chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Blood glucose increased, Death, Diabetes mellitus inadequate control, Diabetic coma, Influenza
Clinical narrative: Initial report was received on 20 February 2014 from an electronic lay press article. A 55 year-old male patient (date of birth not reported) with a history of diabetes had received an influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later developed the flu. The patient first became ill on a Thursday. "That afternoon, his blood sugar spiked, and they were unable to get it down. So they took him to the hospital and from there he flat - lined three times". By Friday night the patient was flown to another hospital where he died in a diabetic coma. Outcome was fatal. Documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia
Clinical narrative: C/O leg/arm muscle pain and weakness ongoing since flu vaccine. Woke up with symptoms the morning following the flu vaccine. Seen 2/26 - Rx ibuprofen tid x 7 days.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 19-MAR-2013, the patient was vaccinated with dose 1 of VAQTA (lot#, expiry not reported) and on 21-AUG-2013, the patient received dose 2 of VAQTA (lot#, expiry not reported). No adverse effects reported. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Shot is on left arm the reaction was red itchy, a little bit of pain, and a big bump.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injection site pain, Joint crepitation, Mobility decreased, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Pain at injection site. Unable to lift arm. Arm made popping sound. 2/7/14 still having problems saw PCP had MRI.
Age: 53.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling abnormal, Headache, Pain, Pyrexia
Clinical narrative: Respiratory issues, slight fever; dazed feeling, head pressure, runny nose, type of rash developed on front of right leg below knee involving swelling, extreme pain, redness, shaped like an inverted triangle.  One week later same type of rash appeared on left ankle same symptoms ongoing.
Age: 53.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash, Respiratory disorder, Rhinorrhoea, Swelling
Clinical narrative: Respiratory issues, slight fever; dazed feeling, head pressure, runny nose, type of rash developed on front of right leg below knee involving swelling, extreme pain, redness, shaped like an inverted triangle.  One week later same type of rash appeared on left ankle same symptoms ongoing.
Age: 0.17
Sex: M
Vaccine: RVX
Symptoms: Eczema weeping
Clinical narrative: Within two days, eczema appeared on the skin of both cheeks and within a week the skin of both cheeks was raw and weeping. Pediatrician initially could not diagnose, but an immunologist diagnosed as eczema. Treatment was eventually successful over the course of several months.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Warm, red, itchy, bumps and sort of hard at injection site. It appeared the night of the injection. I told patient to apply ice to area. I contacted the physician and left him a message about the rxn. Redness has now calmed down to just around injection site after 4 days.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced a local reaction of redness, hot, and swelling at the site of injection. When she first reported it on 2/12/14 it was the size of an orange, and very hot but when I called her to see if it resolved she said it swelled almost to her elbow. She states that it was completely resolved after 4 days. She used ice to try to take down the swelling. She had no other side effects it did not itch.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Received 2 doses of Hepatitis A vaccine at same time.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Varicella rash left chest.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Emotional distress, Screaming
Clinical narrative: Child became inconsolable, with screaming after vaccines and for duration of about 6 hours.
Age: 0.3
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 4 month old patient (unknown gender). On 24-FEB-2014, the patient was inadvertently administered with one dose of VAQTA, intramuscularly. No adverse effects reported. This is one of 2 reports from the same reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash erythematous, Urticaria
Clinical narrative: Approx. 35-45 min. after vaccine, mom alerted nurse child's cheeks red. Nurse noted hives on cheeks, erythematous patches of skin on chest and back. No distress or swelling noted. BENADRYL liquid 12.5mg given. Child observed for 30 minutes. All symptoms completely subside and child sent home with mother.
Age: 0.4
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 4 month old patient (unknown gender). On 24-FEB-2014, the patient was inadvertently administered with one dose of VAQTA (lot#, expiry not reported), intramuscularly. No adverse effects reported. This is one of 2 reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Vaccination site induration, Vaccination site swelling
Clinical narrative: (L) arm swollen and hard in the area where vaccine were given. Gave pt an ice pack to put on swollen area.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Pt reported welts (hives) around injection site that started 2 days after injection. Also, large red ring around the hive that stretched from injection site to elbow. Pt came in after MD office closed so instructed pt to get hydrocortisone 1% cream, BENADRYL/ZYRTEC, and use ice - also call MD in AM, but to go to ER if got worse or pt had trouble breathing. F/U on 2/25 - pt states she started ZYRTEC/hydrocortisone/ice. Rash not worse, seems to be getting better, more red. 2/26 - No answer called lm (3 attempts).
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a physician, for with GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. On 06-NOV-2013, 17-FEB-2014, the patient was vaccinated with the first dose of GARDASIL (route, lot # and expiration date were not provided). On 17-FEB-2014, the patient was vaccinated with the second dose of GARDASIL (route, lot # and expiration date were not provided. In approximately February 2014, the patient discovered she was pregnant. The patient was administered the second dose in her series of GARDASIL and she discovered she was pregnant. The patient's last menstrual period and estimated delivery date were unknown. The patient did not seek medical attention. Therapy with GARDASIL continued. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Cough, Pyrexia, Respiratory tract congestion
Clinical narrative: Congestion, unable to cough up mucus plug, fever.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Redness and swelling of arm where vaccine administered.  No systemic symptoms.  Pain to touch.
Age: 1.96
Sex: M
Vaccine: DTAP, FLU3, HIBV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: No adverse reaction. Patient was given a 2 week expired DTaP vaccine.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Nasopharyngitis, Thirst, Vomiting
Clinical narrative: Severe abdominal cramps, cold, dizzy, thirst and vomited two times.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report was received from a consumer reporting herself, to a female patient of unknown age, with allergy to niacin. Historical conditions included "cholesterol" and "other medical issues". On 08-FEB-2014 the patient was vaccinated with ZOSTAVAX (dose, strength and expiration date was not reported), 1 DF, route reported as "injection". Co-suspect therapies were not reported. Concomitant therapies were reported as "yes, unspecified by the reporter". The patient reported that on 09-FEB-2014, reported as 24 hours after being vaccinated with ZOSTAVAX, the patient developed an injection site reaction. The reaction was described as a "circle of redness" with warm around injection site. It is itchy and tender but doesn't hurt unless is pressed down on. Patient reported that on 10-FEB-2014, the reaction is expanded, and continues itching. The patient referred she seek medical attention when she called the pharmacist, and told her to took TYLENOL and BENADRYL. The outcome of injection site was unknown. The outcome of the reaction is expanded was reported as not recovered. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Urticaria
Clinical narrative: The child developed urticarial looking rash around the injection site. Pt developed about 2 days after and lasted 1 week. Mom did not tell us about it until 2/25/14 when she came in with child's siblings.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report was received from a female consumer of unknown age (reporting of herself) with allergy to Erythromycin IV and codeine. The patient's current condition included endometriosis. In approximately February 2011 (reported as 3 years ago), the patient was vaccinated with a dose of ZOSTAVAX (Lot #, exp date, dose not reported, subcutaneous route in the arm). Concomitant therapy was not reported. In approximately February 2011 the patient developed a hard lump at the injection site. She stated that she developed a hard lump that persisted for three years and felt like it's sitting on a bed of nerves. The patient stated that the lump felt deep and was not in the superficial layers. An unspecified allergist told her that it was a hematoma. She stated that within the last year she had an injury with her left shoulder, on the same arm as the injection site reaction. The patient stated that she used a CPA chair for physical therapy to prepare for a shoulder surgery on the left arm, and when she did her range of motion exercised with the CPA chair, the lump swell and was painful. The patient also reported that she had been seen by an unspecified plastic surgeon to have the lump removed. She stated that the plastic surgeon performed a Magnetic Resonance Imaging (MRI) and determined that the lump was not a hematoma, although the plastic surgeon could not state what the lump was composed of. The patient said that the plastic surgeon told her I'll need to sit down with the my medical books for this one. She stated that in the past she had an injection of "Erythromycin IV" before surgery and that the injection site looked like a huge red birth mark. The patient's outcome for the adverse events was reported as not recovered. Upon internal review, the surgery was considered an other important medical event. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Joint injury, Nuclear magnetic resonance imaging abnormal, Shoulder operation
Clinical narrative: This spontaneous report was received from a female consumer of unknown age (reporting of herself) with allergy to Erythromycin IV and codeine. The patient's current condition included endometriosis. In approximately February 2011 (reported as 3 years ago), the patient was vaccinated with a dose of ZOSTAVAX (Lot #, exp date, dose not reported, subcutaneous route in the arm). Concomitant therapy was not reported. In approximately February 2011 the patient developed a hard lump at the injection site. She stated that she developed a hard lump that persisted for three years and felt like it's sitting on a bed of nerves. The patient stated that the lump felt deep and was not in the superficial layers. An unspecified allergist told her that it was a hematoma. She stated that within the last year she had an injury with her left shoulder, on the same arm as the injection site reaction. The patient stated that she used a CPA chair for physical therapy to prepare for a shoulder surgery on the left arm, and when she did her range of motion exercised with the CPA chair, the lump swell and was painful. The patient also reported that she had been seen by an unspecified plastic surgeon to have the lump removed. She stated that the plastic surgeon performed a Magnetic Resonance Imaging (MRI) and determined that the lump was not a hematoma, although the plastic surgeon could not state what the lump was composed of. The patient said that the plastic surgeon told her I'll need to sit down with the my medical books for this one. She stated that in the past she had an injection of "Erythromycin IV" before surgery and that the injection site looked like a huge red birth mark. The patient's outcome for the adverse events was reported as not recovered. Upon internal review, the surgery was considered an other important medical event. Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Computerised tomogram, Headache, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: Approximately 01:00am Friday morning (2/21/14) she began experiencing right sided neck pain progressing throughout the day to headache; initally the discomfort was localized to her arm, but progressed to right side of neck, then to headache.  Patient went to the ER on Monday (02/24/14) and was diagnosed "tetanus side effect".
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Vaccination complication
Clinical narrative: Approximately 01:00am Friday morning (2/21/14) she began experiencing right sided neck pain progressing throughout the day to headache; initally the discomfort was localized to her arm, but progressed to right side of neck, then to headache.  Patient went to the ER on Monday (02/24/14) and was diagnosed "tetanus side effect".
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Muscle rigidity
Clinical narrative: Within seconds of receiving her fourth vaccine (HPV), patient reports feeling like she might pass out.  She has done this before following pain stimulus.  We leaned her back with head of exam table up and feet up.  She closed her eyes and became rigid for about 5 seconds.  Then she became alert and reported she didn't remember what had just happened.  I observed her for another 15 minutes with no further symptoms/signs.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: NONE.
Age: 1.29
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Decreased appetite, Dizziness, Gait disturbance, Irritability, Lethargy
Clinical narrative: Lethargic for a week, fever lasting three days (99 degrees - 102 degrees), dizziness and trouble walking for a week, irritable for a week, loss of appetite for two weeks.
Age: 1.29
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Lethargic for a week, fever lasting three days (99 degrees - 102 degrees), dizziness and trouble walking for a week, irritable for a week, loss of appetite for two weeks.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Hypoaesthesia, Muscular weakness, Paraesthesia, Temperature intolerance
Clinical narrative: Within minutes, I had tingling and weakness in my arms, which spread to my feet. It soon spread over most of my body, retriggering symptoms from a previous neurological episode that had been dormant. It took 8 months for symptoms to subside. Difficulties included numbness to any amount of pressure on body, body-wide tingling, arm-weakness, and inability to wear shoes. Heat sensitivity occurred, especially in the feet.
Age: 29.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Dizziness, Dry throat, Dysphagia, Injection site erythema, Injection site pruritus
Clinical narrative: Pt came in the clinic at 0930 to get Anthrax and Typhoid for her deployment. She left the clinic feeling fine, she went to lunch and complained about itching and redness to the right shoulder, forearm, and round the mouth. She came back to the Immunization Clinic stating that she can't stop itching and suddenly she felt dizzy and neasua. We laid her down on the exam table in which she later felt her throat dry and that it was getting harder to swallow.
Age: 29.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Nausea
Clinical narrative: Pt came in the clinic at 0930 to get Anthrax and Typhoid for her deployment. She left the clinic feeling fine, she went to lunch and complained about itching and redness to the right shoulder, forearm, and round the mouth. She came back to the Immunization Clinic stating that she can't stop itching and suddenly she felt dizzy and neasua. We laid her down on the exam table in which she later felt her throat dry and that it was getting harder to swallow.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dysarthria, Dyskinesia, General physical health deterioration, Immediate post-injection reaction
Clinical narrative: Patient immediately reported feeling dizzy.  Patient's condition deteriorated quickly.  Patient started experiencing uncontrollable movements in right arm (arm vaccine was administered).  Patient's speech started to become slurred and progressed to incoherent.  Patient's husband stated this has happened 3 or 4 times before and always at night.  He attributed it to low blood sugar.  Patient was given one glucose tablet to chew, which she did without incident and blood sugar was taken.  Patients blood sugar was 120 mg/dl via finger stick.  911 was called and stroke assessment was initiated.  Patient could stick tongue out but was having difficulty repeating a sentence.  EMS arrived and transported patient to ER.  Patient was realesed several hours later with no deffinate diagnosis.  Patient has follow up appointment with primary physician in approximately 1 week.  Patient has EEG scheduled for 2 to 3 weeks from now.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Incoherent, Speech disorder
Clinical narrative: Patient immediately reported feeling dizzy.  Patient's condition deteriorated quickly.  Patient started experiencing uncontrollable movements in right arm (arm vaccine was administered).  Patient's speech started to become slurred and progressed to incoherent.  Patient's husband stated this has happened 3 or 4 times before and always at night.  He attributed it to low blood sugar.  Patient was given one glucose tablet to chew, which she did without incident and blood sugar was taken.  Patients blood sugar was 120 mg/dl via finger stick.  911 was called and stroke assessment was initiated.  Patient could stick tongue out but was having difficulty repeating a sentence.  EMS arrived and transported patient to ER.  Patient was realesed several hours later with no deffinate diagnosis.  Patient has follow up appointment with primary physician in approximately 1 week.  Patient has EEG scheduled for 2 to 3 weeks from now.
Age: 24.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Malaise
Clinical narrative: Pt received influenza vaccine and Hep A dose # 1 vaccines on 2-26-14, aprox. 3 mins after receiving Hep A pt stated he didn't feel well. Pt remained conscious and responsive. Pt had no s/sx of resp. distress, no anaphylactic s/sx. Pt was assisted to reclining position and cool compress applied to forehead. Pt stated this happens when he has blood drawn but has not had this happen from vaccines in past. Pt VS 112/68 and second set 120/72, resp 17.
Age: 0.19
Sex: M
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Rash
Clinical narrative: Rash over leg abdomin and a little on face doesn't seem to bother him at all. He's not scratching or fuzzy, no fever, no redness or swelling at injection site. He also started vitamin D drops and oral Nystain for thrush at the same time.
Age: 1.34
Sex: M
Vaccine: HIBV, MMR
Symptoms: Blood electrolytes normal, Blood glucose decreased, Condition aggravated, Convulsion, Dyspnoea
Clinical narrative: Mom noted that patient was gasping during drive home from hospital, found that he was convulsing. Episode lasted 4 minutes. Brought by EMS to outside hospital and found to have fever up to 103.7. Diagnosed with febrile seizure. No further episodes.
Age: 1.34
Sex: M
Vaccine: HIBV, MMR
Symptoms: Febrile convulsion, Metabolic disorder, Pyrexia
Clinical narrative: Mom noted that patient was gasping during drive home from hospital, found that he was convulsing. Episode lasted 4 minutes. Brought by EMS to outside hospital and found to have fever up to 103.7. Diagnosed with febrile seizure. No further episodes.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Convulsion, Full blood count, Irritability, Pyrexia
Clinical narrative: Started with fussiness and fever, then it developed into seizures, went to Emergency Department on 2/19/14.
Age: 1.32
Sex: M
Vaccine: HIBV
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: DIARRHEA, LOW GRADE FEVER.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash - began on neck; spread to trunk; examined in office 2/13/14 (date of onset is approximate per parent).
Age: 1.56
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Blood test, Chest X-ray, Febrile convulsion, Pyrexia
Clinical narrative: Febrile Seizure, High Fever.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Acupuncture, Biopsy, Blister, Pruritus generalised, Rash pruritic
Clinical narrative: Began as small flea like bites/rash on back of right shoulder that were VERY itchy.  Moved across my upper back and down my spine.  Many small itchy bumps.  Began 1/4 of one 25mg Hydroxizine 2 x's per day on Sunday September 15th, 2013.  Between 9/15 and 10/17, I developed hives in addition to the small bumps on my back and my palms and the inside of my ankles itched like you can't believe.  No rash, not red, just itched.  I was now itching from my scalp to my ankles.  The only relief was bathing and rinsing my hair in apple cider vinegar.   I tried a lot of remedies.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Began as small flea like bites/rash on back of right shoulder that were VERY itchy.  Moved across my upper back and down my spine.  Many small itchy bumps.  Began 1/4 of one 25mg Hydroxizine 2 x's per day on Sunday September 15th, 2013.  Between 9/15 and 10/17, I developed hives in addition to the small bumps on my back and my palms and the inside of my ankles itched like you can't believe.  No rash, not red, just itched.  I was now itching from my scalp to my ankles.  The only relief was bathing and rinsing my hair in apple cider vinegar.   I tried a lot of remedies.
Age: 1.02
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Lymphadenopathy, Ultrasound scan abnormal
Clinical narrative: Chest wall mobile nodular lymph node 2x3 cm ultimately.  Followed closely for 3 weeks and ultimately resolved.  Was about 3-4 cm below R axilla in the same arm MMR and Varicella given.
Age: 1.95
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Induration/erythema at injection site (L) lateral thigh 2 days after vaccine (likely DTaP site). Resolved with cetirizine.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned to facility. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between the dates of 2/12-2/18/14 under lot number (J012212).
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction. S/P vaccination ice to area, Motrin as needed.
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Skin rash after 1st capsule.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fevers, seizures within 2 days of immunization, lasted 1 week.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Concussion, Convulsion, Head injury, Syncope
Clinical narrative: This spontaneous report as received from a consumer (patients mother) via company representative refers to a 12 year old female patient. On an unknown date the patient was vaccinated with her 3rd dose of GARDASIL. No concomitant medications were reported. On 20-FEB-2014, the patient fainted, and also the reporter questioned if this event could have had a seizure (medically significant) and the patient hit her head on the exam table and suffered a concussion during the event. The outcome of event the patient fainted, seizure and concussion was reported as recovering. Relation between the event and GARDASIL was unknown. Upon internal review event seizure was considered medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and need to be returned. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not have been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been indentify the 12 patients who administered HPV vaccine between the dates of 2/12 - 12/18/14 under lot number (J012212).
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned to clinic. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between the dates of 2/12 - 12/18/14 under lot number (J012212).
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between the dates of 2/12 - 2/18/14 under lot number (J012212).
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned. These three vaccines were mistakenly and in administered to three (3) patients, whoever the staff person was who administered 3 doses of the HPV that should not been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between the dates of 2/12 - 2/18/14 under lot number (J012212).
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: Three (3) HPV, lot # (J013324) had bee exposed to the out of range temperature and needed to be returned to clinic. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between the dates of 2/12 - 12/18/`4 under lot number (J012212).
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned to VFC. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between the dates of 2/12 - 2/18/14 under lot number (J012212).
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned to VFC. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between the dates of 2/12 - 2/18/14 under lot number (J012212).
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction. S/P vaccination, ice to area, Motrin as needed.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not have been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccine exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between dates of 2/12 - 12/18/14 under lot number (J012212).
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Incorrect storage of drug
Clinical narrative: Patient received vaccines exposed to the out of range temperature.
Age: 71.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chest X-ray normal, Chills, Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: End of July 2013 pt with cough, chills, fever, rhinitis and sore throat. Rx with antibiotic, cough syrup - cough continued until Oct 2013 with low grade fever at times then resolved - Reports cough in 20 Dec 2012 .
Age: 71.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Rhinitis
Clinical narrative: End of July 2013 pt with cough, chills, fever, rhinitis and sore throat. Rx with antibiotic, cough syrup - cough continued until Oct 2013 with low grade fever at times then resolved - Reports cough in 20 Dec 2012 .
Age: 71.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Cough, Drug administered to patient of inappropriate age, Respiratory tract infection
Clinical narrative: End of July 2013 pt with cough, chills, fever, rhinitis and sore throat. Rx with antibiotic, cough syrup - cough continued until Oct 2013 with low grade fever at times then resolved - Reports cough in 20 Dec 2012 .
Sex: M
Vaccine: HEPAB
Symptoms: Activities of daily living impaired, Asthenia, Dizziness, Fatigue
Clinical narrative: Rec'd #1 Hep A 6/27/13 #2 Hep A 7-24-13 - Returns for final inj. today. Reports had "reaction" approx 8 hrs after rec'q #2. At work and experienced severe fatigue and weakness, "almost passed out". Sent home from work, slept well and had no further problems. Did not report event to clinic or dr. Uncertain if lack of sleep.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: Patient received vaccines exposed to the out of range temperature.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: Patient has infection at the site of injection. There was redness and swelling at the site of injection. Her primary care provider treated the side with antibiotic.
Age: 23.0
Sex: M
Vaccine: TYP, YF
Symptoms: Blood glucose decreased, Face injury, Fall, Head injury, Loss of consciousness
Clinical narrative: Client walked out of the health dept and fell (passed out), and got up and passed out again hitting his head and face on the concrete. He came to very shortly and then said he had passed out once before after vaccines. Taken by ambulance to ER where he got stitches in his chin and was diagnosed with low blood sugar.
Age: 23.0
Sex: M
Vaccine: TYP, YF
Symptoms: Suture insertion
Clinical narrative: Client walked out of the health dept and fell (passed out), and got up and passed out again hitting his head and face on the concrete. He came to very shortly and then said he had passed out once before after vaccines. Taken by ambulance to ER where he got stitches in his chin and was diagnosed with low blood sugar.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 25 year old female patient with drug reaction/allergies to penicillin (unspecified) and no other pertinent medical history. On 04-NOV-2013, the patient was vaccinated with VARIVAX (merck), 0.5 ml, subcutaneous in the left arm. Lot number were not reported. There was no concomitant medication. On the evening of 04-NOV-2013 the patient's left arm was warm, red and itchy and a little sore to the touch at the injection site. All events resolved totally after two weeks on an unspecified date (approximately in November 2013). The patient did not seek medical attention. No lab diagnostic studies were performed. Additional information has been requested.
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The pharmacist reported that the patient was administered ZOSTAVAX (lot#, dose and route unknown) and BOOSTRIX on the same day in different arms on an unspecified date in February 2014. There was no concomitant medication reported. On an unspecified date, after the administration of ZOSTAVAX and BOOSTRIX, the patient sought medical attention at an unspecified physician. The patient reported to pharmacist that physician told her that she had swollen lymph nodes on both sides of her body on an unspecified date in February 2014. Treatment reported was that physician "bandaged arm" in which the ZOSTAVAX was administered. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. It was reported the patient received a first dose of RECOMBIVAX HB (lot#, expiry date, dose, frequency, route and indication not reported) on 19-AUG-2013 and would like to receive the second dose of RECOMBIVAX HB (lot#, expiry date, dose, frequency, route and indication not reported) "now" (20-FEB-2014). No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Gastrointestinal viral infection, Rotavirus test positive, Vomiting
Clinical narrative: This spontaneous report as received from a physician's via company representative refers to a baby of unknown gender and age. The patient's current conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of ROTATEQ vial (dose, route, lot and expiration date were not reported). On an unknown date, the patient experienced vomiting and diarrhea and was seen in an unspecified emergency department on an unspecified date. The baby tested positive for rotavirus and was diagnosed with another gastrointestinal virus. The reporter stated that she did not believe that the patient had active rotavirus infection. At the time of the report, the patient was recovering from gastrointestinal virus. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Gout
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old male patient without drug reactions or allergies. The patient's current conditions or medical history were not reported. On 13-FEB-2014, the patient was vaccinated with a dose of ZOSTAVAX (plaque forming units) 0.65 ml, subcutaneously (lot J011337, exp date 13-DEC-2014). Co suspect were not reported. Concomitant therapies included allopurinol and indomethacin. On an unspecified date in February 2014, the patient developed gout, and went to the pharmacy with prescription for prednisone and colchicine for the treatment of gout. At the time of the report the outcome for gout was unknown. The patient visited a physician for medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Injection site cellulitis, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist refers to an approximately 60 years old female patient. Medical history was reported as none. No known drug allergy was reported. On 14-OCT-2013, the patient was vaccinated with ZOSTAVAX, 19400 PFU (plaque-forming units), lot # J006830; expiry date: 14-SEP-2014, dose (unspecified), frequency (unspecified), in the left arm. Other suspect therapies include: FLUZONE and HEXAVAC (dosing regimen unspecified) were administered (On 14-OCT-2013) in her right arm. On 15-OCT-2013, the patient was diagnosed with cellulitis at the ZOSTAVAX injection site and her left arm injection site was warm to the touch and she had a fever. On 15-OCT-2013, patient sought medical attention at the Medical Center and treatment prescribed at hospital was oral KEFELX. On 16-OCT-2013, patient sought medical attention with an unspecified physician and patient was prescribed oral sulfamethoxazole and BACTRIM and KEFLEX was discontinued. Lab diagnostics studies performed were reported as none. No product quality complaint was involved. The outcome of events was reported as resolved on 27-OCT-2013. Casuality assessment was not provided. This report is linked to 1402USA007824, 1402USA007825 and 1402USA007826 by the same reporter link. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Vaccination failure
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 25 year old female patient. Primary reporter is nurse, who is also the mother of the patient. It was reported that patient was administered all three doses in GARDASIL, series on unspecified dates at 17 or 18 years of age. Concomitant therapies included hormonal contraceptives (unspecified). No product quality complaints (PQC) were filed. Patient received a routine Pap Smear on an unspecified date in 2014. On an unspecified date in February 2014 the patient then received a colposcopy and was diagnosed with Human papillomavirus (HPV) strand 16 and atypical cells. The outcome of the event was reported as not recovered/not resolved. The causality of the event was not reported. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Colposcopy abnormal, Dysplasia, Papilloma viral infection, Smear cervix
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 25 year old female patient. Primary reporter is nurse, who is also the mother of the patient. It was reported that patient was administered all three doses in GARDASIL, series on unspecified dates at 17 or 18 years of age. Concomitant therapies included hormonal contraceptives (unspecified). No product quality complaints (PQC) were filed. Patient received a routine Pap Smear on an unspecified date in 2014. On an unspecified date in February 2014 the patient then received a colposcopy and was diagnosed with Human papillomavirus (HPV) strand 16 and atypical cells. The outcome of the event was reported as not recovered/not resolved. The causality of the event was not reported. Additional information is not expected.
Age: 1.35
Sex: M
Vaccine: DTAP, MMR, VARCEL, VARCEL, VARCEL
Symptoms: Polymerase chain reaction, Rash, Varicella virus test
Clinical narrative: This spontaneous report was received from a physician refers to a 17 month old male patient. Medical history was reported as none. No known drug allergy was reported. On 27-DEC-2013 the patient was vaccinated with first dose VARICELLA (Merck) lot # J006695; expiry: 30-MAY-2015, dose: 0.5 ml (milliliters), subcutaneous in the right thigh. Concomitant therapy was reported was none. On 02-FEB-2014, the patient developed lesion on his right thigh (firm papulovesicular lesions). Approximately on an unknown date in February 2014, the physician sent isolates from the lesions for PCR testing and the results were positive for varicella. It was reported that an unspecified pediatrician referred patient to a dermatologic evaluation on 05-FEB-2014. The physician noted three 3.5 cm (centimeters), well defined, oval, pink thin plaques on his right thigh. The plaques have overlying 1-2 mm (millimeters), round, firm papulovesicular lesions. No medical treatment was prescribed. Approximately on an unknown date in February 2014, Complete Blood Count was negative and HIV (Human immune virus) test-negative. The patient sought medical attention and had an office visit. The outcome of developed lesion on his right thigh (firm papulovesicular lesions) and varicella was reported as resolving at the time of this report. Causality assessment for the events was not provided. Additional information has been requested.
Age: 1.35
Sex: M
Vaccine: DTAP, MMR, VARCEL, VARCEL, VARCEL
Symptoms: Rash papular
Clinical narrative: This spontaneous report was received from a physician refers to a 17 month old male patient. Medical history was reported as none. No known drug allergy was reported. On 27-DEC-2013 the patient was vaccinated with first dose VARICELLA (Merck) lot # J006695; expiry: 30-MAY-2015, dose: 0.5 ml (milliliters), subcutaneous in the right thigh. Concomitant therapy was reported was none. On 02-FEB-2014, the patient developed lesion on his right thigh (firm papulovesicular lesions). Approximately on an unknown date in February 2014, the physician sent isolates from the lesions for PCR testing and the results were positive for varicella. It was reported that an unspecified pediatrician referred patient to a dermatologic evaluation on 05-FEB-2014. The physician noted three 3.5 cm (centimeters), well defined, oval, pink thin plaques on his right thigh. The plaques have overlying 1-2 mm (millimeters), round, firm papulovesicular lesions. No medical treatment was prescribed. Approximately on an unknown date in February 2014, Complete Blood Count was negative and HIV (Human immune virus) test-negative. The patient sought medical attention and had an office visit. The outcome of developed lesion on his right thigh (firm papulovesicular lesions) and varicella was reported as resolving at the time of this report. Causality assessment for the events was not provided. Additional information has been requested.
Age: 1.35
Sex: M
Vaccine: DTAP, MMR, VARCEL, VARCEL, VARCEL
Symptoms: Full blood count normal, HIV test negative, Injection site induration, Injection site plaque, Injection site reaction
Clinical narrative: This spontaneous report was received from a physician refers to a 17 month old male patient. Medical history was reported as none. No known drug allergy was reported. On 27-DEC-2013 the patient was vaccinated with first dose VARICELLA (Merck) lot # J006695; expiry: 30-MAY-2015, dose: 0.5 ml (milliliters), subcutaneous in the right thigh. Concomitant therapy was reported was none. On 02-FEB-2014, the patient developed lesion on his right thigh (firm papulovesicular lesions). Approximately on an unknown date in February 2014, the physician sent isolates from the lesions for PCR testing and the results were positive for varicella. It was reported that an unspecified pediatrician referred patient to a dermatologic evaluation on 05-FEB-2014. The physician noted three 3.5 cm (centimeters), well defined, oval, pink thin plaques on his right thigh. The plaques have overlying 1-2 mm (millimeters), round, firm papulovesicular lesions. No medical treatment was prescribed. Approximately on an unknown date in February 2014, Complete Blood Count was negative and HIV (Human immune virus) test-negative. The patient sought medical attention and had an office visit. The outcome of developed lesion on his right thigh (firm papulovesicular lesions) and varicella was reported as resolving at the time of this report. Causality assessment for the events was not provided. Additional information has been requested.
Age: 1.35
Sex: M
Vaccine: DTAP, MMR, VARCEL, VARCEL, VARCEL
Symptoms: Polymerase chain reaction, Rash papular, Varicella virus test positive
Clinical narrative: This spontaneous report was received from a physician refers to a 17 month old male patient. Medical history was reported as none. No known drug allergy was reported. On 27-DEC-2013 the patient was vaccinated with first dose VARICELLA (Merck) lot # J006695; expiry: 30-MAY-2015, dose: 0.5 ml (milliliters), subcutaneous in the right thigh. Concomitant therapy was reported was none. On 02-FEB-2014, the patient developed lesion on his right thigh (firm papulovesicular lesions). Approximately on an unknown date in February 2014, the physician sent isolates from the lesions for PCR testing and the results were positive for varicella. It was reported that an unspecified pediatrician referred patient to a dermatologic evaluation on 05-FEB-2014. The physician noted three 3.5 cm (centimeters), well defined, oval, pink thin plaques on his right thigh. The plaques have overlying 1-2 mm (millimeters), round, firm papulovesicular lesions. No medical treatment was prescribed. Approximately on an unknown date in February 2014, Complete Blood Count was negative and HIV (Human immune virus) test-negative. The patient sought medical attention and had an office visit. The outcome of developed lesion on his right thigh (firm papulovesicular lesions) and varicella was reported as resolving at the time of this report. Causality assessment for the events was not provided. Additional information has been requested.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, MMR, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 8 MOS AND 29 DAY OLD INFANT PT ARRIVED AT CLINIC TO RECEIVE 6 MOS OLD VACCINE SET WHICH INCLUDES ROTATEQ VACCINE, BUT LATER FOUND OUT THAT ROTATEQ VACCINE IS NOT INDICATED FOR PATIENTS 8 MOS AND 0 DAY OLD AND ABOVE.