chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV4
Symptoms: Mean cell volume increased, Musculoskeletal pain, Neutrophil percentage decreased, Oropharyngeal pain, Pain in extremity
Clinical narrative: Diffuse joint pain within 2 months of vaccination; Blood work up negative RA/ANA. Rheumatology consult drew no conclusions
Age: 15.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV4
Symptoms: Parvovirus B19 serology negative, Polycystic ovaries, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Sensation of heaviness
Clinical narrative: Diffuse joint pain within 2 months of vaccination; Blood work up negative RA/ANA. Rheumatology consult drew no conclusions
Age: 15.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV4
Symptoms: Skin cancer, Streptococcal identification test, Streptococcal identification test positive, Swelling, Tearfulness
Clinical narrative: Diffuse joint pain within 2 months of vaccination; Blood work up negative RA/ANA. Rheumatology consult drew no conclusions
Age: 79.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Oedema peripheral, Skin warm
Clinical narrative: 3/16/08 Redness, itching, area of imm. swollen (R) arm. 3/17/08 Red area (R) arm baseball size - itching - no swelling - warm to touch.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Erythema, Rash pustular
Clinical narrative: Sur with 16-20 Erythema pustule on left arm around recent tattoo. Symptoms can decrease with time.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Pain, Skin discolouration, Swelling
Clinical narrative: Got shot on a Weds Feb. 27th. Next am after vaccination (24 hours) started having pain, redness, swelling which progressed from size of a quarter to 4x4 inches in the next 24 hours. Patient took Ibuprofen thru that day. Saw her primary in the next 2 days on the 29th. At that time there was a golden look under the skin, PA didn't think it was NRSA but pt had previous MRSA, he treated pt with Keflex and Doxycycline for MRSA and cellulitis. With 8 hours, pain was decreasing. It was a painful as a surgical site. Today-redness outline is still there, hardness still there but almost gone. Pt called the consultants office the following Monday, left message for a return call and never heard back from them. She called several more times and only got voice mail, did not leave another message.
Age: 4.0
Sex: F
Vaccine: DTP
Symptoms: Pyrexia
Clinical narrative: Fever about 24hrs after immunizations - given Tylenol/Motrin
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Fatigue, Pain in extremity
Clinical narrative: Chills, sore arm, fatigue and weak started 2 days after administration. Has continued > 4 days.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, soreness, swelling firmness at site.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Urticaria
Clinical narrative: 30 min. after vaccines administered patient developed hives on trunk, arms, chin, neck. No edema, no SOB
Age: 28.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Skin warm
Clinical narrative: Td (L) deltoid 2 days ago - noticed evening of 3/12/08 red, warm area where Td given.
Age: 4.0
Sex: M
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Contusion, Erythema
Clinical narrative: 6 x 8 cm redness, centralized bruising.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: About 24 hours after immunization, pt presented with red, swollen deltoid area on (L).
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: 3/13/08 - Local swelling and tenderness. Aching within hours of the injection. - Advised rest, ice. Advil 400g qid. 3/14/08 - Expanding area of erythema 10cm x 24cm, slightly warm, margins well demarcated. Skin is sensitive. No fever; Rx - Keflex 500 qid x 7 days
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Vaccine reaction on (L) arm 3 1/2 in. "x 3 1/2 inch. Advised parent to use cold water. TYLENOL
Age: 4.0
Sex: M
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Contusion, Erythema
Clinical narrative: 6 x 8 cm left thigh, centralized bruising, redness.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration
Clinical narrative: Left deltoid with 1 x 3in area of redness; 1cm area of induration.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic shock, Electrocardiogram, Hypotension, Loss of consciousness, Nausea
Clinical narrative: Anaphalatic shock, loss of consciousness, tremors, hypotension, nausea for 5 minutes.  ER visit.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor, X-ray
Clinical narrative: Anaphalatic shock, loss of consciousness, tremors, hypotension, nausea for 5 minutes.  ER visit.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Aggression, Amnesia, Blood immunoglobulin G increased, Crying, Emotional disorder
Clinical narrative: Per mother: one hour after administration pt. began to have emotional outbursts and cried a lot. Was consolable. Then for 3 weeks since (so far) had irregular emotional ourbursts, temper tantrums and memory loss about once a day. No reports from school teacher as of yet. No fever. Mother taken the pt. to see alternative physicians, and health care workers. Given many herbs and supplements.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Full blood count normal, Pertussis identification test positive
Clinical narrative: Per mother: one hour after administration pt. began to have emotional outbursts and cried a lot. Was consolable. Then for 3 weeks since (so far) had irregular emotional ourbursts, temper tantrums and memory loss about once a day. No reports from school teacher as of yet. No fever. Mother taken the pt. to see alternative physicians, and health care workers. Given many herbs and supplements.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Blood pressure, Eye rolling, Muscle rigidity, Pallor, Syncope
Clinical narrative: Patient came into walk-in child vaccination clinic. Approx. 10:58 am child sat down in chair--mother and uncle beside her. Mother and child--foreign speaking only--uncle was acting as translator. 11:00 am varicella vaccine administered in right arm SQ followed by Hep A vaccine in right deltoid. Pt. tolerated well--appeared to be happy with no SXS of pain, SOA -- child reported no pain at insertion site--no erythema at site seen by RN--covered with band-aid. 11:10am uncle carried patient back into immunization room--stated she had "fainted" in waiting area. Pt. sat down in chair--pt. appeared to be alert, but look extremely pale. Shortly after sat in chair---patient's arms stiffened up towards chest--body appeared to be rigid and eyes rolled back in head (EMS called)--pt. was lowered onto floor (pt. in supine position)---episode lasted no longer than 20 seconds---ammonia smelling salt placed under nose--pt. able to state name, age and place. Ice pack placed on forehead as well as on abdomen. Vitals were as follows: 11:15 BP (lying down) 92/51 P 57 (EMS arrived) 11:18 BP (lying down) 90/54 P 68 Orthostatic BP started----11:20 BP (lying down) 90/54 P 84  11:23 BP (sitting) 97/63 P 77  11:24 BP (standing) 97/68 P 74. Pt. appeared to be stable. Pt reported no pain, dizziness, or SOA. Pt. alert and oriented--still pale. Asked family if they would like EMS to transport pt. to hospital nearby--declined.  Informed pt.'s family if pt. should show any SXS of reaction or anything like previous episode to take pt. to physician or hospital--pt.'s family verbalized understanding.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Approx one week after vaccination, pt developed shingles on left upper quadrant of abdomen.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Pain, Skin warm
Clinical narrative: ERYTHEMA TO LEFT DELTOID 16cm x 10.5 cm, SLIGHT PAIN AND WARM TO TOUCH. PATIENT WAS PRESCRIBED BACTRIM.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient receive Adacel, Tdap on 3-14-08, then presented in the office with complaints of pain and redness at the injection site on 3-20-08. She had an area of firm induration approximately 12cm by 6 cm. There was no break in the skin and no drainage.  The area was pink and warm to touch. Onset of swelling occurred 3-16-08.  The patient treated herself with ice packs and Midrin. She was diagnosed with cellulitis, Cephalexin 500mg, BID for 10 days and Naproxen were ordered and to follow-up as needed.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Patient receive Adacel, Tdap on 3-14-08, then presented in the office with complaints of pain and redness at the injection site on 3-20-08. She had an area of firm induration approximately 12cm by 6 cm. There was no break in the skin and no drainage.  The area was pink and warm to touch. Onset of swelling occurred 3-16-08.  The patient treated herself with ice packs and Midrin. She was diagnosed with cellulitis, Cephalexin 500mg, BID for 10 days and Naproxen were ordered and to follow-up as needed.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling jittery, Injection site streaking, Tenderness, Tremor
Clinical narrative: Red streak down back of arm at injection site.  Tenderness.  Approx 3 days after injection, I developed a jittery, trembling feeling in both arms (similar to when you overexercise)  No physical signs of trembling are evident, just the feeling.  This has continued with no increase or decrease in the symptom.
Age: 35.0
Sex: M
Vaccine: DTAP, HEPAB, MMR, TYP, YF
Symptoms: Diarrhoea, Mass, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: PT RECEIVED 5 VACCINES ON 14MAR08; TYPHOID, TWINRX #1, MMR, DTaP, AND YELLOW FEVER. THERE WAS NO DOCUMENTION LOGGED AS TO WHICH ARM EACH SHOT WAS GIVEN IN. PT REPORTS TODAY COLD SX, FEVER, DIARRHEA, PRURITIC RASH, SORE, YELLOW SOFTBALL SIZED LUMP LOCATED LEFT TRICEP REGION. UNSURE WHICH VACCINE WAS GIVEN LEFT TRICEP, BUT MMR & YELLOW FEVER WERE GIVEN SUB-Q THAT DATE. OTHER THREE WERE GIVEN IM DELTIOD REGION, BOTH ARMS. PATIENT STATED REACTION ONSET BEGAN 3-4 DAYS AFTER VACCINATION
Age: 35.0
Sex: M
Vaccine: DTAP, HEPAB, MMR, TYP, YF
Symptoms: Rash pruritic
Clinical narrative: PT RECEIVED 5 VACCINES ON 14MAR08; TYPHOID, TWINRX #1, MMR, DTaP, AND YELLOW FEVER. THERE WAS NO DOCUMENTION LOGGED AS TO WHICH ARM EACH SHOT WAS GIVEN IN. PT REPORTS TODAY COLD SX, FEVER, DIARRHEA, PRURITIC RASH, SORE, YELLOW SOFTBALL SIZED LUMP LOCATED LEFT TRICEP REGION. UNSURE WHICH VACCINE WAS GIVEN LEFT TRICEP, BUT MMR & YELLOW FEVER WERE GIVEN SUB-Q THAT DATE. OTHER THREE WERE GIVEN IM DELTIOD REGION, BOTH ARMS. PATIENT STATED REACTION ONSET BEGAN 3-4 DAYS AFTER VACCINATION
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Electroencephalogram, Headache, Malaise
Clinical narrative: Immediately folowing the HPV vaccine patient began feeling sick to her stomach and complaining of bad h/a. These symptoms continued throughout the entire next day and that afternoon she had a seizure. Patient does have hx of seizures, before she had this seizure, but last seizure hadn't been for an entire year.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Crying, Dehydration, Diarrhoea, Enema administration, Fatigue
Clinical narrative: VOMTING, CRYING, DRAWING LEGS UP, DIARRHEA, FEVER, TIRED, DEHYDRATED, THIS OCCURRED FOR THREE DAYS WE TOOK CHILD TO DR TWO DAYS IN A ROW WITH KNOW ANSWER FINALLY WENT TO ER ON THIRD DAY AND THEY DID ULTRASOUND AND FOUND INTUSSUSCEPTION WAS RUSHED TO Hospital AND AIR ENEMA WAS TRIED BUT IT WAS TO LATE SO THEY PERFORMED SURGERY.  4/15/08 Reviewed hospital medical records for 3/8-3/9/2008. FINAL DX: Intussusception, exploratory laparotomy & appendectomy Records reveal patient transferred to higher level of care after having been dx w/IS at outlying ER by US.  Had irritability, vomiting, fever, abdominal pain & distention, diarrhea/constipation x 2 days.  Underwent air contrast enema w/partial reduction & taken to OR.  Findings at time of surgery were resolved IS, edematous bowel.  Progressed diet well & d/c to home.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Intussusception, Pyrexia, Surgery, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: VOMTING, CRYING, DRAWING LEGS UP, DIARRHEA, FEVER, TIRED, DEHYDRATED, THIS OCCURRED FOR THREE DAYS WE TOOK CHILD TO DR TWO DAYS IN A ROW WITH KNOW ANSWER FINALLY WENT TO ER ON THIRD DAY AND THEY DID ULTRASOUND AND FOUND INTUSSUSCEPTION WAS RUSHED TO Hospital AND AIR ENEMA WAS TRIED BUT IT WAS TO LATE SO THEY PERFORMED SURGERY.  4/15/08 Reviewed hospital medical records for 3/8-3/9/2008. FINAL DX: Intussusception, exploratory laparotomy & appendectomy Records reveal patient transferred to higher level of care after having been dx w/IS at outlying ER by US.  Had irritability, vomiting, fever, abdominal pain & distention, diarrhea/constipation x 2 days.  Underwent air contrast enema w/partial reduction & taken to OR.  Findings at time of surgery were resolved IS, edematous bowel.  Progressed diet well & d/c to home.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ, VARCEL
Symptoms: Excoriation, Fall, Loss of consciousness
Clinical narrative: Guardian stated, patient seemed to be passing out and slowly fell on her side to the cement floor. Abrasion on chin and on 2 fingers of each hand noted. 911 was called and paramedics evaluated the patient and patient was transported to Medical Center via ambulance.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Disturbance in attention, Encephalitis, Hypertension, Sensation of heaviness, Thinking abnormal
Clinical narrative: Shot (Tdap) was given 3-5-08. On 3-12-08 patient began to report that her arm (L) felt "heavy". Also felt that her B/P was high. B/P: 140/98 which she reported was high for her. Encouraged her to go to ER. She went to ER 3-12-08. Had a Cat scan which she reports was fine. Reported that they were unable to do an MRI due to the MRI machine being broken. She was released home. Family reports her condition worsened on 3/13/08 and 3/14/08 while at home. Her "thought process and speech were broken and her (L) arm and (L) leg weakened." They took her back to ER 3/14/08. Per family on 3/18/08 the physician diagnosed her with encephalitis. "No other cause was found but the injection. He thinks it was the Tetanus part of the shot," stated her husband. VAERS filed. 7/30/08-records received for DOS 3/14-3/21/08 and rehab 3/21-4/1-08 DC DX Encephalitis. Left hemiparesis/hemiplegia. Episodic myoclonus. Episodic aphasia. adverse effect corticosteroid, adverse effect major tranquilizer. Long QT syndrome. Developed left sided weakness and sensory changes along with expressive aphasia on 3/14/08.Subsequently developed steroid psychosis. C/O photosensitivity and light sensitivity. At time of discharge continued with crural weakness and required a walker.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Nausea, Pain, Stomach discomfort
Clinical narrative: Received TDaP vaccine around 2:30pm in left arm.  At 5pm patient complained of "nausea, chills", (no rash).  7p-8p chills and achy all over.  12am-12:30am vomited x2, 5:30am vomited again.  9A-9:30A stomach still upset, by 12 noon felt better and ate some canned peaches.  By 5pm - felt much better.  No local redness - just soreness at site per patient.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Received TDaP vaccine around 2:30pm in left arm.  At 5pm patient complained of "nausea, chills", (no rash).  7p-8p chills and achy all over.  12am-12:30am vomited x2, 5:30am vomited again.  9A-9:30A stomach still upset, by 12 noon felt better and ate some canned peaches.  By 5pm - felt much better.  No local redness - just soreness at site per patient.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Rash maculo-papular
Clinical narrative: Macular papular rashes; face, trunk and extremities
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Administered shots, pt walked into waiting area and collapsed. About five minutes later she had a seizure, ambulance came and took her to medical center ER.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient slight erythema about 1/2 inch in diameter to VZV site. Advice to apply cold compress to decrease swelling and return to clinic if sign and system get worse.
Age: 61.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Shivering x 2 hrs after injection. Redness, warmth and swelling on arm below injection site, including elbow. Approx 6" in length. Advised ibuprofen and antihistamines. Appt if gets worse.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Parent called 3/21 to report child's left arm at injection site was red and swollen - no systemic reaction - parent gave child Benadryl - RN advised reaction not uncommon - Put ice on site
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Body temperature increased, Crying, Diarrhoea, Faeces discoloured, Oedema peripheral
Clinical narrative: 1/22/08 Cried uncontrollably since shots (R) temp 101 deg. "Like you were cutting his leg off" 2 runny limegreen BM's. legs are swollen diaper and socks mad indention
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 3-17-08- no problem- in for well child exam. 3-18-08-Left thigh warm and red- iced increased redness, increased size. 3-19-08- Left thigh decreased redness, increase size, decreased warmth. 16 x 11 cm erythemic, warm, no tenderness 5x3 cm area within large reaction which is more firm. -no treatment, supportive care monitor signs/symptoms
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV
Symptoms: Injection site swelling
Clinical narrative: - Left arm swollen - Prelone and Keflex given for treatment
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV
Symptoms: Oedema peripheral
Clinical narrative: - Left arm swollen - Prelone and Keflex given for treatment
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: Redness and warmth to her left thigh, fever of 102.1.
Age: 1.5
Sex: M
Vaccine: MEA, MU
Symptoms: Pyrexia
Clinical narrative: 8 days after measles and mumps vaccines were given, he developed a fever of 106.2 for 2 days. No other symptoms noted.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: - Left arm swollen - Prelone and Keflex given for treatment
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site pain, Pain in extremity
Clinical narrative: Pain at injection site (L) upper arm that radiates to (L) axilla and down her arm. Rash left - right side of trunk.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Per mother child received vaccines Monday March 17 and yesterday was concerned because noticed left arm (deltoid) with redness and swelling. Per mother had never seen this happen to any of her other children so she was concerned. Per mother applied warm compress to child's arm for comfort. Denies numbness or tingling to left arm or extremities. Follow up phone call 3/20/08. Mother stated child's arm better.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Erythema of eyelid, Eyelid oedema, Wheezing
Clinical narrative: Student received #4 Polio, #5 Dtap, #2 MMR, #2 Varicella. 15 minutes later had redness and swelling of eyelids, cough and wheezing. 3/4 tsp. Benadryl was given. No outcome; Paramedics gave Albuterol breathing and Epinephrine treatment. Transported to E.R.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Within 1 hour of vaccination, left arm became swollen, red, and warm to touch. Pt brought in following day. It appeared the same. Mom treated with ice, Motrin/Tylenol.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Blister, Erythema, Musculoskeletal discomfort, Oedema peripheral
Clinical narrative: Initial report was received on 21 November 2007 from a nurse. A 46-year-old female patient, with no concurrent illnesses, and a history of hypertension, "MVP" with palpitations, "PAC", "PVC", and "SVT", had received a first, left deltoid, intramuscular dose of Adacel (lot number C2769AA) on 20 October 2007 at 19:00 pm. The following day, approximately eight hours post-vaccination at 03:00 am, the patient developed edema, blistering, redness, and "fiery feeling" up to the shoulder of the left arm. Her axilla was edematous and blistering as well. The patient did not seek medical attention, and no relevant diagnostic tests, or laboratory data were performed. Treatments received were not reported. The patient's symptoms lasted 19 days with recovery date calculated as approximately 09 November 2007. Follow-up information received on 22 January 2008 from a health care professional. The patient had joint involvement at the shoulder. The event did not require medical evaluation by a physician, but the patient was evaluated by the employee health coordinator. Treatment included ice packs followed by warm compresses and analgesics as needed. The patient experienced no prior similar reaction. The final diagnosis was unknown, and the patient recovered on 19 November 2007. 04 February 2008: A corrective version was created with the same latest received date as the previous version (22 January 2008) for the sole purpose of entering the treatment medication, analgesics, into the product screen structure field. No other additional relevant medically significant information was added to the case. The reporter for this case is the same as for cases 2007- 03939, 2007-03940, 2007-03941, and 2007- 03942.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Initial report was received on 21 November 2007 from a nurse. A 46-year-old female patient, with no concurrent illnesses, and a history of hypertension, "MVP" with palpitations, "PAC", "PVC", and "SVT", had received a first, left deltoid, intramuscular dose of Adacel (lot number C2769AA) on 20 October 2007 at 19:00 pm. The following day, approximately eight hours post-vaccination at 03:00 am, the patient developed edema, blistering, redness, and "fiery feeling" up to the shoulder of the left arm. Her axilla was edematous and blistering as well. The patient did not seek medical attention, and no relevant diagnostic tests, or laboratory data were performed. Treatments received were not reported. The patient's symptoms lasted 19 days with recovery date calculated as approximately 09 November 2007. Follow-up information received on 22 January 2008 from a health care professional. The patient had joint involvement at the shoulder. The event did not require medical evaluation by a physician, but the patient was evaluated by the employee health coordinator. Treatment included ice packs followed by warm compresses and analgesics as needed. The patient experienced no prior similar reaction. The final diagnosis was unknown, and the patient recovered on 19 November 2007. 04 February 2008: A corrective version was created with the same latest received date as the previous version (22 January 2008) for the sole purpose of entering the treatment medication, analgesics, into the product screen structure field. No other additional relevant medically significant information was added to the case. The reporter for this case is the same as for cases 2007- 03939, 2007-03940, 2007-03941, and 2007- 03942.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Dizziness, Full blood count, Headache, Influenza serology
Clinical narrative: Initial report received on 20 December 2007 from a health care professional. A 28-year-old female patient had received a left deltoid, intramuscular injection of Adacel, lot number C2889AA, on 19 December 2007. One hour post-vaccination, the patient developed a low grade temperature of 100.2 degrees Fahrenheit, general body aches, headache, dizziness, nausea, and soreness at the injection site. The patient was examined by a physician. CBC, complete metabolic panel, urinalysis, pregnancy test, and influenza testing were pending. At the time of this report, the patient had not recovered.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Laboratory test, Nausea, Pain, Pregnancy test
Clinical narrative: Initial report received on 20 December 2007 from a health care professional. A 28-year-old female patient had received a left deltoid, intramuscular injection of Adacel, lot number C2889AA, on 19 December 2007. One hour post-vaccination, the patient developed a low grade temperature of 100.2 degrees Fahrenheit, general body aches, headache, dizziness, nausea, and soreness at the injection site. The patient was examined by a physician. CBC, complete metabolic panel, urinalysis, pregnancy test, and influenza testing were pending. At the time of this report, the patient had not recovered.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Urine analysis
Clinical narrative: Initial report received on 20 December 2007 from a health care professional. A 28-year-old female patient had received a left deltoid, intramuscular injection of Adacel, lot number C2889AA, on 19 December 2007. One hour post-vaccination, the patient developed a low grade temperature of 100.2 degrees Fahrenheit, general body aches, headache, dizziness, nausea, and soreness at the injection site. The patient was examined by a physician. CBC, complete metabolic panel, urinalysis, pregnancy test, and influenza testing were pending. At the time of this report, the patient had not recovered.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial reported received from a health care professional 24 December 2007. A 30-year old female patient had received an intramuscular  left deltoid injection of Adacel, lot number C2771AA on 21 October 2007, and one day later, she developed pain and redness at the injection site. The symptoms progressed to a 10cm x 13cm area of redness, swelling and pain. Joint pain was also reported in the left shoulder and elbow. Corrective treatment consisted of Benadryl and Prednisone. The patient's past medical history and vaccination history were not provided and it was unknown if the patient was receiving any concomitant medications at the time of vaccination. At the time of the report, the patient had not recovered from the event.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Condition aggravated, Rash
Clinical narrative: This report was received from a health professional on 13 February 2008. An 11-year-old female patient, with a history of asthma (until age 6) and poison ivy, received an injection of Adacel (lot number not reported) in August 2007. Approximately one week prior to receiving Adacel, the patient had been diagnosed with poison ivy/contact dermatitis on the face and arms. She was treated with cortisone cream, and the event was reported to be recovering. After receiving Adacel, the rash worsened, with the same distribution. The patient was evaluated by a dermatologist "who did not feel this was vaccine related". Outcome was not reported.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Rheumatoid arthritis
Clinical narrative: 1 WEEK AFTER AMINISTRATION PT COMPLAINED OF ARTHRITIS IN BOTH WRISTS, MD REPORTING STATES THAT PATIENT NOW HAS EARLY ONSET RHEUMATOID IN BOTH WRISTS - UNSURE IF RELATED TO VACCINE.  5/1/09MR received including PCP and rheumatology consults 2/27/08-4/2009. Pt initially presented 2/27/09 with c/o reaction to flu shot. Pt reports hand swelling which began the day of the injection. The other hand began swelling the next day which was later developed into bilateral arthritis of the wrists, currently dx with RA. PE WNL. Assess:  Wrist pain. glucose intolerance.  Rheum consult 4/22/08 with DX: RA.  High titre ANA with centromere pattern. PE (+) for bilateral wrist warmth, swelling and tenderness. Tx with MTX/Folic Acid and Pred.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rheumatoid arthritis
Clinical narrative: 1 WEEK AFTER AMINISTRATION PT COMPLAINED OF ARTHRITIS IN BOTH WRISTS, MD REPORTING STATES THAT PATIENT NOW HAS EARLY ONSET RHEUMATOID IN BOTH WRISTS - UNSURE IF RELATED TO VACCINE.  5/1/09MR received including PCP and rheumatology consults 2/27/08-4/2009. Pt initially presented 2/27/09 with c/o reaction to flu shot. Pt reports hand swelling which began the day of the injection. The other hand began swelling the next day which was later developed into bilateral arthritis of the wrists, currently dx with RA. PE WNL. Assess:  Wrist pain. glucose intolerance.  Rheum consult 4/22/08 with DX: RA.  High titre ANA with centromere pattern. PE (+) for bilateral wrist warmth, swelling and tenderness. Tx with MTX/Folic Acid and Pred.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Body temperature, Pyrexia, Rash morbilliform, Vomiting
Clinical narrative: Starting 8 days after MMR+V vaccination, patient experienced 102F fever followed by morbilliform rash on abdomen. At 10 days rash expanded to whole body. Fever ranged from 99 to 102 degrees for 8 to 13 days after injection. Patient vomited twice on day 13.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash, Vomiting
Clinical narrative: Starting 8 days after MMR+V vaccination, patient experienced 102F fever followed by morbilliform rash on abdomen. At 10 days rash expanded to whole body. Fever ranged from 99 to 102 degrees for 8 to 13 days after injection. Patient vomited twice on day 13.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Sudden infant death syndrome
Clinical narrative: Patient died of Sudden Infant Death Syndrome the day after receiving DTaP, IPV, HIB, PCV7 and Rotateq.  6/13/08 Autopsy report states COD as SIDS. Report also states slight pulmonary edema & petechial hemorrhages on thymus gland, pericardium of heart & pleurae of lungs.  Patient had been placed down for nap on his left side in adult bed at daycare provider.  Patient found face down & unresponsive approx 45-50 min later.  CPR was started & EMS called. PMH: NSVD, no complications.  Upper respiratory congestion frequently since birth & seen for cold s/s by PCP on 3/3.  Otitis media 2/1 & had mild wheezing.   Sibling w/recent cold symptoms.  Had to be picked up early from daycare x2 the week before death due to vomiting.
Age: 1.26
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Abnormal behaviour, Blood calcium increased, Fatigue, Gaze palsy, Laboratory test normal
Clinical narrative: Mother reports child woke up around 0530 this am.  She brought child to bed with her.  Soon after she felt child was shaking and when looking at him noted his eyes were rolled back, had tonic-clonic activity of all four extremities, was unresponsive, making clicking/gurgling sound, and his face was rigid.  Reports this activity lasted anywhere from 1-2 minutes.  Afterwards child fell asleep until she woke him up to bring to ED.  Reports initially in ED seemed tired, but otherwise acting per usual.  On exam by peds team states he seems back to baseline (~ 5 hours after event).  No tongue biting; reports she noted wet diaper after event but unsure if it was present from overnight.  No color change of lips/extremities during the event.  No recent trauma.  No recent fevers.  Of note, child did receive immunizations yesterday to include: MMRV, DTap, Hep B, IPV, pneumococcal.
Age: 1.26
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Muscle rigidity, Scan brain, Tonic clonic movements, Tremor, Unresponsive to stimuli
Clinical narrative: Mother reports child woke up around 0530 this am.  She brought child to bed with her.  Soon after she felt child was shaking and when looking at him noted his eyes were rolled back, had tonic-clonic activity of all four extremities, was unresponsive, making clicking/gurgling sound, and his face was rigid.  Reports this activity lasted anywhere from 1-2 minutes.  Afterwards child fell asleep until she woke him up to bring to ED.  Reports initially in ED seemed tired, but otherwise acting per usual.  On exam by peds team states he seems back to baseline (~ 5 hours after event).  No tongue biting; reports she noted wet diaper after event but unsure if it was present from overnight.  No color change of lips/extremities during the event.  No recent trauma.  No recent fevers.  Of note, child did receive immunizations yesterday to include: MMRV, DTap, Hep B, IPV, pneumococcal.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Axillary mass, Axillary pain, Biopsy, Biopsy lymph gland, Laboratory test
Clinical narrative: Initial Hepatitis B vaccine from County Health received 6/26/95 & 8/3/95.  University took a titer in 2007.   The result was negative.   Hospital then gave the Recombivax HB (Hepatitis B Vacctine) shots 3, 4, 5, 6 on the following dates:  8/3/07, 10/1/07, 12/19/07, 1/18/08.  In between each shot they found the titer to be negative.   All shots were given in the right arm, except for the 1/18/08 shot.   I had them give it in my left arm because of the lump and pain I was having in my right axilla.   In the first week of January I noticed slight pain and marble sized lump under my right arm.  On January 10th visited my primary physician who ordered CT which found a round soft tissue mass in the right axilla measuring approximately 3.3 x 3.7 x 2.2 cm.   Superficial lymph node biopsy performed 1/22/08.  Pathology report poorly differentiated malignant neoplasm.  Histomorphologic features are suggestive of malignant melanoma although the neoplasm does not mark with the one melanoma specific antibody that was used.   Slides were reviewed by facilities and diagnosis was malignant melanoma unknown primary.  Only presentation was in lymph node on right side where multiple vaccines were given.  PET scan and MRI continue to review no primary.  Disease present only in right axillary lymph system.  4/4/08 Reviewed PCP medical records of 2/5-3/20/2008. FINAL DX: locally advanced metastatic malignant melanoma, primary unknown, s/p complete resection right axilla lymph nodes (12 of 45 + w/subcutaneous extension & extracapsular extension) Records reveal patient experienced tender right axillary lymph node which increased in size over approx 1 mo.  Dermatology, surgery & heme/onc consults done.  Obtained second opinion out of state who concurred w/recommended complete axillary node dissection, done 2/26/08.  Recommended radiation & chemotherapy. Got second opinion out of state & was to receive radiation therapy there.  4/11/08 Reviewed hospital medical records:  1/14/08 MRI of right axillary mass abnormal revealed lymphadenopathy & possibly neoplastic disease.  1/22/08 needle biopsy report malignant cells c/w metastatic melanoma.  1/29/08 excisional biopsy report metastatic poorly differentiated malignant neoplasm c/w melanoma Follow-up: Tumors continue.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Malignant melanoma
Clinical narrative: Initial Hepatitis B vaccine from County Health received 6/26/95 & 8/3/95.  University took a titer in 2007.   The result was negative.   Hospital then gave the Recombivax HB (Hepatitis B Vacctine) shots 3, 4, 5, 6 on the following dates:  8/3/07, 10/1/07, 12/19/07, 1/18/08.  In between each shot they found the titer to be negative.   All shots were given in the right arm, except for the 1/18/08 shot.   I had them give it in my left arm because of the lump and pain I was having in my right axilla.   In the first week of January I noticed slight pain and marble sized lump under my right arm.  On January 10th visited my primary physician who ordered CT which found a round soft tissue mass in the right axilla measuring approximately 3.3 x 3.7 x 2.2 cm.   Superficial lymph node biopsy performed 1/22/08.  Pathology report poorly differentiated malignant neoplasm.  Histomorphologic features are suggestive of malignant melanoma although the neoplasm does not mark with the one melanoma specific antibody that was used.   Slides were reviewed by facilities and diagnosis was malignant melanoma unknown primary.  Only presentation was in lymph node on right side where multiple vaccines were given.  PET scan and MRI continue to review no primary.  Disease present only in right axillary lymph system.  4/4/08 Reviewed PCP medical records of 2/5-3/20/2008. FINAL DX: locally advanced metastatic malignant melanoma, primary unknown, s/p complete resection right axilla lymph nodes (12 of 45 + w/subcutaneous extension & extracapsular extension) Records reveal patient experienced tender right axillary lymph node which increased in size over approx 1 mo.  Dermatology, surgery & heme/onc consults done.  Obtained second opinion out of state who concurred w/recommended complete axillary node dissection, done 2/26/08.  Recommended radiation & chemotherapy. Got second opinion out of state & was to receive radiation therapy there.  4/11/08 Reviewed hospital medical records:  1/14/08 MRI of right axillary mass abnormal revealed lymphadenopathy & possibly neoplastic disease.  1/22/08 needle biopsy report malignant cells c/w metastatic melanoma.  1/29/08 excisional biopsy report metastatic poorly differentiated malignant neoplasm c/w melanoma Follow-up: Tumors continue.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Guillain-Barre syndrome
Clinical narrative: I got Guillain Barre Syndrome a short time after I had the Meningococcal vaccination at the new. 4/30/08 MR received for DOS 7/18-30/2007 with DX:  Guillain-Barre Disease which has resulted in significant motor weakness.  Significant improvement noted after tx with IVIG.  S/P Respiratory Failure 2' to above.  Pneumonia which was improving.   Pt presented with numbness, tingling of the hands and feet and weakness of the legs. Unable to ambulate, having SOB and difficulty clearing secretions.  PE (+) for facial weakness, decreased motor stregth, absent DTRs of the lower extremities bilat and trace in upper extremities bilat. Pt's condition continued to worsen and developed respiratory failure, intubated and placed on vent. Developed fever on 7/19/07-atelectasis with pneumonia. Treated with IVIG and abx.  Extubated 7/23/07. Ambulatory with walker by 7/29/07. D/C to family's home.
Age: 0.13
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Body temperature increased
Clinical narrative: Inconsolable crying/screaming from 7:30 pm on past 10:30 pm.  Parents attempted every conceivable method to calm child, none successful.  Child normally and regularly very calm and quiet.  DTaP vaccine administered about 2 pm same day.  Doctor/nurse only advised Tylenol if fever present.  Temperature of child was 98.1 degrees fahrenheit at 8:30 pm, so did not administer Tylenol.  Called nurse at 10:30 pm, was advised that Tylenol should have been administered to child before vaccine.  Within 10 minutes of giving child Tylenol, child was asleep and quiet.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Aspartate aminotransferase increased, Biopsy muscle abnormal, Blood creatine phosphokinase increased
Clinical narrative: The day after the vaccine, my left arm hurt.  Approximately two to three weeks later, I experienced extreme fatigue and muscle weakness.  I seen three doctors before going to the clinic.  My muscles wasted away in my shoulders and my left hip was in pain and I limped.  I could not dress myself, tie my shoes, wash my hair and could barely drive my vehicle.  I am unable to walk up stairs and walk a long distance.  I fall alot and am not strong enough to pick myself up.  My shoulder bones hurt and ache constantly.  I was put on Prednisone in June of 2007 and underwent pt and ot therapy, to no avail.  In December of 2007, I was also put on Lyrica and Boniva in February.  I went back to the Clinic and they now put me on Methotrexate along with the prednisone, Lyrica and Boniva.  I am still not functionable.  04/04/2008 MR received for several OVs between 4/19/2008 and 2/28/2008 with DX: necrotizing myopathy. Pt reports myalgias and upper extremity weakness beginning a few days after Flu shot  12/11/06 and worsening over the next months.  Requiring assistance with ADL and work related activities. Significant functional impairment noted.  PE(+) for Proximal upper limbs/shoulder girdle atrophy with significant weakness.  Unable to fully abduct shoulders. Proximal weakness of lower limbs. Some improvement with prednisone, however has had several recent falls. Sleep is disturbed. Appetite poor.  Depressed affect. Pt developed rash on chest 2/2008 as well as erythema over the knuckles. ? dematomyositis.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Bone density decreased, Bone pain, Fall, Fatigue, Gait disturbance
Clinical narrative: The day after the vaccine, my left arm hurt.  Approximately two to three weeks later, I experienced extreme fatigue and muscle weakness.  I seen three doctors before going to the clinic.  My muscles wasted away in my shoulders and my left hip was in pain and I limped.  I could not dress myself, tie my shoes, wash my hair and could barely drive my vehicle.  I am unable to walk up stairs and walk a long distance.  I fall alot and am not strong enough to pick myself up.  My shoulder bones hurt and ache constantly.  I was put on Prednisone in June of 2007 and underwent pt and ot therapy, to no avail.  In December of 2007, I was also put on Lyrica and Boniva in February.  I went back to the Clinic and they now put me on Methotrexate along with the prednisone, Lyrica and Boniva.  I am still not functionable.  04/04/2008 MR received for several OVs between 4/19/2008 and 2/28/2008 with DX: necrotizing myopathy. Pt reports myalgias and upper extremity weakness beginning a few days after Flu shot  12/11/06 and worsening over the next months.  Requiring assistance with ADL and work related activities. Significant functional impairment noted.  PE(+) for Proximal upper limbs/shoulder girdle atrophy with significant weakness.  Unable to fully abduct shoulders. Proximal weakness of lower limbs. Some improvement with prednisone, however has had several recent falls. Sleep is disturbed. Appetite poor.  Depressed affect. Pt developed rash on chest 2/2008 as well as erythema over the knuckles. ? dematomyositis.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: HIV antibody negative, Hepatitis A antibody negative, Hepatitis B test negative, Hepatitis C test negative, Muscle atrophy
Clinical narrative: The day after the vaccine, my left arm hurt.  Approximately two to three weeks later, I experienced extreme fatigue and muscle weakness.  I seen three doctors before going to the clinic.  My muscles wasted away in my shoulders and my left hip was in pain and I limped.  I could not dress myself, tie my shoes, wash my hair and could barely drive my vehicle.  I am unable to walk up stairs and walk a long distance.  I fall alot and am not strong enough to pick myself up.  My shoulder bones hurt and ache constantly.  I was put on Prednisone in June of 2007 and underwent pt and ot therapy, to no avail.  In December of 2007, I was also put on Lyrica and Boniva in February.  I went back to the Clinic and they now put me on Methotrexate along with the prednisone, Lyrica and Boniva.  I am still not functionable.  04/04/2008 MR received for several OVs between 4/19/2008 and 2/28/2008 with DX: necrotizing myopathy. Pt reports myalgias and upper extremity weakness beginning a few days after Flu shot  12/11/06 and worsening over the next months.  Requiring assistance with ADL and work related activities. Significant functional impairment noted.  PE(+) for Proximal upper limbs/shoulder girdle atrophy with significant weakness.  Unable to fully abduct shoulders. Proximal weakness of lower limbs. Some improvement with prednisone, however has had several recent falls. Sleep is disturbed. Appetite poor.  Depressed affect. Pt developed rash on chest 2/2008 as well as erythema over the knuckles. ? dematomyositis.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain, Pain in extremity, Positron emission tomogram normal
Clinical narrative: The day after the vaccine, my left arm hurt.  Approximately two to three weeks later, I experienced extreme fatigue and muscle weakness.  I seen three doctors before going to the clinic.  My muscles wasted away in my shoulders and my left hip was in pain and I limped.  I could not dress myself, tie my shoes, wash my hair and could barely drive my vehicle.  I am unable to walk up stairs and walk a long distance.  I fall alot and am not strong enough to pick myself up.  My shoulder bones hurt and ache constantly.  I was put on Prednisone in June of 2007 and underwent pt and ot therapy, to no avail.  In December of 2007, I was also put on Lyrica and Boniva in February.  I went back to the Clinic and they now put me on Methotrexate along with the prednisone, Lyrica and Boniva.  I am still not functionable.  04/04/2008 MR received for several OVs between 4/19/2008 and 2/28/2008 with DX: necrotizing myopathy. Pt reports myalgias and upper extremity weakness beginning a few days after Flu shot  12/11/06 and worsening over the next months.  Requiring assistance with ADL and work related activities. Significant functional impairment noted.  PE(+) for Proximal upper limbs/shoulder girdle atrophy with significant weakness.  Unable to fully abduct shoulders. Proximal weakness of lower limbs. Some improvement with prednisone, however has had several recent falls. Sleep is disturbed. Appetite poor.  Depressed affect. Pt developed rash on chest 2/2008 as well as erythema over the knuckles. ? dematomyositis.
Age: 39.0
Sex: F
Vaccine: HEPAB, TDAP, HEPAB, TD
Symptoms: Arthralgia
Clinical narrative: During an annual OBGYN appointment I was strongly urged by the nurse to have a tetanus shot since I couldn't recall the last time I had received one.  She gave me a bunch of horror stories of what could happen.  I then mentioned that my children's pediatrician had said it was a good idea to get Hep A & B vaccines.  They said they could do it all at the same time. The following morning when I woke up I thought that I was getting the flu because I was tired and my joints were bothering me.  As the days went on, I didn't get sick but my joints became more and more painful, even to sleep.  The following Sunday (February 24th) morning, I could barely get out of bed; my boyfriend had to dress me. I phoned my Dr. and was told to go to urgent care right away. At urgent care, the Dr. ran blood work, but said that he thought that I was having a severe reaction to the vaccine.  He told me to take Advil for the pain and the pain should go away soon.  No one ever called me back regarding the results of the blood work. I lived on Advil and Aleve for the next week or so in order to function. I noticed some red spots on my legs.  I thought they were spider bites, but I kept getting more.  The didn't itch, they hurt.  Eventually I had about 15 or 20 on my legs. On Thursday, March 6th I woke up with swollen joints and my hands so painful that I couldn't hold onto anything well.  I made an appointment with my family practitioner.  He looked at the spots and saw my joints.  He ordered more blood work and put me on a 6 day regimen of steroids.  He also prescribed some Vicodine so I could sleep. By the 3rd day of the steroids I felt much better and by the end of the dosing I was back to normal-I thought. Then on the morning of March 13, I woke up in pain again.  Same as before, extreme joint pain.  Have been to rheumatologist and ran several more test.  Pain is only tolerable when taking steroids and anti-inflammatories.