chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3
Symptoms: Blister, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Case number PHEH2013US024174 is an initial spontaneous report received from a consumer on 15 NOV 2013: This report refers to a 66-year-old male patient. He was vaccinated with FLUVIRIN 2013/2014 (batch number: unknown) intramuscularly on an undetermined date towards the end of OCT 2013. A couple of days after vaccination, he developed a red, itchy rash, hives and blisters all over his body. The reaction had not resolved completely at the time of report, although the consumer commented that it had started to clear up. No further information about seriousness and causality was reported.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US025517 is an initial spontaneous report received from a health care professional on 09 DEC 2013. This report refers to a 2-year-old female patient. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309601; expiry date: APR 2014) 0.5 ml intramuscularly on 04-DEC-2013. No adverse event was reported following this medication error (inappropriate age at vaccine administration). No other information was available.
Age: 1.49
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US025514 is an initial spontaneous report received from a health care professional on 09 DEC 2013. This report refers to a 1-year old male patient. he was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309601; expiry date: APR 2014) 0.5 ml intramuscularly on 04 DEC 2013. No adverse event was reported following this medication error (inappropriate age at vaccine administration). No other information was available.
Sex: U
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site warmth, Wrong drug administered
Clinical narrative: Case number PHEH2013US025328 is an initial, report received from a pharmacist on 04 DEC 2013. This report refers to a patient of an unknown age and gender. The patient was vaccinated with FLUVIRIN (batch number: 1308401; expiry date: not reported) subcutaneously on an unspecified date as it was mistaken for Tuberculosis test. The patient immediately experienced warm, red, itching symptoms at the site of injection. The pharmacist did not have patient information to provide and stated he would try to obtain this information. Outcome of the events, seriousness and causality were not reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: Case number PHEH2013US025146 is an initial report received from a pharmacist on 02 DEC 2013. This report refers to a 60-year-old female patient. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 1307701; expiry date: not reported) intramuscularly on 02 DEC 2013. She only received half of the recommended dose because half of the dose escaped from the needle. No adverse event was reported followed by this administration error. The event outcome, seriousness and causality were not reported.
Age: 1.35
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US025055 is an initial spontaneous report received from a nurse received on 02 Dec 2013 and a follow up report from the health care professional on 03 Feb 2014. This report refers to a 15-month-old male patient. His vaccination history included FLUZONE (batch number: 49281-038815, other manufacturer) on 28 Oct 2013. He was vaccinated with FLUVIRIN (batch number: 131001; expiry date: not reported) at a dose of 0.25 ml intramuscularly on 02 Dec 2013. No adverse event was reported followed by this administration error. The event outcome, seriousness and causality were not reported. Follow up report from the health care professional received on 03 Feb 2014: Vaccination history was added.
Age: 1.03
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US024973 is an initial spontaneous report from the physician received on 26 NOV 2013. This report refers to a 01-year-old female patient who was accidentally vaccinated with FLUVIRIN 2013/2014 (batch number: 1309801) intramuscularly on 21 NOV 2013. No adverse event reported following this medication error.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2013US024968, is an initial spontaneous report received from a physician on 25 NOV 2013 with the follow-up received on 07 JAN 2014. This report refers to a 56-year-old poly medicated female patient. Her medical history included dyslipidemia, arthritis, back pain, allergic rhinitis, insomnia, chronic obstructive pulmonary disease, hypothyroidism, hepatitis C, anxiety, hypertension, coronary artery disease, gastroesophageal reflux disease, gout, congestive heart failure, migraine headache, cardiac catheterization, hysterectomy, back surgery, alcohol use and tobacco use disorder. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309801, expiry date: MAY 2014) inadvertently one dose from opened and unopened MDV's that were stored below the recommended mentioned temperature, at dose of 0.5 ml intramuscularly into right deltoid on 21 NOV 2013 at 11:36. The reporter stated that, the vaccine was not frozen upon administration and was unsure if the vaccine had frozen during the temperature excursion. It was reported that, FLUVIRIN was opened and unopened MDV's reached 32 Fahrenheit (F) for 6  hours on 14  NOV 2013 and 16 NOV 2013. On 17 NOV 2013, it reached for 31 F for 6 hours. No more information was available.   Follow up received from physician on 07 JAN 2014: Updated patient demographics, medical history, concomitant medications and site and time of vaccine administration.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US026015 is an initial spontaneous report received from a pharmacist on 13 DEC 2013 and a follow up report from the physician received on 09 JAN 2014. This report refers to a 49 year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml dose of FLUVIRIN 2013/2014 (batch number: 13391P) intramuscularly on 11 DEC 2013. This FLUVIRIN pre filled syringe reached 48 F on 03 DEC 2013 at 6 PM; at 08:55 AM on 04 DEC 2013 it was at 46 F. This first excursion duration was 15 hours. Same vaccine then reached 47 F on 04 DEC 2013 at 5 PM. This second excursion duration was 16 hours. Reporter stated that the vaccine has been in rage since that excursion. Vaccine was administered to patient after excursions. No adverse reactions were reported. The physician stated that they do not have any patient know with the above details.  Follow up report from the physician received on 09 JAN 2014: Physician's statement regarding the patient was updated.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US026014 is an initial spontaneous report received from a pharmacist on 13 Dec 2013 and a follow up report received from the consumer on 10 Jan 2014. This report refers to a 59-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml FLUVIRIN (batch number: 13391P) intramuscularly on 09 Dec 2013. This FLUVIRIN prefilled syringe reached 48 F on 03 Dec 2013 at 6 pm at 08:55 am and on 04 Dec 2013 it was at 46 F. This first excursion duration was 15 hours. Same vaccine then reached 47 F on 04 Dec 2013 at 5 pm. This second excursion duration was 16 hours. Reporter stated that the vaccine has been in range since that excursion. Vaccine was administered to patient after excursions. No adverse reaction was experienced by the patient following this medication error. Follow up report from the consumer received on 10 Jan 2014: The patient's condition was updated.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US026006 is an initial spontaneous report received from a pharmacist on 13 DEC 2013. This report refers to a 63-year-old male patient . His medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml dose of FLUVIRIN 2013/2014 (batch number: 13391P) intramuscularly on 09 DEC 2013. This FLUVIRIN prefilled syringe reached 48 F on 03 DEC 2013 at 6 PM; at 08:55 AM on 04 DEC 2013 it was at 46 F. This first excursion duration was 15 hours. Same vaccine then reached 47 F on 04 DEC 2013 at 5 PNM. This second excursion duration was 16 hours. Reporter stated that the vaccine has been in rage since that excursion. Vaccine was administered to patient after excursions. No adverse reactions were reported. Seriousness, outcome and causality of the event were unknown.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Alanine aminotransferase, Aspartate aminotransferase decreased, Bilirubin conjugated increased, Blood albumin, Blood alkaline phosphatase
Clinical narrative: Case number PHEH20013US025741 is an initial spontaneous report received from a physician on 11 Dec 2013 with a follow-up received from the physician on 03 Jan 2014. This report refers to a 14-year-old male patient. His medical history included unspecified allergies. His vaccination status was up to date. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 1307901) at a dose of 0.5 ml, intramuscularly on 03 Dec 2013. Starting from 03 Dec 2013, he experienced low grade fever, nausea, vomiting, appetite loss with a weight loss of two three pounds, fatigue, anorexia, lethargy, sleepiness, sporadic headache, elevated total and direct bilirubin levels and a low AST levels. Physician stated that mono tests came back negative. Laboratory tests performed included: Liver function test for ALT (alanine transaminase), AST (aspartate transaminase), bilirubin, albumin and alkaline phosphatase, blood test (complete blood picture), EBV (Epstein Barr virus) culture, erythrocyte sedimentation rate (ESR) and comprehensive metabolism panel. Examination reports and values were not reported for all tests. Outcome of the events was reported as complete recovery on 02 Jan 2014. The reporter assessed the case as non-serious, however no causality assessment was reported. Follow-up received from the physician on 03 Jan 2014: Updated patient demographics, vaccination status, medical history, concomitant medications, dose and route of FLUVIRIN, events (anorexia, lethargy, sleepiness and sporadic headache), laboratory tests and outcome.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Blood bilirubin increased, Decreased appetite, Epstein-Barr virus test, Fatigue, Full blood count
Clinical narrative: Case number PHEH20013US025741 is an initial spontaneous report received from a physician on 11 Dec 2013 with a follow-up received from the physician on 03 Jan 2014. This report refers to a 14-year-old male patient. His medical history included unspecified allergies. His vaccination status was up to date. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 1307901) at a dose of 0.5 ml, intramuscularly on 03 Dec 2013. Starting from 03 Dec 2013, he experienced low grade fever, nausea, vomiting, appetite loss with a weight loss of two three pounds, fatigue, anorexia, lethargy, sleepiness, sporadic headache, elevated total and direct bilirubin levels and a low AST levels. Physician stated that mono tests came back negative. Laboratory tests performed included: Liver function test for ALT (alanine transaminase), AST (aspartate transaminase), bilirubin, albumin and alkaline phosphatase, blood test (complete blood picture), EBV (Epstein Barr virus) culture, erythrocyte sedimentation rate (ESR) and comprehensive metabolism panel. Examination reports and values were not reported for all tests. Outcome of the events was reported as complete recovery on 02 Jan 2014. The reporter assessed the case as non-serious, however no causality assessment was reported. Follow-up received from the physician on 03 Jan 2014: Updated patient demographics, vaccination status, medical history, concomitant medications, dose and route of FLUVIRIN, events (anorexia, lethargy, sleepiness and sporadic headache), laboratory tests and outcome.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Lethargy, Metabolic function test, Mononucleosis heterophile test negative, Nausea
Clinical narrative: Case number PHEH20013US025741 is an initial spontaneous report received from a physician on 11 Dec 2013 with a follow-up received from the physician on 03 Jan 2014. This report refers to a 14-year-old male patient. His medical history included unspecified allergies. His vaccination status was up to date. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 1307901) at a dose of 0.5 ml, intramuscularly on 03 Dec 2013. Starting from 03 Dec 2013, he experienced low grade fever, nausea, vomiting, appetite loss with a weight loss of two three pounds, fatigue, anorexia, lethargy, sleepiness, sporadic headache, elevated total and direct bilirubin levels and a low AST levels. Physician stated that mono tests came back negative. Laboratory tests performed included: Liver function test for ALT (alanine transaminase), AST (aspartate transaminase), bilirubin, albumin and alkaline phosphatase, blood test (complete blood picture), EBV (Epstein Barr virus) culture, erythrocyte sedimentation rate (ESR) and comprehensive metabolism panel. Examination reports and values were not reported for all tests. Outcome of the events was reported as complete recovery on 02 Jan 2014. The reporter assessed the case as non-serious, however no causality assessment was reported. Follow-up received from the physician on 03 Jan 2014: Updated patient demographics, vaccination status, medical history, concomitant medications, dose and route of FLUVIRIN, events (anorexia, lethargy, sleepiness and sporadic headache), laboratory tests and outcome.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Red blood cell sedimentation rate, Somnolence, Vomiting, Weight decreased
Clinical narrative: Case number PHEH20013US025741 is an initial spontaneous report received from a physician on 11 Dec 2013 with a follow-up received from the physician on 03 Jan 2014. This report refers to a 14-year-old male patient. His medical history included unspecified allergies. His vaccination status was up to date. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 1307901) at a dose of 0.5 ml, intramuscularly on 03 Dec 2013. Starting from 03 Dec 2013, he experienced low grade fever, nausea, vomiting, appetite loss with a weight loss of two three pounds, fatigue, anorexia, lethargy, sleepiness, sporadic headache, elevated total and direct bilirubin levels and a low AST levels. Physician stated that mono tests came back negative. Laboratory tests performed included: Liver function test for ALT (alanine transaminase), AST (aspartate transaminase), bilirubin, albumin and alkaline phosphatase, blood test (complete blood picture), EBV (Epstein Barr virus) culture, erythrocyte sedimentation rate (ESR) and comprehensive metabolism panel. Examination reports and values were not reported for all tests. Outcome of the events was reported as complete recovery on 02 Jan 2014. The reporter assessed the case as non-serious, however no causality assessment was reported. Follow-up received from the physician on 03 Jan 2014: Updated patient demographics, vaccination status, medical history, concomitant medications, dose and route of FLUVIRIN, events (anorexia, lethargy, sleepiness and sporadic headache), laboratory tests and outcome.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Case number PHEH2013US025600, is an initial spontaneous report received from the pharmacist on 10 Dec 2013. This report refers to a 71-year-old female patient. Her medical history and concomitant medications was not reported. Her vaccination history included FLUVIRIN, (batch number: not reported) on an unspecified date. On an unspecified date after vaccination, she experienced shingles. The event outcome was unknown. The seriousness and causality was not reported. No additional information was available.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Case number PHEH2013US025599, is an initial spontaneous report received from the pharmacist on 10 Dec 2013. This report refers to a 69-year-old female patient. Her medical history and concomitant medications was not reported. She as vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unspecified date. On 09 Oct 2013, she experienced shingles outbreak. It was reported that she experienced the same event after getting vaccinated with FLUVIRIN (see case number: PHEH2013US025600). The event outcome was unknown. The seriousness and causality was not reported. No additional information was available.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US025576 is an initial spontaneous report received from a health care professional on 09 DEC 2013. This report refers to an 11-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on 07 DEC 2013. The FLUVIRIN PFS and unopened MDV's reached 10C from 05 DEC 2013 through 07 DEC 2013, reached 9.7 C on 08 DEC 2013 and reached 11.7 C on 09 DEC 2013. No adverse event was reported following this administration error.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US025575 is an initial spontaneous report received from a health care professional on 09 Dec 2013. This report refers to a 14-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on 07 Dec 2013. The FLUVIRIN PFS and unopened MDVs reached 10 C from 05 Dec 2013 through 07 Dec 2013, reached 9.7 C on 08 Dec 2013 and reached 11.7 C on 09 Dec 2013. No adverse event was reported following this administration error.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US025574 is an initial spontaneous report received from a health care professional on 09 Dec 2013. This report refers to a 08-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on 07 Dec 2013. The FLUVIRIN PFS and unopened MDVs reached 10 C from 05 Dec 2013 through 07 Dec 2013, reached 9.7 C on 08 Dec 2013 and reached 11.7 C on 09 Dec 2013. No adverse event was reported following this administration error.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US025573 is an initial spontaneous report received from a physician on 09 Dec 2013. This report refers to a 04-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on 07 Dec 2013. The FLUVIRIN PFS and unopened MDVs reached 10 C from 05 Dec 2013 through 07 Dec 2013, reached 9.7 C on 08 Dec 2013 and reached 11.7 C on 09 Dec 2013. No adverse event was reported following this administration error.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US026651 is an initial spontaneous report from a pharmacist received on 20 Dec 2013. This report refers to a 28-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with 0.5ml of FLUVIRIN (batch number: 1345P, expiry date: May 2014) intramuscularly on 26 Dec 2013. He pharmacist reported that the FLUVIRIN which had undergone excursion at 51 F for 9 hours has been administered to the patient. No adverse event was reported following this medication error. No additional information was available.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US026647 is an initial spontaneous report from a pharmacist received on 30 Dec 2013. This report refers to a 41-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5ml of FLUVIRIN (batch number: 13452P, expiry date: May 2014) intramuscularly on 11 Dec 2013. The pharmacist reported that the FLUVIRIN which had undergone excursion at 51F for 9 hours has been administered to the patient. No adverse event was reported following this medication error. No additional information was available.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Case number PHEH2013US026416 is an initial spontaneous report received from a pharmacist on 20 DEC 2013. This report refers to a 56-year-old male patient. His medical history and concomitant medications were not reported. On 20 DEC 2013, he was vaccinated with FLUVIRIN 2013/2014 (batch number: 13375) intramuscularly in the right arm. On the same date, fifteen minutes after vaccination, he developed blurriness in his right eye. The final outcome was reported as condition unchanged. The seriousness and causality of the event were not assessed.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site swelling, Wrong drug administered
Clinical narrative: Case number PHEH2013US026409 is an initial spontaneous report received from a nurse on 20 Dec 2013 with a follow-up received from the nurse on 07 Feb 2014. This report refers to a 63-year-old female patient. Her medical history and concomitant medications were not reported. On 20 Dec 2013, she was vaccinated with FLUVIRIN (batch number: 1309501) intradermally in to the left forearm, instead of the serum to be used for tuberculin skin test. Approximately one hour after vaccination, she found that the vaccination site had become red and raised like the size of a dime, approximately three into three inches. On her return to the pharmacy on 23 Dec 2013, it was noted that her forearm had no raised area and the redness had greatly diminished. She had no pain. She expressed no concern regarding her left arm. She did not contact the clinic since 23 Dec 2013. Outcome of the events was reported as complete recovery. The seriousness and causality of the events were not reported. Follow-up received from the nurse on 07 Feb 2014: Updated patient demographics, site and batch number of FLUVIRIN, description of the event and outcome.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site swelling, Wrong drug administered
Clinical narrative: Case number PHEH2013US026408 is an initial spontaneous report received from a nurse on 20 Dec 2013 with a follow-up received from the nurse on 07 Feb 2014. This report refers to an 18-year-old female patient. Her medical history and concomitant medications were not reported. On 20 Dec 2013, she was vaccinated with FLUVIRIN (batch number: 1309501) intradermally in to the left forearm, at a dose of 0.1ml, instead of the serum to be used for tuberculin skin test. On the same date after vaccination, she found that the vaccination site had become red and was raised like the size of a dime, approximately three inches into four inches on the left forearm. On her return to the pharmacy on 23 Dec 2013, there was no raised area noted on the arm and it appeared normal. There was no redness. She had no complaints and voiced no concerns about her left forearm. Outcome of the events was reported as complete recovery. The seriousness and causality of the events were not reported. Follow-up information received from the nurse on 07 Feb 2014: Updated patient demographics, site and batch number of FLUVIRIN, description of the event and outcome
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US026177 is an initial spontaneous report received from a health care professional on 17 DEC 2013. This report refers to a 03-year old female child. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13109801, expiry date 31 MAY 2013) intramuscularly at a dose of 0.5 ml on 15 NOV 2013. No adverse event was reported following this administration error.
Age: 1.55
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US026176 is an initial spontaneous report received from a health care professional on 17 DEC 2013. This report refers to an 18 month old male infant. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 1310001, expiry date: 31 MAY 2013) intramuscularly at a dose of 0.5 ml on 19 NOV 2013. No adverse event was reported following this administration error.
Age: 1.83
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US026174 is an initial spontaneous report received from a health care professional on 17 DEC 2013. This report refers to a 22 month old female infant. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1310201, expiry date: 31 MAY 2013) intramuscularly at a dose of 0.5 ml on 13 DEC 2013. No adverse event was reported following this administration error.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US026172 is an initial spontaneous report received from a health care professional on 17 DEC 2013. This report refers to an 02 year old female infant. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1310001, expiry date: 31 MAY 2013) intramuscularly at a dose of 0.5 ml on 19 NOV 2013. No adverse event was reported following this administration error.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHEH2013US026142 is an initial spontaneous report from a nurse received on 18 DEC 2013. This report refers to a 17-year-old female patient. She was an inpatient psychiatric ward resident. No concomitant medication was reported. She was erroneously vaccinated with FLUVIRIN 2013/2014 (batch number: 1309101, expiry date: Apr 2014) at a dose of 0.1 ml intradermally instead of PPD for tuberculin skin test on 17 DEC 2013. On the same day immediately after vaccination, she experienced intense itching and stinging at the injection site. On 18 DEC 2013 the injection site was painful upon palpation, tender upon touch, slightly swollen and red. The outcome of the events was reported as condition unchanged. The seriousness and causality were not reported.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Tuberculin test, Wrong drug administered
Clinical narrative: Case number PHEH2013US026142 is an initial spontaneous report from a nurse received on 18 DEC 2013. This report refers to a 17-year-old female patient. She was an inpatient psychiatric ward resident. No concomitant medication was reported. She was erroneously vaccinated with FLUVIRIN 2013/2014 (batch number: 1309101, expiry date: Apr 2014) at a dose of 0.1 ml intradermally instead of PPD for tuberculin skin test on 17 DEC 2013. On the same day immediately after vaccination, she experienced intense itching and stinging at the injection site. On 18 DEC 2013 the injection site was painful upon palpation, tender upon touch, slightly swollen and red. The outcome of the events was reported as condition unchanged. The seriousness and causality were not reported.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHEH2013US026140 is an initial spontaneous report from a nurse received on 18 DEC 2013. This report refers to a 10-year-old male patient. He was an inpatient psychiatric ward resident. No concomitant medication was reported. He was erroneously vaccinated with FLUVIRIN 2013/2014 (batch number:  1309101, expiry date: April 2014) at a dose of 0.1 ml intradermally instead of PPD for tuberculin skin test on 17 DEC 2013. On the same day immediately after vaccination, he experienced intense itching and stinging at the injection site. On 18 DEC 2013 the injection site was painful upon palpation, tender upon touch, slightly swollen and red. The outcome of the events was reported as condition unchanged. The seriousness and causality were not reported.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Tuberculin test, Wrong drug administered
Clinical narrative: Case number PHEH2013US026140 is an initial spontaneous report from a nurse received on 18 DEC 2013. This report refers to a 10-year-old male patient. He was an inpatient psychiatric ward resident. No concomitant medication was reported. He was erroneously vaccinated with FLUVIRIN 2013/2014 (batch number:  1309101, expiry date: April 2014) at a dose of 0.1 ml intradermally instead of PPD for tuberculin skin test on 17 DEC 2013. On the same day immediately after vaccination, he experienced intense itching and stinging at the injection site. On 18 DEC 2013 the injection site was painful upon palpation, tender upon touch, slightly swollen and red. The outcome of the events was reported as condition unchanged. The seriousness and causality were not reported.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHEH2013US026137 is an initial spontaneous report from a nurse received on 18 DEC 2013. This report refers to a 12-year-old female patient. She was an inpatient psychiatric ward resident. No concomitant medications was reported., She was erroneously vaccinated with FLURIVIN 2013/2014 (batch number: 1309101, expiry date: Apr 2014) at a dose of 0.1 ml intradermally instead of PPD for tuberculin skin test on 17 DEC 2013. On the same day immediately after vaccination, she experienced intense itching and stinging at the injection site. On 18 DEC 2013 the injection site was painful upon palpation, tender upon touch and slightly swollen and red. The outcome of the events was reported as condition unchanged. The seriousness and causality were not reported.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Tuberculin test, Wrong drug administered
Clinical narrative: Case number PHEH2013US026137 is an initial spontaneous report from a nurse received on 18 DEC 2013. This report refers to a 12-year-old female patient. She was an inpatient psychiatric ward resident. No concomitant medications was reported., She was erroneously vaccinated with FLURIVIN 2013/2014 (batch number: 1309101, expiry date: Apr 2014) at a dose of 0.1 ml intradermally instead of PPD for tuberculin skin test on 17 DEC 2013. On the same day immediately after vaccination, she experienced intense itching and stinging at the injection site. On 18 DEC 2013 the injection site was painful upon palpation, tender upon touch and slightly swollen and red. The outcome of the events was reported as condition unchanged. The seriousness and causality were not reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US026020 is an initial spontaneous report received from a pharmacist on 13 DEC 2013. The report refers to a 48-year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml does of FLUVIRIN 2013/2014 (batch number: 13464P) intramuscularly on 13 DEC 2013. This FLUVIRIN prefilled syringe reached 48 F on 03 DEC 2013 at 6 PM; at 8:55 AM on 04-DEC-2013 it was at 46 F. This first excursion duration was 15 hours. Same vaccine then reached 47 F on 04 DEC 2013 at 5 PM. This second excursion duration was 16 hours. Reporter stated that the vaccine has been in range since that excursion. Vaccine was administered to patient after excursions. No adverse reactions were reported. Seriousness, outcome and causality of the event were unknown.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US026019 is an initial spontaneous report received from a pharmacist on 13 Dec 2013. This report refers to a 65-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml dose of FLUVIRIN (batch number: 13464P) intramuscularly on 13 Dec 2013. This FLUVIRIN prefilled syringe reached 48 F on 03 Dec 2013 at 6 pm, at 08:55 on 04 Dec 2013 it was at 46 F. This first excursion duration was 15 hours. Same vaccine then reached 47 F on 04 Dec 2013 at 5 pm. This second excursion duration was 16 hours. Reporter stated that the vaccine has been in range since that excursion. Vaccine was administered to patient after excursions. No adverse reactions were reported. Seriousness, outcome and causality of the event were unknown.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US026018 is an initial spontaneous report received from a pharmacist on 13 Dec 2013. This report refers to a 58-year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml dose of FLUVIRIN (batch number: 13464P) intramuscularly on 13 Dec 2013. This FLUVIRIN prefilled syringe reached 48 F on 03 Dec 2013 at 6 pm; at 08:55 am on 04 Dec 2013 it was at 46 F. This first excursion was 15 hours. Same vaccine then reached 47 F on 04 Dec 2013 at 5 pm. This second excursion duration was 16 hours. Reporter stated that the vaccine has been in range since that excursion. Vaccine was administered to patient after excursions. No adverse reactions were reported. Seriousness, outcome and causality of the event were unknown.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US026017 is an initial spontaneous report received from a pharmacist on 13 Dec 2013. This report refers to a 50-year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml dose of FLUVIRIN (batch number: 13464P) intramuscularly on 13 Dec 2013. This FLUVIRIN prefilled syringe reached 48 F on 03 Dec 2013 at 6 pm; at 08:55 am on 04 Dec 2013 it was at 46 F. This first excursion duration was 15 hours. Same vaccine then reached 47 F on 04 Dec 2013 at 5 pm. This second excursion duration was 16 hours. Reporter stated that the vaccine has been in range since that excursion. Vaccine was administered to patient after excursions. No adverse reactions were reported. Seriousness, outcome and causality of the event were unknown.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US026016 is an initial spontaneous report received from a pharmacist on 13 Dec 2013. This report refers to a 58-year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml dose of FLUVIRIN (batch number: 13464P) intramuscularly on 13 Dec 2013. This FLUVIRIN prefilled syringe reached 48 F on 03 Dec 2013 at 6 pm; at 08:55 am on 04 Dec 2013 it was at 46 F. This first excursion duration was 15 hours. Same vaccine reached 47 F on 04 Dec 2013 at 5 pm. This second excursion duration was 16 hours. Reporter stated that the vaccine has been in range since that excursion. Vaccine was administered to patient after excursions. No adverse reactions were reported. Seriousness, outcome and causality of the event were unknown.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site warmth, Pain, Paraesthesia, Poor quality sleep
Clinical narrative: Case number PHEH2014US004926 is an initial spontaneous report from a consumer received on 06 Mar 2014. This report refers to a 64 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13412P) intramuscularly into her left arm on 04 Nov 2013. Since her vaccination, she experienced severe pain at the vaccination site on her left arm. In the past four months, the pain only increased. The patient described the pain in the site as hot and burning pain. She woke up from sleep because of the pain and it was tingling. She could not stretch her muscles without thinking of the pain. She had to stretch a lot as she was short and it hurt when she tried to stretch. She was in pain when a tight jacket or shirt was rubbed against the vaccination site. She was compensating for her pain and due to that her back hurt. Her entire left arm above the elbow was paining, but the most severe pain was localized to the areas immediately above and below her left elbow. She did not try to get any pain relief as nothing made the pain better. She had an appointment with a neurologist followed by an appointment with an orthopedist for pain evaluation. The patient did not recovered from the events. The causality and seriousness of the event were not reported.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Case number PHEH2014US004926 is an initial spontaneous report from a consumer received on 06 Mar 2014. This report refers to a 64 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13412P) intramuscularly into her left arm on 04 Nov 2013. Since her vaccination, she experienced severe pain at the vaccination site on her left arm. In the past four months, the pain only increased. The patient described the pain in the site as hot and burning pain. She woke up from sleep because of the pain and it was tingling. She could not stretch her muscles without thinking of the pain. She had to stretch a lot as she was short and it hurt when she tried to stretch. She was in pain when a tight jacket or shirt was rubbed against the vaccination site. She was compensating for her pain and due to that her back hurt. Her entire left arm above the elbow was paining, but the most severe pain was localized to the areas immediately above and below her left elbow. She did not try to get any pain relief as nothing made the pain better. She had an appointment with a neurologist followed by an appointment with an orthopedist for pain evaluation. The patient did not recovered from the events. The causality and seriousness of the event were not reported.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US004355 is an initial spontaneous report from the nurse received on 28 Feb 2014. This report refers to a 08-year-old male child. The patient was vaccinated with FLUVIRIN (batch number: 1301P) intramuscularly on 25 Oct 2013. It was reported that the FLUVIRIN vaccine which was given the patient was exposed to temperatures down to 32 F for an unknown period of time before vaccination. No adverse event occurred to the patient after this medication error.
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased
Clinical narrative: Case number PHEH2014US002610 is an initial spontaneous report received from a physician on 04 Feb 2014. This report refers to a male patient whose age was not reported. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN, (batch number: not reported) on an unknown date. On an unspecified date, his blood pressure dropped (results were not reported). The event outcome, seriousness and causality were not reported.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018209 is an initial spontaneous report received from a nurse on 09 Sep 2014. This report refers to a 62 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1412701) intramuscularly at a dose of 0.5 ml 09 Sep 2014. It was reported that FLUVIRIN reached a temperature of 50 degree F (10 degree C) for 30 minutes. No adverse events after the maladministration.
Sex: F
Vaccine: FLU3
Symptoms: Needle issue, No adverse event
Clinical narrative: Case number PHEH2014US002500 is an initial spontaneous report received from a pharmacist on 03 Feb 2014: This report refers to a female patient of unknown age. She was administered FLUVIRIN (batch number: 13413P) intramuscularly on 28 Jan 2014. During administering the vaccine, part of it leaked out of the needle before entering her arm. Therefore, the patient did not receive a full 0.5 ml dose. No adverse event was reported following this administration error.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US002268 is an initial spontaneous report received from a pharmacist on 29 Jan 2014. This report refers to a female patient of unknown age. Sh was vaccinated with FLUVIRIN (batch number: 1309301 and expiry date: Apr 2014) intramuscular at a dose of 0.5 ml on 21 Jan 2014. Pharmacist reported that FLUVIRIN was stored improperly. Opened and unopened multi dose vials of FLUVIRIN had reached 20 degree Fahrenheit for 12 to 18 hours. Pharmacist did not know if the vaccine had frozen during the excursion. No adverse event was reported following this administration error.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US002267 is an initial spontaneous report received from a pharmacist on 29 Jan 2014. This report refers to a female patient of unknown age. She was vaccinated with FLUVIRIN (batch number: 1309301 and expiry date: Apr 2014) intramuscularly at a dose of 0.5 ml on 19 Jan 2014. Pharmacist reported that FLUVIRIN was stored improperly. Opened and unopened multidose vials of FLUVIRIN had reached 20 degree Fahrenheit for 12 to 18 hours. Pharmacist did not know if the vaccine had frozen during the excursion. No adverse event was reported following this administration error.
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US002265 is an initial spontaneous report received from a pharmacist on 29 Jan 2014: This report refers to a male patient of unknown age. He was vaccinated with FLUVIRIN (batch number: 1309301 and expiry date: Apr 2014) intramuscularly at a dose of 0.5 ml on 19 Jan 2014. Pharmacist reported that FLUVIRIN was stored improperly. Opened and unopened multi dose vials of FLUVIRIN had reached 20 degree Fahrenheit for 12 to 18 hours. Pharmacist did not know if the vaccine had frozen during the excursion. No adverse event was reported following this administration error.
Age: 1.82
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US002082 is an initial spontaneous report received from a nurse on 27 Jan 2014 with a follow-up received on 25 Feb 2014. This report refers to a 12-month-old male infant. His medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml of FLUVIRIN (batch number: 13462P, expiry date: May 2014) intramuscularly into left thigh on 20 Jan 2014 at 16:50. Nurse reported that the patient under 4 years of age received FLUVIRIN. No adverse event was reported following medication error. Follow up received from health care professional on 25 Feb 2014: Site and time of vaccination updated. Reporter details updated.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US002081 is an initial spontaneous report received from a nurse on 27 Jan 2014 with a follow-up received on 25 Feb 2014. This report refers to a 3-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml of FLUVIRIN (batch number: 13462P, expiry date: May 2014) intramuscularly into left thigh on 20 Jan 2014 at 16:55. Nurse reported that the patient under 4 years of age received FLUVIRIN. No adverse event was reported following medication error. Follow up received from health care professional on 25 Feb 2014: Site and time of vaccination updated. Reporter details updated.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US002079 is an initial spontaneous report received from a nurse on 27 Jan 2014 with a follow-up received on 25 Feb 2014. This report refers to a 3-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of FLUVIRIN, (batch number: 13462P, expiry date: May 2014) intramuscularly into right deltoid on 20 Jan 2014. Nurse reported that the patient under 4 years of age received FLUVIRIN. No adverse event was reported following medication error. Follow up received from health care professional on 25 Feb 2014: Site of vaccination and reporter details updated.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US001903 is an initial spontaneous report from a nurse received on 23 Jan 2014 with a follow-up received on 27 Jan 2014 and 25 Feb 2014. This report refers to a 3-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 13462P, expiry date: May 2014) intramuscularly into right deltoid at a dose of 0.5 ml on 20 Jan 2014 at 16:28. No adverse event was reported following this maladministration. Follow up received from nurse on 27 Jan 2014: Updated patient demographics, FLUVIRIN dose, batch number and expiry date. Changed report type from other to spontaneous report. Follow up received from health care professional on 25 Feb 2014: Site and time of vaccination updated. Reporter details updated.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US001581 is an initial spontaneous report received from a pharmacist on 20 JAN 2014. This report refers to a 46-year-old female patient. She was vaccinated with FLUVIRIN 2013/2014. (batch number: 13453P) intramuscularly on 20 JAN 2014. The vaccine had reached 34.7 degree Fahrenheit overnight but pharmacist stated that it was not frozen. No adverse event was reported following this administration error.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2014US001495 is an initial spontaneous report received from a consumer on 08 Jan 2014. This report refers to a 27 years old pregnant female patient. Her medical history and concomitant medications were not reported. Her vaccination history included a dose of FLUVIRIN (batch number: 13461P) intramuscularly on 15 Nov 2013 (see related case number: PHEH2014US000906). She was further vaccinated with a second dose of FLUVIRIN (batch number: 13461P) intramuscularly on 08 Jan 2014 when she was pregnant. No adverse event was reported following the maladministration.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Case number PHEH2014US001202 is an initial spontaneous report from a nurse received on 14 Jan 2014. This report refers to a male child. The patient received FLUVIRIN (batch number 1308401, expiry Mar 2014) intramuscularly on 09 Jan 2014. The nurse stated that patient was under the age of four and received FLUVIRIN. No further information was reported.