chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2015US022674 is an initial spontaneous report received from a pharmacist on 28 Oct 2015. This report refers to a 61 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) multi dose vial (MDV) on 28 Oct 2015. It was reported that the vaccine administered was pre-drawn into a syringe from multi dose vial for 10 days and held at proper temperature. No adverse events were reported following the maladministration.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2015US022675 is an initial spontaneous report received from a pharmacist on 28 Oct 2015. This report refers to a 52 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) multi dose vial (MDV) on 28 Oct 2015. It was reported that the vaccine administered was pre-drawn into a syringe from multi dose vial for 10 days and held at proper temperature. No adverse events were reported following the maladministration.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2015US022676 is an initial spontaneous report received from a pharmacist on 28 Oct 2015. This report refers to a 54 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported0 multi dose vial (MDV) on 28 Oct 2015. It was reported that the vaccine administered was pre-drawn into a syringe from multi dose vial for 10 days and held at proper temperature. No adverse events were reported following the maladministration.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020606, is an initial spontaneous report received from a nurse on 13 Oct 2015. This report refers to a 65 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1412701) intramuscularly at a dose of 0.5 ml on 08 Oct 2015. No adverse event was reported following this maladministration.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US021448 is an initial spontaneous report received from a nurse on 20 Oct 2015. This report refers to a 47 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1413101) at a dose of 0.5 ml, intramuscularly on 13 Oct 2015. No adverse event was reported following this medication error.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2015US022677 is an initial spontaneous report received from a pharmacist on 28 Oct 2015. This report refers to a 55 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) multi dose vial (MDV) on 28 Oct 2015. It was reported that the vaccine administered was pre-drawn into a syringe from multi dose vial for 10 days and held at proper temperature. No adverse events were reported following this maladministration.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US022797, is an initial spontaneous report from a health care professional received on 04 Nov 2015. This report refers to a 31 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1582040 at a dose of 0.5 ml intramuscularly on 02 Nov 2015. It was reported that the patient received vaccine that had been stored at 8.2 degrees Fahrenheit overnight before administration. The case was assessed as non-serious. No adverse event was reported following this maladministration.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020303, is an initial spontaneous report received from a nurse on 08 Oct 2015. This report refers to a 24 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) 0.5 ml intramuscularly on 07 Oct 2015. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that was stored out of temperature range at 47 Fahrenheit before administration. No adverse event was reported following the medication error.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020302 is an initial spontaneous report received from a nurse on 08 Oct 2015. This report refers to a 63 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly on 07 Oct 2015. The nurse reported that the patient was administered FLUVIRIN multi dose vial (MDV) that was in out of temperature range at 47 degree Fahrenheit. The case was reported as non-serious. No adverse events were reported following the maladministration.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Case number PHEH2014US022452 is an initial spontaneous report received from a nurse on 05 Nov 2014. This report refers to a female patient of an unspecified age. Her past medical history included a life threatening reaction to cephalosporins. On an unspecified date, she was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly, the last season. One day after the vaccination, she noticed redness and swelling at the injection site. It was not painful and was a hive over the injection site which was very localized. She also had itching at the injection site. She was treated with a mycin antibiotic as she was advised not to receive penicillins and carbapenem. She completely recovered from the events on an unspecified date. The seriousness and causality of the events was not reported.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site reaction
Clinical narrative: Case number PHEH2015US022363, is an initial spontaneous report from a nurse received on 29 Oct 2015. This report refers to a 19 years old female patient. Medical history and concomitant medications were not reported. The patient received 0.5 ml of FLUVIRIN (batch number: 1515101) via subcutaneous route on 21 Oct 2015. On the same day after vaccination the patient experienced injection site reaction. Outcome of the event was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: Case number PHEH2015US022364, is an initial spontaneous report received from nurse on 29 Oct 2015. This report refers to a 53 year old female patient. Historical condition and concomitant medication were unknown. The patient was vaccinated with FLUVIRIN (batch number: 1515101) at a dose of 0.5ml subcutaneously on 21 Oct 2015. On the same day after vaccination patient had an injection site reaction. Outcome of the events was reported as unknown. Events were reported to be non-serious and causality of the events was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: Case number PHEH2015US022365, is an initial spontaneous report received from nurse on 29 Oct 2015. This report refers to a 29 year old female patient. Historical condition and concomitant medication were unknown. The patient was vaccinated with FLUVIRIN (batch number: 1515101) at a dose of 0.5ml subcutaneously on 21 Oct 2015. On the same day after vaccination patient had an injection site reaction. Outcome of the events was reported as unknown. Events were reported to be non-serious and causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site reaction
Clinical narrative: Case number PHEH2015US022366, is an initial spontaneous report received from nurse on 29 Oct 2015. This report refers to a 47 year old female patient. Historical condition and concomitant medication were unknown. The patient was vaccinated with FLUVIRIN (batch number: 1515101) at a dose of 0.5ml subcutaneously on 21 Oct 2015. On the same day after vaccination patient had an injection site reaction. Outcome of the events was reported as unknown. Events were reported to be non-serious and causality of the events was not reported.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Case number PHHY2015US022460 is an initial spontaneous report received from a nurse via product technical complaint department (QA reference number: 1008125) on 28 Oct 2015. This report refers to a patient whose identifiers were not reported. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 15733P, expiry date: 30 May 2016) pre-filled syringe on 28 Oct 2015. It was reported that when received the product was packaged in a good condition and the vaccine was removed from the box by the nurse and was placed into a refrigerator. The syringe was removed from the refrigerator to administer the patient. During administration, the vaccine began to leak out from the side of the syringe body/barrel. The nurse found that the barrel was cracked when she noticed the syringe closely. The syringe was discarded (the complaint sample was hence not available) and the patient was administered only a partial dose. No adverse event were reported following the maladministration. The seriousness of the events were not reported. No further information was provided.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US022650 is an initial spontaneous report received from a pharmacist on 03 Nov 2015 and quality assurance department (QA reference nr. 1008394) on 05 Nov 2015 (combined report). This report refers to a 86 years old male patient. Medical history and concomitant medications were not reported. It was reported that the patient may have received expired FLUVIRIN (batch number: 146304) intramuscularly on 02 Nov 2015. The reporter wonders if the PFS was mislabeled because it came with a shipment that included other syringes with different lot number and expiration date. No adverse event was reported.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHEH2015US022656, is an initial spontaneous report from a health care professional received on 03 Nov 2015. This report refers to a 42 years old female patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1515701) incorrectly at a dose of 0.1 ml intradermal on an unknown date. On 02 Nov 2015 the patient experienced redness, swelling and itching at the injection site. Events stop date was reported as 02 Nov 2015. Final outcome of the events were not reported. Seriousness and causality of the events were not reported.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHEH2015US022656 is an initial spontaneous report from a health care professional received on 03 Nov 2015. This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. The patient received  FLUVIRIN (batch number: 1515701) incorrectly at  a dose of 0.1 ml intradermal on an unknown date. On 02 Nov 2015 the patient experienced redness, swelling and itching at the injection site. Events stop date was reported as 02 Nov 2015. Final outcome of the events were not reported. Seriousness and causality of the events were not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Case number PHEH2015US021445, is an initial spontaneous report received from a nurse on 21 Oct 2015. This report refers to a 53 years old female patient. Historical condition and concomitant medication were not provided. Patient had received expired FLUVIRIN (batch number: 1413101) intramuscularly on 13 Oct 2015. No further information was provided following this maladministration (expired vaccine used). Outcome of the event was reported as unknown. Event was reported to be non-serious and causality of the events was not reported.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021519, is an initial spontaneous report from a physician received on 21 Oct 2015. This report refers to 2-year-old patient of unknown gender. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: not reported) intramuscularly on 20 Oct 2015. No adverse event was reported.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US021556 is an initial spontaneous report received from a consumer (wholesale representative) on 22 Oct 2015. This report refers to a patient of an unknown age and gender. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) that was out of normal temperature range, on an unknown date. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020304, is an initial spontaneous report received from a nurse on 08 Oct 2015. This report refers to a 30 year old female patient. Historical condition and concomitant medication were not provided. The patient was vaccinated with FLUVIRIN (batch number: 1515701) intramuscular at a dose of 0.5 ml  on 07 Oct 2015. It was reported that the patient was administered with FLUVIRIN vaccine which was stored out of 47 degree Fahrenheit temperature. No adverse event was reported following this maladministration (incorrect storage if drug).
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020305 is an initial spontaneous report from a nurse received on 08 Oct 2015. This report refers to a 59 years old female patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscular on 07 Oct 2015. It was reported that the patient received FLUVIRIN MDV that was out of temperature range at 47 F before administration. No adverse event was reported following this medication error (incorrect storage of drug).
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020306, is an initial spontaneous report from a nurse received on 08 Oct 2015. This report refers to a 28-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1515701) 0.5 ml intramuscular on 07 Oct 2015. It was reported that the patient received FLUVIRIN MDV that was out of temperature range at 47F before administration. No adverse event was reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020307, is an initial spontaneous report from a nurse on 08 Oct 2015. This report refers to a 54-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1515701) 0.5 ml intramuscular on 07 Oct 2015. It was reported that the patient received FLUVIRIN MDV that was out of temperature range of 47 F before administration. No adverse event was reported.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020308, is an initial spontaneous report from a nurse received on 08 Oct 2015. This report refers to a 61-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1515701) 0.5 ml intramuscular on 07 Oct 2015. It was reported that the patient received FLUVIRIN MDV that was out of temperature range at 47F before administration. No adverse event was reported.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020329 is an initial spontaneous report from a nurse received on 09 Oct 2015. This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. The patient received expired FLUVIRIN (batch number: not reported) on an unknown date. No adverse event was reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US022834 is an initial spontaneous report received from a health care professional on 05 Nov 2015 and from the health care professional on the same date (combined report). This report refers to a 62 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with an expired 0.5 ml dose of FLUVIRIN (batch number: 145004) intramuscularly on 04 Nov 2015. The case was reported as non-serious. No adverse events were reported following the maladministration.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site vesicles, Skin tightness
Clinical narrative: Case number PHEH2015US020579 is an initial spontaneous report received from a health care professional on 14 Oct 2015. This report refers to a 76 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1514601) intramuscularly on an unknown date. It was reported that on 13 Oct 2015, the patient experienced arm pain, swelling, tightness and blisters around the injection site. One of the blisters was the size of a dime and the pain on a scale of 1 to 10 was 9. The events outcome was unknown. The seriousness and causality of the events was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Case number PHEH2015US020561 is an initial spontaneous report received from a nurse on 14 Oct 2015. This report refers to a patient of an unknown age and gender. Historical condition and concomitant medication were not provided. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in gluteal muscle on 10 Oct 2015. No adverse event was reported following this maladministration (vaccine administered at inappropriate site). The nurse stated she cannot provide any information on the case as per their privacy officer.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness, Mobility decreased, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Case number PHEH2015US020375 is an initial spontaneous report received from a pharmacist on 12 Oct 2015. This report refers to a 66 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 15751P) pre-filled syringe (PFS) intramuscularly on an unknown date. It was reported that on 05 Oct 2015 the patient experienced loss of balance, fever at 103 degree Fahrenheit, dizziness, stiffness and he could not move. The events outcome was unknown. The seriousness and causality of the events not reported.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020469 is an initial spontaneous report from a health care professional received on 12 Oct 2015. This report refers to a female patient of an unknown age. The patient was inadvertently vaccinated with an expired FLUVIRIN (batch number: 1412501) intramuscularly on 12 Oct 2015. No adverse event reported following this medication error (expired vaccine used).
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020477, is an initial spontaneous report from a nurse received on 12 Oct 2015. This report refers to a 70-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1515201) intramuscularly that experienced an unknown temperature for up to two hours during a power outage on 12 Oct 2015. No adverse event was reported.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US020568, is an initial spontaneous report received from a pharmacist on 13 Oct 2015. This report refers to female patient of unknown age. Medical history and concomitant medication were not reported. It was reported that the patient was vaccinated with FLUVIRIN (batch number: not reported) subcutaneously on an unknown date. No adverse event was reported following this maladministration.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020587 is an initial spontaneous report received from a nurse on 13 Oct 2015. This report refers to a 35 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1412701) at a dose of 0.5 ml, intramuscularly on 08 Oct 2015. No adverse event was reported following this medication error (expired vaccine used).
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020590, is an initial spontaneous report received from a nurse on 13 Oct 2015. This report refers to a 52 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1412701) intramuscularly at a dose of 0.5 ml on 08 Oct 2015. No adverse event was reported following this maladministration (expired vaccine used).
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020601, is an initial spontaneous report received from a nurse on 13 Oct 2015. This report refers to a 38 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1412701) intramuscularly at a dose of 0.5 ml on 08 Oct 2015. No adverse event was reported following this maladministration (expired vaccine used).
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US022832 is an initial spontaneous report received from a health care professional on 05 Nov 2015 and from the health care professional on the same date (combined report). This report refers to a 64 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with an expired 0.5 ml dose of FLUVIRIN (batch number: 145004) intramuscularly on 04 Nov 2015. The case was reported as non-serious. No adverse events were reported following the maladministration.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US022799, is an initial spontaneous report from a health care professional received on 04 Nov 2015. This report refers to a 46 years old male patient. Medical history and concomitant medications were unknown. The patient was vaccinated with FLUVIRIN (batch number: 158204) at a dose of 0.5 ml intramuscularly on 02 Nov 2015. It was reported that the patient received vaccine that had been stored at 8.2 degrees Fahrenheit overnight before administration. The case was assessed as non-serious. No adverse event was reported following this maladministration.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020610, is an initial spontaneous report received from a nurse on 13 Oct 2015. This report refers to a 30 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1412701) at a dose of 0.5 ml, intramuscularly on 08 Oct 2015. No adverse event was reported following this medication error.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US022798, is an initial spontaneous report from a health care professional received on 04 Nov 2015. This report refers to a 36 years old female patient. Medical history and concomitant medications were unknown. The patient was vaccinated with FLUVIRIN (batch number: 158204) at a dose of 0.5 ml intramuscularly on 02 Nov 2015. It was reported that the patient received vaccine that had been stored at 8.2 degrees Fahrenheit overnight before administration. The case was assessed as non-serious. No adverse event was reported following this maladministration.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HPV9, HEPA, HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 15 year old female patient with asthma exercise induced and no drug reactions or allergies. On 01-FEB-2016, the patient was vaccinated with a dose of GARDASIL 9, dose 1 (dose, anatomical place of vaccination, lot# and expiration date were not provided). Other suspect therapies include HAVRIX 2 dose (dose, anatomical place of vaccination, lot # and expiration date were not provided). Concomitant therapies included drospirenone, LORYNA. On the same date, the patient developed urticarial. Subsequently, on an unknown date, the patient sought for medical attention via telephone call and then on an unknown date, started treatment with BENADRYL indicated for the adverse event. At the time of the report, the outcome of the urticarial was reported as not recovered. The reporter did not provide a causality assessment and no product quality complain was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HPV9, HEPA, HPV9
Symptoms: Erythema, Joint swelling, Pruritus, Swelling, Urticaria
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 15 year old female patient with asthma exercise induced and no drug reactions or allergies. On 01-FEB-2016, the patient was vaccinated with a dose of GARDASIL 9, dose 1 (dose, anatomical place of vaccination, lot# and expiration date were not provided). Other suspect therapies include HAVRIX 2 dose (dose, anatomical place of vaccination, lot # and expiration date were not provided). Concomitant therapies included drospirenone, LORYNA. On the same date, the patient developed urticarial. Subsequently, on an unknown date, the patient sought for medical attention via telephone call and then on an unknown date, started treatment with BENADRYL indicated for the adverse event. At the time of the report, the outcome of the urticarial was reported as not recovered. The reporter did not provide a causality assessment and no product quality complain was involved. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: Patient given ZOSTAVAX vaccine intramuscularly instead of subcutaneously.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a male patient of unknown age. On 03-JUN-2014 the patient was vaccinated with his first dose of GARDASIL (dose, lot # and route were not reported). On 08-FEB-2016, the patient was vaccinated with his second dose of GARDASIL (dose, lot # and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to multiple unspecified patients. On unknown dates the patients were vaccinated with doses of ROTATEQ (lot # L029934, expiration date 01-MAY-2017; lot # L027719, expiration date 28-APR-2017; lot # L013206, expiration date 29-JAN-2017), which were improperly stored at 0.4 centigrade with total cumulative time of 518 hours. There was no previous temperature excursion. No adverse effects reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administration error, Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 10-FEB-2016, the patient was vaccinated with ZOSTAVAX (lot # L028282, exp. 28-OCT-2016, dose not provided, subcutaneous). No concomitant therapy was reported. It was reported that while vaccination the last 0.1 ml did not go into the patient. The reporter stated that either the needles was leaking or there was a problem with the patent's skin. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a pharmacy technician refers to 76-year-old male patient. The patient's concurrent conditions and medical history were not reported. The pharmacy technician reported that on 23-SEP-2015 at 03:15 PM, the patient was subsequently vaccinated with an improperly stored dose of ZOSTAVAX (lot # L006382, an expiration date: 25-MAY-2016) (dose was not provided). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because all scheduled correspondence was received.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030585, expiration date 10-FEB-2017, therapy type RHA). There was no adverse effects reported. Follow up information was received on 05-FEB-2016, stating that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 08-FEB-2016 from the nurse regarding a 4 year old patient of unknown gender. On 10-DEC-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck). This is one of several reports received from the same source. Additional information has been requested. Patient tab, event tab and narrative were updated.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Rash, Skin warm
Clinical narrative: This spontaneous report was received from a 56 year old female patient reporting on herself. On approximately November 2015 (reported as "about 2 months ago"), the patient was vaccinated with ZOSTAVAX (dose, frequency and route of administration were not reported). The patient stated that she developed "inflammation and heat" on her arm then a rash on her face. The patient also stated that she had been in contact with her a new born baby after having received the vaccine. The patient did not say if she was experiencing the adverse events at the time of this contact. The patient also stated that she might not have chickenpox previously. The patient sought medical attention. The outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030585, expiration date 10-FEB-2017, therapy type RHA). There was no adverse effects reported. Follow up information was received on 05-FEB-2016, stating that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 08-FEB-2016 from the nurse regarding a 3 year old patient of unknown gender. On 10-DEC-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck). This is one of several reports received from the same source. Additional information has been requested. Patient tab, event tab and narrative were updated.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a female patient of unknown age and reporting on herself. Information about concurrent conditions, medical history and concomitant medication was not provided. The patient received a PNEUMOVAX 23 injection on 17-DEC-2014 (dose, route and lot# unknown). The patient states that her primary care provider gave her a booster injection of PNEUMOVAX 23 in December 2015. No adverse effects were reported. Additional information is not expected since there was no contact details provided.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Amnesia, Arthralgia, Food craving, Headache
Clinical narrative: This spontaneous report as received from a female patient of unknown age regarding herself. Patient's concurrent condition and medical history was not reported. On an unknown date in November 2013 the patient was vaccinated with first dose of GARDASIL (strength, dose and frequency were not reported) by the physician. On an unknown date she received the second dose and in May 2014 she received the third dose. Concomitant medications were not provided. On an unknown date the patient experienced headaches, joint pain in knees, hips, hands and ankles. In addition she experienced loss of memory, excessive urination and weight gain and loss. The patient stated the pain became more severe after vaccinations. Furthermore, she stated that she can't do things. The patient also experienced cravings. The patient did not seek medical attention. The patient was not treated for the events. The outcome of the events were unknown. Causality assessment was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urine output increased, Weight decreased, Weight increased
Clinical narrative: This spontaneous report as received from a female patient of unknown age regarding herself. Patient's concurrent condition and medical history was not reported. On an unknown date in November 2013 the patient was vaccinated with first dose of GARDASIL (strength, dose and frequency were not reported) by the physician. On an unknown date she received the second dose and in May 2014 she received the third dose. Concomitant medications were not provided. On an unknown date the patient experienced headaches, joint pain in knees, hips, hands and ankles. In addition she experienced loss of memory, excessive urination and weight gain and loss. The patient stated the pain became more severe after vaccinations. Furthermore, she stated that she can't do things. The patient also experienced cravings. The patient did not seek medical attention. The patient was not treated for the events. The outcome of the events were unknown. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 03-FEB-2016 the patient was vaccinated with improperly stored PROQUAD (Merck) (dosing details and route not reported) lot # L034931, expiry: 03-MAR-2017. No concomitant medication was reported. It was reported that the vaccine was exposed to the temperature of 20.3C during a time frame of 5 hours and 22 minutes. There was no previous temperature excursions. No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner referring to a 65 year old female patient. The patient's medical history and concurrent conditions were not provided. On 03-FEB-2016 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (strength, dose, and frequency were not provided), (lot # K005402 expired date 07-NOV-2015). Concomitant therapies were not provided. The nurse practitioner also reported that the dose of PNEUMOVAX 23 had been exposed to different temperatures outside of the recommended range, 35F for 12 hours and 33F for 12 hours prior to administration. The patient did not report an adverse experience. Product quality complaint was not involved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: No adverse event
Clinical narrative: Pt was to get rabies series of 3. 1st vaccine given, 2nd vaccine given 7 days later, 3rd vaccine given 14 days after 1st dose. Should have been 21 days. Give 4th dose at 28 days, no adverse reaction.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure 2/10/16.
Age: 1.17
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash vesicular, Skin lesion, Varicella post vaccine
Clinical narrative: Pt. received his VZV dose on 2/4/16. Vesicular rash erupted 3-4 days later. > 100 lesions. Vaccine associated varicella.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Itchiness, swelling, hives within 12 hours of receiving vaccine - treated with ibuprofen, BENADRYL and prednisone.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 injection (dose, route, lot# and expiration date were not reported). On an unknown date, the patient experienced fainting. The physician seen the patient afterwards because of the adverse event. The outcome of the adverse event and the causality between the adverse event and GARDASIL 9 were not provided. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Depression
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 injection (dose, route, lot# and expiration date were not reported). On an unknown date (reported as subsequently after GARDASIL 9 administration), the patient developed depression. The outcome of the adverse event and the causality between the adverse event and GARDASIL 9 were not provided. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 28-JAN-2016, the patient was vaccinated (expired [product administered) with VAQTA 50/1.0 U/ML, lot # J007800 (expiration date 15-JAN-2016) (dose number, dose and route were not provided). No adverse symptoms were reported. Concomitant medications were not reported. The reporter stated that the VAQTA did not have any previous temperature excursions. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, lot # and expiration date were not provided). The vaccines were exposed to 0.4 degrees C during 518 hours. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (certified medical assistant) refers to patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not specified. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL lot # K023432, expiry date 18-JUN-2016 (dose, strength, route, dose numbers, vaccination site unspecified). The previous temperature excursion was reported at a temperature of 34 degrees F for 15 hours. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (certified medical assistant) refers to patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not specified. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # K008334 with expiry date 09-JUN-2016, K022265 with expiry date 22-OCT-2016, L027733 with expiry date 13-SEP-2017 (dose, strength, route, dose numbers, vaccination site unspecified). The previous temperature excursion for lots (# K008334, K022265, L027733) was reported at a temperature of 34 degrees F for 15 hours. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (certified medical assistant) refers to a patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not specified. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ orally, lot # K020182, expiry date 15-JUN-2016 (dose, strength, dose numbers, vaccination site unspecified). The previous temperature excursion for lot # K020182 was reported at a temperature of 34F for 15 hours. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Hypoaesthesia, Nausea
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old female patient. The patient's pertinent medical history and concomitant medications were not reported. On 19-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L019286, expiration date 14-SEP-2017, dose, route of administration and anatomical location not reported). On an unknown date in August 2015 (reported as "a few hours" after vaccination, the patient experienced dizziness, nausea, headache, and left arm numbness. The patient's symptoms lasted "a couple days" before resolving. The patient's mother decided that the patient would not receive any additional doses of GARDASIL 9. The outcome of dizziness, nausea, headache, and left arm numbness was reported as recovered (on an unknown date in 2015). The patient's brother received two doses of GARDASIL 9: first dose on 19-AUG-2015 (lot # L019286, expiration date 14-SEP-2017) and the second dose on 03-NOV-2015 (lot# L014198, expiry date 05-SEP-2017). No adverse events were reported for the patient's brother. The relatedness between the adverse events and GARDASIL 9 was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-FEB-2016, the patient was vaccinated with an expired dose of VAQTA 50 u/1.0 ml injection, 1 ml, intramuscularly, lot # K010195 with expiration date 15-JAN-2016. There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with first dose of GARDASIL, dose, route unknown. On 02-FEB-2016, the same patient visited physician's office to receive second dose of GARDASIL 9 dose, route unknown. It was reported that the second dose of GARDASIL 9 was received late. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.