chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: U
Vaccine: HEPA, HPV4, HPV4
Symptoms: Pallor, Syncope
Clinical narrative: This spontaneous report as received from a physician and patient's mother refers to a 19 year old patient with no medical history and no drug reactions/allergies. On 26-JUL-2013 the patient was vaccinated with GARDASIL (injection, intramuscular, strength, lot#, dose/frequency and duration were unspecified). No concomitant medication was taken. Physician reported that patient experienced an episode of syncope and loss of consciousness with twitching and seizure-like activity that lasted approximately 5-6 seconds following administration of GARDASIL. The patient was placed in a Trendelenburg position and given juice. The patient was observed for an additional 15 minutes after this episode. The physician also reported that the patient felt light-headed and nauseous both before and after the incident. No lab diagnostics studies were performed. A follow-up phone call to the patient's mother later in the day confirmed that no further incidents had occurred except for the patient feeling fatigued. No further adverse effects reported. The outcome of feeling fatigued was unknown. Upon internal review, loss of consciousness and seizure-like activity were considered as other medical significant events. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEPA, HPV4, HPV4
Symptoms: Dizziness, Fatigue, Loss of consciousness, Muscle twitching, Nausea
Clinical narrative: This spontaneous report as received from a physician and patient's mother refers to a 19 year old patient with no medical history and no drug reactions/allergies. On 26-JUL-2013 the patient was vaccinated with GARDASIL (injection, intramuscular, strength, lot#, dose/frequency and duration were unspecified). No concomitant medication was taken. Physician reported that patient experienced an episode of syncope and loss of consciousness with twitching and seizure-like activity that lasted approximately 5-6 seconds following administration of GARDASIL. The patient was placed in a Trendelenburg position and given juice. The patient was observed for an additional 15 minutes after this episode. The physician also reported that the patient felt light-headed and nauseous both before and after the incident. No lab diagnostics studies were performed. A follow-up phone call to the patient's mother later in the day confirmed that no further incidents had occurred except for the patient feeling fatigued. No further adverse effects reported. The outcome of feeling fatigued was unknown. Upon internal review, loss of consciousness and seizure-like activity were considered as other medical significant events. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEPA, HPV4, HPV4
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: This spontaneous report as received from a physician and patient's mother refers to a 19 year old patient with no medical history and no drug reactions/allergies. On 26-JUL-2013 the patient was vaccinated with GARDASIL (injection, intramuscular, strength, lot#, dose/frequency and duration were unspecified). No concomitant medication was taken. Physician reported that patient experienced an episode of syncope and loss of consciousness with twitching and seizure-like activity that lasted approximately 5-6 seconds following administration of GARDASIL. The patient was placed in a Trendelenburg position and given juice. The patient was observed for an additional 15 minutes after this episode. The physician also reported that the patient felt light-headed and nauseous both before and after the incident. No lab diagnostics studies were performed. A follow-up phone call to the patient's mother later in the day confirmed that no further incidents had occurred except for the patient feeling fatigued. No further adverse effects reported. The outcome of feeling fatigued was unknown. Upon internal review, loss of consciousness and seizure-like activity were considered as other medical significant events. Additional information has been requested.
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Erythema multiforme, Rash
Clinical narrative: None stated.
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Emotional distress, Pyrexia
Clinical narrative: Inconsolable for 2 hours straight, fevers of about 101 for 3-4 days.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy
Clinical narrative: Supraclavicular node noticed six days post vaccination.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt called stating low grade fever through the night.  States redness and swelling by the injection site, warm to touch.  Also states pain down to the elbow of her left hand.  Discussed Motrin and compresses to site also to follow up with physician.  At this time client was not going to follow up due to no insurance.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 year old female patient. The patients medical history included genital herpes simplex. On 23-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001694, subcutaneous in the left arm). On 24-JUL-2013, the patient developed injection site reaction after vaccination with ZOSTAVAX. The injection site(left arm) was swollen, sore, red and itching, the injection site(left arm) is swollen, sore, red and itching, the injection site(left arm) is swollen, sore, red and itching. On 25-JUL-2013, the patient was diagnosed with cellulitis. Treatment rendered for the events were cephalosporin, BENADRYL and hydrocortisone cream. The outcome of the reported events were reported as recovering. The patient sought medical attention. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 year old female patient. The patients medical history included genital herpes simplex. On 23-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001694, subcutaneous in the left arm). On 24-JUL-2013, the patient developed injection site reaction after vaccination with ZOSTAVAX. The injection site(left arm) was swollen, sore, red and itching, the injection site(left arm) is swollen, sore, red and itching, the injection site(left arm) is swollen, sore, red and itching. On 25-JUL-2013, the patient was diagnosed with cellulitis. Treatment rendered for the events were cephalosporin, BENADRYL and hydrocortisone cream. The outcome of the reported events were reported as recovering. The patient sought medical attention. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: Mother noticed swelling, redness and warmth starting the following day. She called the clinic and was told to use cool compresses. It continued to worsen - child constantly scratching and area getting hard.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Nausea, Pyrexia, Syncope
Clinical narrative: Pt. experienced fever increased to 102 degrees, nausea, syncope, achy joints. Pt. also fainted while showering next day.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Papule, Rash
Clinical narrative: Erythematous area around the injection site and small pinpoint papules in the center of rash. (Left SQ arm).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients. The nurse reported that VARIVAX (Merck) vaccines were exposed to 25 F for 420 hours, but did not have lot numbers and expiration dates available for evaluation. The nurse stated that she believed that patients may have received 0.5 ml dose of VARIVAX (Merck) (Lot# not reported) subcutaneously in the month of July 2013. No adverse effects were reported. This is one of several reports from a same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients. The nurse reported that ZOSTAVAX vaccines were exposed to 25 F for 420 hours, but did not have lot numbers and expiration dates available for evaluation. The nurse stated that she believed that patients may have received ZOSTAVAX (Lot#, dose and route not reported) in the month of July 2013. No adverse effects were reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age. On 31-MAY-2007, the patient was vaccinated with first dose of M-M-R II, (lot number, expiry date and route was not reported). On 25-JAN-2008, the patient was vaccinated with second dose of M-M-R II, (lot number, expiry date and route was not reported) less than 12 months after the first dose and no adverse effect was reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 60 year old female patient. On 07-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml,route of administration reported as injection) (lot # J000447, expire date 11-APR-2014). There was no concomitant therapies involved. On an unknown date in 2013, the patient experienced injection site redness (but no rash) after receiving ZOSTAVAX. On an unknown date, in 2013, the patient did not seek medical attention. The outcome of the patient was unknown. The relatedness between ZOSTAVAX and the event was not reported. There was no treatment given for the event. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a company representative who reported that a physician's office had stored ZOSTAVAX in the refrigerator since 13-JUN-2013. Reporter stated that they had administered one dose to one patient, lot#, dose, frequency and route unspecified. No adverse effects reported. No temperature conditions provided, therefore unable to evaluate ZOSTAVAX at this time. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. An expired RECOMBIVAX HB PEDIARIC dose (0.5ml one dose; intramuscularly; lot # 668635/1520Z, exp. date: 04-MAY-2013) was administered to the patient on 18-JUL-2013. No adverse effect was reported. PQC filed because expired dose vial was found in a sealed multi-dose vial carton for RECOMBIVAX HB PEDIATRIC which had a different lot number and expiration date (lot # 669598/1455AA; exp. date: 29-SEP-2013). Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 6 month old patient. On 29-JUL-2013 the patient was vaccinated with RECOMBIVAX HB (lot # not provided) (dose, route not provided) and PEDIARIX. No adverse effects reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse via a company representative refers to a healthy 60 year old female patient. On 01-AUG-2013 the patient was accidentally vaccinated with a dose of VARIVAX (Merck) (lot #, expiration date and route not reported) instead of ZOSTAVAX. The mistake was realized after the patient left the office. No adverse effects were reported. Additional information is not expected.
Age: 39.0
Sex: M
Vaccine: MEN
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Circular rash with a circumference of 7inches to the right tricep. Tender, itchy, warm to touch with redness.
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Influenza like illness, Pain, Skin burning sensation, Tenderness
Clinical narrative: Skin burning like a severe sunburn on right upper back from base of neck to bottom of scapula and wrapping under arm to underneath right breast. It hurts all the time and is worse when anything including clothes touch it. Also had slight flu-type symptoms, but those are not worrisome to me and disappeared. The burning sensation continues.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Oedema peripheral, Skin warm
Clinical narrative: Upper arm swollen three times normal size, hard and hot to touch.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Examination of the left arm shows a tender, erythematous, somewhat indurated area centrally where the shots were given and is tender in this particular area. He also has redness spread down to just above his olecranon process. The other areas of erythema are not particularly tender, however, especially the margins of the erythema. The rest of the hand and arm are normal; neurovascular is intact.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, Nuclear magnetic resonance imaging normal, X-ray limb normal
Clinical narrative: Extreme pain at site of the Fluzone Intradermal injection. Pain in muscle did not go away. It got worse over time and continues to get worse. Dr recommended ice and Advil which did not work. He then recommended an Orthopedic which after 4 months did not help. The Orthopedic recommended a neurologist who I am currently seeing. I have extreme pain in the bicep muscle most of the time with sharp stabbing pain in the bicep muscle when I reach backwards.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient had redness and inflammation on his right deltoid that measured 80 mm. He had TDAP and Menveo administered in this arm.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient had redness and inflammation on his right deltoid that measured 80 mm. He had Tdap and MENVEO administered in this arm on 7-29-13 and came in on 7-31-13 with the reaction.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 7cm swelling and redness, hot to touch. Required antibiotics.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Anxiety, Arthralgia, Fear of death, Haemorrhage, Immediate post-injection reaction
Clinical narrative: Panic attacks, anxiety, fear of death, fever, discharge and excess bleeding, joint pain and swelling.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Joint swelling, Panic attack, Pyrexia, Secretion discharge
Clinical narrative: Panic attacks, anxiety, fear of death, fever, discharge and excess bleeding, joint pain and swelling.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Muscular weakness, Pyrexia
Clinical narrative: Vacc. given 8/2/13 approx 8AM. 8/2/13 evening - musc. weakness and fever. 8/3/13 all day - fever, chills, all over musc. weakness. 8/4/13 - musc. weakness - fever broke. 8/5/13 No fever, musc. weakness lessened.
Age: 1.02
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Rash, Skin lesion
Clinical narrative: Red welt with 1 cm induration, pimple-like lesion to site x 2 days after injection. Pt. developed rash to arms, abdomen, and face 9-10 days after vaccination. Afebrile, non-fussy.
Age: 1.02
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Red welt with 1 cm induration, pimple-like lesion to site x 2 days after injection. Pt. developed rash to arms, abdomen, and face 9-10 days after vaccination. Afebrile, non-fussy.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Angioedema, Blood albumin decreased, Blood creatine phosphokinase normal, Blood culture negative, C-reactive protein increased
Clinical narrative: 6/23 PEDVAX and INFANRIX given. 6/24 doctors visit - urticaria. 6/25 - 6/27 Hospitalized urticaria with angioedema - serum sickness.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Haematocrit normal, Haemoglobin normal, Protein total decreased, Red blood cell sedimentation rate normal, Serum sickness
Clinical narrative: 6/23 PEDVAX and INFANRIX given. 6/24 doctors visit - urticaria. 6/25 - 6/27 Hospitalized urticaria with angioedema - serum sickness.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Urine analysis normal, Urticaria
Clinical narrative: 6/23 PEDVAX and INFANRIX given. 6/24 doctors visit - urticaria. 6/25 - 6/27 Hospitalized urticaria with angioedema - serum sickness.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Autopsy, Death
Clinical narrative: ?SIDS/SUIDS. Death cert. not yet avail. For autopsy report, contact Medical Examiner or HCP.
Sex: F
Vaccine: TDAP
Symptoms: Carpal tunnel syndrome, Fatigue, Immediate post-injection reaction, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 26 July 2013. A female patient (age and date of birth not reported) had received an injection in the left arm of ADACEL (lot number and route not reported) on 09 October 2012. On the same day, the patient experienced muscle weakness, stiffness, carpal tunnel of right hand, fatigue and nausea right after vaccination and symptoms continue to today. Outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 26 July 2013. A female patient (age and date of birth not reported) had received an injection in the left arm of ADACEL (lot number and route not reported) on 09 October 2012. On the same day, the patient experienced muscle weakness, stiffness, carpal tunnel of right hand, fatigue and nausea right after vaccination and symptoms continue to today. Outcome was not recovered. Documents held by sender: None.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pelvic pain
Clinical narrative: This spontaneous report was received from a nurse via a company representative concerning a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patient developed burning and stinging pain in pelvis and pubic regions one hour after receiving a dose of ZOSTAVAX at a local pharmacy. On an unknown date, the patient developed small blister like bumps at the belt line the next morning. The patient sought medical attention (called the nurse). The patient was possibly prescribed with VALTREX. No lab tests were performed. The outcome of all the events was unknown. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Feeling hot, Pain, Pruritus
Clinical narrative: Reddened, warm, painful, itchy. Red, warm, very painful within 6 hours of vaccination. 2 days later still red, warm, itchy.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Haematoma, Myalgia, Paraesthesia, Swelling
Clinical narrative: Sore muscles and swelling tingling in my (L) arm and hand.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Vaccine given 7/15/13 that evening developed red rash on trunk/thigh not at injection site. Some itching.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Induration, Skin warm, Swelling
Clinical narrative: Patient called 7/26/13 1:30p stating area was red, hot, swollen and hard (baseball size). Last night at 9:30-10pm temperature 101.0 degrees F took TYLENOL then temp 7/26/13 a.m. 99.0 degrees F. Temp has increased to 100.0 degrees F at 2:54pm pt stopped in Rx dept. Area baseball size hard red hot advised cold compresses 20 min on 20 off and to stop by her primary to see if they want to treat (if a cellulitis suspected).
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Epistaxis, Full blood count normal, Lymphadenopathy, Platelet count normal, Pyrexia
Clinical narrative: Nosebleed - treated in ED. More nosebleeds over several weeks. Fever 99.6-100.6. Cervical lymphadenopathy.
Age: 1.32
Sex: F
Vaccine: HIBV, MMRV, PNC13
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Fever started 7 days after PROQUAD was given. Rash started 9 days after with severe irritability afebrile on day 9.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: LEFT LEG INJECTION SITE WAS WARM AND DEVELOPED A LARGE RASH- SIZE OF A LARGE DINNER PLATE.  TREATED WITH BENADRYL.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Inflammation, Oedema peripheral, Pruritus, Skin warm, Tenderness
Clinical narrative: Step mother reports patient awoke with right arm swollen and pruritic. Described the swelling on the arm was half the size of a baseball on posterior of arm. Area was warm to touch and very sensitive. Benadryl and Ibuprofen helping. Patient could not tolerate cool packs to area. Clothing also intolerable. The swelling has reduced but the inflammation is now encircling the arm and skin remains sensitive.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Large red site this is 72 hours and it is getting larger.
Age: 1.06
Sex: F
Vaccine: HEPA, HIBV, MMRV, PPV
Symptoms: Irritability, Pyrexia, Rash, Urine analysis normal, Viral infection
Clinical narrative: Pt had a fever,  x 5 days, with a Tmax=103.9 on 8/1/13 followed by a rash (not seen by provider) from 8/1/13 until 8/4/2013. She had increased fussiness for all 5 days, a viral illness cannot be excluded.
Age: 18.0
Sex: F
Vaccine: HEPAB, MNQ, TDAP
Symptoms: Dizziness, Dyspnoea, Pruritus, Rash, Throat irritation
Clinical narrative: C/O SOB, dizziness, rash and itching. Throat itchy. Benadryl 50 mg given and Epi 1ml (1mg/ml). PREDNISONE 20 MG PO 3 TABS PO DAILY X 5DAYS. Rantidine 150 mg PO ONE TAB TWICE A DAY.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: Swelling started on Sunday morning.  Today doctor saw hard, red, swollen area that was 3 inches.
Age: 34.0
Sex: F
Vaccine: YF
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: Pain, muscle weakness, and tenderness at the injection site that has persisted 4+ months.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Cellulitis, Erythema, Hypersensitivity, Induration
Clinical narrative: My arm became hard, painful and red, during the night and I lost my mobility. I went to employee health at 7:30 am on 8/1/2013 and was seen they told me to monitor it use ice that it was a severve local reaction. I monitored it and spoke with several MD's on my unit. At approximately 12:00 it continued to swell and become redder and spread. I had marked it with marking pen to keep track. Spoke with DR and she call in antibiotic because I was told by one of the MD's that it looked like cellulitis. I left work at 3:30 pm picked up my med and went home. Took picture at home to seen to my husband who is an emergency room physician. The redness had continued down my arm to my forearm and had completely wrapped itself around my arm. My arm was now 2 times the size normally. The swelling and pain had also spread to my back and shoulder and up my neck, which caused swelling of my lymph nodes. My husband told me to go to the emergency room at his hospital and he called ahead to tell them I was on my way I leave 3 minutes from the hospital. I was taken straight back and treated for a severe allergic reaction and for rapid spreading cellulitis. I was kept in the emergency room and monitored until approximately 3:00 am on Friday 8/2/2013. I was prescribed Clindamycin and Prednisone to continue taking at home. I was then released into my husbands care. I have contacted employee health, my primary care physician's office, and Risk Management at work.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Lymphadenopathy, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: My arm became hard, painful and red, during the night and I lost my mobility. I went to employee health at 7:30 am on 8/1/2013 and was seen they told me to monitor it use ice that it was a severve local reaction. I monitored it and spoke with several MD's on my unit. At approximately 12:00 it continued to swell and become redder and spread. I had marked it with marking pen to keep track. Spoke with DR and she call in antibiotic because I was told by one of the MD's that it looked like cellulitis. I left work at 3:30 pm picked up my med and went home. Took picture at home to seen to my husband who is an emergency room physician. The redness had continued down my arm to my forearm and had completely wrapped itself around my arm. My arm was now 2 times the size normally. The swelling and pain had also spread to my back and shoulder and up my neck, which caused swelling of my lymph nodes. My husband told me to go to the emergency room at his hospital and he called ahead to tell them I was on my way I leave 3 minutes from the hospital. I was taken straight back and treated for a severe allergic reaction and for rapid spreading cellulitis. I was kept in the emergency room and monitored until approximately 3:00 am on Friday 8/2/2013. I was prescribed Clindamycin and Prednisone to continue taking at home. I was then released into my husbands care. I have contacted employee health, my primary care physician's office, and Risk Management at work.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity, Swelling, Ultrasound scan, White blood cell count increased
Clinical narrative: My arm became hard, painful and red, during the night and I lost my mobility. I went to employee health at 7:30 am on 8/1/2013 and was seen they told me to monitor it use ice that it was a severve local reaction. I monitored it and spoke with several MD's on my unit. At approximately 12:00 it continued to swell and become redder and spread. I had marked it with marking pen to keep track. Spoke with DR and she call in antibiotic because I was told by one of the MD's that it looked like cellulitis. I left work at 3:30 pm picked up my med and went home. Took picture at home to seen to my husband who is an emergency room physician. The redness had continued down my arm to my forearm and had completely wrapped itself around my arm. My arm was now 2 times the size normally. The swelling and pain had also spread to my back and shoulder and up my neck, which caused swelling of my lymph nodes. My husband told me to go to the emergency room at his hospital and he called ahead to tell them I was on my way I leave 3 minutes from the hospital. I was taken straight back and treated for a severe allergic reaction and for rapid spreading cellulitis. I was kept in the emergency room and monitored until approximately 3:00 am on Friday 8/2/2013. I was prescribed Clindamycin and Prednisone to continue taking at home. I was then released into my husbands care. I have contacted employee health, my primary care physician's office, and Risk Management at work.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: X-ray
Clinical narrative: My arm became hard, painful and red, during the night and I lost my mobility. I went to employee health at 7:30 am on 8/1/2013 and was seen they told me to monitor it use ice that it was a severve local reaction. I monitored it and spoke with several MD's on my unit. At approximately 12:00 it continued to swell and become redder and spread. I had marked it with marking pen to keep track. Spoke with DR and she call in antibiotic because I was told by one of the MD's that it looked like cellulitis. I left work at 3:30 pm picked up my med and went home. Took picture at home to seen to my husband who is an emergency room physician. The redness had continued down my arm to my forearm and had completely wrapped itself around my arm. My arm was now 2 times the size normally. The swelling and pain had also spread to my back and shoulder and up my neck, which caused swelling of my lymph nodes. My husband told me to go to the emergency room at his hospital and he called ahead to tell them I was on my way I leave 3 minutes from the hospital. I was taken straight back and treated for a severe allergic reaction and for rapid spreading cellulitis. I was kept in the emergency room and monitored until approximately 3:00 am on Friday 8/2/2013. I was prescribed Clindamycin and Prednisone to continue taking at home. I was then released into my husbands care. I have contacted employee health, my primary care physician's office, and Risk Management at work.
Age: 37.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Chills, fever, rash and redness to injection site; swelling and erythema to injection site measuring 5x4 inches on left deltoid area, warm to touch and hard. Patient given steroid injection of Decadron 8mg.
Age: 37.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Chills, fever, rash and redness to injection site; swelling and erythema to injection site measuring 5x4 inches on left deltoid area, warm to touch and hard. Patient given steroid injection of Decadron 8mg.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Alopecia, Arthralgia, Chest pain, Decreased appetite, Deep vein thrombosis
Clinical narrative: Progressively worse symptoms since shot administered.  Severe migraines and blurred vision in Left eye beginning in October.  On February 10th, patient had deep vein thrombosis of the left arm.  Has progressively gotten worse over time with joint pain, muscle pain, fatigue, high fevers daily, lower jaw pain, chest pain, racing heart, hair loss, abnormal menstrual cycle, weight loss, appetite loss and continues will all mentioned symptoms today.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Fatigue, Menstrual disorder, Migraine, Myalgia, Pain in jaw
Clinical narrative: Progressively worse symptoms since shot administered.  Severe migraines and blurred vision in Left eye beginning in October.  On February 10th, patient had deep vein thrombosis of the left arm.  Has progressively gotten worse over time with joint pain, muscle pain, fatigue, high fevers daily, lower jaw pain, chest pain, racing heart, hair loss, abnormal menstrual cycle, weight loss, appetite loss and continues will all mentioned symptoms today.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Palpitations, Pyrexia, Vision blurred, Weight decreased
Clinical narrative: Progressively worse symptoms since shot administered.  Severe migraines and blurred vision in Left eye beginning in October.  On February 10th, patient had deep vein thrombosis of the left arm.  Has progressively gotten worse over time with joint pain, muscle pain, fatigue, high fevers daily, lower jaw pain, chest pain, racing heart, hair loss, abnormal menstrual cycle, weight loss, appetite loss and continues will all mentioned symptoms today.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Anaemia, Arthralgia, Dizziness, Pyrexia
Clinical narrative: Progressively worse symptoms since shot administered.  Severe migraines and blurred vision in Left eye beginning in October.  On February 10th, patient had deep vein thrombosis of the left arm.  Has progressively gotten worse over time with joint pain, muscle pain, fatigue, high fevers daily, lower jaw pain, chest pain, racing heart, hair loss, abnormal menstrual cycle, weight loss, appetite loss and continues will all mentioned symptoms today.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Alopecia, Arthralgia, Chest pain, Decreased appetite, Deep vein thrombosis
Clinical narrative: This spontaneous report as received from a medical assistant refers to an approximately 17 year old female patient. On 27-DEC-2012, the patient was vaccinated with the third dose of GARDASIL (Lot # 0555AE) intramuscularly. Concomitant therapies included LOESTRIN and RETIN-A. The medical assistant reported that on an unknown date in approximately 2012, the patient experienced severe joint pain, dizziness, fevers and anemia after receiving the third dose of GARDASIL and was hospitalized for an unspecified duration. The patient was treated with NORCO, CELEBREX, and MEDROL. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Fatigue, Menstrual disorder, Migraine, Myalgia, Pain in jaw
Clinical narrative: This spontaneous report as received from a medical assistant refers to an approximately 17 year old female patient. On 27-DEC-2012, the patient was vaccinated with the third dose of GARDASIL (Lot # 0555AE) intramuscularly. Concomitant therapies included LOESTRIN and RETIN-A. The medical assistant reported that on an unknown date in approximately 2012, the patient experienced severe joint pain, dizziness, fevers and anemia after receiving the third dose of GARDASIL and was hospitalized for an unspecified duration. The patient was treated with NORCO, CELEBREX, and MEDROL. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Palpitations, Pyrexia, Vision blurred, Weight decreased
Clinical narrative: This spontaneous report as received from a medical assistant refers to an approximately 17 year old female patient. On 27-DEC-2012, the patient was vaccinated with the third dose of GARDASIL (Lot # 0555AE) intramuscularly. Concomitant therapies included LOESTRIN and RETIN-A. The medical assistant reported that on an unknown date in approximately 2012, the patient experienced severe joint pain, dizziness, fevers and anemia after receiving the third dose of GARDASIL and was hospitalized for an unspecified duration. The patient was treated with NORCO, CELEBREX, and MEDROL. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Anaemia, Arthralgia, Dizziness, Pyrexia
Clinical narrative: This spontaneous report as received from a medical assistant refers to an approximately 17 year old female patient. On 27-DEC-2012, the patient was vaccinated with the third dose of GARDASIL (Lot # 0555AE) intramuscularly. Concomitant therapies included LOESTRIN and RETIN-A. The medical assistant reported that on an unknown date in approximately 2012, the patient experienced severe joint pain, dizziness, fevers and anemia after receiving the third dose of GARDASIL and was hospitalized for an unspecified duration. The patient was treated with NORCO, CELEBREX, and MEDROL. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy rash that began on legs and moved to trunk/torso.
Age: 35.0
Sex: F
Vaccine: PNC
Symptoms: Full blood count abnormal, Pain, Pain in extremity, Pyrexia, Shift to the left
Clinical narrative: Fever, body aches: leg pain.  Left arm pain.
Age: 35.0
Sex: F
Vaccine: PNC
Symptoms: Urine analysis normal, White blood cell count increased
Clinical narrative: Fever, body aches: leg pain.  Left arm pain.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site haemorrhage
Clinical narrative: Bilateral lower extremity petechiae, initially on LLE (resolved in 48 hours) then developed petechiae on RLE (present x 24 hours when evaluated 8/5/13 in office), no bleeding/bruising, infant well other than thrush, no thigh mass/swelling.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Breath holding, Crying, Cyanosis, Hypotonia, Loss of consciousness
Clinical narrative: Patient was crying hard, then seemed to hold her breath, mom sat her up, her face was blue and she was floppy; she was quickly stimulated and 'came to' within 1-2 seconds.  She seemed to have a vasovagal response to holding her breath.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Presyncope
Clinical narrative: Patient was crying hard, then seemed to hold her breath, mom sat her up, her face was blue and she was floppy; she was quickly stimulated and 'came to' within 1-2 seconds.  She seemed to have a vasovagal response to holding her breath.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Facial paresis, Hypoaesthesia, Induration, Local reaction
Clinical narrative: Numbness and paresthesias of Rt cheek (mild), followed by gradual worsening and Rt facial weakness over next 72 hrs or so. Saw neurologist 8/1/13, dx w Bell's palsy. 8/2 am began Prednisone 60 mg tapering course and Doxycycline x 3 wks (previous erythema migrans several years previously; recent deer tick exposure). Sx persist but improving. Also had marked local reaction w erythema and induration (have photo).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging normal, Paraesthesia, VIIth nerve paralysis
Clinical narrative: Numbness and paresthesias of Rt cheek (mild), followed by gradual worsening and Rt facial weakness over next 72 hrs or so. Saw neurologist 8/1/13, dx w Bell's palsy. 8/2 am began Prednisone 60 mg tapering course and Doxycycline x 3 wks (previous erythema migrans several years previously; recent deer tick exposure). Sx persist but improving. Also had marked local reaction w erythema and induration (have photo).
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Abdominal pain, Vaccination site vesicles
Clinical narrative: (Adverse reaction) vesicles in (R) shoulder at the site of vaccine. When the pt was ready to go to ER the patient started to have abdominal pain.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Laboratory test, Lumbar puncture
Clinical narrative: Patient was given ZOSTAVAX immunization on 7/29/12. Patient was diagnosed with Guillain-Barre on 8/22/12. Patient was treated at hospital and diagnosed there, then patient went to Rehab hospital for 10 days.
Age: 0.53
Sex: M
Vaccine: DTAP, HEP, IPV, PNC13, RV5
Symptoms: Injection site rash, Rash generalised
Clinical narrative: RASH ON INNER LEGS AT 2:PM, SPREAD TO ARMS AND BODY AT 7:00PM GIVEN BENADRYL WITH SOME CLEARING BUT RECURRED NEXT DAY.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Patient stated the area started itching, swelling, got hot, minor rash.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Started having tenderness, erythema, and pruritis on left arm at vaccine site, worsened over next few days, even after ice and hydrocortisone cream, went to see provider on 8/5/13 and lateral aspect of upper arm from deltoid to distal humerus was warm, erythematous, coalescing patches, tender. No fevers or any other symptoms.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Chills, Fatigue, Pruritus generalised
Clinical narrative: Weakness, chills, fatigue 8/4-8/5. Intense itching all over body 8/5.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: Chills, dizziness and a fever over 101 degress, called on call physician for practice and he said he had never heard of reaction, child receive HEP A and 1st dose Gardasil vaccine.
Age: 0.7
Sex: M
Vaccine: HEP
Symptoms: Idiopathic thrombocytopenic purpura
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an approximately 8 month old male patient, currently reported at age of "13". The patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unspecified) after birth. Concomitant medication included an unspecified number of vaccines. When the patient was 8-9 months of age, the patient developed chronic idiopathic thrombocytopenic (ITP). The patient received an unspecified therapy as a treatment for the adverse event. The patient sought unspecified medical attention. The outcome of the event was reported as not recovered. Upon internal review chronic idiopathic thrombocytopenic (ITP) was considered medically significant. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Paraesthesia oral, Pyrexia, Urticaria, Vomiting
Clinical narrative: I gave the vaccine 7/31/13 but did not speak to client 8/1/13. She apparently felt a small welt on her face when leaving the building. Later in day felt tongue tingling, got a welt on her Rt. ankle and Rt. upper thigh. Then had fever, dizziness and emesis. Was fine today at p/c.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Fall, Joint injury
Clinical narrative: Patient received HPV #1 (GARDASIL) and MCV4#1 (MENACTRA). No c/o instructed to wait about 20 minutes to monitor for any adverse reactions. Mother stated "My daughter wanted to drink some water, so she walked over to the drinking fountain then I heard to commotion and realized my daughter was on the floor. Patient stated I felt dizzy and I know I was on the floor." Mother staff assisted patient complained of bumping left knee only. No other physical injury reported. Advised mother to follow up at nearest emergency room if symptoms worsen or any problems or concerns.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Feeling hot, Head discomfort, Headache
Clinical narrative: Pt. fell dizzy, felt hot, queasy, almost felt if would have diarrhea, head felt heavy. Gave pt. cold water to drink and cool compress to apply to face and neck. Reaction happened almost immediately. Within less than 5 minutes she felt better. No dizziness, queasiness, cooled off etc, but started headache. Had butalbital already prescribed and she will take it when she gets home.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Pt. fell dizzy, felt hot, queasy, almost felt if would have diarrhea, head felt heavy. Gave pt. cold water to drink and cool compress to apply to face and neck. Reaction happened almost immediately. Within less than 5 minutes she felt better. No dizziness, queasiness, cooled off etc, but started headache. Had butalbital already prescribed and she will take it when she gets home.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Redness appx 8x11 cm, warm Erythema mild. Onset 2d after injection. Cool compresses w/ relief.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Vasovagal syncope after immunization administered. Patient lied down cool cloth to forehead, examined by physician.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Wheals. Pruritus.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Patient reported a headache that began 3-4 days after vaccination. It gradually worsened over the following 7-10 days, then stopped without treatment.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever 102-103, fussiness. No other sign. Went to ECC on 8/2 - no labs done - treated symptoms only and sent home.
Age: 12.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Edema, warmth, redness, larger than size of dollar coin (LA).
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Erythema
Clinical narrative: After injections were given a small, round, red area appeared on the left forearm. Patient was breathing normally with no sign of respiratory distress. Dr. was alerted of possible reaction to vaccines with no noticeable signs of reaction at injection site. Parent refused BENADRYL at that time, a topical ointment was applied. Parent was advised to give patient BENADRYL if condition worsened.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Gait disturbance, Skin induration
Clinical narrative: Developed erythema and induration of skin by evening on day given. Was limping yesterday. No treatment provided at home. Recommended ibuprofen, BENADRYL, heat packs until resolves.
Age: 1.49
Sex: F
Vaccine: DTAP, PNC13, DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Lethargy, Pyrexia
Clinical narrative: 4/23/09 19m WCE 4/24- fever 102, fussy, lethargic, fussy. ? imm- Rxn -> amox given, no source.
Age: 1.49
Sex: F
Vaccine: DTAP, PNC13, DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: 4/23/09 19m WCE 4/24- fever 102, fussy, lethargic, fussy. ? imm- Rxn -> amox given, no source.
Age: 0.36
Sex: F
Vaccine: DTAP, PNC13, DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Lethargy, Pyrexia
Clinical narrative: 3/6/08 PENTACEL #2 (4m WCE). 3/9/08 Fever 101, fussy.
Age: 0.36
Sex: F
Vaccine: DTAP, PNC13, DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: 3/6/08 PENTACEL #2 (4m WCE). 3/9/08 Fever 101, fussy.
Age: 62.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Chills, fever, systemic itching, injection site swelling treated with ZYRTEC, prednisone, cephalexin, pramosone, CLARITIN and ice packs. Injection site resolved by 4 weeks later, but systemic itching has persisted through present time (July 2013).
Age: 12.0
Sex: U
Vaccine: HPV4, MNQ, TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A few hours after the immunization, the child developed a pink-red area around the injection site that spread over the next 3 days until seen. The patient had chills on the first day. It was swollen and tender to the touch. Prescribed prednisone and ZYRTEC.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Blood culture negative, Body temperature increased, Culture urine negative, Full blood count normal, White blood cells urine positive
Clinical narrative: 5/9/08 6 m WCE and vaccine. 5/10/08 urgent care w/ 100-102 bl cx and CBC - nl. 5/11/08 urgent care 104 -> ROCEPHIN IM. 5/12/08 urine 20-40 WBC cx neg -> KEFLEX due to ROCEPHIN IM.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Patient triaged prior to vaccine administration. Mother informed nurse that pt. had allergy to milk, eggs and soy and peanuts. When asked about reaction type when child eats eggs, mother stated, "I don't know, but she doesn't like eggs." Mother stated child had no hx of serious reaction to any vaccine in the past. No hx of any respiratory problems including asthma reported by mother. Approx. 30" following vaccinations mother called PHN to report that child was having difficulty breathing  and was wheezing. Instructed parent to call ambulance and go to emergency dept.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Grand mal convulsion
Clinical narrative: 10 minutes after receiving HPV, pt. had tonic clonic seizure twice in 15 minutes apart, last for 5-10 seconds.
Age: 25.0
Sex: M
Vaccine: MNQ
Symptoms: Activities of daily living impaired, Fatigue, Lethargy, Musculoskeletal stiffness, Pyrexia
Clinical narrative: "Fever couldn't open eyes", fatigue, lethargy, can't go to work. Stiff neck.