumatoid factor. The pt was treated with diclofanao which apparently was effective. "which if he forgets his symptom return. It is unclear if the pt has had a stomach and liver disorder side effects. The pt started sucralfate for his stomach.  The most recent information received on 7/12/00 inferred the symptoms are controlled by Voltaren but are ongoing. Additional information has been requested.  The pt has been persistently incapacitated as he can not perform routine tasks at work.
Age: 57.0
Sex: U
Vaccine: HEP
Symptoms: Dementia, Nervous system disorder
Clinical narrative: Information has been received from a pharmacist concerning a pt who in 1995 was vaccinated with one dose of Hep B vaccine. Subsequently this pt developed Jakob-Creutzfelds disease. The pt sought unspecified medical attention. Upon medical review, the pt's experience was considered an "other medical event." Additional information has been requested.  Follow-up information received on 7/31/00 states that the pt was vaccinated in approximately 1992 with hepatitis b vaccine. Soon after the vaccine, the pt developed accelerated dementia and was transferred to a nursing home, the hepatitis b vaccine was the only potential risk factor for this pt. Additionally the physician noted "did not think that a causal association between the pt's dementia and the vaccination was likely." A definitive diagnosis regarding Jakob-Creutzfeldt disease has not been determined. The physician also noted that the pt's neurologist at the nursing home will be doing a lumbar puncture to evaluate for Jakob-Creutzfeldt disease versus Huntington's disease. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: PNC, PNC
Symptoms: Leukocytoclastic vasculitis, Rash
Clinical narrative: Rash with small vessel type vasculitis on left thigh where shot was given, that progressed to left groin, left trunk, left axilla and left arm. These symptoms started 3 to 4 days, post vax.
Age: 1.5
Sex: F
Vaccine: PNC, PNC
Symptoms: Blister, Injection site oedema, Rash papular
Clinical narrative: Rash with small vessel type vasculitis on left thigh where shot was given, that progressed to left groin, left trunk, left axilla and left arm. These symptoms started 3 to 4 days, post vax.
Age: 1.5
Sex: F
Vaccine: IPV, PNC
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure, lasted about 15 seconds on 7/11/00; sent to ER. Temperature was 103.3 and was given Tylenol.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever to 102 X 24 hours.
Age: 0.7
Sex: F
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Acute urticaria
Age: 1.3
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Urticaria , 1" in diameter and erythema of 2" to 3" at site of injection. Faded after 20 minutes (only a small residual area of erythema).
Age: 35.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Feeling hot, Headache, Myalgia, Rash
Clinical narrative: The pt experienced severe, constant muscle and joint pain, headaches, hot hands, hot feet. 60 Day FU states still has pain in muscles and joints, weird rashes.
Age: 49.0
Sex: M
Vaccine: LYME
Symptoms: Unevaluable event
Clinical narrative: All relevant test/lab data should be available upon request from physicians. All medical releases are enclosed.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema peripheral, Skin nodule, Subcutaneous nodule
Clinical narrative: On 5/10/00, pt noticed a lump on bottom of left foot. On 6/18/00, he noticed bumps on head, under skin surface, bumps on bottoms of both feet with swelling and redness on feet and arms. Seemed to last 2 to 4 days.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Palpitations, Pruritus
Clinical narrative: Recurrent itching of hands, feet and legs. Recurrent heart palpitations, dizziness, fatigue, sleep disturbances, numbness and tingling in bilateral lower extremities. Symptoms started 1 1/2 years ago after initial injection. Has had total of 6 injections.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Sleep disorder
Clinical narrative: Recurrent itching of hands, feet and legs. Recurrent heart palpitations, dizziness, fatigue, sleep disturbances, numbness and tingling in bilateral lower extremities. Symptoms started 1 1/2 years ago after initial injection. Has had total of 6 injections.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Alopecia, Arthralgia, Fatigue
Clinical narrative: Patchy loss of facial hair after 1st shot Lot #FAV020, pain in elbows, feet and knees within the last 3 months (2/23/00) Lot #FAV024, daily extreme fatigue within the last 3 months, Lot #FAV024. Follow up 10/19/2000: "Patient did not recover from adverse events.  Loss of facial hair, lack of energy (chronic). Patient received further shots...EVENT: Increased facial hair loss with each injection."  Follow up 03/27/2001: "I am responding to numerous requestes for access to my medical records.  In my opinion access to these records is not warranted and is therefore denied.  The description of adverse reactions was described in my initial report, and the treatment for loss of my facial hair was hormone shots in the effected areas.  I only subjected myself to one of these painful treatments, since I am required by the Air Force to remain current on the vaccination, and I believe to be the cause of my problem.  I firmly believe that any adverse reaction to the vaccine, like the existence of "Gulf War Illness", will be denied.  Like Agent Orange, if there is ever any evidence of health problems from the vaccine it will be many years before anyone will see any help, so I don't see any point in continuing to pursue this matter.  Thank you for your concern in this matter."
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Anxiety, Joint stiffness, Nervousness, Pain in jaw, Respiratory rate increased
Clinical narrative: Tightening of jaw, stiffness in knees, back and neck. Increased breathing, general anxious or nervous feeling.
Age: 0.7
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Eye oedema, Face oedema, Oedema peripheral, Tongue oedema
Clinical narrative: Pt presented one day post vax with swollen eyes, upper lip and tongue and swollen hands.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Convulsion
Clinical narrative: The same day as vax, the pt experienced seizure activity.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash maculo-papular
Clinical narrative: Pt experienced mild pink colored maculopapular rash on mildly erythematous base over abdomen, left thigh and face approximately one week post vax.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Disorientation, Nausea, Pyrexia, Vomiting
Clinical narrative: Approximately 2 weeks post vax pt experienced high temperature, disorientation, nausea and vomiting. Pt evaluated and given Phenergan.
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Chest pain, Fatigue, Malaise, Pain
Clinical narrative: Pt experienced pain at right side, left chest and shoulder pain. Generalized fatigue and malaise.
Age: 0.9
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Unevaluable event
Clinical narrative: Pt received one more Hepatitis injection than necessary for a total of four injections.
Age: 1.6
Sex: M
Vaccine: DTAP, HEP, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Pt experienced induration and erythema, swollen right thigh. Pt was treated with Benadryl and Keflex.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Hypoventilation, Injection site erythema, Injection site reaction, Pyrexia, Tachycardia
Clinical narrative: Pt experienced irritation and erythema at injection site.
Age: 40.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Headache, Joint stiffness, Memory impairment, Muscle spasms
Clinical narrative: 3 weeks post vax pt began having daily chronic headaches, sore and stiff finger joint, shoulder joint pain, extreme light sensitivity, muscle cramps and muscle pain. Pt also experiencing severe forgetfulness and out of work on disability.
Age: 40.0
Sex: F
Vaccine: RAB
Symptoms: Myalgia, Visual disturbance
Clinical narrative: 3 weeks post vax pt began having daily chronic headaches, sore and stiff finger joint, shoulder joint pain, extreme light sensitivity, muscle cramps and muscle pain. Pt also experiencing severe forgetfulness and out of work on disability.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Approximately 20 minutes post vax, pt developed areas of redness about 10 cm in diameter. Pt was treated with Benadryl
Age: 1.7
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Trihib injected IM L deltoid, Upon returning to room to complete visit, noted unusual redden area at injection site, size of golf ball with small raised area. Notified doctor, who saw pt and advised to apply ice & observe pt. Epil 1.(?) mg for 1st kg ready at nurse's station. Mom informed of necessity to stay and informed of side effects. Pt returned after 1 hr and instructed to use Tylenol & Benadryl.
Age: 45.0
Sex: U
Vaccine: HEP
Symptoms: Muscular weakness, Osteonecrosis, Pain
Clinical narrative: Pain at time of injection that lasted 2-3 weeks. 8 months later, pain developed in right humerous that led to X-ray, bone biospy with dx of necrotic bone. 2 years later, pain continues. Repeated bone biopsy on 4/12/00 with a dx of necrotic bone. Continued pain and muscle weakness in right arm. Per doc 198038, annual follow up received on 08/23/2001: patient continues to have pain in Rt humerous, Rt shoulder. Pain has led to 2 shoulder scopes. Re biopsy of rt humerous showed necrosis. This event has led to the loss of patient's job, continuous pain even after multiple surgery.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Influenza like illness, Liver function test abnormal, Nausea, Pyrexia, White blood cell count increased
Clinical narrative: The pt experienced the onset of flu like symptoms 4 days post vax, with increased WBC and LFT. The pt was hospitalized for 3 days with a complete work up. The pt experienced a fever and nausea.