chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US019686, is a combined initial and follow-up spontaneous report from a nurse received on 01 Oct 2015 and on 02 Oct 2015. This report refers to a 25 year old female patient. Past medical history and concomitant medications were not reported. Nurse reported that the patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) 0.5 ml intramuscular on 30 Sep 2015. No adverse event was reported. No further information was provided.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US018516 is an initial spontaneous report received from a health care professional on 17 Sep 2015. This case refers to a 28 years old female patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 1514501) at a dose of 0.5 ml intramuscularly on 14 Sep 2015, which was left out of refrigerator from Friday night until Monday morning. It was reported that the vaccines were delivered on Friday and it stayed out of the fridge in the original packaging for the weekend. When the reporter called, she was informed that a temperature excursion was permitted for up to 72 hours and the excursion did not exceed this time frame. No adverse reaction was experienced by the patient following this medication error. The reporter declined further follow up contact. Follow up information received from the health care professional on 27 Oct 2015. Clinical notes updated.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US019681 is a combined initial and follow-up spontaneous report from a nurse received on 01 Oct 2015 and on 02 Oct 2015. This report refers to a 21 years old female patient. Past medical history and concomitant medications were not reported. Nurse reported that the patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) 0.5 ml intramuscular on 30 Sep 2015. No adverse event was reported. No further information was provided.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US004140, is an initial spontaneous report from a medical assistant received on 27 Feb 2015. This report refers to a 3 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN, (batch numbers: U5036CA, U5018AA, U5I73AB, UI207AB and 14511P) intramuscularly at a dose of 0.5 ml on 29 Jan 2015, which reached 31 degree Fahrenheit for two hours. No adverse event was reported following this administration error (incorrect storage of drug, drug use in unapproved population).
Age: 1.14
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US004138 is an initial spontaneous report received from medical assistant on 27 Feb 2015: This case refers to a 13 months old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch numbers: U5036CA, U501BAA, U5018AA, UI173AB, UI207AB, UI2O7AB, 14511F) at a dose of 0.5 ml intramuscularly on 05 Feb 2015, which reached 31 degree Fahrenheit for two hours. No adverse event was reported following this administration error.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US019682 is a combined initial and follow-up spontaneous report from a nurse received on 01 Oct 2015 and on 02 Oct 2015. This report refers to a 38 years old female patient. Past medical history and concomitant medications were not reported. Nurse reported that the patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) 0.5 ml intramuscular on 30 Sep 2015. No adverse event was reported. No further information was provided.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US004137 is an initial spontaneous report received from medical assistant on 27 Feb 2015: This case refers to a 58 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch numbers: U5036CA, U501BAA, U5018AA, UI173AB, UI207AB, UI2O7AB, 14511F) at a dose of 0.5 intramuscularly on 05 Feb 2015, which reached 31 degree Fahrenheit for two hours. No adverse event was reported following this administration error.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US004136 is an initial spontaneous report received from medical assistant on 27 Feb 2015: This case refers to a 06 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch numbers: U5036CA, U501BAA, U5018AA, UI173AB, UI207AB, UI2O7AB, 14511F) at a dose of 0.5 ml intramuscularly on 16 Feb 2015, which reached 31 degree Fahrenheit for two hours. No adverse event was reported following this administration error.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US018901 is an initial spontaneous report received from a medical assistant on 23 Sep 2015. This case refers to a 43 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1516101 and expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly on 23 Sep 2015, which had temperature excursion of 0.9c for 1 hour and 8 minutes. No adverse event was reported following this administration error.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US004135 is an initial spontaneous report received from medical assistant on 27 Feb 2015: This case refers to an 11 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch numbers: U5036CA, U501BAA, U5018AA, UI173AB, IU173AB, UI207AB, UI2O7AB, 14511F) at a dose of 0.5 ml intramuscularly on 26 Feb 2015, which reached 31 degree Fahrenheit for two hours. No adverse event was reported following this administration error.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019748, is an initial spontaneous report received from a pharmacist on 05 Oct 2015. This report refers to a 31 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date, which was stored at 70 degree Fahrenheit for 1 hour. No adverse event was reported following this administration error.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US019674, is a combined initial and follow-up spontaneous report from a nurse received on 01 Oct 2015 and on 02 Oct 2015. This report refers to a 27 year old female patient. Past medical history and concomitant medications were not reported. Nurse reported that the patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) 0.5 ml intramuscular on 30 Sep 2015. No adverse event was reported. No further information was provided.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US018518 is a spontaneous report initially received from a health care professional on 17 Sep 2014. This case refers to a 28 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1514501) at a dose of 0.5 ml intramuscularly on 14 Sep 2015, which was left out of refrigerator from Friday night until Monday morning. It was reported that the vaccines were delivered on Friday and it stayed out of the fridge in the original packaging for the weekend. When the reporter called, she was informed that a temperature excursion was permitted for up to 72 hours and the excursion did not exceed this time frame. No adverse event was reported following this administration error. The reporter declined further follow up contact. Follow up information received from the health care professional on 27 Oct 2015. Clinical notes updated.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US004134, is an initial spontaneous report from a medical assistant received on 27 Feb 2015. This report refers to a 13 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch numbers: U5036CA, U5018AA, UI173AB, UI1207AB and 14511P) intramuscularly at a dose of 0.5 ml on 26 Feb 2015, which reached 31 degree F for two hours. No adverse event was reported following this administration error.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US018895 is an initial spontaneous report received from a medical assistant on 23 Sep 2015. This case refers to a 42 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 1516101 and expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly on 23 Sep 2015, which had a temperature excursion of 0.9c for 1 hour and 8 minutes. No adverse event was reported following this administration error.
Age: 1.25
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US004133 is an initial spontaneous report received from medical assistant on 27 Feb 2015: This case refers to a 15 months old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: U5036CA, U501BAA, U5018AA, UI173AB, UI173AB, UI2017AB, UI2O7AB, 14511F) at a dose of 0.5 ml intramuscularly on 26 Feb 2015, which reached 31 degree Fahrenheit for two hours. No adverse event was reported following this administration error.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019308 is an initial spontaneous report received from a pharmacist on 28 Sep 2015. This report refers to a female patient whose age was not reported. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 27 Sep 2015. It was reported that the vaccine administered had a temperature excursion of 47 degree Fahrenheit for 2 hours. No adverse events were reporting following the maladministration.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US004131, is an initial spontaneous report from a medical assistant received on 27 Feb 2015. This report refers to a 2 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch numbers: U5036CA, U5018AA, U5I173AB, UI1207AB and 14511P) intramuscularly at a dose of 0.5 ml on 08 Feb 2015, which reached 31 degree Fahrenheit for two hours. No adverse event reported following this administration error.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US018517 is an initial spontaneous report received from a health care professional on 17 Sep 2015. This case refers to a 26 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1514501) at a dose of 0.5 ml intramuscularly on 14 Sep 2015, which was left out of refrigerator from Friday until Monday morning. It was reported that the vaccines were delivered on Friday and it stayed out the fridge in the original packaging for the weekend. When the reporter called, she was informed that a temperature excursion was permitted for up to 72 hours and the excursion did not exceed this time frame. No adverse reaction was experienced by the patient following this medication error. The reporter declined further follow up contact. Follow up information received from the health care professional on 27 Oct 2015. Clinical notes updated.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: Case number PHEH2015US004597, is an initial spontaneous report from the consumer (patient) received on 06 Mar 2015. This report refers 70-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly in Sep 2014 and went out of the country in Feb 2014. On 02 Feb 2015, she experienced sore throat, fever, runny nose and sneezing. The outcome of the event sore throat was condition unchanged. The outcome of the other events was complete recovery. The seriousness and causality assessment of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, Vaccination site urticaria, Wrong drug administered
Clinical narrative: Case number PHEH2015US015698 is an initial spontaneous report received from a health care professional on 12 Aug 2015. This report refers to a female patient whose age was not reported. Past medical history and concomitant medications were not reported. The patient received an expired dose of FLUVIRIN (batch number: 1412301A, expiry date: 30 Jun 2015) intradermally instead of tuberculin (TB) skin test (other manufacturer, batch number; not reported) on 12 Aug 2015. It was reported that patient had a big welt at the vaccination site on the same date. The outcome, seriousness and causality of welt were not reported. No further information was provided.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site nodule
Clinical narrative: Case number PHEH2015US018754, is an initial spontaneous report from a pharmacist received on 18 Sep 2015. This report refers to a 62-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1514701, expiry date: May 2016) intramuscularly on 18 Sep 2015. On the same day after vaccination, the patient bled a lot (required many gauze) and developed a quarter sized knot at the injection site. However the patient did not feel any pain. The patient recovered from the events on 18 Sep 2015. Seriousness and causality was not reported.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US015697, is an initial spontaneous report from a medical assistant received on 12 Aug 2015. This report refers to a 21 years old patient of an unknown gender. Medical history and concomitant medications were not reported. The patient received expired FLUVRIN PFS (batch number: 145701) intramuscularly on 07 Aug 2015. No adverse event was reported.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2015US019390, is an initial spontaneous report received from a pharmacist on 30 Sep 2015. This report refers to a 58 year old female patient. Medical history and concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 151570) 0.1 ml intramuscular on 30 Sep 2015. No adverse event was reported following the overdose. No further information was provided.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, Injection site urticaria, Vaccination site urticaria, Wrong drug administered
Clinical narrative: Case number PHEH2015US015696 is an initial spontaneous report received from a health care professional on 12 Aug 2015. This report refers to a male patient whose age was not reported. Past medical history and concomitant medications were not reported. The patient received an expired dose of FLUVIRIN (batch number: 1412301A, expiry date: 30 Jun 2015) intradermally instead of tuberculin (TB) skin test (other manufacturer, batch number: not reported) on 12 Aug 2015. It was reported that patient had a big welt at the vaccination site on the same date. The outcome, seriousness and causality of welt were not reported. No further information was provided. Following an internal review, of the data received on 12 Aug 2015, it was identified that the product tuberculin was erroneously not coded and hence it was coded as suspect.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019856, is an initial spontaneous report received from a pharmacist on 02 Oct 2015. This report refers to a 54 year old male patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514801) intramuscularly at a dose of 0.5 ml on 02 Oct 2015. The pharmacist reported that the vaccine FLUVIRIN that had reached 52 degree for 30 minutes was administered to the patient. No adverse event was reported following the medication error.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: The patient reports that on 02/04/2016 when she was being treated for a left palm laceration she received a tetanus booster from the office staff upon orders of Dr. She states that within the last 1-2 days she noticed a hot, red patch spreading out from the injection site at the right deltoid. She reported that it was accompanied by a sensation of muscle stiffness in the right arm. She noted additional well-demarcated patches of red, raised skin of a smaller size spreading distally from the central lesion. She states that someone told her to try applying cortisone but this did not help with the problem. She denies difficulty speaking, tightness in the throat, chest pain, shortness of breath, or difficulty breathing. Examination reveals a large irregularly shaped raised erythematous lesion with maximum dimensions of 10 cm x 7 cm. There is no visible dimpling or injection site wound. There are 4 smaller patches better individually demarcated traveling distally down the arm to just above the elbow. They are also raised. All of these lesions are hot to the touch compared to the surrounding skin. There is no crusting, flaking, induration, exudate, or drainage. Dr. also examined the patient and we question whether or not his may be a case of erysipelas versus some sort of adverse reaction to a vaccine component or preservative. There is no indication that the patient is having an anaphylactic reaction or other life-threatening event. Possible infection spreading distally from infection site. Our POC is to treat with KEFLEX 500 mg p.o. b.i.d. x10 days. Prescription written for 20 capsules, 0 refills. Safer medication use was discussed with the patient. I discussed signs and symptoms of anaphylaxis with the patient and she was advised to seek emergent medical attention if they occur. Plan to recheck in our office in 72 hours otherwise.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Skin lesion
Clinical narrative: The patient reports that on 02/04/2016 when she was being treated for a left palm laceration she received a tetanus booster from the office staff upon orders of Dr. She states that within the last 1-2 days she noticed a hot, red patch spreading out from the injection site at the right deltoid. She reported that it was accompanied by a sensation of muscle stiffness in the right arm. She noted additional well-demarcated patches of red, raised skin of a smaller size spreading distally from the central lesion. She states that someone told her to try applying cortisone but this did not help with the problem. She denies difficulty speaking, tightness in the throat, chest pain, shortness of breath, or difficulty breathing. Examination reveals a large irregularly shaped raised erythematous lesion with maximum dimensions of 10 cm x 7 cm. There is no visible dimpling or injection site wound. There are 4 smaller patches better individually demarcated traveling distally down the arm to just above the elbow. They are also raised. All of these lesions are hot to the touch compared to the surrounding skin. There is no crusting, flaking, induration, exudate, or drainage. Dr. also examined the patient and we question whether or not his may be a case of erysipelas versus some sort of adverse reaction to a vaccine component or preservative. There is no indication that the patient is having an anaphylactic reaction or other life-threatening event. Possible infection spreading distally from infection site. Our POC is to treat with KEFLEX 500 mg p.o. b.i.d. x10 days. Prescription written for 20 capsules, 0 refills. Safer medication use was discussed with the patient. I discussed signs and symptoms of anaphylaxis with the patient and she was advised to seek emergent medical attention if they occur. Plan to recheck in our office in 72 hours otherwise.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain and redness around the immunization site.
Age: 72.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Pain, Pain in extremity, Tenderness
Clinical narrative: Arm was very sore next day. A red spot appeared two days later. It started out tiny, but in a few days grew to the diameter of an orange. It was not raised, warm to the touch, and disappeared after one week. The spot was located to the left front from the injection site on the right arm. Her arm still hurts to the touch and when she moves it.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2015Us017360, is an initial spontaneous report received from a nurse on 02 Sep 2015. This report refers to a 36 years old male patient. Past medical history and concomitant medications was not reported. He was vaccinated with two doses of FLUVIRIN (batch number: 1514501) intramuscularly on the same visit on 02 Sep 2015. No adverse event was reported following the administration error.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US019672, is a combined initial and follow-up spontaneous report from a nurse received on 01 Oct 2015 and on 02 Oct 2015. This report refers to a 38 year old female patient. Past medical history and concomitant medications were not reported. Nurse reported that the patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) 0.5 ml intramuscular on 30 Sep 2015. No adverse event was reported. No further information was provided.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2015US017214 is a spontaneous report initially received from a nurse on 02 Sep 2015. This report refers to a 41 year old female patient. Past medical history was not reported. Her vaccination history include administration of seasonal influenza vaccine (manufacturer and batch number: not reported) for the past 4 years. Her concomitant medications were not reported. She was vaccinated with 0.5 ml FLUVIRIN (batch number: 157103, expiry date: May 2016) pre-filled syringe intramuscularly in the left deltoid on 01 Sep 2015 at 9:40 am. It was reported that the before administration to the patient, the vaccine was out of temperature range at 0.4 degree Celsius for 6 hours, but it was not frozen. The reporter stated that the physician in their office gave his clearance to administer the affected FLUVIRIN vaccines which were not frozen, but was only exposed to low temperature. The reported stated that patient tolerated the injection well and did not have an adverse reaction after maladministration. The caregivers for patient also did not report adverse reaction either. No further information was provided. Follow up information received from the nurse on 02 Oct 2015: Reporter's comments updated. Follow up information received from the nurse on 02 Oct 2015: Updated vaccination history, dose, site, expiry date and time of administration of suspect vaccine and reporter's comment.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US016933, is an initial spontaneous report from a nurse received on 27 Aug 2015. This report refers to a 32-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 157403, expiry date: May 2016) intramuscularly at a dose of 0.5 ml on 27 Aug 2015. It was reported that patient received FLUVIRIN PFS that had a temperature excursion of 10.49 degrees Celsius for up to 25 minutes. No adverse event was reported due to the maladministration.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US016929, is an initial spontaneous report from a nurse received on 27 AUG 2015. This report refers to a 24-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN 2015/2016 (batch number: 157403, expiry date: May 2016) intramuscularly at a dose of 0.5 ml on 27 AUG 2015. It was reported that patient received FLUVIRIN that had a temperature excursion of 10.39 degrees Celsius for up to 25 minutes. No adverse event was reported due to the  maladministration (incorrect storage of drug).
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site extravasation, No adverse event, Underdose
Clinical narrative: Case number PHEH2015US016566, is an initial lspontaneous report from a pharmacist received on 21 AUG 2015. This report refers to a 28-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The reporter stated that the FLUVIRIN 2015/2016 (batch number: 15731P) was administered intramuscularly and the patient had tightened up the arm and the most of the vaccine came back out on 20 AUG 2015. No adverse event was reported.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, Incorrect route of drug administration, Injection site reaction, Urticaria, Wrong drug administered
Clinical narrative: Case number PHEH2015US015705 is an initial spontaneous report received from a health care professional on 12 AUG 2015. This report refers to a male patient whose age was not reported. Past medical history and concomitant medications were not reported. The patient received an expired dose of FLUVIRIN 2014/2015 (batch number: 1412301A, expiry date: 30 JUN 2015) intradermally instead of tuberculin (TB) skin test (other manufacturer, batch number: not reported) on 12 AUG 2015. It was reported that patient had a big welt at the vaccination site on the same date. The outcome, seriousness and causality of welt were not reported. No further information was provided. Following an internal review of the date received on 12 AUG 2015, it was identified that the product tuberculin was erroneously not coded and hence it was recoded as suspect.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US017652, is an initial spontaneous report from a nurse received on 09 SEP 2015. This report refers to 41-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN 2015/2016 (batch number: 157103) pre-filled syringe (PFS) intramuscularly at a dose of 0.5 ml on 14 SEP 2015 (at 15:00) at left deltoid. It was reported that the patient received vaccine w hich was out of temperature range at 33.2 degree Fahrenheit. The event was reported as non-serious. No adverse events were reported following the inadvertent administration . Follow up report from the nurse received on 27 OCT 2015. Updated vaccination date, time and site.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US017651 is an initial spontaneous report received from a nurse on 08 SEP 2015. This report refers to a male patient whose age was not reported. Past medical history and concomitant medications were not reported. His vaccination history included administration of FLUVIRIN (batch number: not reported) for twice on an unknown dates which were tolerated. The patient was vaccinated with 0.5 ml of FLUVIRIN 2015/2016 (batch number: 157103) pre-filled syringe (PFS) intramuscularly into left deltoid on 08 SEP 2015 at 14:30 hours. It was reported that the patient received vaccine which was out of temperature range at 33.2 degree Fahrenheit on 08 SEP 2015. The event was reported as non-serious. No adverse events were reported following the inadvertent administration. Follow-up information received from a nurse on 27 OCT 2015: Patient's demographics (height and weight), vaccination history, time of vaccination, site of vaccination and other clinically relevant information updated in the narrative.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number: PHEH2015US017649, is an initial spontaneous report received from a nurse on 09 SEP 2015. This report refers to a 48 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated wit FLUVIRIN (batch number: not reported) and was well tolerated. He was vaccinated with 0.5 ml of FLUVIRIN 2015/2016 (batch number: 157103) pre-filled syringe (PFS) intramuscularly into the left deltoid on 08 SEP 2015. It was reported that the patient received vaccine which was out of temperature range at 33.2 degree Fahrenheit on 08 SEP 2015. The event was reported as non-serious. No adverse events were reported following the inadvertent administration. Follow up report received from the nurse on 27 OCT 2015: updated patient demographics, vaccination history, vaccination details and other clinically relevant information.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US017580, is an initial spontaneous report from a pharmacist received on 04 SEP 2015. This report refers to an 85-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received expired FLUVIRIN 2014/2015 (batch number: 1411001) intramuscularly on 03 SEP 2015. No adverse event was reported.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: Case number PHEH2015US020017, is an initial spontaneous report received from a healthcare professional on 05 OCT 2015. This report refers to a patient of unknown age and gender. Medical history and concomitant medication were not provided. The patient was vaccinated with FLUVIRIN 2015/2016 (batch number: unknown) intravenously through patient's hemodialysis machine on an unspecified date. Reporter was also calling it as  near miss, as the medicine was drawn out the machine. Outcome and seriousness of the event were unknown. Causality of the event was not reported. No further information was provided.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2015US020012, is an initial spontaneous report received from a pharmacist on 07 Oct 2015. This report refers to a 28-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN, (batch number: 1514501) intramuscularly on an unknown date. On 04 Oct 2015, she experienced severe pain and rash at the injection site on the top of arm, swelling at the injection site on the top of whole arm. On an unknown date, he developed bad itching at the injection site she wants to claw her arm out, warm at the injection site to the touch and swelling hurts to lift her arm up. Symptoms are not localized to injection site only moved to other parts of same arm. The outcome of severe pain, rash and swelling at the injection site was reported as complete recovery on 04 Oct 2015. The outcome of bad itching and warm at the injection site, swelling hurts to lift her arm up was not reported. The seriousness and causality of the events were not reported. No further details provided.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Case number PHEH2015US020012, is an initial spontaneous report received from a pharmacist on 07 Oct 2015. This report refers to a 28-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN, (batch number: 1514501) intramuscularly on an unknown date. On 04 Oct 2015, she experienced severe pain and rash at the injection site on the top of arm, swelling at the injection site on the top of whole arm. On an unknown date, he developed bad itching at the injection site she wants to claw her arm out, warm at the injection site to the touch and swelling hurts to lift her arm up. Symptoms are not localized to injection site only moved to other parts of same arm. The outcome of severe pain, rash and swelling at the injection site was reported as complete recovery on 04 Oct 2015. The outcome of bad itching and warm at the injection site, swelling hurts to lift her arm up was not reported. The seriousness and causality of the events were not reported. No further details provided.
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US019987 is an initial spontaneous report received from a consumer (patient's wife) on 05 OCT 2015. This report refers to a male patient whose age was not reported. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2015/2016 (batch number: not reported) subcutaneously instead of intramuscularly on 05 OCT 2015. No adverse events were reported following the maladministration.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019859, is an initial spontaneous report received from a pharmacist on 02 OCT 2015. This report refers to a 61 year old male patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN 2015/2016 (batch number: 1514801) intramuscularly at a dose of 0.5 ml on 02 OCT 2015. The pharmacist reported that the vaccine FLUVIRIN that had reached 52 degree for 30 minutes was administered to the patient. No adverse event was reported following the medication error (incorrect storage of drug).
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019858, is an initial spontaneous report from a pharmacist received on 02 OCT 2015. This report refers to a 34-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN 2015/2016 (batch number: 1514801) intramuscularly at a dose of 0.5 ml on 02 OCT 2015. The pharmacist reported that the vaccine FLUVIRIN that had reached 52 degree for 30 minutes was administered to the patient. No adverse event was reported following the medication error (incorrect storage of drug).
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019857, is an initial spontaneous report received from a pharmacist on 02 OCT 2015. This report refers to a 60 year old female patient. Historical and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN 2015/2016 (batch number: 1514801) intramuscularly at a dose of 0.5 ml on 02 OCT 2015. The pharmacist reported that the vaccine FLUVIRIN that had reached 52 degree for 30 minutes was administered to the patient. No adverse event was reported following the medication error (incorrect storage of drug).
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019855, is an initial spontaneous report received from a pharmacist on 02 OCT 2015. This report refers to a 46 year old male patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN 2015/2016 (batch number: 1514801) intramuscularly at a dose of 0.5 ml on 02 OCT 2015. The pharmacist reported that the vaccine FLUVIRIN that had reached 52 degree for 30 minutes was administered to the patient. No adverse event was reported following the medication error (incorrect storage of drug).
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Case number PHEH2015US019021, is an initial spontaneous report from a nurse received on 24 Sep 2015. This report refers to a 24 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN, (batch number: 1515401) in the butt (gluteal region) on 24 Sep 2015. No adverse event was reported.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US019671, is a combined initial and follow-up spontaneous report from a nurse received on 01 OCT 2015 and on 02 OCT 2015. The report refers to a 33-year-old patient of unknown gender. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with expired FLUVIRIN 2014/2015 (batch number: 1413801), expiry date: JUN 2015) at a dose of 0.5 ml intramuscularly on 30 SEP 2015. No adverse event was reported. No further information was provided.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US018515 is an initial spontaneous report received from a health care professional on 17 SEP 2015. This case refers to a 62 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN 2015/2016 (batch number: 1514501) at a dose of 0.5 ml intramuscularly on 14 SEP 2015, which was left out of refrigerator from Friday night until Monday morning. It was reported that the vaccines were delivered on Friday and it stayed out of the fridge in the original packaging for the weekend. When the reporter called, she was informed that a temperature excursion was permitted for up to 72  hours and the excursion did not exceed this time frame. No adverse reaction was experienced by the patient following this medication error (incorrect storage of drug). The reporter declined further follow up contact. Follow up information received from the health care professional on 27 OCT 2015: Clinical notes updated.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US018509 is an initial spontaneous report received from a health care professional on 17 SEP 2015. This case refers to a 60 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2015/2016 (batch number: 1514501) at a dose of 0.5 ml intramuscularly on 14 SEP 2015, which was left out of refrigerator from Friday night until Monday morning. It was reported that the vaccines were delivered on Friday and it stayed out of the fridge in the original packaging for the weekend. When the reporter called, she was informed that a temperature excursion was permitted for up to 72 hours and the excursion did not exceed this time frame. No adverse reaction was experienced by the patient following this medication error (incorrect storage of drug). The reporter declined further follow up contact. Follow up information received from the health care professional on 27 OCT 2015: Clinical notes updated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a small amount (unspecified total) of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # K005881, expiration date 14-JAN-2017 (dose and route of administration were not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: Patient was mistakenly given PCV13 instead of Pneumo 23. PCV13 given on 05/19/15 and again on 02/09/16.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus, Skin irritation
Clinical narrative: Vaccinated 2/2/16, onset of erythema 2/5/16 and warm, itchy irritation. Per patient, vigorous massage of site from 2/6/16 to 2/7/2016, at which point patient noted increased itching and erythema measuring 18.5 cm x 7.0 cm in office 2/8/16. Pt states she scratched skin due to itching applied sesame seed oil to site 2/7/16.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Vaccinated 2/2/16, onset of erythema 2/5/16 and warm, itchy irritation. Per patient, vigorous massage of site from 2/6/16 to 2/7/2016, at which point patient noted increased itching and erythema measuring 18.5 cm x 7.0 cm in office 2/8/16. Pt states she scratched skin due to itching applied sesame seed oil to site 2/7/16.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Pain
Clinical narrative: Induration, redness, pain, > 4 days post immunization.
Age: 1.36
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Pyrexia, Seizure
Clinical narrative: Child ran fever up to 103.8. Pt had seizure activity lasting less than 1 minute. Pt. seen in ER.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Pain
Clinical narrative: Induration, redness, pain, > 7 days post immunization.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The concurrent conditions and medical history were not provided. On 01-FEB-2016, the patient was vaccinated with dose of GARDASIL 9 lot #: K026246, expiration date on 28-JAN-2017 (route, dose and anatomical location were not reported); which were incorrectly stored as they underwent a temperature of 30.7F during 20 hours. Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Impetigo, Pneumonia streptococcal, Streptococcus test positive
Clinical narrative: 1-11-16: Diagnosed with streptococcus pneumonia bacterium 4 (four) days after PNEUMOVAX. 1-17-16 signs of impetigo. 1-28-16 Diagnosed with impetigo.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to unspecified patients of unknown age and gender. The concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot #: K026246, expiration date on 28-JAN-2017 or lot #: L045711, expiration date on 08-MAY-2017 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. Temperature: 30.7F. Time frame: 20 hours. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Patients' medical history and concurrent conditions were not reported. Since 19-NOV-2015 (vaccination start date approximated to 2015) the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K009756 exp: 09-JUL-2016 or lot# L021213 exp: 10-JUN-2017). VARIVAX (Merck) (lot # K009756) was stored at -10C for 15 hours and administered to the patient with in a time frame of 1 hour 36 minutes and VARIVAX (Merck) with lot# L021213 was stored at -5C for 16 hours and administered with in a time frame of 1 hour 36 minutes. No adverse effect reported. No product quality complaint (PQC) was involved. This is one of the two reports from the same source. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Fall
Clinical narrative: Patient received PREVNAR 13 vaccine on 12/14/15. Reported on 2/8/16 that episodes of falling down w/wout consciousness since Jan 2016. Patient believes it was from PREVNAR 13 immunization.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to unspecified patients of unknown age and gender. The concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with doses of ROTATEQ oral, lot # L025598, expiration date on 13-JAN-2017 and lot #: L035508, expiration date on 12-MAY-2017 (dose and anatomical location were not reported); which were improperly stored as underwent a temperature of 30.7F during 20 hours. Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Erythema
Clinical narrative: KEFLEX rx lateral aspect leg-erythema secondary cellulitis not related to injection - per emergency room no surrounding erythema or sign of reaction at injection site - per emergency room.
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster
Clinical narrative: This spontaneous report as received fro a physician via company representative refers to an elderly female patient. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (route and site of administration, dose, not number and expiration date were not reported) however it is not documented in her medical record. On an unknown date, the patient developed shingles on her face and complained of pain in her face. The patient sought medical attention via physician visit and was treated with unspecified "antivirals and steroids" and gabapentin. The outcome of herpes zoster and facial pain was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Skin warm
Clinical narrative: 4 cm erythema, warm, not indurated.