chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: TTOX
Symptoms: Cellulitis, Chest pain, Gait disturbance, Headache, Injection site erythema
Clinical narrative: From telephone contact received on 3/26/00, it was reported by a person who claims to be an RN who resides with the pt, that a dose of tetanus toxoid was administered on 2/19/02. On 2/20/02, the pt developed a large local reaction of redness, swelling and inflammation. Physician treated as a site infection with what she called Dicloxacillin 2GM's per day for 2 weeks. Over the course of several days, the pt experienced chest heaviness, headaches, unsteady gait, numbness in hands and feet and decreased sensation from her knees to her feet. Pt was taken to the ER, 6 times. Lab work of undisclosed nature, EKG, and  basic neurological exams were conducted. No neurological consult. Symptoms persist with etiology to be determined.
Age: 63.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site inflammation, Injection site swelling, Paraesthesia
Clinical narrative: From telephone contact received on 3/26/00, it was reported by a person who claims to be an RN who resides with the pt, that a dose of tetanus toxoid was administered on 2/19/02. On 2/20/02, the pt developed a large local reaction of redness, swelling and inflammation. Physician treated as a site infection with what she called Dicloxacillin 2GM's per day for 2 weeks. Over the course of several days, the pt experienced chest heaviness, headaches, unsteady gait, numbness in hands and feet and decreased sensation from her knees to her feet. Pt was taken to the ER, 6 times. Lab work of undisclosed nature, EKG, and  basic neurological exams were conducted. No neurological consult. Symptoms persist with etiology to be determined.
Sex: M
Vaccine: RAB
Symptoms: Headache, Muscle spasms, Neck pain
Clinical narrative: It was reported on 03/25/2002 from the pt it was reported that the pt, an adult male, received "a series of three shots for rabies vaccine." "In less than three years the pt experienced unbearable pain in the back of head and neck." Also developed "spasms and treated for spasms." From correspondence received, it was stated that the pt received pre-exposure rabies immunizations.
Age: 1.6
Sex: M
Vaccine: HIBV, PNC
Symptoms: Bacterial infection, Brain oedema, Bronchitis, Coma, Cyanosis
Clinical narrative: Administered 0.5cc of Prevnar, RT, IM and 0.5cc of Hib, LT, IM per doctor's orders. Per F/U 4/15/02: Group A Streptococcal Sepsis, tracheitis and bronchitis (chronic); cerebral edema with herniation of brain, temperal lobe; thymic petechiae; S/P attempted resuscitation; Blunt force injury of abdomen-laceration of the gastro-splenic ligament, avulsive, recent; retroperitoneal and perinephric hematoma, left (10ml), recent; hemoperitoneum (35ml); blunt force injury of right leg with contusion of thigh, small, organizing; child's abdominal injury is inconsistent with resuscitative efforts. The child was reportedly found unresponsive in his crib by his mother on 3/1/01 AM. She and the child's grandmother are reported to have initiated CPR and called for EMS. EMS found the decedent "unresponsive and cyanotic" at the scene and transported him to the ER. The child's body temperature (R) was measured at 107.9F at the ER.
Age: 1.6
Sex: M
Vaccine: HIBV, PNC
Symptoms: Gastrointestinal disorder, Haematoma, Injury, Nervous system disorder, Petechiae
Clinical narrative: Administered 0.5cc of Prevnar, RT, IM and 0.5cc of Hib, LT, IM per doctor's orders. Per F/U 4/15/02: Group A Streptococcal Sepsis, tracheitis and bronchitis (chronic); cerebral edema with herniation of brain, temperal lobe; thymic petechiae; S/P attempted resuscitation; Blunt force injury of abdomen-laceration of the gastro-splenic ligament, avulsive, recent; retroperitoneal and perinephric hematoma, left (10ml), recent; hemoperitoneum (35ml); blunt force injury of right leg with contusion of thigh, small, organizing; child's abdominal injury is inconsistent with resuscitative efforts. The child was reportedly found unresponsive in his crib by his mother on 3/1/01 AM. She and the child's grandmother are reported to have initiated CPR and called for EMS. EMS found the decedent "unresponsive and cyanotic" at the scene and transported him to the ER. The child's body temperature (R) was measured at 107.9F at the ER.
Age: 1.6
Sex: M
Vaccine: HIBV, PNC
Symptoms: Pyrexia, Renal disorder, Sepsis, Tracheitis, Upper respiratory tract infection
Clinical narrative: Administered 0.5cc of Prevnar, RT, IM and 0.5cc of Hib, LT, IM per doctor's orders. Per F/U 4/15/02: Group A Streptococcal Sepsis, tracheitis and bronchitis (chronic); cerebral edema with herniation of brain, temperal lobe; thymic petechiae; S/P attempted resuscitation; Blunt force injury of abdomen-laceration of the gastro-splenic ligament, avulsive, recent; retroperitoneal and perinephric hematoma, left (10ml), recent; hemoperitoneum (35ml); blunt force injury of right leg with contusion of thigh, small, organizing; child's abdominal injury is inconsistent with resuscitative efforts. The child was reportedly found unresponsive in his crib by his mother on 3/1/01 AM. She and the child's grandmother are reported to have initiated CPR and called for EMS. EMS found the decedent "unresponsive and cyanotic" at the scene and transported him to the ER. The child's body temperature (R) was measured at 107.9F at the ER.
Age: 2.5
Sex: U
Vaccine: HEPA, PNC, HEPA, PNC, HEPA, PNC
Symptoms: Ascites, Bacterial infection, CSF test abnormal, Cellulitis, Cyanosis
Clinical narrative: Per MD, persistent fever, 8 hours post vax. Decreased mobility on 11/4/01. Mosquito bite looking lesion on right lower leg. On 11/5/01, right lower leg discolored and swollen. To ER. On admit to ER, temperature 39.3C, tachycardia and right lower leg cyanotic, purpuric and cold below the knee. Only pulses present in right leg was femoral; others absent. Bleeding profusely from mucous membranes and puncture sites. Rapidly deteriorated and despite very aggressive CPR, reports child expired. Cause of death dx'd as toxic shock syndrome. Per F/U 4/29/02-Pathologic dxs cellulitis on the right lower extremity; petechial rash on the skin of the head, neck, torso and extremities, hospital blood cultures grouwing out beta-hemolytic Streptococcus Group A bacteria, Meningitis due to: Streptococcus pyogenes, Group A, Beta-hemolytic streptococcus; pulmonary congestion and edema; bilateral hydrothraces; ascites; eosinophilic gastroenteritis. COD: Septic Shock and Bacterial Meningitis due to bacteremia due to cellulitis.
Age: 2.5
Sex: U
Vaccine: HEPA, PNC, HEPA, PNC, HEPA, PNC
Symptoms: Feeling cold, Gastroenteritis, Haemorrhage, Hypokinesia, Oedema peripheral
Clinical narrative: Per MD, persistent fever, 8 hours post vax. Decreased mobility on 11/4/01. Mosquito bite looking lesion on right lower leg. On 11/5/01, right lower leg discolored and swollen. To ER. On admit to ER, temperature 39.3C, tachycardia and right lower leg cyanotic, purpuric and cold below the knee. Only pulses present in right leg was femoral; others absent. Bleeding profusely from mucous membranes and puncture sites. Rapidly deteriorated and despite very aggressive CPR, reports child expired. Cause of death dx'd as toxic shock syndrome. Per F/U 4/29/02-Pathologic dxs cellulitis on the right lower extremity; petechial rash on the skin of the head, neck, torso and extremities, hospital blood cultures grouwing out beta-hemolytic Streptococcus Group A bacteria, Meningitis due to: Streptococcus pyogenes, Group A, Beta-hemolytic streptococcus; pulmonary congestion and edema; bilateral hydrothraces; ascites; eosinophilic gastroenteritis. COD: Septic Shock and Bacterial Meningitis due to bacteremia due to cellulitis.
Age: 2.5
Sex: U
Vaccine: HEPA, PNC, HEPA, PNC, HEPA, PNC
Symptoms: Pulmonary congestion, Pulmonary oedema, Purpura, Pyrexia, Skin discolouration
Clinical narrative: Per MD, persistent fever, 8 hours post vax. Decreased mobility on 11/4/01. Mosquito bite looking lesion on right lower leg. On 11/5/01, right lower leg discolored and swollen. To ER. On admit to ER, temperature 39.3C, tachycardia and right lower leg cyanotic, purpuric and cold below the knee. Only pulses present in right leg was femoral; others absent. Bleeding profusely from mucous membranes and puncture sites. Rapidly deteriorated and despite very aggressive CPR, reports child expired. Cause of death dx'd as toxic shock syndrome. Per F/U 4/29/02-Pathologic dxs cellulitis on the right lower extremity; petechial rash on the skin of the head, neck, torso and extremities, hospital blood cultures grouwing out beta-hemolytic Streptococcus Group A bacteria, Meningitis due to: Streptococcus pyogenes, Group A, Beta-hemolytic streptococcus; pulmonary congestion and edema; bilateral hydrothraces; ascites; eosinophilic gastroenteritis. COD: Septic Shock and Bacterial Meningitis due to bacteremia due to cellulitis.
Age: 2.5
Sex: U
Vaccine: HEPA, PNC, HEPA, PNC, HEPA, PNC
Symptoms: Skin ulcer, Tachycardia, Toxic shock syndrome
Clinical narrative: Per MD, persistent fever, 8 hours post vax. Decreased mobility on 11/4/01. Mosquito bite looking lesion on right lower leg. On 11/5/01, right lower leg discolored and swollen. To ER. On admit to ER, temperature 39.3C, tachycardia and right lower leg cyanotic, purpuric and cold below the knee. Only pulses present in right leg was femoral; others absent. Bleeding profusely from mucous membranes and puncture sites. Rapidly deteriorated and despite very aggressive CPR, reports child expired. Cause of death dx'd as toxic shock syndrome. Per F/U 4/29/02-Pathologic dxs cellulitis on the right lower extremity; petechial rash on the skin of the head, neck, torso and extremities, hospital blood cultures grouwing out beta-hemolytic Streptococcus Group A bacteria, Meningitis due to: Streptococcus pyogenes, Group A, Beta-hemolytic streptococcus; pulmonary congestion and edema; bilateral hydrothraces; ascites; eosinophilic gastroenteritis. COD: Septic Shock and Bacterial Meningitis due to bacteremia due to cellulitis.
Age: 2.5
Sex: U
Vaccine: HEPA, PNC, HEPA, PNC, HEPA, PNC
Symptoms: Malaise
Clinical narrative: Per MD, persistent fever, 8 hours post vax. Decreased mobility on 11/4/01. Mosquito bite looking lesion on right lower leg. On 11/5/01, right lower leg discolored and swollen. To ER. On admit to ER, temperature 39.3C, tachycardia and right lower leg cyanotic, purpuric and cold below the knee. Only pulses present in right leg was femoral; others absent. Bleeding profusely from mucous membranes and puncture sites. Rapidly deteriorated and despite very aggressive CPR, reports child expired. Cause of death dx'd as toxic shock syndrome. Per F/U 4/29/02-Pathologic dxs cellulitis on the right lower extremity; petechial rash on the skin of the head, neck, torso and extremities, hospital blood cultures grouwing out beta-hemolytic Streptococcus Group A bacteria, Meningitis due to: Streptococcus pyogenes, Group A, Beta-hemolytic streptococcus; pulmonary congestion and edema; bilateral hydrothraces; ascites; eosinophilic gastroenteritis. COD: Septic Shock and Bacterial Meningitis due to bacteremia due to cellulitis.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Antisocial behaviour, Aphasia, Autism, Neurodevelopmental disorder
Clinical narrative: My son lost all of his speech at around 18 months and started to withdraw from social interactions with everyone except me, his mother. By 27/28 months, he was diagnosed PDD NOS (pervasive developmental delay). He was developing normally prior to MMR. On annual report received 04/22/2003, mother states, "I have contracted a law firm to follow up with the vaccine caused damage done to my son".
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Meningitis, Pigmentation disorder, Pleocytosis, Retinitis
Clinical narrative: Acute posterior multi-focal placoid pigment epitheliopathy with minor inflammation (aseptic) meningitis; nearly complete recovery of vision.
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, IPV, RV
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: The pt presented with intractable seizures of unknown etiology. She has been treated by neurologists and other therapists at different hospitals.
Age: 1.08
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Aphasia, Cognitive disorder, Gastrointestinal disorder, Impaired healing, Neurodevelopmental disorder
Clinical narrative: The pt developed light/sound sensitivity, motor/vestibular/proprioceptive difficulties, lost speech, cognitive dysfunction, GI disturbances. Also it is stated that the pt received 237.5 mcg of Hg from 02/08/1998 to 03/15/1999 which exceeds federal safety limits. The pt is being tested for mercury (DMSA challenge). Profound developmental delay.
Age: 1.08
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Photophobia
Clinical narrative: The pt developed light/sound sensitivity, motor/vestibular/proprioceptive difficulties, lost speech, cognitive dysfunction, GI disturbances. Also it is stated that the pt received 237.5 mcg of Hg from 02/08/1998 to 03/15/1999 which exceeds federal safety limits. The pt is being tested for mercury (DMSA challenge). Profound developmental delay.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Left deltoid erythema and warmth following administration on 01/27/2002.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Skin ulcer
Clinical narrative: Child received Varivax 2-1-01. On 10/1/01, child broke out in "full blown" case of chickenpox per mother. Child was taken to PP for verification.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Dyskinesia, Eye movement disorder, Musculoskeletal stiffness, Somnolence
Clinical narrative: Single seizure lasting about 15 mins. "Body stiffened, arms and legs were jerky and eyes went in different directions," and sleepy afterwards.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Hives covering body,Benadryl 1 tsp every 406 hours
Age: 44.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Injection site erythema, Injection site hypersensitivity, Injection site inflammation, Injection site reaction
Clinical narrative: The pt developed a local reaction (quarter in size) to left upper arm where the vaccine was given. Hot, red and tender to the touch, systemic-complaints of general malaise, aches, nausea and chills, Afebrile.
Age: 44.0
Sex: F
Vaccine: ANTH
Symptoms: Malaise, Nausea, Pain
Clinical narrative: The pt developed a local reaction (quarter in size) to left upper arm where the vaccine was given. Hot, red and tender to the touch, systemic-complaints of general malaise, aches, nausea and chills, Afebrile.
Age: 0.92
Sex: M
Vaccine: FLU3, HBHEPB, PNC, VARCEL
Symptoms: Skin ulcer
Clinical narrative: Vaccinated with Varivax on 11/29/01. Developed chicken pox on 3/30/2002
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Eye swelling, Lethargy, Rash pruritic, Swelling
Clinical narrative: This reports concern a 65 years old male pt who experienced swollen eyes, itchy rash, swollen lips, temperature elevation and lethargy after receiving the fluvirin vaccination on 11/13/2001. On 11/13/2001, the pt received the Fluvirin vaccination and on 11/14/2001 he developed the symptoms mentioned earlier which lasted 5 days. On 11/14/2001, the pt was administered 10mg Loratadine for 7 days to treat his symptoms. The pt recovered on 11/19/2001. There was insufficient info to determine the reporter's causality assessment. Following internal review on 03/18/2002, this event was upgraded to serious.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site warmth, Pruritus
Clinical narrative: 10.5 X 13 erythema on right thigh, Warm to touch, itches. Recommended use of Benadryl, warm compresses, to call if worsens
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Vomiting
Clinical narrative: The pt complained of severe headache and vomited four times approx. 3hrs after initial injection was given.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site reaction
Clinical narrative: Soft, red 33mm x 55mm tender area noted on 04/05/2002 when the pt came for PPD reading. Mother was told to apply ice and to give Tylenol for the symptoms.
Age: 1.2
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Malaise, Rash vesicular
Clinical narrative: Three weeks after varivax, the pt became ill with varicella rash about 30-40 spots. Mom not sure about fever.
Age: 1.2
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Skin ulcer
Clinical narrative: Broke out with chickenpox in 4-4-02
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Coma, Crying, Febrile convulsion, Pyrexia, Staring
Clinical narrative: At 12:35am, mom finds infant in crib starring up on ceiling, temp 103 deg. F., not responding normally, "awake but out of it." This episode lasted 5-15 mins during which called physician and was instructed to put baby in bath and child began crying. Mom had omitted pm dose of Motrin. Gave Tylenol and Motrin as directed. At 1am, the pt responding normally, temp went down. At 7am, slept with parents. Temp remains off and on with use of Tylenol. At 1pm the next day, the pt was seen by a physician and he felt that the child had a "febrile seizure."
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Deep aching pain@site of injection commencing @ time of injection (into left deltoid) on 10/26/00. Left arm movement restricted-unable to raise left arm to shoulder height without deep aching pain. Left deltoid seemed to improve somewhat over time, but for past six weeks symptoms increased. Left arm movement restricted by pain
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site reaction
Clinical narrative: Significant local reaction
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction
Clinical narrative: Significant local reaction.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Injection site reaction
Clinical narrative: Significant local reaction.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Had chicken pox rash about 2 years after varivax.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Had chicken pox rash
Age: 3.5
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Chicken pox rash about 14 months after shot.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema
Clinical narrative: Mother reported redness on injection site beginning and noticed it the day after injection. No fever, pain or limp. Seen in office on 4/3/02; erythema, mild edema left anterior thigh. No tenderness or temperature. Dx'd with inflammation. Warm soak and Benadryl.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: On 3/21/02, telephone call from parent, noticed an area on left arm at area of MMR, today, an irregular rash area and slight swelling. Advised it may be a localized reaction. Can apply cool compresses but if it does not subside in a few days, to consult PMD. On 3/29/02, telephone call. She states that the rash-type redness on left arm lasted to about 3/23/02 and then subsided.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: Rash started on 4/2/02. Not as active, low-grade fever, acts ill but not toxic. Observe.
Age: 74.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Hypokinesia, Nerve compression, Pain, Rash, Tendon disorder
Clinical narrative: Shot administered on 12/13/01. The pt developed bilateral shoulder pain, though to be due to underlying impingement syndrome. The pt called the MD's office and was told to take Aleve but it didn't cut the pain. She was given a prescription to relieve the pain but it didn't help. While in another city, the pt broke out in a rash (MD gave different pain pills and that didn't work). Had extreme pain in both arms and couldn't hardly get out of bed. Has had shoulder X-rays and was thought to have some arthritis. Had MRI and pain still exists. They think it might be torn tendons, but my question is how could this affect both arms at the same time? Even today, I still feel pain where the shots were administered. I have had many shots in the military and since, but have never had an effect like this. Still in pain as of today. The follow up received on 5/1/02 states bilateral shoulder pain after administration of hep B vaccine #3 in R deltoid and hep A #2 vaccine in L deltoid.
Age: 40.0
Sex: M
Vaccine: MMR, TTOX, MMR, TTOX
Symptoms: Arthralgia, Pain
Clinical narrative: On 2/1/02, had upper extremity pain. This pain spread to lower extremities and then involved ankles, hands, wrists and fingers. Symptoms were still present but improving by 3/21/02.
Age: 40.0
Sex: M
Vaccine: MMR, TTOX, MMR, TTOX
Symptoms: Arthralgia, Myalgia, Pain, Paraesthesia
Clinical narrative: On 2/1/02, had upper extremity pain. This pain spread to lower extremities and then involved ankles, hands, wrists and fingers. Symptoms were still present but improving by 3/21/02.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, hot at left deltoid with a knot, 2 days post vax. Pt was prescribed Keflex.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Oedema, Purpura
Clinical narrative: Rash-itching-swelling, 3-19-02, Prednisone taper 3-19-02, Atarax 25 mg three times a day.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Pt developed fever since this morning mom sys a rash starting to appear. On 04/01/2002 pt's family reports rash was resolved within 24 hrs. Given Tylenol and Benadryl.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Right upper thigh-3 days later with 3.5 inches X 2.5 inches erythematous  tender reaction. Advised Ibuprofen, cold compresses
Sex: U
Vaccine: VARCEL
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Rash-10 lesions, papulo vesicular, itching.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Pt's father brought in the pt to the clinic on 03/21/2002. The pt woke up on 03/20/2002 and told her mother "her arm was broken." On 03/22/2002 left arm bright red, swollen, child complained of pain and tenderness. I have not seen this type of post vaccine reaction from DTP.
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Injection site reaction
Clinical narrative: Severe localized reaction to Comvax.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Vesicles grouped ,erythematous base @ site of injection, approximately 12 days post shot.
Age: 30.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Breast pain, Hypoaesthesia, Paraesthesia
Clinical narrative: The pt complained of "numbness, tingling" of the right shoulder, neck, upper back, arm, hand and fingers. Also complained of breast pain. Onset within 15 mins post administration of vaccines.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Pruritus, Pyrexia, Stomach discomfort, Swelling
Clinical narrative: Fever, itching, redness, swelling, upset stomach
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Rash papular
Clinical narrative: On 04/02/2002 the pt developed red papular rash. Generalized tonic-clonic 1-2 mins seven times in 8 hrs.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Drug ineffective, Infection
Clinical narrative: Mild varicella, despite vaccination.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Facial palsy
Clinical narrative: The pt delivered on 11/4/01 and was given Rubella vaccine on 11/6/01, the day of discharge. Noted Bell's Palsy on (R) the next morning, 11/8/01. Still with palsy.
Age: 1.08
Sex: M
Vaccine: HIBV
Symptoms: Rash
Clinical narrative: Rash within 2-3 hours, post vax of Hib vaccine. Persisted X over 2 weeks, especially on legs, most tense at vaccine site with some on trunk and arms. Treated with Benadryl and is recovering.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia, Swelling
Clinical narrative: Swelling and increased temperature
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Rash X 2 days with itching. No fever.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Rash, 24 hours, post vax of Hep-A.
Age: 1.3
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Irritability, Otitis media, Pyrexia, Rash
Clinical narrative: Started 3/27/02 with fever, fussiness, rash. Went to doctor. Also had ear infection. Got antibiotic. By 4/1/02, fever gone, rash almost gone. On Lorabid. Highest fever 103 axillary.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Body temperature increased, Erythema, Rash papular
Clinical narrative: At about 6am on 04/01/2002, patient developed erythematous macules which progressed to edematous papules over trunk and scalp. A few (less than 5) lesions had developed central vesicles at time of office visit about 2pm on 04/01/2002. Mom reported rash was preceded by a temperature of 101 on 3/30/02.
Age: 44.0
Sex: F
Vaccine: LYME
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Chills, fever nausea, aches, starting 2 hours after injection.
Age: 1.3
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Furuncle, Injection site reaction
Clinical narrative: Patient was seen by doctor on 03/25/02. Follow up with another doctor on 3/26/02. Patient came in with a boil to her right thigh near her injection site. Was prescribed Keflex by doctor.
Age: 1.75
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Body temperature increased, Injection site hypersensitivity, Injection site rash, Pruritus, Rash
Clinical narrative: Patient seen on 12/20/2001 for rash around site of varicella injection which was given to thigh. Rash spread to right elbow and on right side of chest. There was itching at site and a low grade temperature. Advised to use Tylenol and Benadryl PRN, and Topical Hydrocortizone.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Injection site abscess, Injection site reaction, Urticaria
Clinical narrative: Developed abscess at injection site immediately following injection. Developed hive at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Asthenia, Hypertrophy, Injection site swelling
Clinical narrative: Patient developed swelling and later hypertrophy of left deltoid area. MRI revealed fatty replacements and pseudohypertrophy and functional weakness.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Right Deltoid, red, swollen, slight rash on upper 1/3 of arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Erythema, Rash, Swelling
Clinical narrative: Left deltoid remained red, bruised, swollen upper 1/3 arm. Rash locally.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Red at injection site 48 hrs post administration of DTaP vaccine.
Age: 23.0
Sex: M
Vaccine: HEPA, IPV, YF
Symptoms: Dyspnoea, Heart rate increased, Respiratory rate increased, Wheezing
Clinical narrative: At 14:20, vaccines administered and at 14:45 the pt was discharged with drill instructor. At 15:20, had SOB and bilateral wheezing. O2 sat 94%, pulse 118, RR 30. Medicines given were oxygen, Benadryl, epinephrine, Solu-Medrol, albuterol nebulizer (2). Pt with a rash over his arms. Symptoms improve and is transported to a special care unit for overnight observation. Temperature 98.7F.
Age: 1.3
Sex: M
Vaccine: HEP, MMR
Symptoms: Autism, Gastrointestinal disorder, Hyperacusis, Speech disorder
Clinical narrative: Severe language delay and hearing sensitivity after vaccines with MMR and Hep-B. Child is now Autistic. Received, ABA, Speech and Occupational therapy. Leaky Gut Syndrome. On annual report received 04/25/2003 mother states, "he is autistic - he has high levels of mercury and lead in his gut. His vaccines contained thermirasol."
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Cyanosis, Hypotonia, Pallor, Respiratory disorder
Clinical narrative: Post vax of DTAP, HIB, IPV and Prevnar, the baby cried very hard. The MA left the room and within a couple of minutes, the mother came out of the exam room carrying a limp, pale and cyanotic infant. The doctor witnessed the event and estimated that the baby did not breathe for 15 seconds but responded to back rubbing. After the baby resumed breathing, she had another shorter spell. The baby was observed overnight in the hospital and did well.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Convulsion
Clinical narrative: A 3 month old with sudden onset of afebrile seizure, lasting 10 minutes. Dx: generalized seizures.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Agitation, Infection, Pyrexia, Rash, Urinary tract infection
Clinical narrative: On 12/7/01, presented with rash, fever (T 100.4F), irritability and crying inconsolably. Hospitalized and treated with IV therapy of Rocephin. (Mother developed a similar rash on 12/8/01. Both mother and child improved in 48 hours). Discharge diagnoses also included urinary tract infection.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Carpal tunnel syndrome, Fatigue, Fibromyalgia, Lymphadenopathy
Clinical narrative: Symptoms started in 10/98 and gradually increased over time. Had fever, fatigue, joint pain, rash and swollen glands. In 6/00, was very ill with symptoms. Dx'd with fibromyalgia and carpal tunnel. On 2/14/02, dx'd with Epstein-Barr Virus. Immunologist stated it was related to the Hep-B immunization. (First Hep-B given on 1/14/97/1622B/IM/LA and second given on 2/11/97). Annual follow up states : No further contact with vaccine recipient.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: Symptoms started in 10/98 and gradually increased over time. Had fever, fatigue, joint pain, rash and swollen glands. In 6/00, was very ill with symptoms. Dx'd with fibromyalgia and carpal tunnel. On 2/14/02, dx'd with Epstein-Barr Virus. Immunologist stated it was related to the Hep-B immunization. (First Hep-B given on 1/14/97/1622B/IM/LA and second given on 2/11/97). Annual follow up states : No further contact with vaccine recipient.
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Cachexia, Chills, Injection site erythema, Injection site hypersensitivity, Injection site reaction
Clinical narrative: Local reaction (dime size, red, tender and warm to the touch). Systemic complaints of general malaise, nausea and aches especially extreme chills (afebrile).
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Malaise, Nausea, Pain
Clinical narrative: Local reaction (dime size, red, tender and warm to the touch). Systemic complaints of general malaise, nausea and aches especially extreme chills (afebrile).
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: The pt presented with fever and rash.
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Febrile convulsion
Clinical narrative: The pt developed febrile seizure with in 12-18 hrs post vaccination. Went to ER and was considered fine.
Age: 7.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Pt has pro cellulitis at right thigh  (local reaction). Pt received four vaccines and unfortunately we didn't record what vaccines went into each leg. Two shots in right leg and the other two on the other leg. Started on 04/09/2002 and will follow up on 04/12/2002.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site reaction
Clinical narrative: The pt developed swollen, red right deltoid area starting on 04/02/2002. When seen in office on 04/04/2002, the pt had normal exam except for right deltoid (indurated area of 2" across with 1.5-2" x 4" erythema).
Age: 1.4
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema
Clinical narrative: Red area left thigh measuring 2 1/2" by 3 1/2". Motrin and warm packs given.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular
Clinical narrative: Few red spots on face and extremities, mild fever for two days. Breakthrough varicella.
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Injection site erythema, Injection site oedema
Clinical narrative: Erythema with swelling on left arm. 17 x 13cm bruising on left deltoid area 6x 7cm around it.
Age: 2.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: The pt developed 11 x 13cm area of induration, redness and mild swelling on right thigh around vaccination site. Treated symptematically with Tylenol, Benadryl, and cool compresses.
Age: 1.3
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular
Clinical narrative: The pt got a fever one day after receiving the vaccines and it continued for five days. had a varicella appearing rash eight days after vaccines which covered entire body and lasted for four days.
Age: 0.75
Sex: F
Vaccine: DTAP
Symptoms: Pharyngitis, Pyrexia, Rash erythematous, Rhinitis
Clinical narrative: Within one week of second shot on 02/07/2002, the pt developed a raised rash on back of right leg where shot was given. This lasted for over a month and a slight rash still exists on that leg. Two weeks after the shot she was sick with a cold and fever. Also, she was irritable for one week after both shots (1st and 2nd).
Age: 1.2
Sex: M
Vaccine: DT, HIBV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: The pt developed swelling 6-8 hrs post DT vaccination on the right thigh and with erythema and pain. ER evaluated and prescribed antibiotics and good resolution in 48 hrs.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: The pt developed cellulitis. Prescribed Cefzil 250 mg for 7 days/
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Convulsion, Pyrexia, Staring, Vomiting
Clinical narrative: On 06/14-fever onset at 4pm with 102 deg. F. On 06/15, vomiting onset during the night on 06/15, 06/16 awoke with 104 deg. F. temp was seen by the physician who thought of posible virus. On 06/17 vomiting continued with fever and seemed to be lowering had seizure at 1pm. Was seen by the physician, still thought to be viral. Sent for blood work, white blood count almost 20,000, blood culture found to be negative. Administered Roftussin antibiotic shot. Temp no longer continued until 06/26. Staring seizure on 06/18 at 6pm and two more shots of the antibiotics were given on 06/18 and 06/19.
Age: 1.9
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Multiple chicken pox lesions with scabs.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Decreased appetite, Irritability, Lethargy, Nasal congestion, Pyrexia
Clinical narrative: Approx 3 hrs post shots, the pt awoke from nap with temp of 104 deg. f. bilateral ear canals. Infant tylenol at approx dose administered for the next four days, he maintained a temp of 101 deg. F-104 deg. F. despite the medication. He developed congestion and expiratory wheezing, lethargy, decreased appetite and extreme irritability during this same time period. No one else in family came down with  respiratory or other illness post vaccination.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Wheezing
Clinical narrative: Approx 3 hrs post shots, the pt awoke from nap with temp of 104 deg. f. bilateral ear canals. Infant tylenol at approx dose administered for the next four days, he maintained a temp of 101 deg. F-104 deg. F. despite the medication. He developed congestion and expiratory wheezing, lethargy, decreased appetite and extreme irritability during this same time period. No one else in family came down with  respiratory or other illness post vaccination.
Age: 1.08
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomited several times the evening of getting vaccines the next day. Diarrhea began the next day and ongoing.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt presented to office with redness, warmth 2cm in diameter at injection site on left thigh. Treated with Keflex 250 mg. Instructed to RTC if symptoms worsen.
Age: 31.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Very red, hot area 3 1/2" x 3/12" in size at injection site.
Age: 1.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: Vomiting, high fever of 102 deg. f. and complete lethargy.
Age: 1.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Cough, Screaming, Wheezing
Clinical narrative: Wheezing, coughing, and crying for 10 mins after administration. Received 2.5 mg albuterol nebulizer treatment and 1.25 mg Cetrizone and had complete resolution.
Age: 1.2
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Blister, Pruritus, Rash
Clinical narrative: The pt developed  generalized itchy blister rash and treated with benadryl and aveeno.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: 16cm x 14cm are of erythema on left deltoid area and also pruritis, warmth. On 04/03/2002 these symptoms started. On 04/01/2002 DTaP injection give at left deltoid.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Dizziness, Injection site hypersensitivity, Pyrexia, Somnolence
Clinical narrative: Severe soarness in vaccinated arm, vomiting, stomach cramps, fever sleepiness, dizziness. The symptoms all resolved on day 4.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Severe soarness in vaccinated arm, vomiting, stomach cramps, fever sleepiness, dizziness. The symptoms all resolved on day 4.
Age: 1.08
Sex: F
Vaccine: HBHEPB, VARCEL
Symptoms: Blister, Drug ineffective, Viral infection
Clinical narrative: Vesicles compatible with mild varicella starting on 03/31/2002.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Myalgia
Clinical narrative: At 7:30 am, back muscles were aching. About 20 mins later, upper abdomin and lower chest region severe pain in muscles. Hurt and ached really bad. pt rates pain level 7. Pt was sweating which lasted 1-1 1/2 hrs. Went to ER but left when pain subsided.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Injection site mass, Pain, Pyrexia
Clinical narrative: Approximately 30 hours after Td vaccination, pt started running  high fever with severe chills and body ache. Also, at the time of reaction, a lump developed at injection site. Pt took 2 doses of 3 aspirin that evening without any relief. Within 24 hours from onset of symptoms, they had all subsided.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Insomnia, Joint range of motion decreased, Lymphadenitis, Lymphadenopathy
Clinical narrative: 3/20 (Day 8) returned with lymphaderitis, pain with movement of left arm. Mild erythema @ vaccine site, no streaking, lymphadynpathy axillary X 3 days (Day 6, 7,8) unable to sleep or perform work duties two hours pain. Tequin 400 mg 1 po qd #5 given; recheck on 3/22   3/22 Increased erythema surrounding vaccinate site ,no streaking to axillary. Approximately 4" diameter around site. Positve lymphadinepathy Avelox 400 mg 1 po qd  3/25 cellullitis resolved-allergic Rx to Relafen-hives
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: 2-22-02 Day following vaccine, started with approximately smaller hives turning into larger 8-12 diameter. Itching noted. Covered tops of legs and went over body. Denies SOB or N & V post immunizations. Interpreter to help. Denies going to ER. Also denies any  difference in foods, bathing soaps or activities of daily living.
Age: 47.0
Sex: F
Vaccine: FLUX, HEP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Moderate swelling on the left arm from the elbow to the shoulder.  Pain in the erythematous area.  Reaction after 8 hours and lasted for 8 days.  No fever or discharge at the injection site.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema, Oedema
Clinical narrative: School Nurse called in with her observation. Allegedly the(R) arm of child appear swollen, red and bigger than the other arm from the injection site to the wrist.
Sex: F
Vaccine: MMR
Symptoms: Muscle twitching, Oedema, Osteoporosis, Pain
Clinical narrative: Information has been received from a lawyer concerning a female who on an unspecified date, was vaccinated with 1 dose of MMRII. Subsequently, the pt developed reflex sympathetic dystrophy (RSD). It was reported, that the RSD was "in relation to the injection procedure, not to the vaccine". Upon internal review, reflex sympathetic dystrophy was determined to be an "Other Important Medical Event". Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: On 4/1/02, it was reported that an adult female pt received a Fluzone SV '01-'02 vaccination (lot U0600AA) on 10/20/01. Two weeks later, she developed muscle weakness in her thighs that became progressively worse in November and December, spreading to her chest, face and neck. The pt was evaluated by a physician and had EMG and sleep apnea tests with negative results.
Age: 2.0
Sex: M
Vaccine: OPV
Symptoms: Asphyxia, Condition aggravated, Hepatic fibrosis, Hepatitis, Quadriplegia
Clinical narrative: Decedent received the Oral Polio Vaccine at the doctor's office on 05/22/2002. Soon after he began developing polio vaccine related quadriplegia. Per F/U 6/20/02: COD-asphyxia due to mechanical ventilator failure dut to polio vaccine related quadriplegia; therapeutic complication.
Age: 0.7
Sex: M
Vaccine: DT, IPV
Symptoms: Cyanosis, Heart rate increased, Hyperventilation, Pyrexia, Tachycardia
Clinical narrative: Fever of 104F; hands/feet turned blue and apical pulse over 200. DGX of: tachycardia, tachypnea and hyperventilation.
Age: 0.7
Sex: M
Vaccine: DT, IPV
Symptoms: Tachypnoea
Clinical narrative: Fever of 104F; hands/feet turned blue and apical pulse over 200. DGX of: tachycardia, tachypnea and hyperventilation.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Irritability, Screaming
Clinical narrative: Mom states the pt had a high pitched cry, unconsolable for four hours and she was controlled temporarily with breast feeding. She was brought to the ER for evaluation, no fever, no vomiting, no diarrhea, no URI, and appetite's fine. She was diagnosed as "fussy baby-no fever."
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Radiculitis brachial
Clinical narrative: Pt developed brachial plexitis a few weeks following his influenza vaccine
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site abscess
Clinical narrative: Developed abscess @ site of injection about 1 week post vaccine (she was the first of  2 recent patients who had infection @ site of injection. Our policies and personnel have not changed and we never had this happen in the past.)
Sex: U
Vaccine: LYME
Symptoms: Arthropathy
Clinical narrative: Joint problems
Age: 62.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Asthenia, Influenza like illness, Weight decreased
Clinical narrative: Flu-like symptoms, joint pain, weakness, 20 lb. weight loss.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: The pt returned on 04/03/2002 with redness, swelling, drainage, cellulitis two hours post vaccinationl. Was prescribed Biarin. Cellulitis resolved on 04/05/2002.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Presented 4/10/02 with 10-20 chicken pox vesicles
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Influenza like illness, Joint swelling
Clinical narrative: This report describes joint pain and swelling in a male vaccinee of unspecified age who received Lyme disease vaccine recombinant OspA. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee reportedly received LYMErix; the number of injections administered was not reported. In a statement of injuries, his attorney alleged that the vaccinee "suffers from pain and swelling in his joints as well as flu-like symptoms. He also suffers from fatigue." Time to onset following immunization, treatment, and outcomes of the alleged events were not specified. The adverse events "joint pain" and "joint swelling" do not meet serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Joint swelling, Myalgia, Synovitis
Clinical narrative: This report describes synovitis in a female "minor" who received Lyme disease vaccine recombinant. This report was received as part of litigation proceedings and has not been verified by a physicians or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee reportedly received LYMErix; the number of injections administered was not reported. In a statement of injuries, her attorney alleged that the vaccinee "has suffered from joint pain and swelling in her hips, ankles, and knees, and muscle pain in her calves and lower back. She has been diagnosed as having symmetrical chronic arthralgias, synovitis and a bilateral patellofemoral malaligment in both knees." Time to onset following immunization, treatment, and outcome of the alleged events were not reported.
Age: 30.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Depression, Fatigue, Influenza like illness
Clinical narrative: This report describes joint pain in a male vaccine of unspecified age who received LYMErix. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee reportedly received LYMErix; the number of injections administered was not reported. In a statement of injuries, his attorney alleged that the vaccinee "suffers from pain in his joints, specifically his ankles, knees, elbows, wrists, hips, and groin. He also experienced fatigue and flu-like symptoms. In addition, his physical condition has caused him to be depressed." Time to onset following immunization, treatment, and outcome of the alleged events were not reported.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Influenza like illness
Clinical narrative: This report describes joint pain in a female vaccinee of unspecified age who received Lyme disease vaccine recombinant. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee reportedly received LYMErix; the number of injections were not reported. In a statement of injuries, her attorney alleged that the vaccinee "suffers from joint pain, particularly in her shoulders and knees. She also experiences flu-like symptoms and fatigue. In addition, she suffers from headaches and dizziness." Time to onset following immunization, treatment, and outcome of the alleged events were not reported. The adverse events "joint pain," headaches," and "dizziness" do not meet serious criteria but are being submitted as an expedited report by special FDA request.