chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test positive, Burning sensation, Formication, Headache, Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old female who on 12-FEB-2008 was vaccinated with ZOSTAVAX (Merck). Subsequently the patient got shingles. It was unknown if the patient sought medical attention. At the time of report, the patient was recovered. Follow-up information was received from the 76 year old female retired consumer with no pre-existing allergies, birth defects or medical conditions who on 12-FEB-2008 was vaccinated with a dose of ZOSTAVAX on her "right side" (dose, route and lot # not provided). There was no illness at time of vaccination. On 25-APR-2012, the patient developed rash in right temple area and into her head, stinging, burning and feeling of something crawling on her face and her hair in her head. The patient also experienced pain in temple and in her head. The rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. She was treated with prednisolone 10 mg and valacyclovir 1 mg. On an unknown date, direct fluorescent antibody was positive; specimen was not collected for PCR and no photos were taken. On an unknown date, the patient recovered from shingles. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunology test, Pain, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old female who on 12-FEB-2008 was vaccinated with ZOSTAVAX (Merck). Subsequently the patient got shingles. It was unknown if the patient sought medical attention. At the time of report, the patient was recovered. Follow-up information was received from the 76 year old female retired consumer with no pre-existing allergies, birth defects or medical conditions who on 12-FEB-2008 was vaccinated with a dose of ZOSTAVAX on her "right side" (dose, route and lot # not provided). There was no illness at time of vaccination. On 25-APR-2012, the patient developed rash in right temple area and into her head, stinging, burning and feeling of something crawling on her face and her hair in her head. The patient also experienced pain in temple and in her head. The rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. She was treated with prednisolone 10 mg and valacyclovir 1 mg. On an unknown date, direct fluorescent antibody was positive; specimen was not collected for PCR and no photos were taken. On an unknown date, the patient recovered from shingles. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor
Clinical narrative: Information has been received from a health professional concerning a 14 year old female with no pre-existing allergies or medical condition or illness at time of vaccination who on 11-JUN-2012 at 15:45 PM was vaccinated with the first dose of GARDASIL (lot#672834/0131AE) into her left arm. There was no concomitant medication. On 11-JUN-2012 at 15:45 PM, the patient experienced dizzy, lightheaded and pale in color. The patient lay down, and elevated legs and head. Ice pack was applied to back of neck. No labs/diagnostics studies were performed. On 11-JUN-2012, the patient recovered from the events. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received a doctor or pharmacy concerning her daughter who on an unspecified dates, was vaccinated in the buttocks with all 3 doses of GARDASIL (date and lot numbers not reported). No adverse effect was reported. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Rash pruritic
Clinical narrative: Rt upper lateral arm is swollen pink and warm, pruritic rash, no lump at site of injection, no axillary adenopathy.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rt upper lateral arm is swollen pink and warm, pruritic rash, no lump at site of injection, no axillary adenopathy.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN
Symptoms: Dyspnoea, Pruritus, Urticaria, Wheezing
Clinical narrative: Wheezing (5/30/2012) - resolved without treatment Rash (5/31/201) - placed on prednisone Vomiting (6/1/2012) - late night Lip swelling (6/1/2012) Presented to the ED on 6/2/2012
Age: 16.0
Sex: M
Vaccine: MNQ, MEN
Symptoms: Lip swelling, Rash, Vomiting, Wheezing
Clinical narrative: Wheezing (5/30/2012) - resolved without treatment Rash (5/31/201) - placed on prednisone Vomiting (6/1/2012) - late night Lip swelling (6/1/2012) Presented to the ED on 6/2/2012
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Computerised tomogram head, Dyskinesia, Electrocardiogram, Full blood count, Headache
Clinical narrative: Information has been received from a nurse concerning a 13 year old female patient who on 06-JUN-2012 was vaccinated with the first dose of GARDASIL, 0.5 ml. The nurse mentioned that on 10-JUN-2012 the patient experienced collapsed after she woke up. Her family brought her to the ER of an unspecified hospital. It was unknown if the patient was admitted or not. At the time of the report, the patient's status was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Loss of consciousness, Metabolic function test, Syncope, Urine analysis, Visual impairment
Clinical narrative: Information has been received from a nurse concerning a 13 year old female patient who on 06-JUN-2012 was vaccinated with the first dose of GARDASIL, 0.5 ml. The nurse mentioned that on 10-JUN-2012 the patient experienced collapsed after she woke up. Her family brought her to the ER of an unspecified hospital. It was unknown if the patient was admitted or not. At the time of the report, the patient's status was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 13 year old female patient who on 06-JUN-2012 was vaccinated with the first dose of GARDASIL, 0.5 ml. The nurse mentioned that on 10-JUN-2012 the patient experienced collapsed after she woke up. Her family brought her to the ER of an unspecified hospital. It was unknown if the patient was admitted or not. At the time of the report, the patient's status was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: TDAP, HEP, TDAP
Symptoms: Discomfort, Mobility decreased, Muscle spasms, Pain
Clinical narrative: Client was given Hepatitis B and Tdap 7-9-12. Client TC to clinic 7-11-12 stating back pain severe. She could not pick up her 3 yr old son it hurt so bad. Client referred to PCP. He gave here muscle relaxer. Per pt.
Age: 27.0
Sex: F
Vaccine: TDAP, HEP, TDAP
Symptoms: Activities of daily living impaired, Back pain
Clinical narrative: Client was given Hepatitis B and Tdap 7-9-12. Client TC to clinic 7-11-12 stating back pain severe. She could not pick up her 3 yr old son it hurt so bad. Client referred to PCP. He gave here muscle relaxer. Per pt.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Nerve conduction studies
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 10 July 2012. A 56-year-old female patient had received an intramuscular injection in the right deltoid of FLUZONE, sanofi pasteur Inc., lot number UH453AB on 26 or 27 December 2011. As soon as the patient received the vaccination, her right arm hurt. She experienced pain a few inches below the injection site and the pain has extended down to her hand. The right arm continued to be painful and she was unable to reach fully behind her back and could not reach back to "fasten bra". The patient had an x-ray done which was normal and had "nerve test done". The patient was diagnosed with tendonitis which then because arm was painful and wasn't being moved resulted in "frozen arm". The patient has had about 30 physical therapy sessions. The movement of the arm improved some but continues to have pain. The patient had no illness at the time of vaccination. Past medical history and concomitant medications were not reported. The patient's outcome was not recovered. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Periarthritis, Tendonitis, X-ray normal
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 10 July 2012. A 56-year-old female patient had received an intramuscular injection in the right deltoid of FLUZONE, sanofi pasteur Inc., lot number UH453AB on 26 or 27 December 2011. As soon as the patient received the vaccination, her right arm hurt. She experienced pain a few inches below the injection site and the pain has extended down to her hand. The right arm continued to be painful and she was unable to reach fully behind her back and could not reach back to "fasten bra". The patient had an x-ray done which was normal and had "nerve test done". The patient was diagnosed with tendonitis which then because arm was painful and wasn't being moved resulted in "frozen arm". The patient has had about 30 physical therapy sessions. The movement of the arm improved some but continues to have pain. The patient had no illness at the time of vaccination. Past medical history and concomitant medications were not reported. The patient's outcome was not recovered. Documents held by sender: None.
Age: 0.28
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash
Clinical narrative: Mom called and stated patient was breaking out in a rash since he was given his imms earlier today.  She took him to the ER and they treated him with Benadryl and he was doing better.  I asked mom to keep me posted on his condition, and also gave her the information of which imm was given where.
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Pain
Clinical narrative: First began with headache... the following day, still had headache, around 6:00 PM, body was sore to touch, similar to Fibromyalgia.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Silver dollar size area of rash on forehead.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pain, Pruritus
Clinical narrative: Red square swollen patch itching and spreading each day to a larger size. Monday, July 16, 2012 went to Dr. for observation.  Provided RX Pednisone tablet 10 mg 2 X in AM & PM. Very painful and swollen.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Abnormal behaviour, Dyskinesia, Hypertonia, Viral rash
Clinical narrative: Dr states, "viral exanthem, hypertonic movement patterns, intelligent but ritualized behaviors."
Age: 1.02
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Apraxia, Childhood disintegrative disorder, Encephalopathy, Regressive behaviour
Clinical narrative: Dr. states, "developmental regression, encephalopathy, changes in tone, behavioral regression, oral motor apraxia onset".
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Limb discomfort, Rotator cuff repair, X-ray abnormal
Clinical narrative: A 62-year-old female with a history of hypothyroid, had received an intramuscular left deltoid injection of TET TOX ADS USP (lot number not reported) on 31 January 2011 and about a week later on 07 February 2011 experienced pain at the left deltoid and could not put her arm behind her back without discomfort. She was referred to an arm specialist by her physician who diagnosed her with impingement in her arm. Treatment was physical therapy but included "working on (her) rotator cuff". Diagnostic tests included an x-ray where impingement was seen. Concomitant medication included Synthroid. Illness at the time of vaccination, other vaccines within four weeks of the suspect vaccine and adverse events following prior vaccinations were all reported as none. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a health care professional on 05 August 2011. The patient was referred to an orthopedic specialist and to physical therapy (PT). The lot number of the ADACEL was reported as Sanofi Pasteur Ltd. C3677 and Sanofi Pasteur Inc. U3553AA. The outcome was not recovered. Follow-up information was received from a health care professional on 22 September 2011. The patient has had no improvement in her shoulder. She is to follow-up with an orthopedic specialist for probable impingement. Follow-up information was received on 28 October 2011 from a health care professional. Contact information was provided for the patient's orthopedic specialist. No further information was available at the time of the report. Documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Malaise, Nausea, Retching, Vomiting
Clinical narrative: States she began to feel ill with nausea and chills shortly after vaccine injection. Then soon began vomiting times approx 4 episodes, through the evening.  The next morning she had episodes of approx 4 more episodes of vomiting and dry heaves following, along with nausea and chills.  By 8 AM on 7/13/2012, she had only a few chills and nausea/ill-feeling. STATED THIS IS EXACTLY HOW SHE FELT AFTER GETTING MULTIPLE VACCINATIONS A FEW YRS AGO IN PREPARATION FOR A MISSION TRIP. Her Temperature at this time was 98.8 temporally, and all other vital signs stable.  Her PCP was notified, and she was sent home as soon as possible.
Age: 20.0
Sex: M
Vaccine: ADEN_4_7, FLU3, MNQ, TDAP
Symptoms: Chest X-ray normal, Chest pain, Echocardiogram normal, Electrocardiogram normal, Pulmonary function test abnormal
Clinical narrative: 20 yo trainee developed URI and chest pain 2 weeks after immunizations.  Chest pain intermittent and resolved in a few weeks, but returned on 5/1/2012 to constant, band--like pain in left upper chest, 6/10, increased with exertion. 2 ED visits, clinic visits.
Age: 20.0
Sex: M
Vaccine: ADEN_4_7, FLU3, MNQ, TDAP
Symptoms: Upper respiratory tract infection
Clinical narrative: 20 yo trainee developed URI and chest pain 2 weeks after immunizations.  Chest pain intermittent and resolved in a few weeks, but returned on 5/1/2012 to constant, band--like pain in left upper chest, 6/10, increased with exertion. 2 ED visits, clinic visits.
Age: 39.0
Sex: F
Vaccine: YF
Symptoms: Blood test, Headache, Urticaria, Wheezing
Clinical narrative: Hives first noticed on left wrist and also had a headache. The hives continued to spread to other parts of her body. She reports she had a brief wheezing episode on 7/11/12. She has been taking oral Benadryl since 7/10/12 and sought medical help on 7/16/12. The doctor prescribed an antihistamine. The patient first informed our clinic about her event on 7/16/12 after seeing her doctor.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus
Clinical narrative: Itching at injection site.
Age: 12.0
Sex: F
Vaccine: MEN
Symptoms: Allergy test negative, Urticaria
Clinical narrative: Full body hives.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Unable to use left arm after vaccination. Arm was extremely painful and I was unable to lift it.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dyskinesia, Gaze palsy, Immediate post-injection reaction, Somnolence, Unresponsive to stimuli
Clinical narrative: Patient was sitting up, received first vaccine, DTap, in right arm. Immediately following, she received 2nd vaccine, Menactra, in the left arm. Immediately following 2nd injection, her eyes rolled back in her head. Nurse used mechanical exam table to lay her back, and father helped to lay supine as mechanical bed was moving down. It was noted that as dad pushed her toward the exam table, her arms jerked 3 times. No leg jerks. She became responsive after being layed down, was drowsy, oriented x3, bp 100/60. Neurologically intact. She was given orange juice and monitored for 1.5 hours in the office. Upon leaving, patient was alert, oriented, talking, laughing, and smiling. She was able to walk, was neurologically intact.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Syncope
Clinical narrative: After being vaccinated patient became pale and diaphoretic while sitting in chair, patient fainted and was unconscious for approxmiately 60 seconds.  Patient's feet were elevated, cold compress was applied to the back of his neck and he was given small sips of orange juice.  Patient remained in recovery position for approximately 10 minutes and was able to sit and then stand without dizziness, ambulated out of immunization clinic without problems.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Antibiotic resistant Staphylococcus test negative, Back pain, Blood culture negative, Cellulitis, Confusional state
Clinical narrative: Pt described severe headache and progressive pain that started in head and traveled to back, then legs. She had tenderness at injection site, local erythema and swelling, fever, body aches and confusion over the course of 7/11/12. She came to the ED on 7/12/12 at 9:45 AM. She was found to have a WBC of 16.5K, febrile and with noted local reaction. Pt was given ertapenem 1 gm IV and admitted later that day due to severity of cellulitis and systemic symptoms. Antibiotics changed to cefazolin + Clindamycin on 7/12/12. WBC increased to 21.8K on 7/13 and pt still febrile. She was changed to Unasyn + Vanco for 1 day, then Ertapenem and Vanco on 7/14.  Pt discharged 7/16.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Headache, Injection site pain, Local reaction, Local swelling
Clinical narrative: Pt described severe headache and progressive pain that started in head and traveled to back, then legs. She had tenderness at injection site, local erythema and swelling, fever, body aches and confusion over the course of 7/11/12. She came to the ED on 7/12/12 at 9:45 AM. She was found to have a WBC of 16.5K, febrile and with noted local reaction. Pt was given ertapenem 1 gm IV and admitted later that day due to severity of cellulitis and systemic symptoms. Antibiotics changed to cefazolin + Clindamycin on 7/12/12. WBC increased to 21.8K on 7/13 and pt still febrile. She was changed to Unasyn + Vanco for 1 day, then Ertapenem and Vanco on 7/14.  Pt discharged 7/16.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain, Pain in extremity, Polymerase chain reaction, Pyrexia, Ultrasound scan normal
Clinical narrative: Pt described severe headache and progressive pain that started in head and traveled to back, then legs. She had tenderness at injection site, local erythema and swelling, fever, body aches and confusion over the course of 7/11/12. She came to the ED on 7/12/12 at 9:45 AM. She was found to have a WBC of 16.5K, febrile and with noted local reaction. Pt was given ertapenem 1 gm IV and admitted later that day due to severity of cellulitis and systemic symptoms. Antibiotics changed to cefazolin + Clindamycin on 7/12/12. WBC increased to 21.8K on 7/13 and pt still febrile. She was changed to Unasyn + Vanco for 1 day, then Ertapenem and Vanco on 7/14.  Pt discharged 7/16.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: White blood cell count increased
Clinical narrative: Pt described severe headache and progressive pain that started in head and traveled to back, then legs. She had tenderness at injection site, local erythema and swelling, fever, body aches and confusion over the course of 7/11/12. She came to the ED on 7/12/12 at 9:45 AM. She was found to have a WBC of 16.5K, febrile and with noted local reaction. Pt was given ertapenem 1 gm IV and admitted later that day due to severity of cellulitis and systemic symptoms. Antibiotics changed to cefazolin + Clindamycin on 7/12/12. WBC increased to 21.8K on 7/13 and pt still febrile. She was changed to Unasyn + Vanco for 1 day, then Ertapenem and Vanco on 7/14.  Pt discharged 7/16.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Oedema peripheral
Clinical narrative: Swollen Right Foot.
Age: 20.0
Sex: M
Vaccine: HPVX
Symptoms: Dizziness, Electrocardiogram, Headache, Hypoaesthesia, Injection site pain
Clinical narrative: Patient first felt pain at injection site. Then dizzy & sick in the stomach. He then passed out. He was given multiple blood pressure checks & an EKG. Five days later he is still feeling sick, he has numbness in his hands plus Headaches.
Age: 20.0
Sex: M
Vaccine: HPVX
Symptoms: Loss of consciousness, Malaise, Nausea
Clinical narrative: Patient first felt pain at injection site. Then dizzy & sick in the stomach. He then passed out. He was given multiple blood pressure checks & an EKG. Five days later he is still feeling sick, he has numbness in his hands plus Headaches.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Nausea, Pallor, Syncope
Clinical narrative: Child left clinic room felt fine. Walked down hall with Dad to exit. Dad turned around and caught him as he fainted. Felt nauseous. Juice given had not eaten since 8:30 AM. Cool compress applied to neck. Assisted to chair. Color returning to face. Dad pulled vehicle up to back door. 100 degree day. Left with Dad feeling back to normal. Counseled to get food and rest today.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Rash pruritic
Clinical narrative: On Saturday 7/14 noticed itchy spots to back (approx 5) and to R knee area (2).  Also site was red, swollen and raised ~2 inches.  No s/s of infection.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Activities of daily living impaired, Injection site swelling, Pain, Pyrexia, Skin warm
Clinical narrative: Significant swelling of the upper arm where vaccine was placed. Arm was hot to touch and caused a low grade fever of around 100 degrees. Treated with 800mg of Motrin. Pain and swelling continued through 9 July 2011, continued to treat with Motrin. Spent all of 8 July in bed with fever.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: Significant swelling of the upper arm where vaccine was placed. Arm was hot to touch and caused a low grade fever of around 100 degrees. Treated with 800mg of Motrin. Pain and swelling continued through 9 July 2011, continued to treat with Motrin. Spent all of 8 July in bed with fever.
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Musculoskeletal discomfort, Rash, Rash pruritic, Swelling
Clinical narrative: Itchy rash on left lower leg, both forearms and back of neck.  Very small red raised area.  Pt didn't feel very uncomfortable except for itching in back of neck.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Body temperature increased, Crying, Irritability, Urine output decreased, Vomiting
Clinical narrative: The patient is a 75-day-old child who is brought in by parents with chief complaint of having vomiting since last night. The one episode last night was just breast milk. They did not think too much about it. Today she has vomited five times, the last three times were bile color of yellow green, bitter smell to it, they said. She has been crying and fussy. She still cries even with holding, but still has appropriate behavior. She has decreased urine output, none since last night. Mom has not been able to nurse since last evening. The child has normal bowel movements. There is no change with quantity. Mom did take a temperature of 100.7 at 1500 hours. No medications were given. The child did get immunizations yesterday. Mom has three other children at home and seems well-educated and appropriate care has been attempted.
Age: 0.46
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Autopsy, Death
Clinical narrative: Pt received vaccines 6/27/12 - found dead in crib (prone) next morning.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Biopsy bone marrow, Blood culture, Computerised tomogram, Dyspnoea, Electrocardiogram normal
Clinical narrative: This spontaneous report as received from a consumer refers to her father a 64 years old male patient. The patient's medical history included lyme disease, cataract surgery and no drug reactions or allergies. The patient was vaccinated with a dose of PNEUMOVAX 23 on 21-MAY-2012 (Lot #, dose and route not reported). No other co-suspects were reported. Concomitant medications included metformin, lisinopril (manufacturer unknown) and prednisone (manufacturer unknown). The patient's daughter reported that the next day on 22-MAY-2012 her father began to have a fever that fluctuated and he was in bed all week. The doctor had been called on 23-MAY-2012. On 14-JUN-2012 the patient had an appointment with the eye doctor. On 15-JUN-2012 the patient was admitted to the hospital. While in the hospital he was given insulin and 3 blood transfusions. The patient had experienced shortness of breath, but his electrocardiogram (EKG) was normal. The patient was advised that his low blood count caused the shortness of breath. His red blood count was 19. A bone marrow biopsy was done that proved inconclusive. He was discharged on 18-JUN-2012. On 28-JUN-2012 he had bloodwork done and it was found that his hematocrit and platelets were bad. He was admitted back to the same hospital where 3 more blood transfusions were performed as well as blood cultures and body scans (results not provided). At the time of the report the events persisted and the patient was in the hospital. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Full blood count decreased, Haematocrit abnormal, Mobility decreased, Platelet count abnormal, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to her father a 64 years old male patient. The patient's medical history included lyme disease, cataract surgery and no drug reactions or allergies. The patient was vaccinated with a dose of PNEUMOVAX 23 on 21-MAY-2012 (Lot #, dose and route not reported). No other co-suspects were reported. Concomitant medications included metformin, lisinopril (manufacturer unknown) and prednisone (manufacturer unknown). The patient's daughter reported that the next day on 22-MAY-2012 her father began to have a fever that fluctuated and he was in bed all week. The doctor had been called on 23-MAY-2012. On 14-JUN-2012 the patient had an appointment with the eye doctor. On 15-JUN-2012 the patient was admitted to the hospital. While in the hospital he was given insulin and 3 blood transfusions. The patient had experienced shortness of breath, but his electrocardiogram (EKG) was normal. The patient was advised that his low blood count caused the shortness of breath. His red blood count was 19. A bone marrow biopsy was done that proved inconclusive. He was discharged on 18-JUN-2012. On 28-JUN-2012 he had bloodwork done and it was found that his hematocrit and platelets were bad. He was admitted back to the same hospital where 3 more blood transfusions were performed as well as blood cultures and body scans (results not provided). At the time of the report the events persisted and the patient was in the hospital. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Red blood cell count decreased, Transfusion
Clinical narrative: This spontaneous report as received from a consumer refers to her father a 64 years old male patient. The patient's medical history included lyme disease, cataract surgery and no drug reactions or allergies. The patient was vaccinated with a dose of PNEUMOVAX 23 on 21-MAY-2012 (Lot #, dose and route not reported). No other co-suspects were reported. Concomitant medications included metformin, lisinopril (manufacturer unknown) and prednisone (manufacturer unknown). The patient's daughter reported that the next day on 22-MAY-2012 her father began to have a fever that fluctuated and he was in bed all week. The doctor had been called on 23-MAY-2012. On 14-JUN-2012 the patient had an appointment with the eye doctor. On 15-JUN-2012 the patient was admitted to the hospital. While in the hospital he was given insulin and 3 blood transfusions. The patient had experienced shortness of breath, but his electrocardiogram (EKG) was normal. The patient was advised that his low blood count caused the shortness of breath. His red blood count was 19. A bone marrow biopsy was done that proved inconclusive. He was discharged on 18-JUN-2012. On 28-JUN-2012 he had bloodwork done and it was found that his hematocrit and platelets were bad. He was admitted back to the same hospital where 3 more blood transfusions were performed as well as blood cultures and body scans (results not provided). At the time of the report the events persisted and the patient was in the hospital. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 56 year old female patient with no drug reactions or allergies and no pertinent medical history who on 11-JUN-2012, was vaccinated with a dose of PNEUMOVAX 23, 0.5mL subcutaneously (lot number 672962/0025AE, expiration date 11-OCT-2013). There was no concomitant medication. On 12-JUN-2012, the patient developed redness, pain and swelling at the injection site, as well as fever after receiving PNEUMOVAX 23. Prednisone, BENADRYL and dicloxacillin were given as a treatment for redness, pain and swelling at the injection site, as well as fever. At the time of the report the patient's outcome was not recovered. No laboratory tests were performed. The patient sought unspecified medical attention, contacted office. This is one of several reports received from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 672962/0025AE in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information received from the registered nurse revealed that on 11-JUN-2012 at 10:38 A.M, the 56 year old patient with seasonal allergies, asthma, anemia, gastrooesophageal reflux disease (GERD) and anxiety was vaccinated with a dose of PNEUMOVAX 23, SQ into her right arm (lot # 672962/0025AE). There was no illness at time of vaccination. On 11-JUN-2012 at 12:30 P.M., the patient's right arm at the injection site reddened, swollen and was not hot to touch. On 12-JUN-2012, the patient felt ill with temperature of 99.5, redness and swelling spread. On 13-JUN-2012, the patient recovered from the events. Arm injection site redness, hot to touch, feeling ill and temperature of 99.5 were considered medically significant by the nurse practitioner. No manufacturing events were noted in lot investigation that are likely to be related to adverse events reviewed. Additional information is not expected.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Dehydration, Pyrexia
Clinical narrative: This spontaneous report as received from a company representative refers to her mother a 93 years old patient with allergy to codeine. The patient's medical history included breast cancer 5 years ago. The patient was vaccinated with a dose of ZOSTAVAX on 21-JUN-2012. Concomitant medications included HYZAAR, atenolol and ARIMIDEX. On 10-JUL-2012 the patient had been hospitalized due to fever, confusion, dehydration. The patient was given fluids and antibiotics for the adverse event. At the time of the report, the patient was recovering. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Skin plaque, Urticaria
Clinical narrative: 24 hrs after vaccine developed pruritic 4cm plaque/urticarial lesion.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Burning sensation, Decreased appetite, Erythema
Clinical narrative: Large red circle, itching, burning, soreness & pain. Headache, flu symptoms - aching joints and severe malaise. Fever twice and blisters once in nose. Loss of appetite, trouble sleeping - All over a month before I was well.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza, Insomnia, Malaise, Pain
Clinical narrative: Large red circle, itching, burning, soreness & pain. Headache, flu symptoms - aching joints and severe malaise. Fever twice and blisters once in nose. Loss of appetite, trouble sleeping - All over a month before I was well.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: Large red circle, itching, burning, soreness & pain. Headache, flu symptoms - aching joints and severe malaise. Fever twice and blisters once in nose. Loss of appetite, trouble sleeping - All over a month before I was well.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram normal, Laboratory test normal
Clinical narrative: Patient complained of chest tightness and shortness of breath.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: 1st day - headache - 2nd day - fever - bright red rash under breast about 4" deep under both. Lft. injection site swelled size of an orange - very red & painful - took BENADRYL at night x 2.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: 1st day - headache - 2nd day - fever - bright red rash under breast about 4" deep under both. Lft. injection site swelled size of an orange - very red & painful - took BENADRYL at night x 2.
Age: 17.0
Sex: F
Vaccine: HPV4, MMR, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: Clinic hot and humid. Pt had no b-fast in morning. After shots administered (see #13 for order), pt passes out without warning - immediately 10 AM. Pale. Nursing care given. Pt responsive, color returns. Pt leaves clinic at 10:45, fully recovered. Hx irregular periods.
Age: 8.0
Sex: F
Vaccine: TYP, YF
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Pt given vaccine for travel. Clinic hot & humid. Client did not eat bfast prior to vaccines. At checkout pt c/o dizziness, nausea, sweating - clinic rm, ice pack back of neck, feet up, supine position, after recover pt given apple juice -> home with father to get food.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Dizziness, Feeling abnormal, Loss of consciousness, Nausea
Clinical narrative: Patient stated "I don't feel good. I feel like I'm going to pass out." Patient passed out. When patient came to was shaking and stated she seen spots and felt nauseated. Was pale in color.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Tremor, Visual impairment
Clinical narrative: Patient stated "I don't feel good. I feel like I'm going to pass out." Patient passed out. When patient came to was shaking and stated she seen spots and felt nauseated. Was pale in color.
Age: 9.0
Sex: F
Vaccine: FLUN3, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 3cm circular erythema patch on right deltoid, warm to touch. Minimal induration & minimal tenderness to palpation.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 6/21/12 Pt called stating recv'd HPV and VARIVAX (Lt) arm on 6/19/12 - pt states arm was itching with rash next day - took BENADRYL PO. Now (Lt) arm red, hard/swollen and painful. Pt came to office on nurses instruction. (Lt) upper arm painful with 8cm by 4cm redness/induration. Dr observed. Pt f/up instructions: BENADRYL, Ibuprofen q 8 hrs (po), Cool compress PRN, off work today, RTC PRN.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Oedema peripheral, Pain in extremity, Pruritus, Rash
Clinical narrative: 6/21/12 Pt called stating recv'd HPV and VARIVAX (Lt) arm on 6/19/12 - pt states arm was itching with rash next day - took BENADRYL PO. Now (Lt) arm red, hard/swollen and painful. Pt came to office on nurses instruction. (Lt) upper arm painful with 8cm by 4cm redness/induration. Dr observed. Pt f/up instructions: BENADRYL, Ibuprofen q 8 hrs (po), Cool compress PRN, off work today, RTC PRN.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site rash, Irritability, Pyrexia
Clinical narrative: 7/3/12 - Rash fine red clusters, lower back. Fussy, clingy to mother. Fever of 100 with TYLENOL 7/10 - still has rash, fever - mostly rash resolved now. Has a couple red spots on leg from injection site., fever 100.4.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: 7/3/12 - Rash fine red clusters, lower back. Fussy, clingy to mother. Fever of 100 with TYLENOL 7/10 - still has rash, fever - mostly rash resolved now. Has a couple red spots on leg from injection site., fever 100.4.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus
Clinical narrative: Onset 1 day after immunization. States that 5min felt itchy and when she scratches it leaves a "red patch." Pt has asthma but has noticed no increase in symptoms. Denies SOB. Pt. is diabetic.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Cellulitis of (L) upper arm w/ erythema and swelling to appx 2x the size of the (R) upper arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Pt developed rash at the injection site and possible herpes outbreak under the nose. Pt reports having history of herpes. Pt concerned because she was in contact w/ grandchild.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Pallor
Clinical narrative: Tolerated injection but was tense and anxious about injection. While sitting in waiting room approximately 10 min after injection became lightheaded. Assisted to floor, elevated legs, pillow under head. Skin pale, dry. BP 111/62 P 48 P. ox 100%. Alert, oriented. After 5 min BP 105/60 P 50 P. ox 99% with legs lowered. Color pink. Assisted to sitting in chair. Remains seated 5 min until discharge with father.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: On 7/6/12, 2 days after injection, at injection site - it was hot to the touch, swelling and redness started shortly after, very painful and itchy.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: On 7/6/12 pt woke up with intense pain in (L) arm, tender to touch, noticed swelling and redness.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Dyspnoea, Dysstasia, Nausea
Clinical narrative: I had difficulty breathing, dizziness, weakness shortness of breath of standing, felt like I wanted to vomit. I went to.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Myalgia, Vertigo
Clinical narrative: Fatigue myalgias vertigo.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Rash
Clinical narrative: Pt. has onset of rash 5 days ago with small vesicles on an erythematous base on legs, trunk, and face, no other symptoms. She had been vaccinated w/ VZ on 6/8/12.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood pressure increased, Headache, Heart rate increased, Injection site pain, Pain
Clinical narrative: Few hrs after MENVEO yesterday, Pt experienced arm pain at shot site, HA, fever 100 degrees, body aches, elevated HR and BP 170/90 by home BP monitor. Pt. took ADVIL and felt better. Came today for eval but feels fine today - 7/11/12.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Few hrs after MENVEO yesterday, Pt experienced arm pain at shot site, HA, fever 100 degrees, body aches, elevated HR and BP 170/90 by home BP monitor. Pt. took ADVIL and felt better. Came today for eval but feels fine today - 7/11/12.
Age: 25.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 7-17-12 (1400) erythema (R) arm at injection site with redness measuring approximately 2 inches in diameter reassured pt., encouraged use of cold compresses to area and can use OTC BENADRYL as directed - referred to private MD if needed.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Oedema peripheral, Syncope, Vomiting
Clinical narrative: Sick to stomach, headache, chills, arm swollen and had episode of syncope the next day.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Induration, Skin lesion
Clinical narrative: We have had two impressive but non life threatening reactions to MMR vaccine Lot 1449AA in patients in our clinic. Two children, unrelated. Both with approx 5 cm indurated lesion. No streaking, fever, or signs of infection.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at the site of Tdap and varicella injection.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: Shot given. Pt tolerated well. Old pt to wait 15 mins. for any reaction.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a healthcare worker, concerning a 73 year old female patient with codeine and shellfish allergy and none pertinent medical history, who on 07-MAY-2012 was vaccinated with PNEUMOVAX 23 (lot# 671607/1169AA, Expiration date 06-MAY-2013), 0.5ml, IM on the left arm. Concomitant therapy included PAXIL, ezetimibe (+) simvastatin (MSD) and ibuprofen. It was reported that following vaccination the patient experienced on the left arm redness and swelling at the injection site and warm to the touch. On 09-MAY-2012 the patient was diagnosed cellulitis. Also it was reported that cefalexin as a treatment was given. The patient sought medical attention - she visited the office. None lab diagnostics studies were performed. At the time of reporting the patient status was recovered. This is the one of several report received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse also a 60 years old female patient with allergy to sulfa. The patient was vaccinated subcutaneously with "a standard dose" 0.65 ml dose of ZOSTAVAX in her arm on 28-JUN-2012. No other co-suspects were reported. "A lot of medications" were reported as concomitant medication. On approximately 28-JUN-2012 the patient experienced severe local injection site reactions that lasted more than a week. The nurse reported that the area was very red and painful and size was about 8 inches by 5 inches around upper arm. She also reported that the injection site was very hot to touch and about egg size area, right around the injection site was very hard and had "a white ring around the edge of the red arm" and she also experienced itching around injection site. The patient did not seek for medical attention. BENADRYL and ice packs were given as treatment. At the time of reporting, the size of the affected area was much smaller but she still had some itching and inflammation. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This spontaneous report as received from a registered nurse also a 60 years old female patient with allergy to sulfa. The patient was vaccinated subcutaneously with "a standard dose" 0.65 ml dose of ZOSTAVAX in her arm on 28-JUN-2012. No other co-suspects were reported. "A lot of medications" were reported as concomitant medication. On approximately 28-JUN-2012 the patient experienced severe local injection site reactions that lasted more than a week. The nurse reported that the area was very red and painful and size was about 8 inches by 5 inches around upper arm. She also reported that the injection site was very hot to touch and about egg size area, right around the injection site was very hard and had "a white ring around the edge of the red arm" and she also experienced itching around injection site. The patient did not seek for medical attention. BENADRYL and ice packs were given as treatment. At the time of reporting, the size of the affected area was much smaller but she still had some itching and inflammation. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Hypoaesthesia oral, Needle issue
Clinical narrative: Information has been received from a pharmacist, for ZOSTAVAX, a Pregnancy Registry product, concerning herself a 45 years old 16 weeks pregnant female patient with no medical history and concurrent conditions. The patient's history of previous pregnancies and live births is not known. On 06-JUL-2012 the pharmacist was preparing a ZOSTAVAX injection (lot# 672606/1655AA, expired date 21-JAN-2013) for an anonymous consumer. The reconstituted ZOSTAVAX was in the syringe and ready to give to the consumer. The needle was not tight onto the syringe and fell off. The ZOSTAVAX splashed into the 16 wks pregnant pharmacist's face, eyes and mouth. The pharmacist's mouth had become numb and had not recovered. The ZOSTAVAX did not get on the consumer. The consumer did not receive any of the ZOSTAVAX dose either. No other co-suspects were reported. Concomitant medications included: vitamins (unspecified) (vitamins (unspecified)). The patient became pregnant with an LMP of approximately 16-MAR-2012 and an EDD of approximately 21-DEC-2012. Initial exposure to ZOSTAVAX was at 16 week (s). The patient was exposed to ZOSTAVAX during trimester 2. No treatment information was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated intramuscularly with dose 1 of LIQUID PEDVAXHIB on 09-FEB-2012 (lot # and dose not reported) and 44 days after on 23-MAR-2012 was vaccinated with dose 2 of LIQUID PEDVAXHIB (lot #, dose and route not reported). No other co-suspects and no concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a medical assistant referred to a patient of unknown age. The patient was vaccinated with dose 2 of GARDASIL late on 22-MAY-2012. The first dose of GARDASIL was given at another provider's office. No other co-suspects were reported. No concomitant medications were reported. The patient was not experienced any known symptoms. No treatment information was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX (Lot # not reported expiration date 09-JUN-2012) on 11-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of lot # (669692/0615AA, expiration date 02-JUL-2012) of ZOSTAVAX on 03-JUL-2012 (dose and route not reported). No other co-suspects and no concomitant medications were reported. No adverse event was reported. Additional information has been requested.