chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: FLUN4, SMALL
Symptoms: Chest pain, Pericarditis
Clinical narrative: This case was received on 04 December 2013 via a third party query tool search on the VAERS database, under reference number 503255. A 23 year-old female patient had received the following vaccines on 06 September 2013: a left arm injection of ACAM2000 (lot number VV04003A) and intranasal FLUMIST (MedImmune lot number BH2026). On the same day of vaccination at 0530 the patient experienced chest pain. At 0715, patient was evaluated at the clinic and was transported to the ER (emergency room). The patient was diagnosed with pericarditis. Treatments included Indomethacin and omeprazole. The patient's lab data, other medications, current illnesses and history were reported as none. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Hypersensitivity, Rhinitis allergic, Throat tightness, Urticaria
Clinical narrative: Initial report was received from a healthcare professional, who was also the patient, on 27 September 2013. A 32-year-old female patient had received an intramuscular injection in the right deltoid of FLUZONE, lot number UH909AB, on 20 September 2013 and within four hours experienced airway tightness, coughing and hives. The patient was treated in the emergency room of the hospital and had symptoms "off and on throughout the following weekend". As of the time of the report, the symptoms have resolved and has not experienced any further symptoms. The patient had no illness at the time of vaccination, no past medical history and allergies to morphine sulfate and MAXAIR. Outcome was recovered. Follow-up information received on 12 November 2013 from a healthcare provider. The patient received BENADRYL 50 mg po and DECADRON 10 mg IM as treatment for the event. No diagnostic tests were performed. Per the reporter, the patient was diagnosed with allergic rhinitis, acute allergic reaction with the etiology reported as the flu shot by the reporter. The patient fully recovered on 20 September 2013 at 13:51. The time of onset of the reaction was not reported. The reporter advised that they had no additional information to provide. No further details were available at the time of this report. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus, Throat irritation, Throat tightness, Urticaria
Clinical narrative: Initial report received on 09 October 2013 from a healthcare professional (nurse). A 30-year-old female had received an intradermal injection in the left arm of FLUZONE INTRADERMAL, lot number UT4725AA on 30 September 2013 and the same day experienced itching, hives at upper body and felt as if her throat was closing. The patient took BENADRYL x 2. The following day, the symptoms returned and went to the emergency room where she received DECADRON. The patient had a history of allergies to penicillin and vancomycin. It was reported that the patient was not sick at the time of vaccination. The patient recovered on an unreported date. Follow-up information received from a healthcare professional on 04 November 2013. On the 30 September 2013 the patient complained of itching about an hour after receiving the vaccine. At about 18:00 is when the slight difficulty breathing started with the hives. She then took BENADRYL 25 mg po and repeated the med at 22:00. She then went to sleep and woke up fine 01 October 2013. By 09:00 she stated the hives, itching started again with her throat feeling uncomfortable. She checked into the ER and got DECADRON 10 mg IM injection and BENADRYL 25 mg po within 1 hour the hives and throat discomfort was gone. She went home from work at the ER Dr. suggestion and slept for a few hours. When she awoke at 16:00 all symptoms were gone and did not return. Documents held by sender: None. Follow-up information received from a healthcare professional on 02 December 2013: No allergy tests were done. The events recovered on 07 October 2013.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Epstein-Barr virus antibody positive, Fall, Muscular weakness
Clinical narrative: Case received from a healthcare professional (nurse) on 25-Oct-2013. A 51-year-old female patient, with no reported personal and family medical history, and no reported concomitant therapies, had received her intradermal dose of FLUZONE INTRADERMAL (batch number UT4721BA, anatomical site of administration not reported) on 16-Oct-2013. On 18-Oct-2013, the patient developed leg weakness which caused her to fall a few times. She was hospitalized on 24-Oct-2013. The diagnosis was "possible case of Guillain-Barre Syndrome". At the time of the report, her symptom had not progressed past her lower extremities. There were no other reported cases. The outcome was unknown. Follow-up information received from a healthcare professional on 24-FEB-2014: The patient had a history of Epstein-Barr virus infection. Regarding clinical features and elements confirming the diagnosis: the patient had no motor disorders, no bilateral and flaccid weakness of limbs, no sensory disorders, no cranial nerve abnormalities, no autonomic disorders, no decreased or absent tendon reflex in weak limbs, no interval between onset between 12h and 28 days followed by clinical plateau. An infectious check-up performed was positive for Epstein-Barr virus IgG. The diagnosis of Guillain-Barre syndrome was not confirmed. The patient recovered on an unspecified date. Follow-up information received from a healthcare professional on 14 April 2014: The patient's initials were provided. The reporter's relation to patient was reported as vaccine provider. The patient did not receive any other vaccine within 4 weeks prior to the administration of FLUZONE INTRADERMAL on 16 October 2014. She did not present with any illness at the time of vaccination. None adverse event following prior vaccination was reported. The patient was taking other medications at the time of the vaccination: CELEXA and WELLBUTRIN; indications, dosages, start dates and routes of administration were not reported. No final diagnosis was reported. The patient did not receive any corrective therapy. She was hospitalized in 4 different hospitals respectively: from 24-OCT-2013 to 26-OCT-2013, from 28-OCT-2013 to 29-OCT-2013, from 02-NOV-2013 to 02-11-2013, and from 09-NOV-2013 to 11-NOV-2013; which represents a total of 9 days.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Initial report was received from a healthcare professional on 26 September 2013. An 84-year-old male patient received an intramuscular injection in the deltoid of FLUZONE HIGH-DOSE, lot number U4758AA, on 18 September 2013. On 23 September 2013, the patient was admitted to the hospital. The patient was diagnosed with acute disseminated encephalomyelitis. The physician stated the patient is in a non-recoverable state and causality was to be determined. Relevant diagnostic tests/laboratory data was not provided at the time of the report. The patient was on multiple medications but was otherwise healthy. Outcome was reported as unknown. Documents held by sender: None. Follow-up information received from an healthcare professional on 12 May 2014: No additional information could be provided. The patient's date of birth was amended.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Conjunctivitis, Eye discharge, Purulent discharge, Throat tightness
Clinical narrative: Initial report was received from a healthcare professional on 31 October 2013. This reporter is the same as case number 2013SA112445. A 65-year-old male patient had received an intramuscular injection of FLUZONE HIGH-DOSE, lot number U4758AA, on 25 October 2013 (site not reported) and four hours later developed shaking uncontrollably chills, throat felt tight, vomited for two hours and eyes were pink eye like with pus. The patient felt better the next morning and had recovered in two days. The patient had no illness at the time of vaccination and no known allergies (NKA). Outcome was recovered. Follow-up information received on 21 November 2013 from a healthcare provider. The vaccine was administered into the right deltoid. The patient did not receive any previous doses or any vaccine within 4 weeks of vaccination. The patient did not receive treatment in the office or emergency room. No laboratory tests were performed. No further details were available at the time of this report. The patient outcome was recovered. Documents held by sender: None. Follow-up information received from a healthcare professional on 13 December 2013. It was reported that the patient had not received any treatment in office for reaction and for pink eye. There was no final diagnosis.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: Initial report was received from a healthcare professional on 31 October 2013. This reporter is the same as case number 2013SA112445. A 65-year-old male patient had received an intramuscular injection of FLUZONE HIGH-DOSE, lot number U4758AA, on 25 October 2013 (site not reported) and four hours later developed shaking uncontrollably chills, throat felt tight, vomited for two hours and eyes were pink eye like with pus. The patient felt better the next morning and had recovered in two days. The patient had no illness at the time of vaccination and no known allergies (NKA). Outcome was recovered. Follow-up information received on 21 November 2013 from a healthcare provider. The vaccine was administered into the right deltoid. The patient did not receive any previous doses or any vaccine within 4 weeks of vaccination. The patient did not receive treatment in the office or emergency room. No laboratory tests were performed. No further details were available at the time of this report. The patient outcome was recovered. Documents held by sender: None. Follow-up information received from a healthcare professional on 13 December 2013. It was reported that the patient had not received any treatment in office for reaction and for pink eye. There was no final diagnosis.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Convulsion, Pyrexia
Clinical narrative: Based on follow-up received on 20 October 2014, this case became medically confirmed. Initial case received from a consumer who works in a physician's office, on 11 March 2014. A male infant, with no reported medical history or concomitant medications, received a dose of FLUZONE (lot number not reported) in the Fall of 2013. An unspecified amount of time post-vaccination, the patient experienced fever and a seizure. Outcome was not reported, and the reporter did not have any more information available at the time of the report. Additional information has been requested. Follow-up information received from a consumer who works in a physician's office, on 26 September 2014. The patient received an intramuscular dose of FLUZONE (lot number U4767AA) in the left thigh. He did not receive other vaccine at the time of vaccination with FLUZONE. The patient did not have any relevant medical history, concomitant medications or ongoing illness. He did not experience febrile seizure before vaccination, nor since recovery of the event. The patient was seen in the ED. The patient's outcome was reported as recovered. Follow-up information received on 20 October 2014 from a healthcare professional. Report was reviewed by the patient's responsible physician, which medically confirmed the case. The date of vaccination was reported as 13 September 2013. There was no further information provided. Reporter mentioned that they were unable to provide third party medical records and suggested to contact directly the hospital. Additional documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Asthenia, Chest X-ray, Computerised tomogram thorax, Dysphonia
Clinical narrative: Initial report received from a consumer (patient's husband) on 16 December 2013. A 66-year-old female patient had received a first dose of FLUZONE HD (batch number and route of administration was not reported) in left arm on 25 September 2013. The patient had medical history of allergy to SELDANE and codeine. No concomitant drug was reported. And the patient had no illness at the time of vaccination. On 26 September 2013, next days after vaccination the patient noticed that the voice got hoarse and could hardly talk. Patient experienced difficulty in breathing, most difficulty with exhale, arthritis in her hands and weak. Oxygen level was ok. The patient was hospitalized for overnight. Corrective treatments were not reported. Chest x-ray, CT chest was performed. At the time of this report the patient was not recovered.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Speech disorder
Clinical narrative: Initial report received from a consumer (patient's husband) on 16 December 2013. A 66-year-old female patient had received a first dose of FLUZONE HD (batch number and route of administration was not reported) in left arm on 25 September 2013. The patient had medical history of allergy to SELDANE and codeine. No concomitant drug was reported. And the patient had no illness at the time of vaccination. On 26 September 2013, next days after vaccination the patient noticed that the voice got hoarse and could hardly talk. Patient experienced difficulty in breathing, most difficulty with exhale, arthritis in her hands and weak. Oxygen level was ok. The patient was hospitalized for overnight. Corrective treatments were not reported. Chest x-ray, CT chest was performed. At the time of this report the patient was not recovered.
Age: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, Medication error
Clinical narrative: Case number PHHY2014US019860, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518730) website on 17 Feb 2014. This report refers to a 17-year-old male patient who was accidentally vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly in the left arm on 07 Jan 2014. No adverse event reported following this medication error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 17 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: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Case number PHHY2014US028923 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518731) on 06 Mar 2014: This report refers to a 13-year-old male patient. Medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX(batch number: 010011A) intramuscularly in to the left arm on 07 Jan 2014. 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 06 Mar 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: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US029420, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518887 and 518889) web site on 06 Mar 2014. This report refers to a 13-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly into the left arm on 07 Jan 2014. 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 06 Mar 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: 7.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US001109 is an initial spontaneous report received from a nurse on 13 Jan 2014 and a follow up report from the Vaccine Adverse Event Reporting System (VAERS reference number: 519105) web site on 17 Feb 2014. This report refers to a 07-year-old male patient. His medical history and concomitant medications were not reported. He had no known problems and drug allergies. He was vaccinated with FLUCELVAX (batch number: 009011A) intramuscularly in the right arm on 10 Jan 2014. No adverse event was reported following this maladministration. Follow up report from the Vaccine Adverse Event Reporting System web site on 17 Feb 2014: Added VAERS ID. Updated FLUCELVAX vaccinated arm and medical history. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 17 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".
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US047351, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 519261) website on 14 APR 2014. This report refers to a 14-year-old female patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: 010011A) intramuscularly in the left arm on 30 DEC 2013. No adverse event reported following this medication error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 14 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 PHHY2014US047373, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 519269) website on 14 APR 2014. This report refers to a 12-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: 010011A) intramuscularly in the left arm on 06 JAN 2014. No adverse event reported following this medication error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 14 APR 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: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US047378, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 519271) website on 14 APR 2014. This report refers to a 13-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: 010011A) intramuscularly in the left arm on 07 JAN 2014. No adverse event reported following this medication error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 14 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: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US047183, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 519275) website on 14 APR 2014. This report refers to a 16-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX 2013/2014 (batch number: 006011A) via intramuscular into left arm on 12 OCT 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 14 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: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US047203 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 519276) web site on 14 APR 2014. This report refers to a 14 year old female patient. She had no medical history or current illness. She was vaccinated with FLUCELVAX 2013/2014 (batch number: 0066011A) via intramuscular route into left arm on 12 OCT 2013. No adverse event was reported following this medication error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 14 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: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US047232 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 519278) web site on 14 APR 2014. This report refers to a 17 year old male patient. He had no medical history or current illness. He was vaccinated with FLUCELVAX 2013/2014 (batch number: 01011WA) via intramuscular route into right arm on 06 JAN 2014. No adverse event was reported following this medication error (inappropriate age at vaccine administration). Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 14 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: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US047247 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 519279) web site on 14 APR 2014. This report refers to a 13 year old male patient. He had no medical history or current illness. He was vaccinated with FLUCELVAX 2013/2014 (batch number: 010011A) via intramuscular route into left arm on 07 JAN 2014. No adverse event was reported following this medication error (inappropriate age at vaccine administration). Following an internal review on 18 AUG 2014 of the data received on 14 APR 2014, it was identified that the BPI 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: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, Product use issue
Clinical narrative: Case number PHHY2014US048224 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 519280) web site on 14 Apr 2014. This report refers to a 16 year old female patient. Her past medical history and concomitant medications were not reported. It was reported that this patient under 18 years of age was vaccinated with FLUCELVAX (batch number: 008011A) intramuscularly into her left arm on 11 Nov 2013. The event was reported non-serious. No adverse events were reported following this maladministration. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 14 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: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHHY2014US045479 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 519284) web site on 08 Apr 2014. This report refers to a 13 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly into her left arm on 07 Jan 2014 at the age of 13 years. The event was reported non-serious. No adverse events were reported following this medication error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 08 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: 11.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US045502 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 519285) web site on 08 Apr 2014. This report refers to an 11 year old male patient. His medical history and concomitant medications were not reported. On 07 Jan 2014, he was vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly into left arm. 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 08 Apr 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: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, Pain in extremity
Clinical narrative: Case number PHHY2014US048280 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 519288) web site on 14 Apr 2014. This report refers to a 13 year old female patient. Her medical history and concomitant medications were not reported. It was reported that this patient under 18-years of age was vaccinated with FLUCELVAX (batch number: 010911A) intramuscularly in the left arm on 03 Jan 2014. On same day after vaccination she experienced sore arm. The event outcome was reported as complete recovery. The events were reported non serious. The causality was not reported. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 14 Apr 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: 10.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Injection site pain, Peripheral swelling, Rash
Clinical narrative: Case number PHEH2013US026689, is an initial spontaneous report from a health care professional received on 31 Dec 2013. This report refers to a 10-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on 30 Dec 2013. On the same day after vaccination, she developed redness at the injection site and on forearms. She was treated with BENADRYL. The final outcome of the events was complete recovery. The seriousness and causality were not reported. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 31 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: 10.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered to patient of inappropriate age, Erythema, Injection site erythema
Clinical narrative: Case number PHEH2013US026689, is an initial spontaneous report from a health care professional received on 31 Dec 2013. This report refers to a 10-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on 30 Dec 2013. On the same day after vaccination, she developed redness at the injection site and on forearms. She was treated with BENADRYL. The final outcome of the events was complete recovery. The seriousness and causality were not reported. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 31 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: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US048375, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 519377) website on 14 Apr 2014. This report refers to a 13-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly in to the left arm on 07 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 14 Apr 2014: 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: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHHY2014US047186 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 519408) website on 14 Apr 2014. This report refers to a 13 years old female patient. She was inadvertently vaccinated with FLUCELVAX (batch number: 006011A) intramuscularly into left arm on 07 Jan 2014. No adverse reaction was reported following this medication error (Inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 14 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: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHHY2014US047196 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 519421) website on 14 Apr 2014. This report refers to a 17 years old male patient. He was inadvertently vaccinated with FLUCELVAX (batch number: 006011A) intramuscularly into left arm on 22 Nov 2013. No adverse reaction was reported following this medication error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 14 Apr 2014: 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: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US047069 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 519600) website on 14 Apr 2014. This report refers to a 14 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly in the left arm on 24 Dec 2013. This case was assessed as non-serious. No adverse event was reporting following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 14 Apr 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: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US048675 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520684) website on 14 Apr 2014. This report refers to a 16 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly in the left arm on 27 Dec 2013. The seriousness of the case was reported as non-serious. No adverse event was reporting following this administration error. Following an internal review on 18 Aug 2014 of the data received on 14 Apr 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: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US048684 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520696) website on 14 Apr 2014. This report refers to a 17 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly in the left arm on 29 Dec 2013. The seriousness of the case was reported as non-serious. No adverse event was reporting following this administration error. Following an internal review on 18 Aug 2014 of the data received on 14 Apr 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: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHHY2014US048699 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520700) website on 14 Apr 2014. This report refers to a 17 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly in the left arm on 07 Jan 2014. The seriousness of the case was reported as non-serious. No adverse event was reporting following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 14 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: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHHY2014US048710 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520701) website on 14 Apr 2014. This report refers to a 16 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 1010011A) intramuscularly in the right arm on 06 Jan 2014. The seriousness of the case was reported as non-serious. No adverse event was reporting following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 14 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: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US048714 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520710) website on 14 Apr 2014. This report refers to a 14 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly in the left arm on 06 Jan 2014. The seriousness of the case was reported as non-serious. No adverse event was reporting following this administration error. Following an internal review on 18 Aug 2014 of the data received on 14 Apr 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: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHHY2014US048695 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 520737) on 14 Apr 2014. This report refers to 17 years old male patient. His medical history and concomitant medications were not reported. This patient under 18-years of age was vaccinated with FLUCELVAX (batch number: 006011A) intramuscularly in right arm on 30 Dec 2013. The event was reported as non-serious. No adverse event was reported after this maladministration. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 14 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: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHHY2014US048951, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521195) website on 14 Apr 2014. This report refers to a 13-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 008011A) intramuscularly in to the right arm on 11 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 14 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: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHHY2014US048963, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521196) website on 14 Apr 2014. This report refers to a 14-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly in to the left arm on 11 Nov 2013. 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 14 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: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHHY2014US048913 is an initial spontaneous report received from the vaccine adverse reporting system (VAERS reference number: 521197) web site on 14 Apr 2014. This report refers to a 17 year old male patient. He had no medical history or current illness. He was vaccinated with FLUCELVAX (batch number: not reported) via intramuscular route into left arm on 11 Nov 2013. No adverse event was reported following this medication error (inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 14 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: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHHY2014US048725 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 521944) website on 14 Apr 2014. This report refers to a 13 years old female patient. She was inadvertently vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly into right arm on 06 Jan 2014. No adverse reaction was reported following this medication error (inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 14 Apr 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: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US048730 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 522048) website on 14 Apr 2014. This report refers to a 13 year old female patient. She was inadvertently vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly into right arm on 04 Jan 2014. No adverse reaction was reported following this medication error. Following an internal review on 18 Aug 2014 of the data received on 14 Apr 2014, it was identified that the BPI 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: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US048746 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 522145) website on 14 Apr 2014. This report refers to a 12 years old male patient. He was inadvertently vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly into left arm on 06 Jan 2014. No adverse reaction was reported following this medication error (Inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 14 Apr 2014: The 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: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHHY214US048752 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 522147) website on 14 Apr 2014. This report refers to a 17 years old male patient. He was inadvertently vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly into left arm on 20 Dec 2013. No adverse reaction was reported following this medication error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 14 Apr 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "Drug use in approved population".
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHHY2014US048759 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 522148) website on 14 Apr 2014. This report refers to a 17 years old female patient. She was inadvertently vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly into left arm on 22 Dec 2013. No adverse reaction was reporting following this medication error (Inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 14 Apr 2014: The 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: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US048763 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 522149) website on 14 Apr 2014. This report refers to a 15 years old male patient. He was inadvertently vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly into left arm on 27 Dec 2013. No adverse reaction was reported following this medication error (inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014 of the data received on 14 Apr 2014, it was identifier that the BPI labelling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labelling was now changed as unlisted and second indication off-label use was added to the case.
Age: 12.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US048766 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 522150) website on 14 Apr 2014. This report refers to a 12 year old female patient. She was inadvertently vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly into left arm on 02 Jan 2014. No adverse reaction was reported following this medication error. Following an internal review on 18 Aug 2014 of the data received on 14 Apr 2014, it was identified that the BPI 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.