chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003608 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 16-year-old male patient. His medical history and concomitant medications were not reported. On an unknown date in NOV 2013, he was vaccinated with FLUCELVAX (batch number: 004011A) intramuscularly. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration"  was erroneously captured as listed and hence the labeling was not changed as unlisted and second indication off-label use was added to the case.
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003607 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 16-year-old female patient. Her medical history and concomitant medication was not reported. On an unknown date in JAN 2014, she was vaccinated with FLUCELVAX (batch number: 006031A) intramuscularly. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003605 is a spontaneous report initially received from a pharmacist on 20 FEB 2014 with a follow-up received on 07 APR 2014. Pharmacist confirmed patient demographics on 07 APR 2014; therefore the case was processed as a valid case. This report refers to a 13-year-old female patient. Her medical history and concomitant medication were not reported. Her vaccination history included administration of flu vaccines in the last which were well tolerated. She was vaccinated with FLUCELVAX 2014/2014 (batch number: 010031A) intramuscularly into the right deltoid at 0.5 ml on 08 DEC 2013. This was the initial application of FLUCELVAX. No adverse event was reported following this administration error (inappropriate age at vaccine administration). She was vaccinated with a dose of FLUVIRIN 2014/2014 (batch number: unknown) on 13 JAN 2014., which was approved for her age.  Follow-up received from the pharmacist on 27 APR 2014: After receiving confirmation on patient identifiers, this case was data based as a valid case with four minimum criteria met. Therefore, the report type was changed from "other" to "spontaneous". Updated patient demographics, vaccination history, details about FLUCELVAX (batch number, dosage and route and site of administration), date of vaccination and information about re-vaccination with the age appropriate flu vaccine (FLUVIRIN).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 07 APR 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003695, is an initial spontaneous report from a pharmacist received on 21 FEB 2014 with a follow-up received on 26 MAR 2014. This report refers to a 12-uear-old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 010031A, expiration date: JUNE 2014) at a dose of 0.5 ml intramuscularly in to the left arm on 24 NOV 2013 at 6:00 PM. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Follow-up received from the pharmacist on 26 MAR 2014: Updated site and time of application of FLUCELVAX.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 26 MAR 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003603, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 14-year-old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 010031A, expiration date:  JUNE 2014) at a dose of 0.5 ml intramuscularly on 24 NOV 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 8.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003596 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 09-year-old female child. On 26 NOV 2013, she was accidentally vaccinated with FLUCELVAX (batch number: 010031A) intramuscularly. No adverse event was reported following the administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
Age: 17.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003598 is an initial spontaneous report received from a pharmacist on 20 FEB 2014. This report refers to patient who age was less than 17 years. The patient's medical history and concomitant medications were not reported. This patient who was under 18-years was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on an unspecified date. No adverse event was reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 20 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 66.0
Sex: F
Vaccine: FLUC3
Symptoms: Neck pain, Tenderness, Vaccination site pain
Clinical narrative: Case number PHEH2014US022236 is an initial spontaneous report received from a consumer on 03 Nov 2014. This report refers to a 66 year old female patient. Her past medical history included migraine headaches for which she was treated with NEURONTIN and faced adverse events. Her vaccination history included flu vaccinations with seasonal influenza vaccine (manufacturer and batch number: not reported). Sometimes, after the vaccination, she used to have reactions which would linger up to two weeks but then would go away. Her concomitant medications were not reported. On 07 Oct 2014, she was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly into her arm. On the same day, she was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly into her arm. On the same day, after the vaccination, she experienced pain in the arm at the vaccination site, pain radiated up her neck and in her shoulder. The patient went back to the clinic and the nurse practitioner checked her arm. She had no redness; there was a lot of tenderness. The nurse practitioner recommended NEURONTIN but she was not willing to take NEURONTIN due to the adverse events she had earlier. The patient treated herself with muscle rub and went out to do yard work. The outcome of the events was condition unchanged. The seriousness and causality of the events were not reported.
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022256 is an initial spontaneous report received from a pharmacist on 03 Nov 2014. This case refers to a 16 years old female patient. Past medical history and concomitant medication were not reported. he was vaccinated with FLUCELVAX (batch number: 11021A), intramuscularly on 29 Oct 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022265 is an initial spontaneous report received from a physician on 03 Nov 2014. This report refers to a 13 year old female patient. Her past medical history and concomitant medications were not reported. On 02 Nov 2014, she received FLUCELAX (batch number: not reported) at a dose of 0.5 ml intramuscularly. No adverse events were reported following this medication error (inappropriate age at vaccine administration).
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022270 is an initial spontaneous report received from a physician on 03 Nov 2014. This report refers to a 16 year old female patient. Her past medical history and concomitant medications were not reported. On 02 Nov 2014, she received FLUCELVAX (batch number: not reported) at a dose of 0.5 ml intramuscularly. No adverse events were reported following this medication error (inappropriate age at vaccine administration).
Age: 7.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022293 is an initial spontaneous report received from a physician on 04 Nov 2014. This report refers to a seven year old male patient. His past medical history and concomitant medications were not reported. On 04 Nov 2014, he received FLUCELVAX (batch number: 161207) intramuscularly at an age of seven years. No adverse events were reported following the medication error (inappropriate age at vaccine administration).
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022299. is an initial spontaneous report from a pharmacist received on 04 Nov 2014. This report refers to a 16-year-old male patient. Medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX (batch number: 011021A) intramusularly at a dose of 0.5 ml on 01 Nov 2014. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Age: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022305, is an initial spontaneous report from a pharmacist received on 04 Nov 2014. This report refers to a 13-year-old female patient. Medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX (batch number: 011021A) intramuscularly at a dose of 0.5 ml on 01 Nov 2014. No adverse event was reported following this medication error.
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022453, is an initial spontaneous report from  a nurse received on 07 Nov 2014. This report refers to a 13 years old male patient. Medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX (batch number: 013011A) intramuscularly on 07 Nov 2014. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Sex: F
Vaccine: FLUC3
Symptoms: No adverse event, Underdose
Clinical narrative: Case number PHEH2014US022474 is an initial spontaneous report from the pharmacist received on 07 Nov 2014. This report refers to a female patient of an unknown age. The patient was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on 06 Nov 2014. It was reported that the vaccine ran out of the injection site. No adverse event reported followed this medication error (vaccine underdose).
Age: 13.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022568, is an initial spontaneous report received from a physician on 08 Nov 2014. This report refers to a 13 year old patient of unknown age. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: Not reported) intramuscularly on 08 Nov 2014. No adverse events reported after the maladministration (inappropriate age at vaccine administration).
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022755, is an initial spontaneous report from a nurse received on 11 Nov 2014. This report refers to a 17-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX (batch number: 131070) intramuscularly on 20 Oct 2014. No adverse event was reported following the maladministration.
Age: 10.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022573, is an initial spontaneous report received from a pharmacist on 07 Nov 2014. This report refers to a 10 year old male patient. Pharmacist reproted that this patient received FLUCELVAX (batch number: 011021A) on 07 Nov 2014. No adverse event was reported. No further details provided.
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US023984 is an initial spontaneous report received from a nurse on 12 Nov 2013 with a follow up information received from a health care professional on 16 Dec 2013. This report refers to a 16 years-old female patient. Her medical history and concomitant medications were not reported. her vaccination status was uptodate. This patient under 18-years of age was vaccinated with a 0.5 ml intramuscular dose of FLUCELVAX (batch number: 008011A, expiry date: 30 Jun 2014) intramuscularly in the left deltoid on 07 Nov 2013. No adverse event was reported following the maladministration. Follow up information received from a health care professional on 16 Dec 2013: Reporter information, patient demographics (gender), batch number and site of vaccination updated. Following an internal review on 18 Aug 2014 for the information received on 16 Dec 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US025053 is an initial spontaneous report received from a pharmacist on 27 Nov 2013. This case refers to a 17-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 00923031A and expiry date: Jun 2014) at dose of 0.5 Ml intramuscularly on 26 Nov 2013. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 27 Nov 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population.
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US025054 is an initial spontaneous report received from a pharmacist on 27 Nov 2013. This case refers to a 15-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 0092031A and expiry date: Jun 2014) at a dose of 0.5 ml intramuscularly on 27 Nov 2013. No adverse event was reported following this medication error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 27 Nov 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug use in unapproved population".
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2013US023974 is an initial spontaneous report received from a nurse on 12 Nov 2013 with a follow-up received on 16 Dec 2013. This report refers to a 17 years-old male patient. His medical history did not included any relevant underlying disease and his concomitant medications were not reported. His vaccination history was up to date with all inoculations. This patient under 18 years of age was vaccinated with a 0.5 ml intramuscular dose of FLUVELVAX (batch number: 0080011A, expiry date: 30 Jun 2014) on 07 Nov 2013. No adverse event was reported following the maladministration. Follow-up received from the nurse on 16 Dec 2013: Updated patient's demographic (male), medical history and vaccination history. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 16 Dec 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US025056 is an initial spontaneous report received from a pharmacist on 27 Nov 2013. This case refers to a 15-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 0092031A and expiry date: Jun 2014) at dose of 0.5 ml intramuscularly on 26 Nov 2013. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 27 Nov 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2013US023216 is an initial spontaneous report received from a pharmacist on 04 Nov 2013, with a follow up received from the pharmacist on 24 Dec 2013. This case refers to a 13-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 006011A and expiry date: Jun 2014) at dose of 0.5 ml intramuscularly in the deltoid on 01 Nov 2013 at 20:00 PM. No adverse event was reported following this administration error. Follow up received from the pharmacist on 24 Dec 2013: Site and time of vaccination was updated. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 24 Dec 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population.
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US025057 is an initial spontaneous report received from a pharmacist on 27 Nov 2013. This case refers to a 16-year-old male patient. Past medical history and concomitant medication were not reported. On 30 Nov 2013, he was vaccinated inadvertently vaccinated with FLUCELVAX (batch number: 006031A) intramuscularly. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 02 Dec 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 11.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US025229, is an initial spontaneous report received from a nurse on 03 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 FLUCELVAX (batch number: 009031A and expiry date: Jun 2014) at a dose pf 0.5 ml intramuscularly on 20 Nov 2013. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 03 Dec 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "Adult product administered to child.
Age: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US025312 is an initial spontaneous report received from a pharmacist on 04 Dec 2013. This report refers to a 14-year-old female patient. She was vaccinated with FLUCELVAX (batch number: unknown) intramuscularly on 04 Dec 2013. No adverse event was reported following medication error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 04 Dec 2013. The labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: Discomfort, Feeling abnormal, Mobility decreased, Musculoskeletal pain
Clinical narrative: Case number PHEH2014US021632, is an initial spontaneous report received from a consumer (patient's husband) on 24 Oct 2014. This report refers to a 52 years old female patient. Her medical history and concomitant medications were not reported. Her vaccination history included administration of seasonal influenza vaccine (unknown brand name, batch number: not reported) on unspecified dates from four years and experienced discomfort after first flu shot (see related case number: PHEH2014US022185). She was vaccinated with FLUCELVAX (batch number: 140233) at a dose of 0.5 ml in the deltoid on 01 Oct 2014. She felt two things seemed different from previous vaccinations including the location of the injection seemed higher on the arm and she felt different during vaccination which was further described as creaky hinge and similar to when receiving epidural. It was reported that, 2 nights after vaccination her shoulder was painful when she tried to lie on that shoulder. After three weeks it was ok to lie on that shoulder but still had restricted movement. The arm was not sore to touch but movements that require raising the arm above the shoulder or head is painful in that shoulder. She was treated with ibuprofen which was helpful. The final outcome of the events was not reported. The seriousness and causality of the events were not reported.
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US025388 is an initial spontaneous report received from a pharmacist on 05 Dec 2013: This report refers to a 15-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 010021A) intramuscularly on 04 Dec 2013. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 05 Dec 2013: The labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 28.0
Sex: F
Vaccine: FLUC3
Symptoms: Chills, Lymphadenopathy
Clinical narrative: Case number PHEH2014US020959, is an initial spontaneous report from a consumer received on 16 Oct 2014. This report refers to a 28-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 161281) intramuscularly on 07 Oct 2014. On the same day, after vaccination, she experienced swollen lymph nodes and slight chills. Outcome of the events was reported as unknown. Seriousness and causality of the events was not reported.
Age: 25.0
Sex: F
Vaccine: FLUC3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2014US020511, is an initial spontaneous report from a nurse received on 13 Oct 2014. This report refers to a 25-year-old female pregnant patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUCELVAX (batch number: 015011A) intramuscularly on 09 Oct 2014. It was reported that the patient was pregnant and no adverse event was reported.
Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: Malaise, Pain
Clinical narrative: Case number PHEH2014US020488, is an initial spontaneous report received from health care professional via pharmacist on 07 Oct 2014. This report refers to a 52 year old female patient. Medical history and concomitant medication was not reported. Current conditions included allergies and smoking. She was vaccinated with FLUCELVAX (batch number: 160233) at a dose of 0.5 ml intramuscular into right deltoid on 01 Oct 2014. On the same day she experienced general malaise, aches and pains. Final outcome of the events was completely recovered. Reporter assessed the events as non-serious. Causality assessment was not reported.
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US000597 initial spontaneous report received from a pharmacist on 06 Jan 2014. This report refers to a 16-year-old male patient. His medical history and concomitant medication were not reported. It was reported that this patient under 18-years of age was vaccinated with FLUCELVAX (batch number: 010011A) on 04 Jan 2014. No adverse event was reported following the maladministration. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 06 Jan 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US000645 is an initial spontaneous report received from a pharmacist on 06 Jan 2014 with the follow-up received on 21 Feb 2014. This report refers to a 17-year-old female patient who was inadvertently vaccinated with one dose of FLUCELVAX (batch number: 010031A) into left deltoid at 0.5 ml, intramuscularly on 02 Jan 2014. No adverse event was reported following this administration error. Follow-up received from a pharmacist on 21 Feb 2014: Site of vaccination and batch number updated. Following an internal review on 18 Aug 2014 of the data received on 21 Feb 2014, it was identified that the labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Age: 74.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: Case number PHEH2014US019006 is an initial spontaneous report received from a consumer on 19 Sep 2014. This report refers to a 74 year old female patient. Her past medical history and concomitant medications were not reported. On 03 Sep 2014, she was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly into her arm. On the same ay, after the vaccination, she developed hotness and itching on her arm at the site of injection. She completely recovered from the vents on 10 Sep 2014. The seriousness and causality of the events were not reported.
Age: 11.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US000649 is an initial spontaneous report received from a pharmacist on 06 Jan 2014 and a follow up report received from the pharmacist on 18 Jan 2014: This report refers to an 11-year-old male patient who was inadvertently vaccinated with 0.5 ml of FLUCELVAX (batch number: 010031A) intramuscularly in the left deltoid on 02 Jan 2014. No adverse event was reported following this administration error. Follow up report received from the pharmacist on 18 Jan 2014: FLUCELVAX vaccination site and batch number were updated. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 18 Jan 2014: BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug use in unapproved population".
Age: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US000713, is a spontaneous initial report received from a pharmacist on 06 Jan 2014, with a follow up received on 21 Feb 2014. This case refers to a 17-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 010031A and expiry date: Jun 2014) at a dose of 0.5 ml intramuscularly into the left deltoid on 05 Jan 2014 at 13:20 PM. No adverse event was reported following this maladministration. Follow up received from a pharmacist on 21 Feb 2014: Updated date and site of vaccination with FLUCELVAX. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 21 Feb 2014: The labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US000710 is an initial spontaneous report received from a pharmacist on 06 Jan 2014. This case refers to a 13-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 010031A and expiry date: Jun 2014) at dose of 0.5 ml intramuscularly into left deltoid on 05 Jan 2014 at 1:20 pm. No adverse event was reported following this administration error. Follow-up received from a health care professional on 25 Feb 2014: Site and time of vaccination updated. Date of vaccination amended. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 25 Feb 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population.
Age: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US020975, is an initial spontaneous report from a health care professional received on 17 Oct 2014. This report refers to a 12-year-old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX (batch number: 161208) intramuscularly on 16 Oct 2014. No adverse event was reported following this medication error.
Age: 8.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US020985 is an initial spontaneous report received from a nurse on 17 Oct 2014. This report refers to an eight year old female patient. Her past medical history and concomitant medications were not reported. On 15 Oct 2014, she was vaccinated with FLUCELVAX (batch number: 015031A) intramuscularly at an age of eight years. No adverse events were reported following this medication error.
Sex: U
Vaccine: FLUC3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2014US021079 is an initial spontaneous report from the nurse received on 18 Oct 2014. This report refers to an adult patient of an unknown gender. It was reported that the patient was inadvertently vaccinated with two doses of FLUCELVAX (batch number: 013611A) intramuscularly on 17 Oct 2014. No adverse event reported following this medication error.
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2014US021089, is an initial spontaneous report from a pharmacist received on 16 Oct 2014. This report refers to a 15-year-old female patient. Her medical history and concomitant medications were not reported. On 15 Oct 2014, the patient inadvertently received an intramuscular dose of FLUCELVAX (batch number: 015011A) instead of FLUVIRIN (batch number: unknown). No adverse event was reported following this medication error.
Age: 43.0
Sex: M
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US021207 is an initial spontaneous report received from a nurse on 20 Oct 2014. This case refers to a 43-years-old male patient. past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: not reported), intramuscularly on 13 Oct 2014, which had reached room temperature for four days. no adverse event was reported following this administration error (incorrect storage of drug).
Age: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US021285 is an initial spontaneous report received from a nurse on 20 Oct 2014. This case refers to a 14-year-old female patient. past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 013011A), at dose of 0.5 ml intramuscularly on 17 Oct 2014. No adverse event was reported following this administration error.
Age: 10.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US021289 is an initial spontaneous report received from a nurse on 20 Oct 2014. This case refers to a 10-years-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 013011A), at dose of 0.5 ml intramuscularly on 17 Oct 2014. No adverse event was reported following this administration error.
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US021291 is an initial spontaneous report from the health care professional received on 20 Oct 2014. This report refers to a 16-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 014021A) intramuscularly on 14 Oct 2014. No adverse event reported following this medication error.
Age: 3.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US021416 is an initial spontaneous report received from a nurse on 22 Oct 2014. This case refers to a 03 years old male patient 9who is almost 4 years of age). past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 017021A), intramuscularly on 21 Oct 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US021530 is an initial spontaneous report received from a pharmacist on 22 Oct 2014. This case refers to a 17 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 161207), intramuscularly on 22 Oct 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 4.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US021549 is an initial spontaneous report received from a nurse on 24 Oct 2014. This report refers to a 04 years old male patient. his medical history and concomitant medication were not reported. he was vaccinated with FLUCELVAX (batch number: 161208) via intramuscular route on 24 Oct 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Sex: F
Vaccine: FLUC3
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: Mother case: Case number PHEH2014US021768 is an initial spontaneous report received from a health care professional (pharm resident) on 27 Oct 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. It was reported that she was expecting and was vaccinated with a dose of FLUCELVAX (batch number: not reported) intramuscularly on 13 Oct 2014. She was vaccinated with another dose of FLUCELVAX (batch number: not reported) intramuscularly on 13 Oct 2014. She was vaccinated again with another dose of FLUCELVAX (batch number: not reported) on 27 Oct 2014. No adverse events were reported following the maladministration.
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US021809 is an initial spontaneous report received from a nurse on 29 OCT 2014. This case refers to a 17 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on an unknown date. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 51.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US022006, is an initial spontaneous report from a pharmacist received on 31 OCT 2014. This report refers to a 51-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUCELVAX (batch number: 161281) subcutaneously on 31 OCT 2014. No adverse event reported. No further information provided.
Age: 10.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022087 is an initial spontaneous report received from a medical assistant on 31 OCT 2014. This case refers to a 10 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX 2014/2015 (batch number 161208) intramuscularly on 31 OCT 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 10.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US019656, is an initial spontaneous report from a nurse received on 29 SEP 2014. This report refers to a 10-year-old male patient. Past medical history and concomitant medication was not reported. The patient was inadvertently vaccinated with FLUCELVAX 2014/2015 (batch number 160984) intramuscularly on 29 SEP 2014. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2044UYS019582, is an initial spontaneous report received from a health care professional on 26 SEP 2014. This report refers to a 52 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 012031A) intramuscularly at a dose of 0.5 ml on 26 SEP 2014 and it was reported that the vaccine which she received  reached 61 F for more than 11 hours. No adverse events were reported following the maladministration.
Age: 46.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site pain, Myalgia, Tenderness
Clinical narrative: Case number PHEH2014US019579 is an initial spontaneous report received from a pharmacist on 29 SEP 2014 and a follow up report from the pharmacist received on 06 NOV 2014. This report refers to a 46 year old female patient. Her medical history included metabolic disorders. Her previous vaccinations were tolerated. She was vaccinated with FLUCELVAX 2014/2016 (batch number: 013031A) at a dose of 0.5 ml intramuscularly on left side (unspecified whether arm or leg) on 26 SEP 2014 (at 2:05 PM). On 27 SEP 2014, after vaccination she experienced increased muscle pain and tenderness and arm tenderness. The pain started to decree from 27 SEP 2014 to 29 SEP 2014. The patient reported to the immunologist that she had increased pain at site of injection on 29 SEP 2014. The events recovered on 30 SEP 2014. On 01 NOV 2014, the patient stated that she had no other issues. The seriousness and causality of the events were not reported.  Follow up report from the pharmacist received on 06 NOV 2014. Added event pain at site of injection and medical history. Updated vaccination date, onset event dates and recovery date and final outcome.
Age: 63.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US019578 is an initial spontaneous report from a health care professional received on 26 SEP 2014. This report refers to a 63-year-old female patient. She was vaccinated with FLUCELVAX 2014/2015 (batch number 012031A) at a dose of 0.,5 ml intramuscularly on 26-SEP-2014. It was reported that the vaccine received by the patient has reached 61 F for not more than 11 hours before administration. No adverse event reported following this medication error (incorrect storage of vaccine).
Age: 73.0
Sex: M
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US019575 is an initial spontaneous report received from a health care professional on 26 Sep 2014. This report refers to a 73 years old male patient. her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 012031A) intramuscularly at a dose of 0.5 ml on 26 Sep 2014 and it was reported that the vaccine which she received reached 61 F for more than 11 hours. No adverse events were reported following the maladministration.
Age: 71.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US019571, is an initial spontaneous report from a health care professional received on 26 Sep 2014. This report refers to a 71-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUCELVAX (batch number: 012031A) at a dose of 0.5 ml intramuscularly on 26 Sep 2014. It was reported that the vaccine received by the patient has reached 61 F for not more than 11 hours before administration. No adverse event reported following this medication error (incorrect storage of vaccine).
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US019549 is an initial spontaneous report received form a Healthcare Professional on 29 Sep 2014. This report refers to a 15 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with a dose of FLUCELVAX (batch number: not reported) intramuscularly on 29 Sep 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 66.0
Sex: F
Vaccine: FLUC3
Symptoms: Ageusia, Crying, Decreased appetite, Weight decreased
Clinical narrative: Case number PHEH2014US019507 is an initial spontaneous report received from a physician on 29 Sep 2014 with a follow up report received from the reporter on 29 Sep 2014. This report refers to a 66 year old female patient (reporter's wife). her past medical history and concomitant medications were not reported. Her vaccination history included five doses of seasonal influenza vaccine in the past five year prior to this report. On 21 Sep 2014, she was vaccinated with FLUCELVAX (batch number: not reported). On 22 Sep 2014, she experienced loss of sweet and salty taste sensations due to which she had no appetite and lost seven pounds of weight in seven days. It was reported that everything tasted bland or could taste nothing at all but it was also reported that she could taste spicy foods like wasabi. It was reported that the patient cries as she loves to eat but now cannot eat anything and at this rate she would die of starvation. She has not lost her sense of smell. It was reported that nothing made her better and it had gotten worse sine the date of vaccination. The outcome of the events was condition unchanged. The seriousness and causality of the events were not reported. Follow up report was received from the reporter on 29 Sep 2014: The vaccination history and the events (weight loss and had no appetite) were updated.
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US019449 is an initial spontaneous report received from a pharmacist on 25 Sep 2014. This report refers to a 17 year old female patient. Her past medical history and concomitant medications were not reported. On 24 Sep 2014, she received FLUCELVAX (batch number: 017031A) intramuscularly at the age of 17 years. No adverse events were reported following this maladministration (inappropriate age at vaccine administration).