chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Throat tightness
Clinical narrative: This spontaneous case was initially received on 24-Feb-2016. The case report was received from a Non Health Professional and concerns a 48 years old female patient. Weight: 125 pounds, Height: 63 inches. Concurrent medical condition (s), medical and drug history: The patent has a medical history of allergy to bees and allergy to metals. She had flu shots in the past but not sure if the vaccines were AFLURIA. For concomitant medication and therapy dates refers to the appropriate report sections. Suspect drug (s), timing and conditions surround the onset of reaction (s)/ event (s): The patient received AFLURIA for indication protection against influenza virus on 26-Oct-2015 - 26-Oct-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: no information provided. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On 26-Oct-2015, about 1-2 hours after starting / treatment with AFLURIA, the patient experienced itchy (non serious, outcome: Recovered/ Resolved). Later in the day, she developed throat tightness/throat was getting tight (non serious, outcome: Recovered/ Resolved). She went to the hospital and was treated at the hospital (did not know what she was treated with). She did not stay overnight at the hospital and symptoms resolved on 26-Oct-2015 after treatment. Action taken: discontinued. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case was initially received on 24-Feb-2016. The case report was received from a Non Health professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/ event (s): The patient received AFLURIA for indication not provided. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On an unknown date, after starting/ treatment with AFLURIA the patient experienced pain and swelling in her left arm (non serious, outcome: Not Recovered/ Not Resolved) for several months after the vaccine was administered. No additional information was provided. Action taken: discontinued. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case was initially received on 23-Feb-2016. The case report was received from a Health Professional and concerns a 13 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refers to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication prevention of seasonal influenza on 17-Feb-2015- 17-Feb-2016, Batch no: U50309, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s) event (s) and outcome: On 17-Feb-2016, AFLURIA PFS was previously exposed to a temperature excursion of 9.5 degree C for 2 hours (non serious, outcome: Unknown) and had been administered. No adverse effect had been reported. Action taken: discontinued. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Age: 37.0
Sex: U
Vaccine: FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody positive, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 37 year old patient with unknown gender. On 30-Sep-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C, HIV), hepatitis B vaccine and flu vaccine. On 05-Oct-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B core antibody and was negative for hepatitis B surface antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown.
Age: 37.0
Sex: U
Vaccine: FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Underdose, Wrong technique in product usage process
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 37 year old patient with unknown gender. On 30-Sep-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C, HIV), hepatitis B vaccine and flu vaccine. On 05-Oct-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B core antibody and was negative for hepatitis B surface antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 29 years old female patient. The patient had no known illnesses. She gave birth exactly one month prior to vaccination. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had no medical history and no known illnesses. She gave birth exactly 1 month prior to vaccination. The patient received AFLURIA on 06-Oct-2015 - unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml, Site: right arm. No additional drugs suspected. On 06-Oct-2015, 1 week 0 days after starting / treatment with AFLURIA the patient experienced Allergic reaction, Hivers covering face, chest and arms. Event treatment: Diphenhydramine eased the symptoms. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 46.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pyrexia
Clinical narrative: At her exit from the hospital, the patient received a flu shot and for -4 days, she has had intermittent low-grade fevers to about 100.4.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This health authority case was initially received on 03-Nov-2015. The case report was received from a Health Professional and concerns a 23 year old female patient. Weight: 240 pounds, Height: 74 inches. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 09-Oct-2015 - 09-Oct-2015, Batch no: T51608, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 09-Oct-2015, the patient received an IM dose of expired AFLURIA. For relevant test results see appropriate report section. Reporter's assessment:  Case correction (08-Dec-2015): AE #1 and #2 combined and coded to PT 'Expired product administered'.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was initially received on 03-Nov-2015. The case report was received from a Health Professional and concerns a 23 years old male patient. Weight: 240 pounds, Height: 74 inches. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 09-Oct-2015, Batch no: T51608, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 09-Oct-2015, the patient received an IM dose of expired AFLURIA. (Medication error). For relevant test results see appropriate report section. Case correction (08-Dec-2015): AE #1 and #2 combined and coded to PT 'Expired product administered'.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous case was initially received on 28-Sep-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 28-Sep-2015 - 28-Sep-2015, Batch no: U56907, Route of administration: Intramuscular, Dose: 0.5 ml. The AFLURIA PFS had a previous temperature excursion at 67 degrees F for about 14 hours. No additional drugs suspected. On 28-Sep-2015, the patient experienced Received AFLURIA PFS today (28Sep2015) after a temperature excursion occurring overnight/Medication error. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The reporter assessed the case as non-serious and reported the term 'Medication error'.
Sex: U
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: This spontaneous case was initially received on 29-Sep-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/ event (s): The patient received AFLURIA for indication not reported on unknown dates, Batch no: not provided, Route of administration: Unknown, Dose: no information provided. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On an unknown date, the patient experienced an Unspecified reaction on an unspecified date to AFLURIA (non serious, outcome: Unknown).
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous case was initially received on 29-Sep-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA. No additional drugs suspected. On 23-Sep-2015, after starting treatment with AFLURIA the patient experienced improperly stored dose of AFLURIA was administered. On an unknown date, after starting treatment with AFLURIA the patient experienced improperly stored dose of AFLURIA. For relevant test results see appropriate report section.
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This spontaneous case was initially received on 29-Sep-2015. The case report was received from a Health Professional and concerns a female patient. The patient received AFLURIA not on unknown dates, Batch no: not provided, Route of administration: Unknown, Dose: no information provided. Unspecified vaccine (possibly Tdap), Indication: not provided. On an unknown date, after starting treatment with AFLURIA the patient experienced Systemic hives. Reporter's assessment: Not reported.
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Expired product administered, Pain in extremity
Clinical narrative: This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Non Health Professional and concerns a female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 15-Oct-2015 - 15-Oct-2015, Batch no: U56907 (expiry 30-Jun-2016), Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On Oct-2015, after starting treatment with AFLURIA the patient experienced her arm starting hurting/arm pain . On 15-Oct-2015, after starting treatment with AFLURIA the patient experienced heard a loud airy sound during administration. On an unknown date, after starting treatment with AFLURIA the patient experienced chest sensation described as shortness of breath/shortness of breath, administration of expired vaccine. For relevant test results see appropriate report section. Reporter's assessment: The reporter stated the expiration date is 30-Jun-2015. Case correction (01-Dec-2015); AE 4 (hear a loud airy sound during administration) deleted.
Sex: U
Vaccine: FLU3
Symptoms: Exposure during breast feeding
Clinical narrative: This spontaneous case was initially received on 29-Sep-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 29-Sep-2015 - unknown stop date, Batch no: U56006, Route of administration: not provided, Dose: 0.5 ml. No additional drugs suspected. On 29-Sep-2015, after starting treatment with AFLURIA the patient experienced Breastfeeding mother received AFLURIA. For relevant test results see appropriate report section. Reporter's assessment: The reporter considered events non serious.
Sex: U
Vaccine: FLU3
Symptoms: Exposure during breast feeding
Clinical narrative: This spontaneous report was initially received on 29-SEP-2015. The case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medications and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 29-SEP-2015 - unknown stop date, batch no: not provided. Route of administration: not provided. Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 29-SEP-2015, after starting / treatment with AFLURIA the patient experienced Received AFLURIA via breastfeeding (non serious, outcome: Recovered / Resolved). Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. The relevant test results see appropriate report section, please add other relevant test results manually as appropriated. Reporter's assessment: None
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous case was initially received on 02-OCT-2015. This case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 01-OCT-2015 - 01-OCT-2015, Batch no: not provided, Route of administration not provided, Dose: 1 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 01-OCT-2015, after starting / treatment with AFLURIA the patient received a 1 ml dose of AFLURIA instead of 0.5 ml/Overdose (non serious, outcome: Unknown). Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The reporter stated that all the patients seemed fine, and confirmed that none of the patients were pregnant. The 1 ml dose was due to clinical error, which did not confirm the dosage.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, Medication error
Clinical narrative: This spontaneous case was initially received on 02-Oct-2015. The case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 01-Oct-2015 - 01-Oct-2015, Batch no: not provided, Route of administration: not provided, Dose: 1 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/events(s) and outcome: On 01-Oct-2015, after starting / treatment with AFLURIA the patient received a 1 ml dose of AFLURIA, instead of 0.5 ml/Overdose (non serious, outcome: Unknown). On an unknown date, after starting / treatment with AFLURIA the patient experienced Medication error (non serious, outcome: Unknown). Action taken: Details manually to be entered, Event treatment: Details manually to be entered, Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The reporter stated that all the patients seemed fine, and confirmed that none of the patients were pregnant. The 1 ml dose was due to clinical error, which did not confirm the dosage.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous case was initially received on 02-OCT-2015. The case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 01-OCT-2015 - 01-OCT-2015, Batch no: not provided, Route of administration: not provided, Dose: 1 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 01-OCT-2015, after starting / treatment with AFLURIA the patient received a 1 ml dose of AFLURIA, instead of 0.5 ml/Overdose (non serious, outcome: Unknown). On an unknown date, after starting / treatment with AFLURIA the patient experienced Medication error (non serious, outcome: Unknown). Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The reporter stated that all the patients seemed fine, and confirmed that none of the patients were pregnant. The 1 ml dose was due to clinical error, which did not confirm the dosage. Company's evaluation and comment: Seriousness criterion/criteria: Non serious.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: This spontaneous case was initially received on 03-DEC-2015. This case report was received from a(n) Health Professional and concerns a(n) adult female patient. Weight:  not provided, Height: not provided. Linked caseID9s): US-BEH-20150555519 (Same patient, 2015 episode) and US-BEH-2016058106 (Same patient 2014 episode). For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received Flu shot on unknown dates, Batch no: not provided, Route of administration: not provided, Dose: Administered in 2013.  Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting / treatment with Flu shot the patient experienced Joint pain (non serious, outcome: Unknown); Fever (non serious, outcome: Unknown), Chills (non serious, outcome: Unknown), Headaches (non serious, outcome: Unknown). Action taken: Details manually to be entered, Event treatment: Details manually to be entered, Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: n/a.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: The case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and genger. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 01-OCT-2015 - 01-OCT-2015, Batch no: not provided, Route of administration: not provided, Dose: 1 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 01-OCT-2015, after starting / treatment with AFLURIA the patient received a 1 ml dose of AFLURIA, instead of 0.5 m./Overdose (non serious, outcome: Unknown). On an unknown date, after starting / treatment with AFLURIA the patient experienced error (non serious, outcome: Unknown). Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The reporter stated that all the patients seemed fine and confirmed that none of the patients were pregnant. The 1 ml dose was due to clinical error, which did not confirm the dosage.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: The case report was received from a Health Professional and concerns a 58 year old male patient who had a pacemaker, high cholesterol, high blood pressure, overactive narcolepsy. Concomitant medications were unknown as the patient attended a different pharmacy. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): the patient received AFLURIA on 01-OCT-2015 - 01-OCT-2015 in the right arm, Batch no: T52508, Route of administration: Intramuscular, Dose: 0.5 ml, and on unknown dates, Batch no: not provided, Route of administration: not provided, Dose: Another dose was given in Oct, 2 weeks after first dose. AFLURIA was stored incorrectly. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 01-OCT-2015, the expired AFLURIA was administered in the patient's right arm (non serious, outcome: Recovered / Resolved). The patient was called and informed of mistake and he came in two weeks later to receive the correct AFLURIA vaccination serious, outcome: Recovered / Resolved), Medication error (non serious, outcome Recovered / Resolved). IT was reported that he was feeling normal and experienced no side effects. Outcome: Recovered. Action taken: not provided. Event treatment: not provided. Rechallenge/Dechallenge information: not provided. For relevant test results see appropriate report section. Reporter's assessment: The health Professional considered the event(s) Expired AFLURIA was administered in the patient's right arm, came in 2 weeks later to receive correct AFLURIA vaccine. Medication error as non-serious and causality of "Certain/Highly probable" in relation to AFLURIA. The reporter reported the term "Medication error".
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous case was initially received on 02-OCT-2015. The case report was received from a(n) Health Professional and concerns a(n) female, pregnant patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 02-OCT-2015 - unknown stop date, Batch no: 11349221A, Route of administration: Intramuscular, Dose: 1 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 02-OCT-2015, after starting / treatment with AFLURIA the patient received 1.0 ml IM dose of AFLURIA/Overdose (non serious, outcome: Unknown). No adverse reactions have been reported. Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: not provided.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anxiety, Back pain, Muscle spasms
Clinical narrative: This health authority case was initially received on 26-OCT-2015. The case report was received from a Health Professional and concerns a 58 year old female patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Asthma, Hypertension and Depression. The patient had no current illness at the time of vaccination. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 14-SEP-2015 - unknown stop date, Batch no: U56406, Route of administration: Intramuscular, Dose; 0.5 ml. Additional suspect drug(s): PNEUMOVAX, Indication, not provided. Reaction(s)/event(s) and outcome: On 14-SEP-2015, shortly after starting / treatment with AFLURIA the patient experienced Back pain (non serious, outcome: Recovered / Resolved), Spasms / Muscle spasms (non serious, outcome: Unknown). Patient recovered while waiting and stated that she felt unrelated to immunization but thought to be back spasm. She also stated that she was extremely anxious about receiving shots and could also be anxiety related. Patient insisted she was fine and that event was possibly related to how she twisted when she sat on the bench. Reporter's assessment: non serious.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous case was initially received on 02-OCT-2015. The case report was received from a(n) Health Professional and concerns a(n) female, pregnant patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 02-OCT-2015 - unknown stop date, Batch no: 11349221A, Route of administration: Intramuscular, Dose: 1 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 02-OCT-2015, after starting / treatment with AFLURIA the patient received 1.0 ml IM dose of AFLURIA/Overdose (non serious, outcome: Unknown). No adverse reactions have been reported. Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: Not provided.
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous case was initially received on 02-OCT-2015. The case report was received from a(n) Health Professional and concerns a(n) male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 02-OCT-2015 - unknown stop date, Batch no: 11349221A, Route of administration: Intramuscular, Dose: 1 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 02-OCT-2015, after starting / treatment with AFLURIA the patient received 1.0 ml IM dose of AFLURIA/Overdose. Action taken: Details manually to be entered. Event treatment: Details manually to be entered, Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: Not provided.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous case was initially received on 05-OCT-2015. The case report was received from a(n) Health Professional and concerns a(n) 65 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s):The patient received AFLURIA on 05-OCT-2015 - unknown stop date, Batch no: U54606, Route of administration: not provided, Dose: no information provided. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 05-OCT-2015, after starting / treatment with AFLURIA the patient experienced Temperature excursioned AFLURIA administration/medication error (non serious, outcome: Recovered / Resolved). On an unknown date, after starting / treatment with AFLURIA the patient experienced Temperature excursion occurred due to power outage (non serious, outcome: Recovered / Resolved). Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: Not provided.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was initially received on 08-OCT-2015. The case report was received from a(n) Health Professional and concern(s) a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and concomitant medications and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): the patient received AFLURIA on 06-OCT-2015 - 06-OCT-2015, Batch no: T57505, Route of administration: intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 06-OCT-2015, the patient inadvertently administered expired AFLURIA PFS. Reporter Comment(s): the reporter stated that she heard no complaints from any of the 10 patients. She also continued that no patients were pregnant. Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.  Reporter's assessment: Not provided.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was initially received on 08-OCT-2015. The case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 06-OCT-2015 - 06-OCT-2015, Batch no: T57505, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 06-OCT-2015, the patient inadvertently administered expired AFLURIA PFS. Reporter comments: The reporter stated that she heard no complaints from any of the 10 patients. She also confirmed that no patient were pregnant. Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: Not provided.
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Cough, Oropharyngeal pain, Swelling, Swelling face
Clinical narrative: This consumer spontaneous report (initial receipt 25-SEP-2015) concerns an adult female patient who had no known allergies or medical conditions. On an unspecified date in 2008, the patient received flu vaccine (manufacturer and batch number not provided). The name of the flu vaccine was not known. On an unspecified date following the flu vaccine administration, the patient experienced swelling of her body and face, chest tightness, throat pain and coughing. The outcome was not reported.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site reaction, Injection site warmth
Clinical narrative: This spontaneous case was initially received on 28-SEP-2015. The case report was received from a(n) Health Professional and concerns a(n) 65 year old female patient. The patient has no pertinent medical history and no drug reactions/allergies. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug9s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 09-SEP-2015 - unknown stop date, Batch  no: U57407, Route of administration: Unknown, Dose: 0.5 ml, Site: Opposite arm to ZOSTAVAX administration. Additional suspect drug(s): PREVNAR13 and ZOSTAVAX, Site: Opposite arm to AFLURIA administration.  Reaction(s)/event(s) and outcome: On 17-SEP-2015, 1 week 4 days after starting / treatment with AFLURIA the patient experienced Injection site was painful/pain at the injection site (non serious, outcome: Recovering / Resolving), Injection site reaction (non serious, outcome: Recovered / Resolved). On an unknown date but by 21-SEP-2015 when the pharmacist spoke to the patient, after starting / treatment with AFLURIA the patient experienced the redness encompassed the patient's whole tricep and down onto the elbow of the patient (non serious, outcome: Recovering / Resolving), Injection site was red (non serious, outcome: Recovering / Resolving), Injection site was warm to touch (non serious, outcome: Recovering / Resolving). The pharmacist stated there was no visible rash outside of the redness on the arm of the patient that was administered ZOSTAVAX. The patient began to experience pain at the injection site of the ZOSTAVAX on 17-SEP-2015. The patient said she could "feel" the injection site reaction coming in the arm that got AFLURIA on 17-SEP-2015, however, the reaction did not appear until 18-SEP-2015. The injection site reaction resolved by itself. She is feeling fine. It is unknown whether the patient has received AFLURIA before. Event treatment: The patient has not treated her reaction. Reporter's assessment; Not reported.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: HIV antibody negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative, Hepatitis C antibody negative
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 35-year-old male patient. On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for anther event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccine (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (batch number: 11049221A) in the arm. The patient was offered blood pathogen testing, (hep B, hep C, HIV), hepatitis B vaccine and flu vaccine. On 05-OCT-2015, the patient underwent Laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antique and hepatitis C antibody. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, Incorrect product storage, Multiple use of single-use product
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 35-year-old male patient. On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for anther event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccine (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (batch number: 11049221A) in the arm. The patient was offered blood pathogen testing, (hep B, hep C, HIV), hepatitis B vaccine and flu vaccine. On 05-OCT-2015, the patient underwent Laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antique and hepatitis C antibody. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Peripheral swelling
Clinical narrative: This spontaneous case was initially received on 03-DEC-2015. The case report was received from a(n) Health Professional and concerns a(n) 54 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing conditions surrounding the onset of reaction9s)/event(s): The patient received AFLURIA on 03-DEC-2015 - 03 DEC-2015, Batch no: U59308, Route of administration: Intramuscular, Dose; 0.5 ml. AFLURIA was stored correctly. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 03-DEC-2015, immediately after administration of AFLURIA, the patient experienced Swollen arm/Arm swelled up (non serious, outcome: Recovered / Resolved), Red arm at injection site (non serious outcome: Recovered / Resolved), Bleed at injection site / Bleeding from site after injection (non serious, outcome: Recovered / Resolved). Rechallenge/Dechallenge information: N/A. For relevant test results see appropriate report section. Reporter's assessment: non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: This spontaneous case was initially received on 03-Dec-2015. The case report was received from a Health Professional and concerns an adult female patient. Weight: not provided, Height: not provided. Linked Case ID: US-BEH-2016058107 (Same patient, 2013 episode) and US-BEH-2015055519 (Same patient, 2015 episode). In 2013, the patient received a flu shot and experienced fever, chills, headaches and joint pain. For concomitant medication and therapy dates refer to the appropriate report sections. On an unspecified date in 2014, the patient received AFLURIA on unknown dates, Batch no: not provided, Route of administration: not provided, Dose: Administered in 2014. No additional drugs suspected. On an unknown date, after starting treatment with AFLURIA the patient experienced Joint pain, Fever, Chills, Headaches. For relevant test results see appropriate report section.
Sex: U
Vaccine: FLUX
Symptoms: Headache, Impaired work ability, Malaise
Clinical narrative: This spontaneous case was initially received on 03-Dec-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received Influenza vaccine for indication not reported on unknown dates, Batch no: not provided, Route of administration: Unknown, Dose: no information provided. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On an unknown date, after starting /treatment with Influenza vaccine the patient missed work for 2 days (non serious, outcome: unknown), experienced headache (non serious, outcome: unknown) and was sick (non serious, outcome: unknown).
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous case was initially received on 02-Dec-2015. The case report was received from a Health Professional and concerns a 60 year old female patient. On 02-Oct-2014, the patient received FLUZONE (batch number: UI89AD, expiry date, 30-Jun-2015). Weight: not provided, Height: not provided. The patient has a medical history of Penicllin and some opiods allergy. Penicillin (Indication:-; Reaction: Allergy). The patient received flu vaccine on 04-Nov-2015 - unknown stop date, Batch no: not provided, Route od administration: not provided, Dose: no information provided. ZOSTAVAX, batch number L012476, Indication: Prevention of shingles and Unspecified pneumococcal vaccine, Indication not provided. On an unknown date, after vaccination, the patient experienced a rash at the injection site which was "a little bigger than the size of a quarter" and she also described it as being flat, warm and a little painful. The outcome was not yet recovered. Unspecified dose of diphenhydramine. For relevant test results see appropriate report section.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: This health authority case was initially received on 26-Oct-2015. The case report was received from a Health Professional and concerns a 26 years old female patient. The patient disclosed no illness or illness at the time of vaccination. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFULRIA for indication not reported on 26-Aug-2016- unknown stop date, Batch no: U55806, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): BOOSTRIX, Indication: not provided. Reaction (s)/event (s) and outcome: On 26-Aug-2015, 1 day after starting/treatment with AFLURIA the patient experienced soreness of upper left arm (injection site)/Injection site pain (non serious, outcome: Unknown), X-ray limb normal (non serious, outcome: Unknown). Event treatment: The patient was taken to a walk-in clinic and prescribed a MEDROL dose pack on 04-Sep-2015. The patient underwent an X-ray which revealed no damage to bone or surrounding area. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Erythema, Feeling hot, Hyperhidrosis, Pruritus
Clinical narrative: This spontaneous case was initially received on 09-Dec-2015. The case report was received from a Health Professional and concerns a 72 years old female patient who had never gotten the flu vaccine until this year. She did not believe she needed the flu shot because she had never gotten the flu. Weight: not provided, Height: not provided. Concurrent medical condition (s), medical and drug history: The patient has a medical history of Latex allergy and Sensitive to a lot of stuff. She had cancer removal surgery last year and there was an incident. The doctor used latex during surgery and the latex was inside her body. It almost killed her. She did not sue her doctor because he saved her life. The doctor misunderstood her latex allergy for latex sensitivity. The doctor had to give her a bolus of epinephrine because she was in anaphylactic shock. She required a cardiac monitor for days before blood pressure and heart rate went back up. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA injection for indication prevention of influenza on 12-Nov-2015 - 12-Nov-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml, prefilled syringe. This was the only injection she received that day. Her job forced her to get the flu vaccine this year. If employees did not comply, they will be asked for a voluntary resignation. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 12-Nov-2015, 5 mins after starting/ treatment with AFLURIA, the patient felt itchy and sick to the stomach. Ten minutes after the injection, she felt sweaty and the pharmacist urged the patient to stay for additional monitoring. Twenty five minutes after the injection, the nurse stated she had blood red hands. The pharmacist wanted to give her an Epipen and the patient declined because it was expensive ($360 with her insurance). The patient argued with the pharmacist. The pharmacist then asked the patient to stay for additional time and the patient agreed and waited 1 hour before she left. The pharmacist advised the patient to take diphenhydramine for the itching. The patient could not take diphenhydramine because she could not be sleepy at work. She had to work the next day on 13-Nov-2015. She felt very itchy and it got hot because she was moving patients. The heat exaggerated the itchiness. He co-workers said that the patient looked like a 'dog scratching fleas'. The patient was upset about this. Her symptoms lasted for 2.5 days and clearly by the evening of 14-Nov-2015 or morning of 15-Nov-2015. For relevant test results see appropriate report section.