chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019215 is an initial spontaneous report received from a nurse on 23 SEP 2014 with a follow up report received from the nurse on 31 OCT 2014. This report refers to a 53 year old female patient. Her medical history included hypertension. Her concomitant medications included lisinopril at a dose of 10 mg per oral daily for hypertension, famotidine at a dose of 20 mg per oral daily as necessary for heartburn and Vagifen at a dose of 10 mcg vaginally twice a week for atrophic vaginitis. She had tolerated the vaccination in the past. On 23 SEP 2014, at 04:30 PM, the patient was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412201) intramuscularly into her left deltoid at a dose of 1.0 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).  Follow up report was received from the nurse on 31 OCT 2014. Updated medical history, concomitant medications, time of vaccination, anatomical location of the vaccine administration and vaccination tolerance in the past.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Case number PHEH2014US019295 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 61 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. Currently no complain was received from the patient. No adverse event was reported following this maladministration (vaccine overdose).
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2014US016357 is an initial spontaneous report received from a pharmacist on 25 SEP 2014. This case refers to a 77 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with two doses of FLUVIRIN 2014/2015 (batch number: not reported), intramuscularly on the same day (24 SEP 2014). No adverse reaction was reported following this administration error.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2014US019416 is an initial spontaneous report from the nurse received on 24 SEP 2014. This report refers to an adult (at her 50's) female patient. On 23 SEP 2014, she was inadvertently vaccinated with 0.5 ml FLUVIRIN 2014/2015 (batch number: 1411001) via subcutaneous route as it was administered with a TB needle. No adverse event reported following these medication errors (inappropriate route of vaccine administration and wrong technique in drug usage process).
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2014US019426 is an initial spontaneous report from the nurse received on 24 SEP 2014. This report refers to an adult (at her 50's) female patient. On 23 SEP 2014, she was inadvertently vaccinated with 0.5 ml FLUVIRIN 2014/2015 (batch number: 1411001) via subcutaneous route as it was administered with  TB needle. No adverse event reported following these medication errors (inappropriate route of vaccine administration and wrong technique in drug usage process).
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Case number PHEH2014US019462 is an initial spontaneous report from a nurse received on 24 SEP 2014 with a follow up received from nurse on 04 NOV 2014.  This report refers to a 3.5 year old male child. Past medical history and concomitant medication was not reported. The patient vaccination status was up to date and previous vaccinations were tolerated well in the past. He was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: unknown) intramuscularly at a dose of 0.5 ml into the left thigh on 24 SEP 2014 at 15:00. No adverse reaction occurred following this medication error (inappropriate age at vaccine administration.   Follow up received from nurse on 04 NOV 2014. Updated dose, site and time of vaccination of FLUVIRIN and other clinically relevant information in the narrative.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US019506 is an initial spontaneous report from the nurse received on 29 SEP 2014. This report refers to a 69 year old female patient. She was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1413201A) via intravenous route instead of intramuscular route on 28 SEP 2014. No adverse event reported following this medication error (inappropriate route of vaccination).
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Case number PHEH2014US019580 is an initial spontaneous report from a pharmacist received on 26 SEP 2014. This report refers to a 59-year-old female patient. Past medical history and concomitant medication was not provided. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413501) intramuscularly on 25 SEP 2014. On 26 SEP 2014, the patient developed a 1 cm red, blistered area at the injection site. Outcome of the events was reported as ongoing at the time of this report. The seriousness and causality of the events was not reported.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event, Product label issue
Clinical narrative: Case number PHEH2014US019635 is an initial spontaneous report received from a medical assistant on 29 SEP 2014 and a follow up report from the medical assistant received on 31 OCT 2014. This report refers to a 34 year old female patient. Her past medical history and concomitant medications were not reported. On 29 SEP 2014 (at 11:54 am) she was vaccinated with an expired FLUVIRIN 2013/2014 (batch number: 1307701, expiry date: MAR 2014) at a dose of 0.5 ml in the right deltoid. The reporter stated that there was no harm to the patient. No adverse events were reported following the medication error (expired vaccine used). IT was reported that the box in which the vial placed stated batch number as 1412201 (expiry date: May 2015) but on the vial it was mentioned as batch number 1307701, expiry date: MAR 2014 and it was wrongly packaged.  Follow up report from the medical assistant received on 31 OCT 2014: Updated vaccination time, expiry date of the vaccine, does of vaccine and site of vaccination. Added event product label issue.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US019650, is an initial spontaneous report from a pharmacist received on 29 SEP 2014. This report refers to a 62-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 14515P) intramuscularly at a dose of 0.5 ml on 28 SEP 2014. It was reported that she received vaccine after it reached 49 F for up to a maximum duration of 1 hour. No adverse events were reported following the maladministration.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019648 is an initial spontaneous report received from a nurse on 26 SEP 2014. This report refers to a 40 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with season influenza vaccine (other manufacturer and batch number: not reported) on 17 SEP 2014. It was reported that she was inadvertently administered a second dose again with FLUVIRIN 2014/2015 (batch number: 1411901) intramuscularly on 26 SEP 2014. No adverse reaction was reported following the maladministration.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US019651 is an initial spontaneous report received from a pharmacist on 29 SEP 2014. This report refers to a 64 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 14515P) intramuscularly at a dose of 0.5 ml on 29 SEP 2014. It was reported that he received vaccine after it reached 49 F for up to a maximum duration of 1 hour. No adverse events were reported following the maladministration.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cold sweat, Pyrexia
Clinical narrative: Case number PHEH2014US019657 is an initial spontaneous report received from a consumer received on 30 SEP 2014. This report refers to a 65 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: unknown) intramuscularly on 25 SEP 2014. The reporter stated that she had 100 degrees Fahrenheit plus fever., cold sweats and no energy since receiving FLUVIRIN 5 days ago. Outcome of the events was reported as unknown. Seriousness and causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US019675 is an initial spontaneous report received from a Medical Assistant on 29 SEP 2014. This report refers to a 58 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 141001, 141301) intramuscularly at a dose of 0.5 ml on or between 19 SEP 2014 to 23 SEP 2014. It was reported that before vaccination the FLUVIRIN multi dose vial was kept at -1.7 to 11.8 degree C for a total of 191 hours. No adverse event was reported following this medication error (incorrect storage of drug).
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US018318 is an initial spontaneous report from a pharmacist received on 10 SEP 2014. This report refers to a 74-year-old female patient. Past medical history and concomitant medications were not reported. On 09 SEP 2014, she received 5 ml dose of FLUVIRIN 2014/2015 (batch number: 1411201) intramuscularly instead of 0.5 ml dose. No adverse events were reported following the maladministration. No additional information was available.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2014US016419 is an initial spontaneous report from a consumer (patient's wife) received on 12 AUG 2014. This report refers to a 57-year-old male patient. Past medical history and concomitant medication was not reported. On 12 AUG 2014, the patient was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: unknown) intramuscularly instead of quadrivalent flu vaccine. No adverse reaction reported following this medication error (wrong vaccine administered).
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018214 is an initial spontaneous report from the consumer received on 09 SEP 2014. This report refers to an adult male patient. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 145402) at a dose of 0.5 ml intramuscularly on an unknown date. It was reported that the vaccine received by the patient had been stored at 32F for 10 hours before administration to the patient. No adverse event reported following this medication error (incorrect storage of drug).
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018207 is an initial spontaneous report received from a consumer on 09 SEP 2014. This report refers to an elderly male patient of unknown age. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 145402) intramuscularly  at a dose of 0.5 ml on an unspecified date. IT was reported that FLUVIRIN was stored at temperature of 32 degree F (0 degree C) for 10 hours. No adverse events reported after the maladministration.
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019153 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a male patient of an unknown age. Past medical history and concomitant medication was not reported. On 18 SEP 2014, the patient was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 1.0 ml instead of the recommended 0.5 ml does. No adverse event was reported following this medication error (overdose).
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018205 is an initial spontaneous report received from a consumer on 09 SEP 2014. This report refers to an adult female patient of unknown age. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145402) intramuscularly at a dose of 0.5 ml on an unspecified date. It was reported that FLUVIRIN was stored at temperature of 32 degrees F (0 degree C) for 10 hours. No adverse events reported after the maladministration.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018202, in an initial spontaneous report from a pharmacist received on 09 SEP 2014. This report refers to a 56-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145205) intramuscularly at a dose of 0.5 ml on 05 SEP 2014. It was reported that the FLUVIRIN received by her was stored at 49 F for two  hours. No adverse event was reported following the medication error (incorrect storage of drug).
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Overdose, Wrong drug administered
Clinical narrative: Case number PHEH2014US018961 is an initial spontaneous report received from a pharmacist on 19 SEP 2014. This report refers to a 64 year old female patient . Her medical history and concomitant medication were not reported. She was supposed to get a dose of FLUVIRIN and a shingles shot (varicella zoster vaccine). But she was inadvertently vaccinated with two does of FLUVIRIN 2014/2015 (batch number: 1413301) one subcutaneously and other intramuscularly on 19 SEP 2014. No adverse event was reported following these administration errors (wrong vaccine administered and overdose).
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US018889 is an initial spontaneous report from the health care professional (nuclear technologist)via medical communications on 18 SEP 2014. This report refers to a 49-year-old ale patient. The patient was accidentally vaccinated with an expired FLUVIRIN 2013/2014 vaccine (batch number: 1309701), expiry date: May 2014), intramuscularly on 22 AUG 2014. No adverse event reported following this medication error (expired vaccine used).
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Case number PHEH2014US018638 is an initial spontaneous report received from a consumer (pharmacist) reporting on herself on 15 SEP 2014. This report refers to a 25 year old female patient. Her past medical history and concomitant medications were not reported. On 15 SEP 2014, she was withdrawing a dose of FLUVIRIN 2014/2015 (batch number: 1411901) into a syringe with luer lock 25 gauge needle. The vaccine leaked onto her skin. No adverse events were reported following this administration error (inadvertent exposure to vaccine).
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018608, is an initial spontaneous report from a pharmacist received on 15 SEP 2014. This report refers to a 65-year-old female patient. Past medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145401) intramuscularly on 15 SEP 2014. It was reported that the FLUVIRIN reached 34 degrees Fahrenheit (F) on 12 AUG 2014 and 15 AUG 2014, both excursions lasted less than 12 hours each, this unfreezed vaccine administered to patient. No adverse event was reported following the medication error (incorrect storage of drug).
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US018497, is an initial spontaneous report from a pharmacist received on 14 SEP 2014. This report refers to a 75-year-old male patient. Historical conditions were not reported. No concomitant medications was reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) subcutaneously on 14 SEP 2014. No adverse reactions had occurred since the maladministration (inappropriate route of vaccination).
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site extravasation
Clinical narrative: Case number PHEH2014US018445, is an initial spontaneous report received from a pharmacist on 11 SEP 2014 with a combined follow-up received from a pharmacist and quality assurance department (QA ref number: 325083) on 12 SEP 2014 and a follow up received from QA department on 19 SEP 2014. This report refers to a 31 year old female patient. Past medical history and concomitant medication was not reported. Pharmacist reported that during the administration of FLUVIRIN 2014/2015 (batch number: 1410901) intramuscular from a multidose vial "quite a bit" of FLUVIRIN leaked out from the injection site on the patient's arm on 08 SEP 2014. A week later, the patient was revaccinated with FLUVIRIN and "only a little bit" leaked out (see related case: PHHY2014US121197). The patient did received FLUVIRIN last year, but this was the first time it leaked out of the injection site on the patient. The patient did not experience any adverse events to FLUVIRIN. No sample was available for return. Upon the follow-up from QA department, it was reported that investigation cannot be performed as they refer to FLUVIRIN vial batches. Hence this presentation does not include a syringe, therefore this was not an event which could be related to the FLUVIRIN product. No further information provided.   Combined follow-up received from a pharmacist and quality assurance department on 12 SEP 2014. Vaccination history, narrative and quality reference number updated.   Follow-up received from quality assurance department on 19 SEP 2014; Updated QA department comments.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US018326, is an initial spontaneous report from a pharmacist received on 10 SEP 2014. This report refers to a 92-year-old male patient. Past medical history and concomitant medications were not reported. On 09 SEP 2014, the patient received 5 ml dose of FLUVIRIN 2014/2015 (batch number: 1411201) intramuscularly instead of 0.5 ml dose. No adverse events were reported following the maladministration. No additional information was available.
Sex: U
Vaccine: FLU3
Symptoms: Blister, Injection site pain
Clinical narrative: Case number PHEH2014US019142, is an initial spontaneous report from a consumer received on 23 SEP 2014. This report refers to patient of unknown demographics. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308501, expiration date: Mar 2014) on an unknown date. On an unknown date after vaccination, the patient experienced burning at the injection site and then blistering. The outcome, seriousness and causality were not reported.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019134 is an initial spontaneous report from a nurse received on 19 SEP 2014. This report refers to a 58-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. On 18 SEP 2014, he was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. Currently no complain was received from the patient. No adverse event was reported following this maladministration (overdose).
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2014US019017 is an initial spontaneous report received from a pharmacist on 19 SEP 2014. This report refers to a female patient of an unspecified age who was an employee. Her past medical history and concomitant medications were not reported. On an unspecified date, she was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411201) with a TV syringe with a half inch needle. She stated that she felt like she had not received the vaccine. She does not believe that the vaccine was administered subcutaneously. However, she was not sure. No adverse events were reported following this medication error (wrong technique in drug usage process).
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Case number PHEH2014US019176 is a initial spontaneous report received fr om a nurse on 19 SEP 2014. This report refers to a 53 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly on 18 SEP 2014. It was reported that he was vaccinated with 1.0 ml of vaccine instead on 0.5 ml. No adverse events reported after the maladministration (vaccine overdose).
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018964, is an initial spontaneous report from a health care professional received on 19 SEP 2014. This report refers to a patient of unknown identifiers. Past medical history and concomitant medication was not reported. On 19 SEP 2014 the patient was vaccinated an intramuscular dose of FLUVIRIN 2014/2015 (batch number: unknown) from a multidose vial that was out of range at 18 degrees Celsius for 14 hours. No adverse event reported following this medication error (incorrect storage of drug).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018985 is an initial spontaneous report received from a pharmacist on 19 SEP 2014. This report refers to a 66 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145204 (intramuscularly on 16 SEP 2014. It was reported that before administration the FLUVIRIN prefilled syringe was kept at 33.8 degree Fahrenheit for overnight and the next night it reached 32 degree Fahrenheit. It was further reported that the vaccine did not freeze as it was kept in the front of the refrigerator by the door. No adverse event was reported following the administration error (incorrect storage of drug).
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US018991 is an initial spontaneous report received from a Healthcare Professional on 19 SEP 2014. This report refers to a 74 year old male patient. His medical history and concomitant medication were not reported. He was intramuscularly vaccinated with FLUVIRIN 2014/2015 (batch number: 1411301) on 15 SEP 2014 and a second dose on 19 SEP 2014. No adverse event was reported following this administration error (inappropriate schedule of vaccine administered).
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US019004, is an initial spontaneous report from a medical assistant received on 19 SEP 2014. This report refers to a 67-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with an expired dose of FLUVIRIN 2013/2014 (batch number: 1310301) intramuscularly on 18 SEP 2014. No adverse reaction was reported following the maladministration (expired vaccine used).
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Case number PHEH2014US019175 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 58 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly on 18 SEP 2014. It was reported that he was vaccinated with 1.0 ml dose of vaccine instead of 0.5 ml. No adverse events reported after the maladministration (vaccine overdose).
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014USO19177 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 43 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Case number PHEH2014US019178 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 45 year old male patient. His medical history and concomitant medication was not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLURIVIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. No adverse event was reporter following this medication error (overdose).
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Case number PHEH2014US019179 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 42 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Case number PHEH2014US019190 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 59 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Case number PHEH2014US019191 is an initial spontaneous report received from a nurse on 18 SEP 2014. This report refers to a 56 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. No adverse event was reported following the medication error (overdose).
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHYEH2014US019165 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 55 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. Currently no complain was received from the patient. No adverse event was reported following this maladministration (vaccine overdose).
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Case number PHEH2014US019166 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 60 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. Currently no complain was received from the patient. No adverse event was reported following this maladministration (vaccine overdose).
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019167 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 63 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. Currently no complaint was received from the patient. No adverse event was reported following this maladministration (vaccine overdose).
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Case number PHEH2014US019168 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 22 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014 he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml stead of the recommended 0.5 ml dose. Currently no complain was received from the patient. No adverse event was reported following this maladministration (vaccine overdose).
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019169 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 61 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2013/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. Currently no complain was received from the patient. No adverse event was reported following this maladministration (vaccine overdose).
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019170 is a initial spontaneous report received from a nurse on 19 Sep 2014. This report refers to a 57 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1412001) intramuscularly on 18 Sep 2014. It was reported that he was vaccinated with 1.0 ml of vaccine instead of 0.5 ml. No adverse events reported after the maladministration.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019156, is an initial spontaneous report received from a nurse on 19 Sep 2014. This report refers to a 64-year-old male patient. Past medical history and concomitant medication was not reported. On 18 Sep 2014, the patient was inadvertently vaccinated with FLUVIRIN (batch number: 1412001) intramuscularly at a dose of 1.0 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019157, is an initial spontaneous report received from a nurse on 19 Sep 2014. This report refers to a 74-year-old male patient. Past medical history and concomitant medication was not reported. On 18 Sep 2014, the patient was inadvertently vaccinated with FLUVIRIN (batch number: 1412001) intramuscularly at a dose of 1.0 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019159, is an initial spontaneous report received from a nurse on 19 Sep 2014. This report refers to a 45-year-old male patient. Past medical history and concomitant medication was not reported. On 18 Sep 2014, the patient was inadvertently vaccinated with FLUVIRIN (batch number: 14120010 intramuscularly at a dose of 1.0 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019160, is an initial spontaneous report received from a nurse on 19 Sep 2014. This report refers to a 61-year-old male patient. Past medical history and concomitant medication was not reported. On 18 Sep 2014, the patient was inadvertently vaccinated with FLUVIRIN (batch number: 1412001) intramuscularly at a dose of 1.0 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019163, is an initial spontaneous report received from a nurse on 19 Sep 2014. This report refers to a 53-year-old female patient. Past medical history and concomitant medication was not reported. On 18 Sep 2014, the patient was inadvertently vaccinated with FLUVIRIN (batch number: 1412001) intramuscularly at a dose of 1.0 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019164 is an initial spontaneous report received from a nurse on 19 Sep 2014. This report refers to a 59 year old male patient. His medical history and concomitant medication were not reported. On 18 Sep 2014, he was inadvertently vaccinated with FLUVIRIN (batch number: 1412001) intramuscularly at a dose of 0.1 ml instead of the recommended 0.5 ml dose. Currently no complain was received from the patient. No adverse event was reported following this maladministration (vaccine overdose).
Sex: U
Vaccine: FLU3
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: Case number PHEH2014US02276, is an initial spontaneous report received from a nurse on 03 Nov 2014. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1413901) on an unspecified date. It was reported that FLUVIRIN was stored in the refrigerator at an appropriate temperature and when the reporter pulled the vaccine out it had a frothy and bubble look. It was also reported that reporter was not sure that while patient was being vaccinated, the vaccine was frothy or not. Patient was fine. No adverse events reported after the maladministration.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pruritus, Eye swelling, Fatigue, Ocular hyperaemia
Clinical narrative: Case number PHEH2014US022377 is an initial spontaneous report received from a pharmacist on 04 Nov 2014. This report refers to a 81 year old male patient. His past medical history and concomitant medications were not reported. On 15 Oct 2014, he was vaccinated with FLUVIRIN (batch number: 1413701) intramuscularly. He consulted a physician nine days after the vaccination. On 02 Nov 2014, he had fatigue and after 02 Nov 2014, he developed swollen red and itchy eyes. The patient completely recovered from the events. The seriousness and causality of the events was not reported.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Case number PHEH2014US022366, is an initial spontaneous report received from a consumer (patient) on 05 Nov 2014. This report refers to a 57 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscular on 03 Oct 2014. It was reported that on 05 Nov 2014 she experienced pain at injection site and muscle weakness. The outcome of events was reported as unknown. The seriousness and causality of the events were not reported.
Age: 1.5
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022358 is an initial spontaneous report from the nurse received on 06 Nov 2014. This report refers to a 18-months-old female patient who was inadvertently vaccinated with 0.25 ml of FLUVIRIN (batch number: 1413201) intramuscularly on 05 Nov 2014. No adverse event reported following this medication error (inappropriate age at vaccine administration).
Sex: F
Vaccine: FLU3
Symptoms: Injection site extravasation, No adverse event
Clinical narrative: Case number PHEH2014US022295, is an initial spontaneous report from a pharmacist received on 05 NOV 2014. This report refers to female patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 14581P) intramuscularly on 04 NOV 2014. It was reported that some of the vaccine leaked out of injection site and ran down to the patient elbow. No adverse event was reported.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Case number PHEH2014US022277 is an initial spontaneous report received from a consumer (who was a medical assistant) on 03 NOV 2013, with the follow-up received on 11 NOV 2014. This report refers to a 43 years old female patient. Her medical history and concomitant medications were not reported. The reporter stated that she got some FLUVIRIN 2014/2015 (batch number: 411201) topically on her when she was withdrawing the vaccine on 03 NOV 2014. No adverse events were reported following the medication error.   11/16/2015: Follow-up report received from a consumer on 11 NOV 2014: Updated vaccine exposure date (03 NOV 2014). Non significant follow up report from Vaccine Adverse Event Reporting System (VAERS) received on 30 March 2015, updated the VAERS ID 561556.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site extravasation, No adverse event, Underdose
Clinical narrative: Case number PHEH2014US019007 is an initial spontaneous report received from a consumer (pharmacist) on 19 Sep 2014. This report refers to  44 year old female patient. Her past medical history and concomitant medications were not reported. On 18 Sep 2014, she was vaccinated with a dose of FLUVIRIN (batch number: not reported) by her colleague. After the vaccination, half of the FLUVIRIN dose ran down her arm. It was also reported it felt like someone squeezed an alcohol pad down her arm. No adverse events were reported following the maladministration and medication error (vaccine underdose and inadvertent exposure to vaccine).
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of wrong vaccine administered in a adult female patient who received INFANRIX. On an unknown date, the patient received INFANRIX at an unknown date. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: Adult patient was given INFANRIX vaccine instead of BOOSTRIX.
Age: 1.03
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient received adult dose of Hepatitis A vaccine instead of pediatric dose. Patient was monitored and released to parents. She showed no signs of adverse reaction.
Age: 17.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 17-year-old patient who received PEDIARIX. On 21st October 2014, the patient received PEDIARIX. On 21st October 2014, an unknown time after receiving PEDIARIX, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown. Additional information: PEDIARIX was administered to a family instead of flu vaccine. Family members were 17, 15, 11 and 6 years of age. No other information was provided.
Age: 11.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 11-year-old patient who received PEDIARIX. On 21st October 2014, the patient received PEDIARIX. On 21st October 2014, an unknown time after receiving PEDIARIX, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown. Additional information: PEDIARIX was administered to a family instead of flu vaccine. Family members were 17, 15, 11 and 6 years of age. No other information was provided.
Age: 6.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 6-year-old patient who received PEDIARIX. On 21st October 2014, the patient received PEDIARIX. On 21st October 2014, an unknown time after receiving PEDIARIX, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown. Additional information: PEDIARIX was administered to a family instead of flu vaccine. Family members were 17, 15, 11 and 6 years of age. No other information was provided.
Age: 15.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 15-year-old patient who received PEDIARIX. On 21st October 2014, the patient received PEDIARIX. On 21st October 2014, an unknown time after receiving PEDIARIX, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown. Additional information: PEDIARIX was administered to a family instead of Flu vaccine. Family members were 17, 15, 11 and 6 years of age. No other information was provided.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of feeling unwell in a female patient who received Influenza vaccine. On an unknown date, the patient received influenza vaccine at an unknown dose. On an unknown date, several hours after receiving Influenza vaccine, the patient experienced feeling unwell and dry cough. On an unknown date, the outcome of the feeling unwell and dry cough was unknown. It was unknown if the reporter considered the feeling unwell and dry cough to be related to influenza vaccine.
Age: 46.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a pharmacist and described the occurrence of drug dose administered interval too long in a 46-year-old male patient who received TWINRIX ADULT. Previously administered products included TWINRIX (3 doses of accelerated schedule 1 and 1/2 years ago). On an unknown date, the patient received the 4th dose of TWINRIX adult. On an unknown date, an unknown time after receiving TWINRIX adult, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Mass, Neck mass, Urticaria
Clinical narrative: Information was received from a mother of a male consumer who on 13-OCT (year unspecified) received his second dose of GARDASIL, 1 single injection, route not specified. Concomitant medication included an unspecified nasal spray flu vaccine. On 18-NOV-2014 the patient broke out with chronic hives and developed a lump on the right side of his neck, a lump on the right wrist, and a lump on the right side of his hip. The patient sought medical attention at the emergency room. Treatment was not reported. The outcome of the events was not recovered at the time of this report. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a other health professional (nurse) refers to a 76 year old female patient. Patient's medical history and drug allergies were not reported. On 06-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 in the left arm (Lot # 018528, expiration date: 14-APR-2016) for routine administration. Concomitant medications were not reported. On 06-JAN-2015, patient experienced cellulitis in her left arm. Patient's arm hurt and she was in pain. On an unknown date, patient sought medical attention and went to see the doctor. No treatment was given for the adverse event. Outcome of the event was reported as not recovered. No product quality complaint (PQC) was involved. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate schedule of vaccine administered in a patient who received PEDIARIX. Previously administered products included PEDIARIX. On 19 December 2005, the patient received PEDIARIX 2. On 27th January 2006, the patient received PEDIARIX 3. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown. Additional information: PEDIARIX schedule of administration deviated from the prescribing information. Dose 1 was given on 13 June 2005, dose 3 on 19 December 2005 and dose 3 on 27 January 2006.
Sex: F
Vaccine: DTAP
Symptoms: Accidental exposure to product, Eye irritation, Eye pain, Headache, Pain
Clinical narrative: This case was reported by a nurse and described the occurrence of burning sensation in eye in a female patient who received INFANRIX (batch number F43Z7, expiry date 31st October 2015). On 28th October 2014 09:30, the patient received INFANRIX .5 ml. On 28th October 2014, an unknown time after receiving INFANRIX, the patient experienced inadvertent exposure to vaccine. On 28th October 2014 09:32, the patient experienced burning sensation in eye, headache, nasal discharge and pain. On 28th October 2014, the outcome of the burning sensation in eye, headache, nasal discharge and pain were recovered/resolved. On an unknown date, the outcome of the inadvertent exposure to vaccine was unknown. It was unknown if the reporter considered the burning sensation in eye, headache, nasal discharge and pain to be related to INFANRIX. Additional information received: Per HCP, while RN was administering INFANRIX vaccine, the needle and syringe came apart causing the liquid portion of the vaccine to come in contact with right eye. RN reported right eye began to burn and become achey within 2-3 mins after the event. Shortly after then started with a headache and right nasal drainage. RN stated she removed her right eye contact lens, flushed her right eye with saline. Per RN all symptoms resolved completely within an hour of the occurrence.