chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: Exessive Crying. Fever 103. Rash/Redness at injection site. Pain in Right Leg (site of injection).
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Hyperhidrosis, Loss of consciousness, Malaise, Pallor, Vomiting
Clinical narrative: Was given vaccines at 11:45 am.  Proceeded to front desk to get shot record. While in waiting room sat down and said he didn't feel well.  Passed out per mom's report. Nurse to front desk where pt. was vomiting, sweating and pale. Vitals taken: BP 120/82, pulse 80 resp. 13. Taken back to clinic, given a soda, observed for approx 16 minutes, was stable and went home.
Age: 59.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Dizziness, Fall, Vertigo, Vomiting
Clinical narrative: Patient had sudden episode of severe dizziness; "the room was spinning" and she fell onto couch.  She started vomiting.  Patient was taken to ED and was diagnosed with "severe vertigo".  They gave her a medicine to take and it did help a little.  She has had several episodes since then, but today, Monday, April 2, she states that she feels much better.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Chills, Dizziness, Erythema, Lymph node pain, Oedema peripheral
Clinical narrative: Injection given 3/26/12. Next day arm was swollen red, painful. Posterior side of arm swollen, Tenderness in line nodes of L axial. Light Head & chilled. No fever. Itches.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Injection given 3/26/12. Next day arm was swollen red, painful. Posterior side of arm swollen, Tenderness in line nodes of L axial. Light Head & chilled. No fever. Itches.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Redness, warm to touch.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Maternal exposure during pregnancy
Clinical narrative: I was not aware pt. was pregnant until after I administered her #3 GARDASIL.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Rash, Sensory loss, Vomiting
Clinical narrative: Rash, vomiting, and could not feel face or left leg.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous
Clinical narrative: Rash over belly, back, legs, extending just a bit onto arms and neck. Dots are red, almost like tiny bug bites. Not a dark red though.
Age: 0.76
Sex: M
Vaccine: RV5
Symptoms: Dermatitis diaper, Diarrhoea, Diet refusal, Irritability, Mucous stools
Clinical narrative: For several days after the Roto virus vax my son was vomiting, refusing to nurse or eat, has loose, mucousy stools, a red raw anus, diaper rash and general fussiness.
Age: 0.76
Sex: M
Vaccine: RV5
Symptoms: Perianal erythema, Vomiting
Clinical narrative: For several days after the Roto virus vax my son was vomiting, refusing to nurse or eat, has loose, mucousy stools, a red raw anus, diaper rash and general fussiness.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Sudden onset of Vomiting and Diarrhea. No fever.
Age: 0.58
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Contusion, Crying, Dysphonia, Injection site haemorrhage, Insomnia
Clinical narrative: Bled at injection site, cried inconsolably.  Nurse indicated bleeding is normal. Proceeded to cry throughout day/night.  After 48 hours, baby continued to have regular inconsolable crying spells, could not sleep, seemed in pain.  Pale bruise appeared over entire thigh.  Crying spells lasted one week, culminating with a hoarse voice.  Tried to discuss with doctor, message was not returned.  Nurse indicated it was probably teething.
Age: 0.58
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Pain, Pallor, Teething
Clinical narrative: Bled at injection site, cried inconsolably.  Nurse indicated bleeding is normal. Proceeded to cry throughout day/night.  After 48 hours, baby continued to have regular inconsolable crying spells, could not sleep, seemed in pain.  Pale bruise appeared over entire thigh.  Crying spells lasted one week, culminating with a hoarse voice.  Tried to discuss with doctor, message was not returned.  Nurse indicated it was probably teething.
Age: 13.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Asthenia, Chest discomfort, Chromaturia, Dyspnoea, Headache
Clinical narrative: Tightness of chest, trouble breathing, fever, weakness, dark orange urine, headache.
Age: 13.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Pyrexia
Clinical narrative: Tightness of chest, trouble breathing, fever, weakness, dark orange urine, headache.
Age: 1.16
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cough, Pyrexia, Wheezing
Clinical narrative: 5 days after MMR, varicella, and hepatitis A vaccines patient developed cough, wheezing, and fever.  Mom attributes these symptoms to the vaccine and requested they be reported.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Oral herpes, Pain of skin, Tooth impacted, Toothache
Clinical narrative: Top of my head was extremely tender to the touch; impacted wisdom tooth started aching; slight fever blister started on my lip but was gone by next day; just didn't feel chipper.
Age: 1.02
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Red rash and fever.
Age: 0.28
Sex: M
Vaccine: HEP, PNC
Symptoms: Urticaria
Clinical narrative: Hives all over face that eventually spread through out the body within the next week. They were activated by touch to skin. Lasted 2 weeks. Used herbal remedies to cleanse system.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Limb discomfort, Pain, Pyrexia
Clinical narrative: Site red and swollen, arm felt funny, felt feverish and achy. No visit to clinic for treatment.
Age: 5.0
Sex: F
Vaccine: RAB
Symptoms: Culture urine negative, Urinary incontinence, Urine analysis normal
Clinical narrative: Rabies vaccine round #2 Wed 3/28/12 approximately 1000, urinary incontinence approximately 1700 (also Thurs 3/29/12 x 2, Fri 3/30/12 x 1, Sat 3/31 x 1) Sun 4/1/12 round #3 approximately 1000, incontinent of urine approximately 1700. Seen Mon 4/2/12 negative UA and exam normal (no weakness, normal DTRs, etc.)
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Blood culture, Febrile convulsion, Full blood count, Metabolic function test, Urine analysis
Clinical narrative: Febrile seizure following vaccines. Patient taken to ER.
Age: 11.0
Sex: U
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Pt - passed out after receiving injections.
Age: 0.76
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Rash
Clinical narrative: Telephone call from Mom with concerns of 101 degrees temp. after HepB booster. At this time denies any fussiness, tugging at ears or any symptoms besides fever. Advised by nurse to monitor, give TYLENOL 145mg 4-6 hours (based on wt.) Friday 102.9 temp., Sunday rash on head & spread to torso.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cough, Erythema, Urticaria, Vomiting
Clinical narrative: About 45-50 min after getting vaccines, patient coughed a few times & vomited. Became red in the face, and color became reddish purple to nose, eyes & eyes. Was given 2 tsp BENADRYL. Face did get pretty bad & developed 5 (five) hives on abdomen. Was stable & improved at f/u phone call 3 hr. later (from admin. time).
Age: 45.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Cellulitis, Differential white blood cell count abnormal, Erythema, Full blood count abnormal, Pain
Clinical narrative: Redness, pain started 3/28/12. It progressively got worse, seen at ER on 3/31/12. DX (1) vaccination complication (2) cellulitis. Tx: BENADRYL Rx - KEFLEX - MEDROL Dose Pack, VICODIN, IV ROCEPHIN 3/31, 4/1 AND 4/2.
Age: 45.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Vaccination complication
Clinical narrative: Redness, pain started 3/28/12. It progressively got worse, seen at ER on 3/31/12. DX (1) vaccination complication (2) cellulitis. Tx: BENADRYL Rx - KEFLEX - MEDROL Dose Pack, VICODIN, IV ROCEPHIN 3/31, 4/1 AND 4/2.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal distension, Gastrointestinal sounds abnormal, Livedo reticularis, Vomiting
Clinical narrative: Emesis of all feeds, unable to hold down any breast milk, abdominal distension, decreased bowel sounds & ? pain with palpation, slight mottling of skin. ? intussusception - referred to ER for U/S and possible more imaging, blood work.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blood test, Injection site erythema, Injection site rash, Pruritus, Rash erythematous
Clinical narrative: 3-20-12 Mom states child had bad bright red rash to (R) thigh. The red spots are on his legs, arms, face, trunk area. The spots mom states are raised but not oozy. No fever. States he is itching. 3-22-12 Went to dr and got blood test drawn. Dr prescribed a cream but hasn't got it cause it not covered by medical card.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Axillary mass, Axillary pain, Cellulitis, Erythema, Headache
Clinical narrative: Case number PHHY2010US093042 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 405415) on 31 Dec 2010 with a follow up received from the quality assurance department (reference number:148793) on 02 Mar 2012 and a follow up received from the quality assurance department on 21 Mar 2012. This case refers to a 21-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 111795P1) intramuscularly into her right arm on 24 Oct 2010. On the same day, she was also vaccinated with PPV (other manufacturer, batch number: 0509Y) intramuscularly into her right arm. On 24 Oct 2010, she initially felt pain at the injection site. She began noticing pain radiating into right armpit at 11:30 PM, took MOTRIN for pain relief. She woke up in the morning of 25 Oct 2010, noted warmth at the injection site, redness extending from the injection down into the armpit and two hard lumps in the armpit region. She also experienced headache without fever. She saw a physician and received antibiotic prophylaxis for the diagnosis of cellulitis. She had recovered completely on an unspecified date. Based on the batch review report, it was stated that the concerned FLUVIRIN batch 111795P1 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the quality assurance department (reference number: 148793) 02 Mar 2012: Updated reference number. Follow up information received from the quality assurance department on 21 Mar 2012: Updated batch review report.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2010US093042 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 405415) on 31 Dec 2010 with a follow up received from the quality assurance department (reference number:148793) on 02 Mar 2012 and a follow up received from the quality assurance department on 21 Mar 2012. This case refers to a 21-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 111795P1) intramuscularly into her right arm on 24 Oct 2010. On the same day, she was also vaccinated with PPV (other manufacturer, batch number: 0509Y) intramuscularly into her right arm. On 24 Oct 2010, she initially felt pain at the injection site. She began noticing pain radiating into right armpit at 11:30 PM, took MOTRIN for pain relief. She woke up in the morning of 25 Oct 2010, noted warmth at the injection site, redness extending from the injection down into the armpit and two hard lumps in the armpit region. She also experienced headache without fever. She saw a physician and received antibiotic prophylaxis for the diagnosis of cellulitis. She had recovered completely on an unspecified date. Based on the batch review report, it was stated that the concerned FLUVIRIN batch 111795P1 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the quality assurance department (reference number: 148793) 02 Mar 2012: Updated reference number. Follow up information received from the quality assurance department on 21 Mar 2012: Updated batch review report.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Mobility decreased, Pyrexia, Vaccination complication
Clinical narrative: Case number PHHY2010US093083 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 405423) on 31 Dec 2010 with a follow up received from the quality assurance department (reference number: 148830) on 02 Mar 2012 and a follow up received on 21 Mar 2012. This case refers to a 24-year-old female patient. Her medical history included of lymphangioleiomyomatosis. Her concomitant medications included of hydrocodone/acetaminophen (10 mg/325 mg) 1 tablet orally every six hours, ibuprofen 400 mg tablet twice daily orally, SIROLIMUS 1.5 mg tablet twice daily orally, XANAX 0.25 mg tablet thrice daily orally. She was vaccinated with FLUVIRIN (batch number: 11162605) intramuscularly into her right arm on 19 Oct 2010. On the same day, she was also vaccinated with PPV (other manufacturer, batch number: 0883Z) intramuscularly into her right arm. On 20 Oct 2010, she experienced soreness and redness at the vaccination site, and had a temp of 100 degrees. She was instructed to seek medical attention for fever, redness or difficulty moving her arm. On 22 Oct 2010, she presented to her local ED with complaint of fever (102) and redness at the vaccine site. She was diagnosed with a vaccine reaction and treated with NSAID's. On 24 Oct 2010, she returned to the ED with persistent symptoms. She was treated with a single dose of IV antibiotics and a course of oral antibiotics for cellulitis. The outcome was reported as condition unchanged. The quality assurance department opened a complaint for this case with reference number 148830. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 11162605 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the quality assurance department (reference number: 148830) on 02 Mar 2012: Updated reference number. Follow up received from the quality assurance department (reference number: 148830) on 21 Mar 2012. QA reference no and batch review report updated.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vaccination site pain
Clinical narrative: Case number PHHY2010US093083 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 405423) on 31 Dec 2010 with a follow up received from the quality assurance department (reference number: 148830) on 02 Mar 2012 and a follow up received on 21 Mar 2012. This case refers to a 24-year-old female patient. Her medical history included of lymphangioleiomyomatosis. Her concomitant medications included of hydrocodone/acetaminophen (10 mg/325 mg) 1 tablet orally every six hours, ibuprofen 400 mg tablet twice daily orally, SIROLIMUS 1.5 mg tablet twice daily orally, XANAX 0.25 mg tablet thrice daily orally. She was vaccinated with FLUVIRIN (batch number: 11162605) intramuscularly into her right arm on 19 Oct 2010. On the same day, she was also vaccinated with PPV (other manufacturer, batch number: 0883Z) intramuscularly into her right arm. On 20 Oct 2010, she experienced soreness and redness at the vaccination site, and had a temp of 100 degrees. She was instructed to seek medical attention for fever, redness or difficulty moving her arm. On 22 Oct 2010, she presented to her local ED with complaint of fever (102) and redness at the vaccine site. She was diagnosed with a vaccine reaction and treated with NSAID's. On 24 Oct 2010, she returned to the ED with persistent symptoms. She was treated with a single dose of IV antibiotics and a course of oral antibiotics for cellulitis. The outcome was reported as condition unchanged. The quality assurance department opened a complaint for this case with reference number 148830. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 11162605 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the quality assurance department (reference number: 148830) on 02 Mar 2012: Updated reference number. Follow up received from the quality assurance department (reference number: 148830) on 21 Mar 2012. QA reference no and batch review report updated.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site cellulitis, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Case number PHHY2010US093146 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 406698) website on 31 Dec 2010 and a follow up received from the quality assurance department (quality reference number: 148787) on 01 Mar 2012 and a follow up received from the quality assurance department on 21 Mar 2012. This report refers to a 62 year old female patient. The patient's medical history included environmental allergies and hypertension. The patient was vaccinated with FLUVIRIN (batch number: 111808P1) intramuscularly in left arm on 01 Nov 2010. On 02 Nov 2010, she experienced pain in arm. Her arm was red, warm and swollen. On 03 Nov 2010, she was diagnosed with cellulitis of arm around area that was injected. The outcome of events was reported as condition unchanged as of 03 Nov 2010. Based on the batch review report, it was stated that the concerned FLUVIRIN batch number 111808P1 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the quality assurance department on 02 Mar 2012: Updated only the quality reference number. Follow up information received from the quality assurance department on 21 Mar 2012: Updated batch review report.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Cellulitis, Chills, Contusion, Injection site cellulitis
Clinical narrative: Case number PHHY2010US093301 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 408082) website on 31 Dec 2010 with a follow up received from the quality assurance department reference number: 148834) on 02 Mar 2012 and a follow up received from the quality assurance department on 21 Mar 2012. This report refers to a 77-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 111824P1) through unspecified route on to right arm and pneumococcal polysaccharide (other manufacturer, batch number: 0933Z) through unspecified route on to right arm on 26 Oct 2010. On the same day, she experienced chills, cellulitis of injected arm from right arm injection site (bicep) to wrist, rash, bruising on forearm, ache in back and general malaise. The outcome of the events was reported as complete recovery as of 01 Nov 2010. Based on the batch review report, it was stated that the concerned FLUVIRIN batch number 111824P1 was manufactured in accordance with approved internal procedures and it as in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the quality assurance department (reference number: 148834) 02 Mar 2012: Updated reference number. Follow up information received from the quality assurance department on 21 Mar 2012: Updated batch review report.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Rash
Clinical narrative: Case number PHHY2010US093301 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 408082) website on 31 Dec 2010 with a follow up received from the quality assurance department reference number: 148834) on 02 Mar 2012 and a follow up received from the quality assurance department on 21 Mar 2012. This report refers to a 77-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 111824P1) through unspecified route on to right arm and pneumococcal polysaccharide (other manufacturer, batch number: 0933Z) through unspecified route on to right arm on 26 Oct 2010. On the same day, she experienced chills, cellulitis of injected arm from right arm injection site (bicep) to wrist, rash, bruising on forearm, ache in back and general malaise. The outcome of the events was reported as complete recovery as of 01 Nov 2010. Based on the batch review report, it was stated that the concerned FLUVIRIN batch number 111824P1 was manufactured in accordance with approved internal procedures and it as in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the quality assurance department (reference number: 148834) 02 Mar 2012: Updated reference number. Follow up information received from the quality assurance department on 21 Mar 2012: Updated batch review report.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHHY2011US115347 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 412560) on 01 Feb 2011 with a follow up received from the quality assurance department (reference number: 148823) on 02 Mar 2012 and a follow up received on 21 Mar 2012. This case refers to a 24-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 111824P1) intramuscularly into her left arm on 01 Dec 2010. On 02 Dec 2010, she developed cellulitis at the injection site. She had an emergency department visit due to the event. She had recovered completely on an unspecified date. The quality assurance department opened a complaint for this case with reference number 148823. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 111824P1 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the quality assurance department (reference number: 148823) 02 Mar 2012: Updated reference number. Follow up received from the quality assurance department (reference number: 148823) on 21 Mar 2012: QA reference no and batch review report updated.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Case number PHHY2011US115388 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 412773) on 01 Feb 2011 and a follow up received from the quality assurance department on 01 Mar 2012 and a follow up received on 21 Mar 2012. This case refers to a 26-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 111814P1) in her left arm on 18 Nov 2010. On 21 Nov 2010 she found out that she was pregnant, but she was unaware at the time of vaccination. She went to doctor on 30 Nov 2010 and the doctor stated that she was supposed to be seven weeks pregnant according to her last menstrual period. They did an ultrasound discovered the baby had not developed properly. She eventually had a miscarriage. She had recovered completely on an unspecified date. A quality assurance investigation had been registered with reference number 148853. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 111814P1 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the quality assurance department on 02 Mar 2012: Updated only the quality reference number. Follow up received from the quality assurance department (reference number: 148853) on 21 Mar 2012. QA reference no and batch review report updated.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Foetal disorder, Maternal exposure during pregnancy, Pregnancy test, Ultrasound antenatal screen abnormal
Clinical narrative: Case number PHHY2011US114821 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 415130) website on 01 Mar 2011 with a follow up received from the quality assurance department (reference number: 148838) on 02 Mar 2012, and a follow up received from the quality assurance department on 21 Mar 2012: This report refers to a 29-year-old female patient. She was pregnant. She was vaccinated with FLUVIRIN (batch number: 111772P1) into the left arm on 25 Oct 2010. On 08 Nov 2010, she reported that she and her husband found that their baby did not have a heartbeat. At 10th week ultrasound, the baby measured 6 weeks and the said that it had shrunk (it was not clearly reported, whether this ultrasound finding was found before or after vaccination). The patient had a natural miscarriage and passed the baby on 29 Nov 2011. The patient reported that once she passed the baby, she had to get her Beta hormones checked until they were less than or equal to 5. They were equal to 5 on 28 Dec 2011. The outcome of the events was not reported. Based on the batch review report, it was stated that the concerned FLUVIRIN batch number 111772P1 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the quality assurance department (reference number: 148838) 02 Mar 2012: Update reference number. Follow up information received from the quality assurance department on 21 Mar 2012: Updated batch review report.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Local reaction, Pyrexia
Clinical narrative: Case number PHHY2011US115070 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 418435) website on 05 May 2011 with a follow up received from the quality assurance department (reference number:148801) on 02 Mar 2012 and a follow up received on 21 Mar 2012. This report refers to a 51-year-old female patient. Her medical history included asthma with acute exacerbation and concomitant medications were levothyroxine, QVAR and albuterol. She was vaccinated with FLUVIRIN (batch number: 112945P1) through unspecified route on to right arm and PNEUMOVAX 23 (other manufacturer, batch number: 1066Z) through unspecified route on to right arm on 23 Feb 2011. On the same day, she experienced fever with temperature 102 degrees, local reaction at deltoid and cellulitis. She did not visit emergency room. The outcome of the events was reported as complete recovery as of 10 Mar 2011. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 112945P1 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the quality assurance department (reference number: 148801) 02 Mar 2012: Updated reference number. Follow up received from the quality assurance department (reference number: 148801) on 21 Mar 2012. Batch review report updated.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Influenza like illness, Maternal exposure during pregnancy, Premature labour, Twin pregnancy
Clinical narrative: Case number PHHY2011US114712 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ref: 441138) website on 30 Dec 2011 with a follow up received from the quality assurance department on 10 Jan 2012 with a follow up received on 21 Mar 2012. This report refers to a 20-year-old female pregnant patient. She was pregnant with twins, 20 weeks of gestation. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 97847P2), into right arm on 01 Oct 2009. On 07 Oct 2009, she experienced with Flu like symptoms and preterm labor resulting in the loss of twins pregnancy at 20 weeks. She was hospitalized for 2-days. The causality and outcome of the events were not reported at the time of reporting. A quality investigation had been registered with reference number 140810. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 97847P2 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the quality assurance department on 10 Jan 2012: updated only the quality reference number. Follow up received from the quality assurance department (reference number: 140810) on 21 Mar 2012: QA reference no and batch review report updated.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Immediate post-injection reaction, Mobility decreased, Nerve injury
Clinical narrative: The shot was given in an incorrect area and immediately my arm went very cold & the numbness went down each finger. Since then I have not been able to move my left arm behind my back. I did report this to the Clinic by phone and email. I did receive 2 calls from a clinic rep. She advised that the nerve damage would eventually heal and that the event would be reported to the CDC. I did see a neurologist and he told me that there was no treatment for this damage. However, 6 months out, I still have pain and lost about 50% range of motion in my left arm. This has severely affected my life, especially the pain at night, can't dress myself as well, i.e. can't tuck in blouses or hook bras, etc. Really upset that incompetent people are let loose on the public. Nowhere to turn for help.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Peripheral coldness
Clinical narrative: The shot was given in an incorrect area and immediately my arm went very cold & the numbness went down each finger. Since then I have not been able to move my left arm behind my back. I did report this to the Clinic by phone and email. I did receive 2 calls from a clinic rep. She advised that the nerve damage would eventually heal and that the event would be reported to the CDC. I did see a neurologist and he told me that there was no treatment for this damage. However, 6 months out, I still have pain and lost about 50% range of motion in my left arm. This has severely affected my life, especially the pain at night, can't dress myself as well, i.e. can't tuck in blouses or hook bras, etc. Really upset that incompetent people are let loose on the public. Nowhere to turn for help.
Age: 40.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Vomiting
Clinical narrative: Initial report was received from a health care professional on 12 December 2011. A 40-year-old male patient received an intramuscular injection (dose 1) in the left deltoid of MENACTRA, sanofi pasteur Inc., lot number U4249AA on 08 December 2011 at 2:30 PM. On 11 December 2011 at 6:00 AM, the patient vomited one time and had numbness from the tip of the tongue to the right ear and from the right hand to the forearm and elbow. The patient had no illness at the time of vaccination, allergies or past medical history. The patient did not take any concomitant medications. No other vaccinations were given within four weeks prior to 08 December 2011. The patient's wife had shingles. No further information was available at the time of the report. The patient's outcome was unknown. Follow-up information was received from a health care professional on 26 March 2012. Based upon the new information provided, this case has been upgraded to serious. The patient had seen three different physicians, one of them a neurologist, for the numbness in his face/tongue. The patient had an MRI which was negative. The patient continued to have numbness in face/tongue and also in nasal area and cheeks. The patient had not recovered. Documents held by sender: none.
Age: 40.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Nuclear magnetic resonance imaging normal, Vomiting
Clinical narrative: Initial report was received from a health care professional on 12 December 2011. A 40-year-old male patient received an intramuscular injection (dose 1) in the left deltoid of MENACTRA, sanofi pasteur Inc., lot number U4249AA on 08 December 2011 at 2:30 PM. On 11 December 2011 at 6:00 AM, the patient vomited one time and had numbness from the tip of the tongue to the right ear and from the right hand to the forearm and elbow. The patient had no illness at the time of vaccination, allergies or past medical history. The patient did not take any concomitant medications. No other vaccinations were given within four weeks prior to 08 December 2011. The patient's wife had shingles. No further information was available at the time of the report. The patient's outcome was unknown. Follow-up information was received from a health care professional on 26 March 2012. Based upon the new information provided, this case has been upgraded to serious. The patient had seen three different physicians, one of them a neurologist, for the numbness in his face/tongue. The patient had an MRI which was negative. The patient continued to have numbness in face/tongue and also in nasal area and cheeks. The patient had not recovered. Documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Antibody test negative, Injection site rash, Pruritus, Rash, Rash maculo-papular
Clinical narrative: Localized rash at injection site on left deltoid with 4 to 5 maculopapular pruritic lesions.  Tender to palpation.  Lesions grew slowly larger and itchier.
Age: 33.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Skin lesion, Tenderness
Clinical narrative: Localized rash at injection site on left deltoid with 4 to 5 maculopapular pruritic lesions.  Tender to palpation.  Lesions grew slowly larger and itchier.
Age: 1.35
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Inflammation, Rash, Rash morbilliform, Skin lesion
Clinical narrative: MMR given 3-16-12 - rash started 25 - Sun 28 - classic "measles" rash with palpable lesions face & trunk - happy afebrile - palms inflamed.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: States developed itchy rash on trunk and back of body approximately 29 hours after receiving vaccination of Tdap. States has had Td without problems in the past. Feels has sensitivity to vaccines. Has hx of skin reactions to latex and nitrile gloves. Did not take antihistamine or seek medical care. Rash resolving by 4/2/12.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Vaccination site cellulitis
Clinical narrative: Received vaccines on 3/29/12. Presented to ER on 4/1/12 with cellulitis at site where vaccines were given.
Age: 0.21
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Left thigh red & swollen, very fussy & irritable.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Cardiac arrest, Laboratory test abnormal, Oral candidiasis, Sickle cell trait
Clinical narrative: 4/2/2012 child was taken to the hospital by EMS on arrival asystole. 3/15/2012 - ER visit oral thrush given Nystatin oral suspension.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying
Clinical narrative: Uncontrollable crying for several hours.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: Local - LT red, swollen, crying for 2-3 hrs.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash distal to immun. injection site.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Livedo reticularis, Oedema peripheral
Clinical narrative: Information has been received from a medical assistant concerning an approximately 74 year old female patient (currently 75 year old) with allergy to penicillin, hypothyroidism, asthma, hypertension and tachycardia, who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). Concomitant therapy included aspirin, calcium, (unspecified) (+) vitamin D (unspecified), omega-3 marine triglycerides, FLOVENT, levothyroxine Na, lisinopril-HCTZ (manufacturer unknown), vitamins (unspecified) and PREMARIN. The reporter stated that on an unknown date the patient developed a red, swollen left arm (the same arm where she received the PNEUMOVAX 23) and the entire arm was red swollen. This resolved 1 week later. The patient sought unspecified medical attention - spoke to physician's office. At the time of the report the patient's status was recovered. Follow up information has been received from the physician concerning the approximately 72 year old female retired patient with allergy to penicillin and no illness at time of vaccination, who in 1998 was vaccinated with the first dose of PNEUMOVAX 23 (route and lot number not reported). The physician stated that in 2008 the patient received a booster of the PNEUMOVAX 23 (route and lot number not reported). The physician reported that 24 hours after injection, it was noted swelling and red-mottled arm, 6 inches lower than injection site, and it "threw everyone off". The physician stated that the patient was advised after the fact that this could had resulted in muscle loss. At the time of the report, the patient's muscle loss outcome was unknown. The events were considered to be immediately life-threatening by the reporting physician. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Painful, swollen lump (L) delt found on day 7 after immunization given. Rx'd ice packs, TYLENOL, watchful waiting & to call office if worsens.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Large, red swelling on (L) arm at site of injection. Had fever of 102 F.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Diagnosed with Guillain-Barre Syndrome by a neurologist at Medical Center.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Conjunctivitis, Lip swelling, Mycoplasma test positive, Oedema mouth
Clinical narrative: Swollen macerated lips and oral mucosa, severe conjunctivitis. Seen 03/20/2012 and sent to ER. Admitted to hospital for 3 days and diagnosed with Stevens-Johnson Syndrome. Also diagnosed with mycoplasma pneumoniae, a known cause of S-J Syndrome.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pneumonia mycoplasmal, Stevens-Johnson syndrome
Clinical narrative: Swollen macerated lips and oral mucosa, severe conjunctivitis. Seen 03/20/2012 and sent to ER. Admitted to hospital for 3 days and diagnosed with Stevens-Johnson Syndrome. Also diagnosed with mycoplasma pneumoniae, a known cause of S-J Syndrome.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: C-reactive protein increased, Chapped lips, Cheilitis, Chest X-ray abnormal, Condition aggravated
Clinical narrative: Swollen macerated lips and oral mucosa, severe conjunctivitis. Seen 03/20/2012 and sent to ER. Admitted to hospital for 3 days and diagnosed with Stevens-Johnson Syndrome. Also diagnosed with mycoplasma pneumoniae, a known cause of S-J Syndrome.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Conjunctival hyperaemia, Conjunctivitis, Cough, Erythema multiforme, Eye swelling
Clinical narrative: Swollen macerated lips and oral mucosa, severe conjunctivitis. Seen 03/20/2012 and sent to ER. Admitted to hospital for 3 days and diagnosed with Stevens-Johnson Syndrome. Also diagnosed with mycoplasma pneumoniae, a known cause of S-J Syndrome.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hilar lymphadenopathy, Injection site erythema, Lacrimation increased, Lip dry, Lip exfoliation
Clinical narrative: Swollen macerated lips and oral mucosa, severe conjunctivitis. Seen 03/20/2012 and sent to ER. Admitted to hospital for 3 days and diagnosed with Stevens-Johnson Syndrome. Also diagnosed with mycoplasma pneumoniae, a known cause of S-J Syndrome.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lip swelling, Lung infiltration, Lymphocyte percentage decreased, Mouth ulceration, Mycoplasma test positive
Clinical narrative: Swollen macerated lips and oral mucosa, severe conjunctivitis. Seen 03/20/2012 and sent to ER. Admitted to hospital for 3 days and diagnosed with Stevens-Johnson Syndrome. Also diagnosed with mycoplasma pneumoniae, a known cause of S-J Syndrome.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Neutrophil percentage increased, Oedema mouth, Oral pain, Platelet count increased, Pneumonia mycoplasmal
Clinical narrative: Swollen macerated lips and oral mucosa, severe conjunctivitis. Seen 03/20/2012 and sent to ER. Admitted to hospital for 3 days and diagnosed with Stevens-Johnson Syndrome. Also diagnosed with mycoplasma pneumoniae, a known cause of S-J Syndrome.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Protein total increased, Pulmonary embolism, Pyrexia, Red blood cell sedimentation rate increased, Skin maceration
Clinical narrative: Swollen macerated lips and oral mucosa, severe conjunctivitis. Seen 03/20/2012 and sent to ER. Admitted to hospital for 3 days and diagnosed with Stevens-Johnson Syndrome. Also diagnosed with mycoplasma pneumoniae, a known cause of S-J Syndrome.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Stevens-Johnson syndrome, White blood cell count increased
Clinical narrative: Swollen macerated lips and oral mucosa, severe conjunctivitis. Seen 03/20/2012 and sent to ER. Admitted to hospital for 3 days and diagnosed with Stevens-Johnson Syndrome. Also diagnosed with mycoplasma pneumoniae, a known cause of S-J Syndrome.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Local swelling
Clinical narrative: Gradually worsening local swelling Right deltoid and biceps, erythema, pain.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: I got shingles from the shingles vaccine.  Started as soreness and itching.  A rash appeared and lasted until late March.  I continue to have itching and pain, altho diminishing.
Age: 23.0
Sex: F
Vaccine: MNQ
Symptoms: Anaemia, Chest discomfort, Heart rate increased
Clinical narrative: Patient stated of having a heavy chest and fast heartbeats. Patient denied having difficulty breathing. Advised patient to see doctor immediately. Patient refused to get medical help. Patient stated being diagnosed with anemia.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Crying, Screaming
Clinical narrative: High pitched screaming and crying. Inconsolable for hours.
Age: 40.0
Sex: M
Vaccine: ANTH, TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: ARM SWOLLEN NEARLY TWICE NORMAL SIZE. EXTREME REDNESS, WARM TO TOUCH, PAINFUL. PATIENT REPORTS NO FEVER/CHILLS/OTHER SYMPTOMS.
Age: 1.53
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Abnormal behaviour, Body temperature increased, Chest X-ray, Influenza virus test, Irritability
Clinical narrative: Temperature rise to 104.6F. Start alternating between Tylenol 7 Ibuprofen. Doctor visit on 03/30/2012 continue same treatment. Temperature peaked at 107.2F on 03/31/2012, rushed to ER. Temperature went down on 04/01/2012. Showing excessive irritability & fussiness. Change of behavior. Rash come out on 04/03/2012.
Age: 1.53
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Rash, Respiratory syncytial virus test
Clinical narrative: Temperature rise to 104.6F. Start alternating between Tylenol 7 Ibuprofen. Doctor visit on 03/30/2012 continue same treatment. Temperature peaked at 107.2F on 03/31/2012, rushed to ER. Temperature went down on 04/01/2012. Showing excessive irritability & fussiness. Change of behavior. Rash come out on 04/03/2012.
Age: 1.04
Sex: M
Vaccine: DTPHIB, HEPA, MMR, VARCEL
Symptoms: Influenza virus test negative, Pyrexia, Rotavirus test negative
Clinical narrative: High fever of 103.8 lasting for over one week.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Pt had developed fever 101.0 F on 3.30.12 after having KINRIX, MMR and VZV done on 3.28.12. Also, cellulitis on the left arm. Dr prescribed Amoxicillin 400 bid x 10 days.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Eye pain, Immediate post-injection reaction, Measles antibody, Pyrexia, Rash
Clinical narrative: 10 days post vaccine experienced bilateral ocular pain, some blurriness in vision for 5-7 days. Experienced "chest rash"/fever immediately post vaccine - resolved.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Vision blurred
Clinical narrative: 10 days post vaccine experienced bilateral ocular pain, some blurriness in vision for 5-7 days. Experienced "chest rash"/fever immediately post vaccine - resolved.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Pain in extremity, Pyrexia, Rash
Clinical narrative: Fever, rash (face), arm pain, swollen glands.
Age: 18.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Injected limb mobility decreased, Pyrexia, Urticaria
Clinical narrative: On evening of vaccine administration, 03-28-12, developed fever, which continued until AM of 03-30-12 reports she could not lift either arm, on 04-01-12, developed hives on both knees which progressed to generalized hives by 04-02-12. Was seen by PCP, pediatrician. Vaccines ordered prior to splenectomy scheduled for 04-11-12. Temp was 103 degrees F per client.
Age: 1.02
Sex: M
Vaccine: HIBV, PNC13
Symptoms: No adverse event
Clinical narrative: Pt tolerated well. Instructed parent to let pt wait for 15 mins to observe any allergic reactions and RTC for DTaP#4 after trip.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Dyspnoea, Neck pain, Pericarditis, Troponin increased
Clinical narrative: C/O difficulty breathing, chest pain & neck pain. Went ER. Diagnosed with pericarditis.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Areflexia, Asthenia, Ataxia, Choking, Confusional state
Clinical narrative: 11/13/11 Began with weakness exhaustion 11/18/11. Ataxic - confused - disoriented - weak. Choking episodes - hoarse. Without gag reflex. Hospitalized 11/26 overnight. Nystagmus. To ER 11/28 more choking stridor. Hospital 12/2/11 12/7/11. Temp paralyzed vocal cord.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Disorientation, Dysphonia, Encephalitis brain stem, Fatigue, Nystagmus
Clinical narrative: 11/13/11 Began with weakness exhaustion 11/18/11. Ataxic - confused - disoriented - weak. Choking episodes - hoarse. Without gag reflex. Hospitalized 11/26 overnight. Nystagmus. To ER 11/28 more choking stridor. Hospital 12/2/11 12/7/11. Temp paralyzed vocal cord.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Paralysis, Stridor, Vocal cord paralysis
Clinical narrative: 11/13/11 Began with weakness exhaustion 11/18/11. Ataxic - confused - disoriented - weak. Choking episodes - hoarse. Without gag reflex. Hospitalized 11/26 overnight. Nystagmus. To ER 11/28 more choking stridor. Hospital 12/2/11 12/7/11. Temp paralyzed vocal cord.
Age: 0.31
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever Tmax 102.2. Fussiness. Acetaminophen.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 3/21/12: Patient c/o itching and redness on left deltoid. No warmth, tenderness, induration. Area was outlined in pen RTC in 2 days. 3/23/12 Area of redness increased slightly. ATARAX given.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Reddened area to site of VARIVAX injection. Started itching - no BENADRYL given and then reaction developed. After using Ibuprofen, Children's BENADRYL - reaction resolved.