chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Fall, Guillain-Barre syndrome, Muscular weakness, Weight bearing difficulty
Clinical narrative: Initial case received from health care professional, on 06 February 2012. A 75-year-old male patient received an injection (route and site not reported) of FLUZONE HIGH-DOSE, sanofi pasteur Inc. lot number UH458AC, on 13 October 2011. The patient's medical history, any concomitant medications, and any illnesses at the time of vaccination were not reported. On 26 October 2011, the patient developed symptoms of weakness in both lower limbs. The patient was unable to put any weight on either leg and would fall down. The patient was diagnosed with Guillain-Barre Syndrome (GBS). The outcome was not reported. Documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Initial case received from health care professional, on 06 February 2012. A 75-year-old male patient received an injection (route and site not reported) of FLUZONE HIGH-DOSE, sanofi pasteur Inc. lot number UH458AC, on 13 October 2011. The patient's medical history, any concomitant medications, and any illnesses at the time of vaccination were not reported. On 26 October 2011, the patient developed symptoms of weakness in both lower limbs. The patient was unable to put any weight on either leg and would fall down. The patient was diagnosed with Guillain-Barre Syndrome (GBS). The outcome was not reported. Documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Fall, Guillain-Barre syndrome, Muscular weakness, Weight bearing difficulty
Clinical narrative: Weakness of both lower limbs within 2 weeks of shot. Guillain-Barre Syndrome within 2 wks of shot.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Weakness of both lower limbs within 2 weeks of shot. Guillain-Barre Syndrome within 2 wks of shot.
Sex: M
Vaccine: TDAP
Symptoms: Bordetella test positive, Pertussis
Clinical narrative: Initial case received from health care professional on 06 February 2012. A male patient received an injection (route and site not reported) of ADACEL, sanofi pasteur Ltd. lot number not reported, three to four years ago (date of vaccination not provided). The patient's medical history, any concomitant medications, and any illnesses at the time of vaccination were not reported. Three to four years post-vaccination with ADACEL, the patient tested positive for Pertussis. The outcome was not reported. Documents held by sender: none.
Sex: F
Vaccine: PPV
Symptoms: Malaise, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a healthcare worker (also reported as a wholesaler) who received an email from a doctor's office concerning a female who on 18-JAN-2012 was vaccinated with a dose of PNEUMOVAX 23 (lot# 672074/1502AA). On an unspecified date the patient had "bad reaction", experienced itching and swelling on 1 arm from hand to elbow and a general ill feeling. The patient was admitted to the hospital (name and location of the hospital is unknown). No information on the treatment given at the hospital was provided. At the time of reporting, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy normal, Human chorionic gonadotropin negative, Laboratory test normal, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning about her currently 20 year old daughter with yeast infection and none drug reactions who in approximately January 2012, was vaccinated during doctor office visit (for yeast infection) with a dose of GARDASIL, (dose, number of prior doses, route and Lot # unknown). In approximately January 2012 (in the moment of vaccination) patient underwent unspecified pregnancy test and unspecified sexually transmitted disease (STD) test were both negative. In approximately January 2012 (reported as "one week later"), her Papanicolaou smear (PAP) was off. Two weeks after receiving GARDASIL a colposcopy was done and was negative but the scraping was positive for possible cancer. The patient did not seek medical attention. No treatment was given for adverse events. At the time of the report the patient status was unknown. Upon internal review, Scraping was positive for possible cancer was determined to be an other important medical event. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Fall, Immediate post-injection reaction, Lethargy, Pallor, Syncope
Clinical narrative: Client vaccinated 1st, 3 brothers vaccinated after. Client seemed fine until directly before departure. Client fainted and fell to the floor hitting right upper cheek on floor/carpet. Client had small rug burn on upper cheek. Immediately after fainting (cont'd on back) mother picked up off floor. I grabbed the smelling salts & prepared, then client woke up. Smelling salt was not needed. I provided client with a juice & a cool rag for his face. During fainting episode client urinated in his clothes. Monitored client for approx. 25 minutes. Checked pulse, within average range. Pulse was 92 bpm. Client regained some color in his face & was able to walk to restroom with mother's assistance. Client remained very lethargic after fainting episode. Referred mother to urgent care due to client bumping cheek/face on the floor and continuous lethargy. Client being vaccinated 1st then watching 3 brothers being vaccinated along with wearing heavy winter coat could have contributed to fainting episode. 8:40 am 2/14/12 Spoke with mother. Client is well & back to normal. They did go to urgent care, urgent care directed them to take client home & monitor for a couple of hours & if needed then seek care at ER if felt necessary. After leaving urgent care client vomited then felt better, family went and had ice cream. Client vomitted shortly after consuming ice cream. Mother said after that he was doing well & back to himself. They did check on him a couple of times through the night.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Vomiting
Clinical narrative: Client vaccinated 1st, 3 brothers vaccinated after. Client seemed fine until directly before departure. Client fainted and fell to the floor hitting right upper cheek on floor/carpet. Client had small rug burn on upper cheek. Immediately after fainting (cont'd on back) mother picked up off floor. I grabbed the smelling salts & prepared, then client woke up. Smelling salt was not needed. I provided client with a juice & a cool rag for his face. During fainting episode client urinated in his clothes. Monitored client for approx. 25 minutes. Checked pulse, within average range. Pulse was 92 bpm. Client regained some color in his face & was able to walk to restroom with mother's assistance. Client remained very lethargic after fainting episode. Referred mother to urgent care due to client bumping cheek/face on the floor and continuous lethargy. Client being vaccinated 1st then watching 3 brothers being vaccinated along with wearing heavy winter coat could have contributed to fainting episode. 8:40 am 2/14/12 Spoke with mother. Client is well & back to normal. They did go to urgent care, urgent care directed them to take client home & monitor for a couple of hours & if needed then seek care at ER if felt necessary. After leaving urgent care client vomited then felt better, family went and had ice cream. Client vomitted shortly after consuming ice cream. Mother said after that he was doing well & back to himself. They did check on him a couple of times through the night.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Per Mom - "swelling of whole upper arm, redness, fever. She forgot to mention child had chicken pox at age 2".
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Foetal malposition, Human chorionic gonadotropin positive, Maternal exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a 20 year old female consumer for GARDASIL, a Pregnancy Registry product, concerning her own experience, with "sulfa allergies" and with no pertinent medical history who on approximately 01-JUN-2010 was vaccinated with a first dose of GARDASIL (dose, route and Lot # not reported), "Three months from the second dose" on approximately 01-SEP-2010 was vaccinated with a second dose of GARDASIL (dose, route and Lot # not reported) and on "around first of December" approximately 01-DEC-2010 was vaccinated with a third dose of GARDASIL (dose, route and Lot # not reported). There was no concomitant medication. A pregnancy test was performed, which was positive. No adverse event reported. At the time of the report the patient had 15 days of gestation (LMP approximately on 01-NOV-2010; EDD on 08-AUG-2011). Follow-up information was received from a health professional who stated that the female patient on 10-DEC-2010, was vaccinated with the third 0.5 ml dose of GARDASIL (lot# 666595/0887Z). Her last menstrual period was stated to have been on 01-NOV-2010 and her estimated delivery date was reported to be 08-AUG-2011. Follow up information has been received via telephone call from the patient's grandmother who reported that the patient gave birth via cesarean section to a full term baby girl on 02-AUG-2011 (also reported as 02-AUG-2012). The baby girl was "perfectly healthy" and weighed 6lbs 8oz. The reporter stated that she believed the C-section was determined necessary in delivery because the baby "was carrying wrong". The pregnancy was reported to be normal otherwise and the grandmother stated that both the mom and the baby had no other complications after birth. Upon internal review C-section was considered to be an other important medical event. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Aborted pregnancy, Human chorionic gonadotropin positive, Maternal exposure during pregnancy, Uterine dilation and curettage
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female with no medical history or drug allergies, who on an unspecified date was vaccinated IM with a second 0.5 ml dose of GARDASIL (lot # 666163/0664Z). On an unspecified date after receiving GARDASIL, the patient became pregnancy. Lab diagnostics studies performed included urine pregnancy test. No adverse effect reported. The patient sought unspecified medical attention. At the time of report, the patient's present status was not provided by the reporter. Follow up information has been received from a Registered Nurse (R.N.) reported that she had scanty details about outcomes. The patient's LMP was 27-OCT-2010 and on an unspecified date in December 2010; the patient had a dilation and curettage (D&C) and aborted the pregnancy. The nurse was asked to clarify if the D&C was performed due to an incomplete spontaneous abortion or as an elective abortion. She stated that was not clearly specified in the patient's record. There was no information regarding an examination of fetal contents done post D&C. The patient had a history of 2 spontaneous abortions. One spontaneous abortion occurred in April 2006 and one in October 2006; both at 7-8 weeks gestation. In 2008, she gave birth to a live healthy infant at 40 weeks. Upon internal review dilation and curettage (D&C) and aborted the pregnancy was considered to be an other important medical event. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Malaise, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a healthcare worker (also reported as a wholesaler) who received an email from a doctor's office concerning a female who on 30-JAN-2012 was vaccinated with a dose of PNEUMOVAX 23 (lot# 672074/1502AA). On an unspecified date the patient had a "bad reaction", the patient experienced itching and swelling on 1 arm from hand to elbow and a general ill feeling. The patient was admitted to the hospital (name and location of the hospital is unknown). No information on the treatment given at the hospital was provided. At the time of reporting, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Lethargy, Pallor, Vomiting
Clinical narrative: C/o lethargy, pale, no fever, c/o vomiting x3 days, 1-26-12 through 1-28-12. C/o watery, uncontrolled diarrhea stool x3 over 1-26-12 through 1-28-12. Consulted family physician, no treatment. Gave child PEDIALYTE.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Wheezing, after 3 1/2 months of no issues.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Blood creatine phosphokinase, Injection site reaction, Myalgia, Red blood cell sedimentation rate
Clinical narrative: Sore muscles in right shoulder and upper arm.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient seen in the Urgent Care Center approximately 2 days after administration of vaccine with complaints of redness, warmth at injection site and mild induration.  Pt was treated with Ibuprofen and Benadryl and advised to follow up with primary care clinic for any further problems.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Dyskinesia, Erythema, Posturing, Respiratory arrest
Clinical narrative: Pt seized about 3-5 minutes after receiving vaccine.  She became very red, not breathing, tonic and posturing that lasted about 1-2 minutes.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Autopsy, Death
Clinical narrative: Baby found dead by mother.
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Confusional state, Disorientation, Feeling hot, Hyperhidrosis, Loss of consciousness
Clinical narrative: Client states he woke up feeling hot. He ate breakfast then lay on the couch in the living room watching TV. He then got up, walked to the table and back to the couch. Per his wife he collapsed onto the couch and had snoring respirations for about 15 minutes. She was unable to arouse him. She did not call 911. Client states he felt disoriented, confused, and sweaty for about 30 minutes after regaining consciousness. He has felt well since then. No further episodes or symptoms.
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Snoring, Syncope, Unresponsive to stimuli
Clinical narrative: Client states he woke up feeling hot. He ate breakfast then lay on the couch in the living room watching TV. He then got up, walked to the table and back to the couch. Per his wife he collapsed onto the couch and had snoring respirations for about 15 minutes. She was unable to arouse him. She did not call 911. Client states he felt disoriented, confused, and sweaty for about 30 minutes after regaining consciousness. He has felt well since then. No further episodes or symptoms.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Same evening after vaccination began with red area around injection site. On 2/10/12 area was larger - redder and warm to touch. Diagnosed with cellulitis and treated with KEFLEX.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Erythema, Oedema peripheral, Skin warm
Clinical narrative: 24 hrs after receiving INFLUENZA vaccine, around 7 pm, (L) arm was swollen, red, hives, hot to touch. Dizziness and SOB.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 24 hrs after receiving INFLUENZA vaccine, around 7 pm, (L) arm was swollen, red, hives, hot to touch. Dizziness and SOB.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Dysphonia, Erythema
Clinical narrative: Redness on chest and (R) & (L) upper arm and pt was hoarse.
Age: 26.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness, Vaccine positive rechallenge
Clinical narrative: Patient with a 5 year history of flu like symptoms after receiving the flu vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: none
Age: 1.13
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13
Symptoms: Conjunctivitis, Cough, Irritability, Measles antibody negative, Pallor
Clinical narrative: Red rash, fussiness, cough, conjunctivitis, coryza 5 days before presentation. fever 102.8 two days before presentation. Seen in urgent care twice in those 5 days. Rash in office: brownish-red, raised, blanchable, coalescing in some areas. Present on trunk, legs down to feet, arms down to hands, neck.
Age: 1.13
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13
Symptoms: Pyrexia, Rash papular, Rhinitis
Clinical narrative: Red rash, fussiness, cough, conjunctivitis, coryza 5 days before presentation. fever 102.8 two days before presentation. Seen in urgent care twice in those 5 days. Rash in office: brownish-red, raised, blanchable, coalescing in some areas. Present on trunk, legs down to feet, arms down to hands, neck.
Age: 24.0
Sex: M
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Headache, Injection site pain, Pain
Clinical narrative: Pain surrounding injection site (in deltoid muscle)-could not move arm without intense pain shooting down arm.  Headache. Unable to perform normal exercise routines or sleep on affected arm as a result. Duration of symptoms: Two weeks straight following injection.  No treatment.
Age: 59.0
Sex: M
Vaccine: TTOX
Symptoms: Chills, Diarrhoea, Pain, Productive cough, Pyrexia
Clinical narrative: 1/22 sneezing, runny nose, achy, chilling, temp about 100, diarrhea on/off, fever peaked 102 on 1/25/12, productive cough, temp decreasing to 100 1/28, feeling much improved 2/8/12.
Age: 59.0
Sex: M
Vaccine: TTOX
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: 1/22 sneezing, runny nose, achy, chilling, temp about 100, diarrhea on/off, fever peaked 102 on 1/25/12, productive cough, temp decreasing to 100 1/28, feeling much improved 2/8/12.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Pain in extremity
Clinical narrative: Arm hurt right away, felt like a rock in my arm for about a week.  Arm is still hurting during certain range of movements.
Age: 9.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Raised red area 4.5 cm in diameter left upper posterior aspect of arm, warm to touch, itches. Symptoms started this afternoon. Treated with BENADRYL & ice.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Influenza like illness, Rash pustular, Scab
Clinical narrative: Two crusted pustules on face both <5mm size. Flu like symptoms.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Red swollen area noticed by pt on Sat on (R) arm. Warm to touch. Instructed by NP to take ibuprofen & may take antihistamines as well. RTC if sx does not resolved in next 1-2 days.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Approximately 18 hours after getting the vaccine I developed nausea, chills/sweats, headache, muscle & joint pain, extreme fatigue, mild fever that lasted about 3 days.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Approximately 18 hours after getting the vaccine I developed nausea, chills/sweats, headache, muscle & joint pain, extreme fatigue, mild fever that lasted about 3 days.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Approximately 18 hours after getting the vaccine I developed nausea, chills/sweats, headache, muscle & joint pain, extreme fatigue, mild fever that lasted about 3 days.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Approximately 18 hours after getting the vaccine I developed nausea, chills/sweats, headache, muscle & joint pain, extreme fatigue, mild fever that lasted about 3 days.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Approximately 18 hours after getting the vaccine I developed nausea, chills/sweats, headache, muscle & joint pain, extreme fatigue, mild fever that lasted about 3 days.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: 1/24/12 at 0400 experienced chills, fever 100; body aches, & nausea, was seen by dr, family physician. Treated w/amoxicillin?mg twice a day x 10 days. Says doctor suspected pt. had onset of "a cold" just before vaccine administration.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: 1/24/12 at 0400 experienced chills, fever 100; body aches, & nausea, was seen by dr, family physician. Treated w/amoxicillin?mg twice a day x 10 days. Says doctor suspected pt. had onset of "a cold" just before vaccine administration.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: 1/24/12 at 0400 experienced chills, fever 100; body aches, & nausea, was seen by dr, family physician. Treated w/amoxicillin?mg twice a day x 10 days. Says doctor suspected pt. had onset of "a cold" just before vaccine administration.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: 1/24/12 at 0400 experienced chills, fever 100; body aches, & nausea, was seen by dr, family physician. Treated w/amoxicillin?mg twice a day x 10 days. Says doctor suspected pt. had onset of "a cold" just before vaccine administration.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: 1/24/12 at 0400 experienced chills, fever 100; body aches, & nausea, was seen by dr, family physician. Treated w/amoxicillin?mg twice a day x 10 days. Says doctor suspected pt. had onset of "a cold" just before vaccine administration.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ammonia increased, Angiogram, Asthenia, Blood cortisol, Blood creatine phosphokinase
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 70 year old female patient who on 04-NOV-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 671610/1164AA) (dose and route not reported). On 06-NOV-2011, two days after ZOSTAVAX (Merck) was given, the patient experienced severe pain, redness and felt feverish. The patient's symptoms continued and on 05-JAN-2012 she was admitted to intensive care and diagnosed with serum sickness, renal failure, lethargic, hypotension, increased liver function tests and elevated ammonium levels. The patient was hospitalized for 13 days and has now been discharged from the hospital (discharge date 18-JAN-2012). It was reported that the patient continued to present with redness at the injection site and weakness presently. At the time of the report, the patient's outcome was recovering. Serum sickness, renal failure, lethargic, hypotension, increased liver function tests, elevated ammonium levels, redness at the injection site, severe pain and feeling feverish were considered to be other important medical events because they required intervention to prevent serious criteria, immediately life threatening and disabling by the reporter. A lot check has been initiated. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood thyroid stimulating hormone, Central venous catheterisation, Chest X-ray, Computerised tomogram abdomen, Computerised tomogram head
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 70 year old female patient who on 04-NOV-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 671610/1164AA) (dose and route not reported). On 06-NOV-2011, two days after ZOSTAVAX (Merck) was given, the patient experienced severe pain, redness and felt feverish. The patient's symptoms continued and on 05-JAN-2012 she was admitted to intensive care and diagnosed with serum sickness, renal failure, lethargic, hypotension, increased liver function tests and elevated ammonium levels. The patient was hospitalized for 13 days and has now been discharged from the hospital (discharge date 18-JAN-2012). It was reported that the patient continued to present with redness at the injection site and weakness presently. At the time of the report, the patient's outcome was recovering. Serum sickness, renal failure, lethargic, hypotension, increased liver function tests, elevated ammonium levels, redness at the injection site, severe pain and feeling feverish were considered to be other important medical events because they required intervention to prevent serious criteria, immediately life threatening and disabling by the reporter. A lot check has been initiated. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Hepatic enzyme increased, Hypotension, Injection site erythema
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 70 year old female patient who on 04-NOV-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 671610/1164AA) (dose and route not reported). On 06-NOV-2011, two days after ZOSTAVAX (Merck) was given, the patient experienced severe pain, redness and felt feverish. The patient's symptoms continued and on 05-JAN-2012 she was admitted to intensive care and diagnosed with serum sickness, renal failure, lethargic, hypotension, increased liver function tests and elevated ammonium levels. The patient was hospitalized for 13 days and has now been discharged from the hospital (discharge date 18-JAN-2012). It was reported that the patient continued to present with redness at the injection site and weakness presently. At the time of the report, the patient's outcome was recovering. Serum sickness, renal failure, lethargic, hypotension, increased liver function tests, elevated ammonium levels, redness at the injection site, severe pain and feeling feverish were considered to be other important medical events because they required intervention to prevent serious criteria, immediately life threatening and disabling by the reporter. A lot check has been initiated. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Intensive care, Lethargy, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 70 year old female patient who on 04-NOV-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 671610/1164AA) (dose and route not reported). On 06-NOV-2011, two days after ZOSTAVAX (Merck) was given, the patient experienced severe pain, redness and felt feverish. The patient's symptoms continued and on 05-JAN-2012 she was admitted to intensive care and diagnosed with serum sickness, renal failure, lethargic, hypotension, increased liver function tests and elevated ammonium levels. The patient was hospitalized for 13 days and has now been discharged from the hospital (discharge date 18-JAN-2012). It was reported that the patient continued to present with redness at the injection site and weakness presently. At the time of the report, the patient's outcome was recovering. Serum sickness, renal failure, lethargic, hypotension, increased liver function tests, elevated ammonium levels, redness at the injection site, severe pain and feeling feverish were considered to be other important medical events because they required intervention to prevent serious criteria, immediately life threatening and disabling by the reporter. A lot check has been initiated. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Renal failure, Serum sickness, Skin warm
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 70 year old female patient who on 04-NOV-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 671610/1164AA) (dose and route not reported). On 06-NOV-2011, two days after ZOSTAVAX (Merck) was given, the patient experienced severe pain, redness and felt feverish. The patient's symptoms continued and on 05-JAN-2012 she was admitted to intensive care and diagnosed with serum sickness, renal failure, lethargic, hypotension, increased liver function tests and elevated ammonium levels. The patient was hospitalized for 13 days and has now been discharged from the hospital (discharge date 18-JAN-2012). It was reported that the patient continued to present with redness at the injection site and weakness presently. At the time of the report, the patient's outcome was recovering. Serum sickness, renal failure, lethargic, hypotension, increased liver function tests, elevated ammonium levels, redness at the injection site, severe pain and feeling feverish were considered to be other important medical events because they required intervention to prevent serious criteria, immediately life threatening and disabling by the reporter. A lot check has been initiated. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ammonia increased, Asthenia, Erythema, Hepatic function abnormal, Hypotension
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 70 year old female patient who on 04-NOV-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 671610/1164AA) (dose and route not reported). On 06-NOV-2011, two days after ZOSTAVAX (Merck) was given, the patient experienced severe pain, redness and felt feverish. The patient's symptoms continued and on 05-JAN-2012 she was admitted to intensive care and diagnosed with serum sickness, renal failure, lethargic, hypotension, increased liver function tests and elevated ammonium levels. The patient was hospitalized for 13 days and has now been discharged from the hospital (discharge date 18-JAN-2012). It was reported that the patient continued to present with redness at the injection site and weakness presently. At the time of the report, the patient's outcome was recovering. Serum sickness, renal failure, lethargic, hypotension, increased liver function tests, elevated ammonium levels, redness at the injection site, severe pain and feeling feverish were considered to be other important medical events because they required intervention to prevent serious criteria, immediately life threatening and disabling by the reporter. A lot check has been initiated. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Intensive care, Lethargy, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 70 year old female patient who on 04-NOV-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 671610/1164AA) (dose and route not reported). On 06-NOV-2011, two days after ZOSTAVAX (Merck) was given, the patient experienced severe pain, redness and felt feverish. The patient's symptoms continued and on 05-JAN-2012 she was admitted to intensive care and diagnosed with serum sickness, renal failure, lethargic, hypotension, increased liver function tests and elevated ammonium levels. The patient was hospitalized for 13 days and has now been discharged from the hospital (discharge date 18-JAN-2012). It was reported that the patient continued to present with redness at the injection site and weakness presently. At the time of the report, the patient's outcome was recovering. Serum sickness, renal failure, lethargic, hypotension, increased liver function tests, elevated ammonium levels, redness at the injection site, severe pain and feeling feverish were considered to be other important medical events because they required intervention to prevent serious criteria, immediately life threatening and disabling by the reporter. A lot check has been initiated. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Renal failure, Serum sickness
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 70 year old female patient who on 04-NOV-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 671610/1164AA) (dose and route not reported). On 06-NOV-2011, two days after ZOSTAVAX (Merck) was given, the patient experienced severe pain, redness and felt feverish. The patient's symptoms continued and on 05-JAN-2012 she was admitted to intensive care and diagnosed with serum sickness, renal failure, lethargic, hypotension, increased liver function tests and elevated ammonium levels. The patient was hospitalized for 13 days and has now been discharged from the hospital (discharge date 18-JAN-2012). It was reported that the patient continued to present with redness at the injection site and weakness presently. At the time of the report, the patient's outcome was recovering. Serum sickness, renal failure, lethargic, hypotension, increased liver function tests, elevated ammonium levels, redness at the injection site, severe pain and feeling feverish were considered to be other important medical events because they required intervention to prevent serious criteria, immediately life threatening and disabling by the reporter. A lot check has been initiated. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Joint swelling, Oedema peripheral, Pruritus
Clinical narrative: Within hours pt's arm became red, swollen & itchy. Within 24 hrs swelling became circumferential from shoulder to wrist. Pt went to the ER.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pyrexia
Clinical narrative: Fever 38.0 - 39.2. Entire upper arm became red, hot, and swollen.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dysmenorrhoea, Eye disorder, Feeling hot, Immediate post-injection reaction, Moaning
Clinical narrative: 7:50 AM 4 injections given. Immediately after completed, client was pale, moaning, extremities stiff and flexed, eyes open but unresponsive. Client was sitting in a chair assisted by myself and mother to floor. Client responded to mother's voice. Mother states client passed out prior when giving blood. Client c/o nausea without emesis, c/o being hot. Client remained on side able to drink water and eat crackers. 0800 AM Color pink but c/o severe menstrual cramps treated with heat. 0830 AM client recovered and left with mother.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Nausea, Pallor, Unresponsive to stimuli, Vomiting
Clinical narrative: 7:50 AM 4 injections given. Immediately after completed, client was pale, moaning, extremities stiff and flexed, eyes open but unresponsive. Client was sitting in a chair assisted by myself and mother to floor. Client responded to mother's voice. Mother states client passed out prior when giving blood. Client c/o nausea without emesis, c/o being hot. Client remained on side able to drink water and eat crackers. 0800 AM Color pink but c/o severe menstrual cramps treated with heat. 0830 AM client recovered and left with mother.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Biopsy, Full blood count, Laboratory test, Urticaria
Clinical narrative: Hives (all over my body).
Age: 1.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13
Symptoms: Varicella
Clinical narrative: Developed varicella, without complications.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Blood electrolytes, Computerised tomogram head, Computerised tomogram normal, Full blood count normal, Grand mal convulsion
Clinical narrative: INFLUENZA vaccine given at approx 11 am 2/14/12. Pt was well at the time. At approx 4:45 pm 2/14/12 pt had generalized tonic clonic seizure. No fever noted. Seen in ER. Head CT normal. Labs normal.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test normal, Toxicologic test normal
Clinical narrative: INFLUENZA vaccine given at approx 11 am 2/14/12. Pt was well at the time. At approx 4:45 pm 2/14/12 pt had generalized tonic clonic seizure. No fever noted. Seen in ER. Head CT normal. Labs normal.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Headache, Muscle spasms, Nausea, Pyrexia
Clinical narrative: Leg cramp on 02/14/2012 at 7:00 PM. At 11:00 PM client woke up with chills and had no temp. 02/15/2012 client had a fever of 100.6 at 5:00 AM. Advil and currently complains of headache and nausea.  Advised to call MD.
Age: 35.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Pruritus, Rash
Clinical narrative: Rash to all extremities with itching.  Took OTC Benadryl w/o effect.  Symptoms resolved.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Computerised tomogram, Injection site pain, Local swelling, Migraine, Oedema peripheral
Clinical narrative: Severe pain at shot location then after 2 days swelling in shoulder arm and neck area with severe migrane headaches was prescribed muscle relaxers and pain killers after 2 weeks was prescribed physical therapy and still not getting any relief from pain or swelling at this time.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: X-ray limb
Clinical narrative: Severe pain at shot location then after 2 days swelling in shoulder arm and neck area with severe migrane headaches was prescribed muscle relaxers and pain killers after 2 weeks was prescribed physical therapy and still not getting any relief from pain or swelling at this time.
Age: 0.11
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Breath holding, Emotional distress, Respiratory arrest, Screaming
Clinical narrative: Screamed x 3 hours inconsolable - "stopped breathing" per mother taken to ER admitted - stable ER/pediatrics thought breath holding spell.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia
Clinical narrative: Continuous mild aching all joints of right arm beginning six hours after vaccination in right arm. No other joints affected. No edema, redness, or warmth.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Chills, Fall, Feeling abnormal, Feeling hot
Clinical narrative: Spouse reports husband reported not feeling good, nervous after got home & later that night he fell backwards, "knees collapsed", did not lose consciousness, face hot, no fever, shaking a lot - lay there awhile before, had chills. Went to bed. Shakes BP went up 148/98s. Next day was ok.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Muscular weakness, Nervousness, Tremor
Clinical narrative: Spouse reports husband reported not feeling good, nervous after got home & later that night he fell backwards, "knees collapsed", did not lose consciousness, face hot, no fever, shaking a lot - lay there awhile before, had chills. Went to bed. Shakes BP went up 148/98s. Next day was ok.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: Pt received PNEUMOVAX at 09:59 on 2/6/12 in left deltoid. No immediate problem, but said his arm really started to ache & feel hot around 4:00 pm. Pt called here & was told to take BENADRYL, but forgot he couldn't due to his prostate. Seen this a.m. by dr. Rx'd with prednisone.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Laboratory test normal
Clinical narrative: Redness, sore, swelling - all occur 24 hours later (at site of injection).
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed itching, redness, swelling, and warm to touch on and around area of injection. Left arm measured approximately 5 in x 5 in, right arm measured 3.5 in x 3.5 in. Patient developed reaction on both arms, but right arm had a central clearing.
Age: 0.63
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizures. One 2/8 & one 2/9/12. Was seen in ER 2/8 and ER 2/9.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Mobility decreased, Pain, Pharyngeal exudate
Clinical narrative: Fever 102.5 8 1/2cm x 9 1/2cm (L) upper arm induration & pink red color. Pain & decreased mobility secondary to pain. Ibuprofen & BENADRYL given. Also has tonsils with exudate but not red. Rapid strep test (-). Back-up sent to lab.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Fever 102.5 8 1/2cm x 9 1/2cm (L) upper arm induration & pink red color. Pain & decreased mobility secondary to pain. Ibuprofen & BENADRYL given. Also has tonsils with exudate but not red. Rapid strep test (-). Back-up sent to lab.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Irritability, Urticaria
Clinical narrative: Extreme fussiness & crying which started about 2-3 hours after vaccines, lasted 3-4 hours followed by hives about 3 hours after vaccination. Hives gradually worsened, becoming more generalized. Treated with BENADRYL. Hives still present 48 hours later then put on prednisone.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased
Clinical narrative: Temp to 103.7 x2 days after vaccine was given.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth, & pruritus at the site of injection. The area was larger the day after vaccine, than today, so improving w/o treatment. Recommended warm compress, cetirizine.
Age: 1.7
Sex: F
Vaccine: DTAP
Symptoms: Petit mal epilepsy, Staring, Unresponsive to stimuli
Clinical narrative: Initial report was received from a health care professional on 06 February 2012. A 20-month-old female patient had received an injection of DAPTACEL, sanofi pasteur Ltd., lot number C4002AA (route, site and date of administration not reported) and 30 minutes later experienced an "absent seizure" in which the patient "stared ahead" and was unresponsive. It was unknown if the patient had any illness at the time of vaccination, any pre-existing medical conditions, took any concomitant medications or had any other vaccinations within four weeks of DAPTACEL. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
Age: 58.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Developed pruritic rash at injection site 2 days post vaccination. Described rash as "mosquito bite" like. Only at injection site.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Initial report received from a health care professional on 09 February 2012. A male patient received 0.5 milliliter (ml) injection (route and site not reported) of INFLUENZA VACCINE (reported as FLUVIRIN but was later corrected to be FLUZONE), sanofi pasteur Inc. lot number not reported, on an unknown date. The patient also received a pneumococcal vaccine (manufacturer and lot number not reported) earlier that day. The patient complained of chest tightness and numbness/tingling in the mouth. The outcome was not reported. Documents held by sender: None.
Age: 1.2
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Exposure to communicable disease, Varicella post vaccine
Clinical narrative: Child developed varicella disease after exposure to shingles. Given Acyclovir 200/5 1 1/4 tsp qid x 5 days.
Age: 1.56
Sex: M
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Hypersensitivity, Injection site erythema, Injection site inflammation, Injection site rash, Injection site swelling
Clinical narrative: Mother advised child received routine 18 month vaccinations HepA to right leg and PEDIARIX (DTaP, IPV, & HepB) to left leg on 1/27/2012. He was in good health with pre-existing keratosis pilaris and eczema to both legs when given (normal skin for him). Mom advised no prior reactions to other childhood vaccinations (specifically PEDIARIX). Approximately 1/29/2012 (day 2), mom advised he developed a fever (100.1 rectal) with warm -hot redness and swelling to his left thigh vaccine injection site (pictures taken). (He had no reaction to right thigh vaccination site.) He was seen by nearby ER 1/30/2012 with temperature 98.7F being diagnosed with left leg rash and inflammatory reaction from vaccination. Mom was advised to monitor and follow up with PCP 1/31/12. PCP placed child on antibiotics (cephalexin) for possible cellulitis as redness had expanded past margins marked by ER. Mom said rash was markedly improved after one dose of antibiotic. 2/1/2012 exam by provider noted 5x10cm erythematous area to anterior left thigh that was pale red with no increase in marked margins 1/31/12. Skin was warm to touch (similar to surrounding skin) with no induration or swelling palpated. Site blanched to touch and child noted to move extremity, stand and bend without distress. There were multiple fine pinprick macules to lateral thigh adjacent to marked erythematous area. Mom advised this was his normal keratosis pilaris and eczema reactions present prior to vaccinations. 2/3/2012 follow up with PCP noted complete resolution of redness and swelling with provider diagnosing as allergic reaction possible cellulitis. Follow up on 2/7/2012 found child happy and playful with no further skin reactions.
Age: 1.56
Sex: M
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Mother advised child received routine 18 month vaccinations HepA to right leg and PEDIARIX (DTaP, IPV, & HepB) to left leg on 1/27/2012. He was in good health with pre-existing keratosis pilaris and eczema to both legs when given (normal skin for him). Mom advised no prior reactions to other childhood vaccinations (specifically PEDIARIX). Approximately 1/29/2012 (day 2), mom advised he developed a fever (100.1 rectal) with warm -hot redness and swelling to his left thigh vaccine injection site (pictures taken). (He had no reaction to right thigh vaccination site.) He was seen by nearby ER 1/30/2012 with temperature 98.7F being diagnosed with left leg rash and inflammatory reaction from vaccination. Mom was advised to monitor and follow up with PCP 1/31/12. PCP placed child on antibiotics (cephalexin) for possible cellulitis as redness had expanded past margins marked by ER. Mom said rash was markedly improved after one dose of antibiotic. 2/1/2012 exam by provider noted 5x10cm erythematous area to anterior left thigh that was pale red with no increase in marked margins 1/31/12. Skin was warm to touch (similar to surrounding skin) with no induration or swelling palpated. Site blanched to touch and child noted to move extremity, stand and bend without distress. There were multiple fine pinprick macules to lateral thigh adjacent to marked erythematous area. Mom advised this was his normal keratosis pilaris and eczema reactions present prior to vaccinations. 2/3/2012 follow up with PCP noted complete resolution of redness and swelling with provider diagnosing as allergic reaction possible cellulitis. Follow up on 2/7/2012 found child happy and playful with no further skin reactions.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Induration, Myalgia, Pruritus, Rash erythematous, Tenderness
Clinical narrative: High dose flu vaccine adm. 12-08-11, c/o itching tenderness in (rt) arm, sm. hard spot approx. dime size, in last 1-2 wks "red pin pain rash." Now c/o muscle ache in (rt). arm.