chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Apnoea, Blood glucose decreased, Dyskinesia, Intensive care, Intubation
Clinical narrative: Patient received hepatitis B vaccination.  One hour later the mother called RN's in because she notice that the child was not breathing.  CPR was performed, patient was intubated, atropine was give.  Patient flinched arms/legs and bit OET rhythmically.  Blood glucose was 26.  Dextrose given.  Patient was transferred to the Neonatal Intensive care unit for further evaluation.  No new seizures at this time.  Investigation is ongoing.  03/10/2008 MR received for DOS 2/28/08 with Impression: Apnea and cardiac arrest probably 2' to hypoglycemia. 2 day old newborn infant found by mom to be limp and not breathing.  No apical pulse detected. Code Blue was called and pt bagged until intubation and resuscitation initiated. After Atropine, a pulse was detected. Accucheck 26 and D25 initiated  IV. Pt placed on vent. Tonic-clonic movements of all extremities noted ~2 hours after episode. Transfered to higher level of care.  4/1/2008 MR received for NICU stay 2/28-3/23/2008 with D/C DX: 1) Neonatal Seizures. 2)Clinical Sepsis/Presumptive Meningitis. 3) Respiratory Insufficiency 2' to neonatal seizures/high dose phenobarb. 4) Laryngotracheal malacia 5) Systolic murmur. 6) Altered tone. 7) Mild hypomagnesemia and hypophosphatemia. 8) Anemia. 9) Delayed enteral feeds and gavage feed dependent. 10) Conjunctivitis bilat. 11) Reri-anal rash-improving. Infant transfered to current facility after above incident. Multiple abnormal EEGs but improving. Severly hypotonic on admission, nearly normal by d/c except decreased truncal tone.
Sex: M
Vaccine: HEP
Symptoms: Respiratory arrest, Resuscitation
Clinical narrative: Patient received hepatitis B vaccination.  One hour later the mother called RN's in because she notice that the child was not breathing.  CPR was performed, patient was intubated, atropine was give.  Patient flinched arms/legs and bit OET rhythmically.  Blood glucose was 26.  Dextrose given.  Patient was transferred to the Neonatal Intensive care unit for further evaluation.  No new seizures at this time.  Investigation is ongoing.  03/10/2008 MR received for DOS 2/28/08 with Impression: Apnea and cardiac arrest probably 2' to hypoglycemia. 2 day old newborn infant found by mom to be limp and not breathing.  No apical pulse detected. Code Blue was called and pt bagged until intubation and resuscitation initiated. After Atropine, a pulse was detected. Accucheck 26 and D25 initiated  IV. Pt placed on vent. Tonic-clonic movements of all extremities noted ~2 hours after episode. Transfered to higher level of care.  4/1/2008 MR received for NICU stay 2/28-3/23/2008 with D/C DX: 1) Neonatal Seizures. 2)Clinical Sepsis/Presumptive Meningitis. 3) Respiratory Insufficiency 2' to neonatal seizures/high dose phenobarb. 4) Laryngotracheal malacia 5) Systolic murmur. 6) Altered tone. 7) Mild hypomagnesemia and hypophosphatemia. 8) Anemia. 9) Delayed enteral feeds and gavage feed dependent. 10) Conjunctivitis bilat. 11) Reri-anal rash-improving. Infant transfered to current facility after above incident. Multiple abnormal EEGs but improving. Severly hypotonic on admission, nearly normal by d/c except decreased truncal tone.
Age: 43.0
Sex: M
Vaccine: YF
Symptoms: Rash pruritic
Clinical narrative: Presented to the clinic with an itchy, rash on the feet and legs.  (mostly on the feet)
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: CSF protein increased, CSF virus no organisms observed, CSF white blood cell count increased, Meningitis aseptic, Viral test negative
Clinical narrative: Aseptic Meningitis - Bacterial and Viral Cultures negative.  Hospitalized for 5 days, received antibiotics for 48 hrs. until cultures confirmed negative.  3/19/08 Reviewed hospital medical records of 1/28-2/1/2008 admission. FINAL DX: Aseptic meningitis & SIADH. Records reveal patient experienced HA x 5 days, fever & nausea/vomiting x 2 days.  Seen by pcp & also noted to have photophobia, meningismus, dehydration & gen myalgias.  LP done.  Tx w/IVF, IV antibiotics.  Discussed w/ID.  Continued to be febrile through d/c but clinically improved. D/C to home w/pcp f/u.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Bacterial culture negative, CSF culture negative, CSF protein increased, CSF white blood cell count positive, Meningitis aseptic
Clinical narrative: Aseptic Meningitis - Bacterial and Viral Cultures negative.  Hospitalized for 5 days, received antibiotics for 48 hrs. until cultures confirmed negative.  3/19/08 Reviewed hospital medical records of 1/28-2/1/2008 admission. FINAL DX: Aseptic meningitis & SIADH. Records reveal patient experienced HA x 5 days, fever & nausea/vomiting x 2 days.  Seen by pcp & also noted to have photophobia, meningismus, dehydration & gen myalgias.  LP done.  Tx w/IVF, IV antibiotics.  Discussed w/ID.  Continued to be febrile through d/c but clinically improved. D/C to home w/pcp f/u.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Virus culture negative
Clinical narrative: Aseptic Meningitis - Bacterial and Viral Cultures negative.  Hospitalized for 5 days, received antibiotics for 48 hrs. until cultures confirmed negative.  3/19/08 Reviewed hospital medical records of 1/28-2/1/2008 admission. FINAL DX: Aseptic meningitis & SIADH. Records reveal patient experienced HA x 5 days, fever & nausea/vomiting x 2 days.  Seen by pcp & also noted to have photophobia, meningismus, dehydration & gen myalgias.  LP done.  Tx w/IVF, IV antibiotics.  Discussed w/ID.  Continued to be febrile through d/c but clinically improved. D/C to home w/pcp f/u.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Development of cellulitis at vaccine site
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Wrong drug administered
Clinical narrative: Nurse discoved that pediatric influenza vaccine was administered by mistake
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Wrong drug administered
Clinical narrative: Nurse discovered that pediatric influenza vaccine was administered by mistake.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Erythema, Pyrexia, Retching, Urticaria, Vomiting
Clinical narrative: 4 month old with fever experienced vomiting and onset of red urticarial rash and gagging 3 days after administration of ROTATEQ.  Seen in ER, appeared well with recovering urticarial rash.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Heart rate increased, Hypotonia, Listless, Respiratory rate increased, Staring
Clinical narrative: Approximately 5 minutes after vaccination, GM brings patient back to clinic room states "patient has went limp".  Upon assessment, patient was limp, eyes open in fixed stare, unresponsive/listless.  Patient's heart rate 120, rr 40: no labored breathing.  After 5 minutes of monitoring, patient became attentive and alert.  Referred to pcp for assessment.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Approximately 5 minutes after vaccination, GM brings patient back to clinic room states "patient has went limp".  Upon assessment, patient was limp, eyes open in fixed stare, unresponsive/listless.  Patient's heart rate 120, rr 40: no labored breathing.  After 5 minutes of monitoring, patient became attentive and alert.  Referred to pcp for assessment.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Mass
Clinical narrative: Mother stated small raised area about 4 cm with small bump around area on the Rt thigh.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site scab, Injection site vesicles
Clinical narrative: A few small patches developed near injection site. Patches are itchy, raised, somewhat like pimples, yellow center surrounded by red, size of pen cap, scabby. Not oozing, warm, swollen or painful. Advised Benadryl, warm compresses.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pain in left arm (where injection) became painful (throbbing also) immediately (within 24 hours); Since then pain has been severe with throbbing, (intermittently) and loss some range of motion! By 2-19-08 pain has worsened, not lessened. Severe pain left arm only!
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Oedema peripheral, Pain, Paraesthesia, Pruritus
Clinical narrative: Started 2 days after the immunization with rash/itching - persistent.  Later (after couple months) developed tingling/pain both intermittent.  By Nov. 8, 2007 developed swelling of same arm (2 cm > circumference than opposite are), increased sensitivity to light touch. 3/14/08 Spoke w/reporter who stated patient experienced shingles type rash at injection site.  Tx w/ topical cream.  Rash now resolved but arm remains swollen & extremely sensitive to touch or clothing.  Tx symptomatically w/pain meds.  MD expects complete recovery in time.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Ultrasound Doppler normal
Clinical narrative: Started 2 days after the immunization with rash/itching - persistent.  Later (after couple months) developed tingling/pain both intermittent.  By Nov. 8, 2007 developed swelling of same arm (2 cm > circumference than opposite are), increased sensitivity to light touch. 3/14/08 Spoke w/reporter who stated patient experienced shingles type rash at injection site.  Tx w/ topical cream.  Rash now resolved but arm remains swollen & extremely sensitive to touch or clothing.  Tx symptomatically w/pain meds.  MD expects complete recovery in time.
Age: 21.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Pregnancy, Pregnancy test positive
Clinical narrative: MMR vaccine just prior to conception; LMP: 12/30/07 and vaccine given 01/10/08; positive pregnancy test on 02/25/08
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Chest pain, Erythema, Groin pain
Clinical narrative: Red, itchy rash on right shoulder, progressing to center of chest over 2 week period. Sharp stabbing pains in chest and groin. One large burning lesion in left vulvar area appeared on 02/10/08. UPPER respiratory infection began on 02/01/2008 and has not yet cleared up. Rash on shoulder and chest has gone. This is in follow-up to report(s) previously submitted on 6/24/2008. Initial information has been received from a 69 year old female concerning herself and follow up information was received from her physician. The patient had no known drug reactions/allergies and breast cancer since 09-MAY-2007, on the morning of 27-DEC-2007 was vaccinated intramuscularly with a dose of ZOSTAVAX (Merck) (LOT# 658838/1412U). Vaccination included influenza virus vaccine (unspecified) and pneumococcal 23v polysaccharide vaccine (manufacturer unknown) on 18-DEC-2007. Concomitant therapy included atenolol and "aromansin". There was no illness at the time of vaccination. On 20-JAN-2008 the patient stated she got a very red itchy rash on her right shoulder and right chest area. After a few days, it turned yellow and continued to itch. Another large patch broke out on 27-JAN-2008 on the right side below the first patch. On 01-FEB-2008 she had an upper respiratory tract infection. On 05-FEB-2008, a red, itchy, rash broke out in the middle of her chest between her breasts. On 09-FEB-2008 she had an extremely sharp pain in her groin areas and the next day (10-FEB-2010) she felt a huge blister in the left vulva area, it did not itch but it burned. That cleared up about ten days later. The physician reported that the patient was seen on 18-FEB-2008. The rash did not appear like varicella. On an unspecified date, the patient recovered from the events. There were no lab studies performed. The patient stated that she is not on chemotherapy and is taking oral medication for cancer. There was no product quality complaint involved. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy rash on right shoulder, progressing to center of chest over 2 week period. Sharp stabbing pains in chest and groin. One large burning lesion in left vulvar area appeared on 02/10/08. UPPER respiratory infection began on 02/01/2008 and has not yet cleared up. Rash on shoulder and chest has gone. This is in follow-up to report(s) previously submitted on 6/24/2008. Initial information has been received from a 69 year old female concerning herself and follow up information was received from her physician. The patient had no known drug reactions/allergies and breast cancer since 09-MAY-2007, on the morning of 27-DEC-2007 was vaccinated intramuscularly with a dose of ZOSTAVAX (Merck) (LOT# 658838/1412U). Vaccination included influenza virus vaccine (unspecified) and pneumococcal 23v polysaccharide vaccine (manufacturer unknown) on 18-DEC-2007. Concomitant therapy included atenolol and "aromansin". There was no illness at the time of vaccination. On 20-JAN-2008 the patient stated she got a very red itchy rash on her right shoulder and right chest area. After a few days, it turned yellow and continued to itch. Another large patch broke out on 27-JAN-2008 on the right side below the first patch. On 01-FEB-2008 she had an upper respiratory tract infection. On 05-FEB-2008, a red, itchy, rash broke out in the middle of her chest between her breasts. On 09-FEB-2008 she had an extremely sharp pain in her groin areas and the next day (10-FEB-2010) she felt a huge blister in the left vulva area, it did not itch but it burned. That cleared up about ten days later. The physician reported that the patient was seen on 18-FEB-2008. The rash did not appear like varicella. On an unspecified date, the patient recovered from the events. There were no lab studies performed. The patient stated that she is not on chemotherapy and is taking oral medication for cancer. There was no product quality complaint involved. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Upper respiratory tract infection
Clinical narrative: Red, itchy rash on right shoulder, progressing to center of chest over 2 week period. Sharp stabbing pains in chest and groin. One large burning lesion in left vulvar area appeared on 02/10/08. UPPER respiratory infection began on 02/01/2008 and has not yet cleared up. Rash on shoulder and chest has gone. This is in follow-up to report(s) previously submitted on 6/24/2008. Initial information has been received from a 69 year old female concerning herself and follow up information was received from her physician. The patient had no known drug reactions/allergies and breast cancer since 09-MAY-2007, on the morning of 27-DEC-2007 was vaccinated intramuscularly with a dose of ZOSTAVAX (Merck) (LOT# 658838/1412U). Vaccination included influenza virus vaccine (unspecified) and pneumococcal 23v polysaccharide vaccine (manufacturer unknown) on 18-DEC-2007. Concomitant therapy included atenolol and "aromansin". There was no illness at the time of vaccination. On 20-JAN-2008 the patient stated she got a very red itchy rash on her right shoulder and right chest area. After a few days, it turned yellow and continued to itch. Another large patch broke out on 27-JAN-2008 on the right side below the first patch. On 01-FEB-2008 she had an upper respiratory tract infection. On 05-FEB-2008, a red, itchy, rash broke out in the middle of her chest between her breasts. On 09-FEB-2008 she had an extremely sharp pain in her groin areas and the next day (10-FEB-2010) she felt a huge blister in the left vulva area, it did not itch but it burned. That cleared up about ten days later. The physician reported that the patient was seen on 18-FEB-2008. The rash did not appear like varicella. On an unspecified date, the patient recovered from the events. There were no lab studies performed. The patient stated that she is not on chemotherapy and is taking oral medication for cancer. There was no product quality complaint involved. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Chest pain, Genital pain, Pain
Clinical narrative: Red, itchy rash on right shoulder, progressing to center of chest over 2 week period. Sharp stabbing pains in chest and groin. One large burning lesion in left vulvar area appeared on 02/10/08. UPPER respiratory infection began on 02/01/2008 and has not yet cleared up. Rash on shoulder and chest has gone. This is in follow-up to report(s) previously submitted on 6/24/2008. Initial information has been received from a 69 year old female concerning herself and follow up information was received from her physician. The patient had no known drug reactions/allergies and breast cancer since 09-MAY-2007, on the morning of 27-DEC-2007 was vaccinated intramuscularly with a dose of ZOSTAVAX (Merck) (LOT# 658838/1412U). Vaccination included influenza virus vaccine (unspecified) and pneumococcal 23v polysaccharide vaccine (manufacturer unknown) on 18-DEC-2007. Concomitant therapy included atenolol and "aromansin". There was no illness at the time of vaccination. On 20-JAN-2008 the patient stated she got a very red itchy rash on her right shoulder and right chest area. After a few days, it turned yellow and continued to itch. Another large patch broke out on 27-JAN-2008 on the right side below the first patch. On 01-FEB-2008 she had an upper respiratory tract infection. On 05-FEB-2008, a red, itchy, rash broke out in the middle of her chest between her breasts. On 09-FEB-2008 she had an extremely sharp pain in her groin areas and the next day (10-FEB-2010) she felt a huge blister in the left vulva area, it did not itch but it burned. That cleared up about ten days later. The physician reported that the patient was seen on 18-FEB-2008. The rash did not appear like varicella. On an unspecified date, the patient recovered from the events. There were no lab studies performed. The patient stated that she is not on chemotherapy and is taking oral medication for cancer. There was no product quality complaint involved. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash pruritic, Upper respiratory tract infection, Vulval disorder
Clinical narrative: Red, itchy rash on right shoulder, progressing to center of chest over 2 week period. Sharp stabbing pains in chest and groin. One large burning lesion in left vulvar area appeared on 02/10/08. UPPER respiratory infection began on 02/01/2008 and has not yet cleared up. Rash on shoulder and chest has gone. This is in follow-up to report(s) previously submitted on 6/24/2008. Initial information has been received from a 69 year old female concerning herself and follow up information was received from her physician. The patient had no known drug reactions/allergies and breast cancer since 09-MAY-2007, on the morning of 27-DEC-2007 was vaccinated intramuscularly with a dose of ZOSTAVAX (Merck) (LOT# 658838/1412U). Vaccination included influenza virus vaccine (unspecified) and pneumococcal 23v polysaccharide vaccine (manufacturer unknown) on 18-DEC-2007. Concomitant therapy included atenolol and "aromansin". There was no illness at the time of vaccination. On 20-JAN-2008 the patient stated she got a very red itchy rash on her right shoulder and right chest area. After a few days, it turned yellow and continued to itch. Another large patch broke out on 27-JAN-2008 on the right side below the first patch. On 01-FEB-2008 she had an upper respiratory tract infection. On 05-FEB-2008, a red, itchy, rash broke out in the middle of her chest between her breasts. On 09-FEB-2008 she had an extremely sharp pain in her groin areas and the next day (10-FEB-2010) she felt a huge blister in the left vulva area, it did not itch but it burned. That cleared up about ten days later. The physician reported that the patient was seen on 18-FEB-2008. The rash did not appear like varicella. On an unspecified date, the patient recovered from the events. There were no lab studies performed. The patient stated that she is not on chemotherapy and is taking oral medication for cancer. There was no product quality complaint involved. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blood count normal, Body temperature increased, Influenza serology negative, Virus serology test
Clinical narrative: Patient received vaccines 2/22/08 about 8:30 am.  Patient spiked a temperature of 105.8 at 10:30 pm 2-23-08; went to the ER where his blood count was NNL and tested negative for Influenza.  RSV is now being R/O by pediatrician.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: C-reactive protein increased, Full blood count, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Pt presented to clinic 7 days post vaccination complaining of symptoms at injection site that developed 5 days post vaccination. Noted erythema, edema, tenderness gradually increasing in size until clinic visit. PE - 13 cm x 9.5 cm circular, indurated, erythematous lesion on (R) deltoid. Tx: (1) Rocephin 1 mg IM x 1, (2) Clindamycin 400 mg qd x 10 d, (3) Benadryl PRN.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site swelling, Skin lesion
Clinical narrative: Pt presented to clinic 7 days post vaccination complaining of symptoms at injection site that developed 5 days post vaccination. Noted erythema, edema, tenderness gradually increasing in size until clinic visit. PE - 13 cm x 9.5 cm circular, indurated, erythematous lesion on (R) deltoid. Tx: (1) Rocephin 1 mg IM x 1, (2) Clindamycin 400 mg qd x 10 d, (3) Benadryl PRN.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Pharyngeal erythema, Pruritus, Rash
Clinical narrative: Chills, itchy, horrible burning rash in throat, short of breath, throat very red inside mouth.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat irritation
Clinical narrative: Chills, itchy, horrible burning rash in throat, short of breath, throat very red inside mouth.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site pain
Clinical narrative: On 10-20-07 "Patient" complained she had pain, bruise on site of Fluzone injection (on 10/16/07); Looked like she got alot of bleeding under skin. Saw Dr.. HAD PRESCRIPTION: KEFLEX 500MG BOD X7D
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin induration, Skin reaction, Skin warm
Clinical narrative: Inj 2/19/08. Skin rx noticed 2/20/08 - red, warm, firm skin - 5" x 3" 2-22 PM area limb - now 2/22/08 3 inch area. Treated with: PO Benadryl, topical steroid and Cipro.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Complement factor C3, Complement factor C4, Immunology test, Musculoskeletal pain
Clinical narrative: Left shoulder pain with without swelling post AVA #3. Symptom: Joint Pain, Isolated Start: 01/26/2008 End: 02/04/2008 Comment: left shoulder
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Patient came back to office with rash on right leg for 12 days per mother.  15 cm x 6 cm (hive like lesion).  Erythematous.
Age: 22.0
Sex: M
Vaccine: TTOX
Symptoms: Chills, Pain, Paraesthesia, Pyrexia
Clinical narrative: Donor states a few hours after injection he felt all over body aches; fever/chills with some tingling in hands that have persisted for 2 days so far; no Shortness of breath; No rash
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Induration, Inflammation, Oedema peripheral
Clinical narrative: Right deltoid area inflamed, hard and swollen.  Benadryl, Cortaid, ice pack, Tylenol recommended.  If symptoms persist to return to clinic ASAP.
Age: 73.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: (L) shoulder swollen, red and itchy.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: 12-24 hours after injections - left thigh swollen, red, sl tenderness. 48 hours after injection left thigh double the size q right thigh. 7" area of erythema
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt returned for recheck appt. of other problem - showed injection site (L) upper arm - red and swollen.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: 24 hours after receiving vaccine, patient developed swelling, redness, tenderness in arm. Required Atenol, wistuart cream, and Keflex for therapy. Also added cool compressions
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Injection Site - Erythematous, induration; No fever; No itching; No pain
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Chest X-ray, Chills, Electrocardiogram, Erythema
Clinical narrative: Swelling from top of right shoulder to right elbow. Redness in the same area of arm. Arm was aching and still somewhat sore. Cold chills for about 12 hours, plus flushed feeling.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Flushing, Oedema peripheral, Pain in extremity
Clinical narrative: Swelling from top of right shoulder to right elbow. Redness in the same area of arm. Arm was aching and still somewhat sore. Cold chills for about 12 hours, plus flushed feeling.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Full blood count normal, Pain in extremity, Skin burning sensation
Clinical narrative: Painful red burning area on right upper arm.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Loss of consciousness, Stomach discomfort
Clinical narrative: After receiving Hep A injection, pt felt dizzy and stomach "felt funny". Pt laid down on exam table and "passed out" for a couple of seconds and waited in room for 10 minutes. Pt recovered quickly. BP was taken 90/60. Pt left with mother feeling well.
Age: 1.8
Sex: M
Vaccine: HEPA, MMR
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizures x2
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Dizziness, Injection site pruritus, Injection site warmth, Joint stiffness
Clinical narrative: Description: concerned with left arm swelling within 24 hrs post AVA #3 on 11 Jul 07. With AVA #1 in Dec 05 he reported the normal burning, felt light headed for 14 hrs, denied swelling or redness. With AVA #2 on 22 Jun 07 he reported joint pain in wrist and elbow for 10 days without swelling and all symptoms fully resolved before AVA #3. With his third shot he reported that the area was itchy and warm. He stated that his wrist, elbow and shoulder joints of his left arm were stiff, and that his biceps felt tight. He stated that the swelling did spread below elbow but improved after a couple of days. He denied fever and headache and did not seek medical attention.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Oedema peripheral, Skin burning sensation
Clinical narrative: Description: concerned with left arm swelling within 24 hrs post AVA #3 on 11 Jul 07. With AVA #1 in Dec 05 he reported the normal burning, felt light headed for 14 hrs, denied swelling or redness. With AVA #2 on 22 Jun 07 he reported joint pain in wrist and elbow for 10 days without swelling and all symptoms fully resolved before AVA #3. With his third shot he reported that the area was itchy and warm. He stated that his wrist, elbow and shoulder joints of his left arm were stiff, and that his biceps felt tight. He stated that the swelling did spread below elbow but improved after a couple of days. He denied fever and headache and did not seek medical attention.
Age: 8.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Abdominal pain upper, Anorexia, Body temperature increased, Lethargy, Medication error
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of low grade temperature in an 8-year-old female subject who was vaccinated with BOOSTRIX, GlaxoSmithKline.  The healthcare professional reported the specific age of the subject as 8 years, 7 months and 10 days.  The subject's medical history included pertussis exposure on 31 October 2007.  Concurrent medical conditions, reported on 7 November 2007, included a urinary tract infection "for the last 5 weeks which was unresolved."  The subject had no adverse events following receipt of previous immunizations.  On 5 November 2007 at 1:00 p.m., the subject received 5th dose of BOOSTRIX (.5 ml, unknown, left arm).  Concurrent vaccination on 5 November 2007 included SANOFI, MMRII, Merck, and VARIVAX, Merck.  The healthcare professional did not believe the other vaccines given were co-suspects.  As a result of the BOOSTRIX administration on 5 November 2007, the subject experienced a vaccination error.  On 6 November 2007, 1 day after vaccination with BOOSTRIX, the subject experienced low grade temperature, vomiting, stomach cramps, lethargy, and no appetite.  The subject was seen at a physician's office.  The healthcare professional reported that she believed the subject was having flu like symptoms and was really getting the flu.  At the time of reporting the events were unresolved.
Age: 8.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of low grade temperature in an 8-year-old female subject who was vaccinated with BOOSTRIX, GlaxoSmithKline.  The healthcare professional reported the specific age of the subject as 8 years, 7 months and 10 days.  The subject's medical history included pertussis exposure on 31 October 2007.  Concurrent medical conditions, reported on 7 November 2007, included a urinary tract infection "for the last 5 weeks which was unresolved."  The subject had no adverse events following receipt of previous immunizations.  On 5 November 2007 at 1:00 p.m., the subject received 5th dose of BOOSTRIX (.5 ml, unknown, left arm).  Concurrent vaccination on 5 November 2007 included SANOFI, MMRII, Merck, and VARIVAX, Merck.  The healthcare professional did not believe the other vaccines given were co-suspects.  As a result of the BOOSTRIX administration on 5 November 2007, the subject experienced a vaccination error.  On 6 November 2007, 1 day after vaccination with BOOSTRIX, the subject experienced low grade temperature, vomiting, stomach cramps, lethargy, and no appetite.  The subject was seen at a physician's office.  The healthcare professional reported that she believed the subject was having flu like symptoms and was really getting the flu.  At the time of reporting the events were unresolved.
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Arthritis
Clinical narrative: This case was reported by a consumer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with DTPa (with small D + P), manufacturer unspecified.  The reporter is the subject.  A physician or other health care professional has not verified this report.  The subject's medical history included acid reflux and slow thyroid.  Concurrent medications included Omeprazole and Thyroxine sodium (Thyroxine).  On 11 July of an unspecified year, at 11:30 a.m., the subject received 1st dose of DTPa (with small D + P) (unknown).  The subject indicated that she was given a "TDAP vaccine" but was unsure whether or not it was a GSK vaccine.  On 13 July of an unspecified year, 2 days after vaccination with DTPa (with small D +P), the subject "woke up with" joint pain that included her right shoulder, right arm including her wrist, her left wrist, and both legs.  She was treated for pain at the emergency room as well as at the clinic where she received the vaccine.  The subject reported that a healthcare professional said the events were arthritis.  At the time of initial reporting the events were worse.
Sex: F
Vaccine: TDAP, UNK
Symptoms: Blood glucose increased
Clinical narrative: This case was reported by a physician and described the occurrence of elevated blood glucose in an adolescent female subject who was vaccinated with Boostrix (GlaxoSmithKline).Concurrent medical conditions included diabetes. Previous and/or concurrent vaccination included unspecified vaccines given the same day as Boostrix. On an unspecified date the subject received 1st dose of Boostrix (.5 ml, unknown). At an unspecified time after vaccination with Boostrix, the subject experienced elevated blood glucose. The reporting physician was contacted on 14 November 2007 regarding the elevated blood glucose that were not reported as severe. No other details were provided. At the time of reporting, the outcome of the event was unspecified.
Age: 19.0
Sex: F
Vaccine: JEV
Symptoms: Eye swelling, Infectious mononucleosis, Lymphadenopathy, Pharyngolaryngeal pain, Respiratory tract congestion
Clinical narrative: Initial report received from a physician on 19 April 2007. A 19 year old, female patient developed swelling of both eyes after she received her second dose of JE-VAX (lot number EJN228A) subcutaneously in the right arm on 09 April 2007. She also had a sore throat, congestion and lymph node enlargement-neck. She received her first dose of JE-VAX (lot number EJN228A) subcutaneously in the left arm on 02 April 2007. She was treated with Benadryl on 18 April 2007. At the time of the report, she had not recovered. Follow up information received on 02 July 2007 from a physician in USA; The patient had recovered. No sensitization tests done as she declined further service since 20 April 2007. On 23 April 2007 the patient's mother reported that the patient diagnosed with "mono" and "UTI". On 08 May 2007 the patient did not report any prolonged symptoms. Follow-up information received on 23 July 2007 from a health care professional. The reported events were confirmed as mononucleosis and urinary tract infection. Per the reporter, any laboratory results done between 20 April and 23 April were done by the patient's primary care physician "not my clinic."
Age: 19.0
Sex: F
Vaccine: JEV
Symptoms: Urinary tract infection
Clinical narrative: Initial report received from a physician on 19 April 2007. A 19 year old, female patient developed swelling of both eyes after she received her second dose of JE-VAX (lot number EJN228A) subcutaneously in the right arm on 09 April 2007. She also had a sore throat, congestion and lymph node enlargement-neck. She received her first dose of JE-VAX (lot number EJN228A) subcutaneously in the left arm on 02 April 2007. She was treated with Benadryl on 18 April 2007. At the time of the report, she had not recovered. Follow up information received on 02 July 2007 from a physician in USA; The patient had recovered. No sensitization tests done as she declined further service since 20 April 2007. On 23 April 2007 the patient's mother reported that the patient diagnosed with "mono" and "UTI". On 08 May 2007 the patient did not report any prolonged symptoms. Follow-up information received on 23 July 2007 from a health care professional. The reported events were confirmed as mononucleosis and urinary tract infection. Per the reporter, any laboratory results done between 20 April and 23 April were done by the patient's primary care physician "not my clinic."
Age: 25.0
Sex: F
Vaccine: JEV
Symptoms: Lip pain, Rash, Urticaria
Clinical narrative: A 25 year old, female patient (with no known allergies) developed generalized pruritus throughout the body after she received JE-VAX (lot number EJN235A, site of administration not reported) subcutaneously on 01 May 2007.  She received Hepatitis A vaccine (manufacturer and lot number unknown) on 26 April 2007.  The patient denied actual urticaria or hives and denied rash.  She also complained of feeling sore on the inside of the lips.  She was not treated by a doctor but she took some medication with some effect, but it returns.  At the time of the vaccination, she was taking vitamins and denied any illness.  It was reported that she had not recovered.
Sex: U
Vaccine: HEP, HEPA, IPV, JEV, TTOX, YF
Symptoms: Erythema, Night sweats, Rash generalised
Clinical narrative: A patient reported experiencing 'red dots, raised rash generalized, and night sweats' several days after receiving JE-Vax, YF-Vax, Hepatitis A, Hepatitis B, Tetanus, Polio, and Meningitis vaccines (lot numbers not provided). No additional information was provided.
Age: 29.0
Sex: F
Vaccine: JEV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: A 29 year old female patient, received on 14 June 2007 first subcutaneous dose of JE VAX (lot# EJN228A) into the right arm.  The patient experienced on 15 June 2007 localized reaction of redness and swelling that resolved after 2 to 3 days.  The patient had recovered.  Treatment was not reported.  On 05 June 2007, the patient received RABAVERT (NOVARTIS, lot# U12011A) intramuscular first dose into the left deltoid.  No illness at vaccination time.  No pre-existing physician diagnosed allergies or medical conditions.  The patient did not receive any other medications.  Follow-up information received on 01 October 2007 from a health care professional.  The case was reviewed, and there was no additional information at this time.
Age: 1.02
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Crying, Hypersomnia, Pharyngitis, Pyrexia
Clinical narrative: Rec'd MMR, Varicella, Comvax, Prevnar on 4/5/05.  Presented afternoon of 4/6/05 with having slept well, but with longer nap and several hours of crying on 4/6.  PE significant for pharyngitis, normal TM's, no fever.  Mother called 4/15/05 to report overnight fever to 103 but child did not require visit.  After consideration, mother reports (2/08) memory of prolonged screaming, thrashing and fever over a period of 2 hours the evening of 4/14/05.  The child was fatigued but otherwise normal the next day.
Age: 23.0
Sex: M
Vaccine: HEPA, MNQ, PPV
Symptoms: Pyrexia, Syncope
Clinical narrative: Syncope at approximately 3:10 AM, syncope at approximately 3:15 AM, fever of 101 degrees Fahrenheit through approximately 2PM of March 1 2008 (down to 100 degrees thereafter).  Treatment:  aspirin, fluids.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Back pain, Convulsion, Diet refusal, Feeling abnormal, Irritability
Clinical narrative: On Feb. 22, late in the afternoon, patient received her third DTaP, polio and Heb B vaccine. Her mother gave her Tylenol. By 8 p.m. she became lethargic.  Her mother gave her Tylenol as recommended throughout the night.  Mother called the pediatrician around 7.25 a.m. to advise that her fever was at 103.5.  By 8:15 a.m on Sat. Feb. 23, she went into a seizure followed by a shock like state.  911 was called and she was taken to Hospital.  She is still sick with fussiness, seems to be achy in her back, sleepier more than normal, momentarily spaced out with eyes blank and open on 3/1/07, not eating solid foods, bowels irritated.  Physician referred her to a neurologist.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Irritable bowel syndrome, Pyrexia, Shock, Somnolence, Staring
Clinical narrative: On Feb. 22, late in the afternoon, patient received her third DTaP, polio and Heb B vaccine. Her mother gave her Tylenol. By 8 p.m. she became lethargic.  Her mother gave her Tylenol as recommended throughout the night.  Mother called the pediatrician around 7.25 a.m. to advise that her fever was at 103.5.  By 8:15 a.m on Sat. Feb. 23, she went into a seizure followed by a shock like state.  911 was called and she was taken to Hospital.  She is still sick with fussiness, seems to be achy in her back, sleepier more than normal, momentarily spaced out with eyes blank and open on 3/1/07, not eating solid foods, bowels irritated.  Physician referred her to a neurologist.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Urine analysis normal
Clinical narrative: On Feb. 22, late in the afternoon, patient received her third DTaP, polio and Heb B vaccine. Her mother gave her Tylenol. By 8 p.m. she became lethargic.  Her mother gave her Tylenol as recommended throughout the night.  Mother called the pediatrician around 7.25 a.m. to advise that her fever was at 103.5.  By 8:15 a.m on Sat. Feb. 23, she went into a seizure followed by a shock like state.  911 was called and she was taken to Hospital.  She is still sick with fussiness, seems to be achy in her back, sleepier more than normal, momentarily spaced out with eyes blank and open on 3/1/07, not eating solid foods, bowels irritated.  Physician referred her to a neurologist.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Blood test normal, Bone marrow oedema, Bursitis, Injection site irritation, Injection site pain
Clinical narrative: Shot was given too high, into shoulder joint.  Burning when given, pain down to elbow.  General soreness following week.  10 days after severe sharp shooting pain began, weakness, burning.  Treated with anti-inflammatory, MRI showed bone marrow edema and bursitis.  4 months later, shoulder still sore.  This is due to an improper injection, into the joint instead of the muscle.  Shot was given at work through by Occupational Health nurse.  Two others have the same issues.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Muscular weakness, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain, Wrong technique in drug usage process
Clinical narrative: Shot was given too high, into shoulder joint.  Burning when given, pain down to elbow.  General soreness following week.  10 days after severe sharp shooting pain began, weakness, burning.  Treated with anti-inflammatory, MRI showed bone marrow edema and bursitis.  4 months later, shoulder still sore.  This is due to an improper injection, into the joint instead of the muscle.  Shot was given at work through by Occupational Health nurse.  Two others have the same issues.
Age: 0.75
Sex: M
Vaccine: FLUX
Symptoms: Antisocial behaviour, Childhood disintegrative disorder, Diarrhoea, Feeling abnormal, Food allergy
Clinical narrative: Systemic hives 7 days following vaccination and continued for 2 weeks intermittently. Gastrointestinal pain and diarrhea for 6 weeks. Withdrew socially, stopped responding to name, started "zoning out", stopped progressing with language development for 6 months.
Age: 0.75
Sex: M
Vaccine: FLUX
Symptoms: Gastrointestinal pain, Radioallergosorbent test, Urticaria
Clinical narrative: Systemic hives 7 days following vaccination and continued for 2 weeks intermittently. Gastrointestinal pain and diarrhea for 6 weeks. Withdrew socially, stopped responding to name, started "zoning out", stopped progressing with language development for 6 months.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Dry skin, Head injury, Loss of consciousness, Skin warm
Clinical narrative: Pt felt dizzy after receiving Hep A vaccine. He left the immunes room and walked to the dental room across the hall. Pt passed out and hit head on door several times until someone noticed he had passed out. On assessment post vaccination, skin was unremarkably warm and dry. Not on any medications. Pt then told us, he had not eaten or drank much over past 48 hours. Lungs clear, temp of 102.9. EKG done. MD assessed. EMTS came to evaluate pt. Did not go to hospital.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Cyanosis, Hypotonia, Laboratory test normal, Livedo reticularis
Clinical narrative: Pt collapsed, stopped breathing, flaccid, cyanotic lips and hands. Mottled areas on body. I started CPR on him because I am a registered nurse, rushed him to ER. Temp 106, Ambu bagged, responds, placed on cooling pad.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Respiratory arrest, Resuscitation, Syncope, Vaccination complication
Clinical narrative: Pt collapsed, stopped breathing, flaccid, cyanotic lips and hands. Mottled areas on body. I started CPR on him because I am a registered nurse, rushed him to ER. Temp 106, Ambu bagged, responds, placed on cooling pad.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 21 February 2008 from the patient.  A 43-year-old female patient received a right upper arm, intramuscular injection of Adacel, lot number not reported, on 28 October 2007.  Immediately upon insertion of the needle, the patient complained of pain in the right arm and shoulder which continues to persist.  The patient additionally has periodic numbness and tingling in the right arm.  MRI showed a sprained rotator cuff.  The patient was treated with a tens unit, lidocaine patch, Flexeril, and Vicodin.  At the time of this report, the patient had not recovered.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 21 February 2008 from the patient.  A 43-year-old female patient received a right upper arm, intramuscular injection of Adacel, lot number not reported, on 28 October 2007.  Immediately upon insertion of the needle, the patient complained of pain in the right arm and shoulder which continues to persist.  The patient additionally has periodic numbness and tingling in the right arm.  MRI showed a sprained rotator cuff.  The patient was treated with a tens unit, lidocaine patch, Flexeril, and Vicodin.  At the time of this report, the patient had not recovered.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 21 February 2008 from the patient.  A 43-year-old female patient received a right upper arm, intramuscular injection of Adacel, lot number not reported, on 28 October 2007.  Immediately upon insertion of the needle, the patient complained of pain in the right arm and shoulder which continues to persist.  The patient additionally has periodic numbness and tingling in the right arm.  MRI showed a sprained rotator cuff.  The patient was treated with a tens unit, lidocaine patch, Flexeril, and Vicodin.  At the time of this report, the patient had not recovered.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia, Rotator cuff syndrome
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 21 February 2008 from the patient.  A 43-year-old female patient received a right upper arm, intramuscular injection of Adacel, lot number not reported, on 28 October 2007.  Immediately upon insertion of the needle, the patient complained of pain in the right arm and shoulder which continues to persist.  The patient additionally has periodic numbness and tingling in the right arm.  MRI showed a sprained rotator cuff.  The patient was treated with a tens unit, lidocaine patch, Flexeril, and Vicodin.  At the time of this report, the patient had not recovered.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Death, Laboratory test
Clinical narrative: Information has been received from a consumer concerning her 17 week old grandson, who in July 2007, was vaccinated with PedvaxHIB (Lot# "VFIG4AA"). Concomitant suspect vaccination included Comvax. Other concomitant therapies included "five unspecified vaccinations and teething pills." The patient sought unspecified medical attention. Laboratory diagnostics were performed, however the specific were unknown. On 19-SEP-2007 the patient died. The cause of death was unspecified. No product quality complaint was involved. Additional information has been requested.  5/13 Autopsy report state COD as anoxic encephalopathy due to interrupted SIDS. Report states patient found pulseless & apneic followed by successful parental CPR; hospitalized 9/16-9/19/2007 w/supportive care & developed seizures & condition deteriorated; diffuse anoxic encephalopathy; scene & circumstances c/w interrupted SIDS.