chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous case was initially received on 21-Sep-2015. The case report was received from a health professional and concerns a 39 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 and conditions surrounding the onset of reaction (s) /event(s): The patient received AFLURIA on 12-Sep-2015, Batch no: U55006, route of administration: Intramuscular, dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 12-Sep-2015, after receiving AFLURIA the patient experienced pain in arm after injection/pain in her arm that [radiated from injection site] to her entire arm (non serious, outcome: not recovered / not resolved), pain [in her arm that radiated from] injection site [to her entire arm] (non serious, outcome: Not recovered / not resolved), Cannot use her arm without significant pain (non serious, outcome: not resolved / not resolved). For relevant test results see appropriate report section. Reporter's assessment: The health professional considered the event(s) pain in arm after injection/pain in her that [radiated from injection site] to her entire arm, pain [in her arm that radiated from] injection site [to her entire arm], cannot use her arm without significant pain as non-serious and related. Additional information was received from the health authority on 16-Dec-2015; The patient had medical history of allergy to acetylsalicylic acid and penicillin and nerve damage in leg. Her concomitant medication included gabapentin. On 12-Sep-2015, the patient received AFLURIA injection in the right arm. On 12-Sep-2015, the patient developed swelling and extreme sharp pain in the right arm. The right arm also had limited range of motion and tightness pain in the upper right arm. The outcome was not recovered. Reporter's comments: The health authority assessed the events as non-serious and coded additional term injection site reaction.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous case was initially received on 05-Oct-2015. The case report was received from a Health Professional and concerns a 60 years old female patient. Weight: not provided, Height: not provided. The patient has a medical history of Diabetes and High blood pressure. She had no drug reactions/allergies. For concomitant medication and therapy dates refer to the appropriate report sections: the patient was on many unspecified medications. The patient received Influenza vaccine on 20-Sep-2015 - unknown stop date, Batch no: not provided. Route of administration: not provided, Dose: no information provided. On 20-Sep-2015, the patient also received ZOSTAVAX, batch number: not provided, 0.62 mL once via the subcutaneous route. On 23-Sep-2015, 4 days after starting treatment with Unspecified influenza vaccine, the patient developed a rash with 'little bumps' on her left arm around the injection site which she described as oval in shape measuring '12cm long by 5cm wide'. The patient reported that the rash appeared red in colour, warm to the touch, 'spot was itchy' and hurt to scratch. She felt 'feverish' and as if she was 'getting sick'. There was a 'larger and lighter in colour area around the main rash' which began to subside on 24-Sep-2015. The 'main rash' also began to subside, but it was still sore to the touch. No additional AE information provided. For relevant test results see appropriate report section.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: This spontaneous case was initially received on 05-Oct-2015. The case report was received from a Health Professional and concerns a 60 years old female patient. Weight: not provided, Height: not provided. The patient has a medical history of Diabetes and High blood pressure. She had no drug reactions/allergies. For concomitant medication and therapy dates refer to the appropriate report sections: the patient was on many unspecified medications. The patient received Influenza vaccine on 20-Sep-2015 - unknown stop date, Batch no: not provided. Route of administration: not provided, Dose: no information provided. On 20-Sep-2015, the patient also received ZOSTAVAX, batch number: not provided, 0.62 mL once via the subcutaneous route. On 23-Sep-2015, 4 days after starting treatment with Unspecified influenza vaccine, the patient developed a rash with 'little bumps' on her left arm around the injection site which she described as oval in shape measuring '12cm long by 5cm wide'. The patient reported that the rash appeared red in colour, warm to the touch, 'spot was itchy' and hurt to scratch. She felt 'feverish' and as if she was 'getting sick'. There was a 'larger and lighter in colour area around the main rash' which began to subside on 24-Sep-2015. The 'main rash' also began to subside, but it was still sore to the touch. No additional AE information provided. For relevant test results see appropriate report section.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dosing regimen and frequency unknown). No concomitant medication was reported. On an unknown date approximately 3 days later, the patient experienced Bell's Palsy. The outcome of Bell's Palsy was unknown. The relatedness of the event to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Follow up information has been received from the pharmacist during a phone call on 01-JUN-2016. The pharmacist stated that she was reporting on behalf of another pharmacist and she had no additional information to share regarding this report. Upon internal review, facial paralysis was considered to be medically significant. Additional information has been requested. Adverse event and narrative were updated.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Constipation, Influenza, Musculoskeletal pain
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 36 year old female patient. The patient has no medical history and did not suffer from any current illness at the time of vaccination. On 20-Oct-2015, the patient received an intramuscular injection of AFLURIA (batch no: U56106) to the left arm. On 20-Oct-2015, the patient experienced soreness of the neck, arm, back and buttocks, heart palpitations, face breakouts, back stiffness and soreness/pain, constipation, chills and cold/flu symptoms. The outcome was reported as recovered. The health authority assessed the events as non-serious. The health authority reported the preferred term 'pain'.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Nasopharyngitis, Neck pain, Pain in extremity, Palpitations
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 36 year old female patient. The patient has no medical history and did not suffer from any current illness at the time of vaccination. On 20-Oct-2015, the patient received an intramuscular injection of AFLURIA (batch no: U56106) to the left arm. On 20-Oct-2015, the patient experienced soreness of the neck, arm, back and buttocks, heart palpitations, face breakouts, back stiffness and soreness/pain, constipation, chills and cold/flu symptoms. The outcome was reported as recovered. The health authority assessed the events as non-serious. The health authority reported the preferred term 'pain'.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 36 year old female patient. The patient has no medical history and did not suffer from any current illness at the time of vaccination. On 20-Oct-2015, the patient received an intramuscular injection of AFLURIA (batch no: U56106) to the left arm. On 20-Oct-2015, the patient experienced soreness of the neck, arm, back and buttocks, heart palpitations, face breakouts, back stiffness and soreness/pain, constipation, chills and cold/flu symptoms. The outcome was reported as recovered. The health authority assessed the events as non-serious. The health authority reported the preferred term 'pain'.
Age: 56.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Feeling cold, Pain, Pyrexia
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-Oct-2015) concerns a 56 year old male patient. The patient had medical history of diabetes. On 10-Oct-2015, the patient received unspecified dose of influenza virus vaccine (manufacturer and batch number not reported) and PNEUMOVAX 23 (batch number not reported). On the night of 10-Oct-2015, the patient developed body aches, chills and a fever at 99.9 degree Celsius. The outcome was not reported. Reporter's comments: The reporter assessed the case as serious (fatal). Follow-up information received on 17-Nov-2015: It was reported that there was no death occurred with the patient. No further information was provided.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site pain, Injection site swelling, Oedema, Pain, Swelling
Clinical narrative: This spontaneous case was initially received on 14-Oct-2015. The case report was received from a Health Professional and concerns a 76 years old female patient. Weight: 144 pounds, Height: 66 inches. At the time of the event the patient concomitantly suffered from Diabetes, High blood pressure and Penicillin allergy. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had this exact same adverse reaction soreness and swelling happen to her 40 years ago after receiving an unspecified pneumococcal vaccine. The patient received Influenza vaccine on 05-Oct-2015 - unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. PNEUMOVAX. On 05-Oct-2015, 4 hours after starting treatment with Unspecified flu shot the patient experienced Swelling [and tenderness] goes almost all the way to her left shoulder, [Swelling and] tenderness goes almost all the way to her left shoulder, Left arm started to swell at the site of injection, Left arm was very sore at the site of injection. Action taken: None. Ice, ibuprofen. For relevant test results see appropriate report section.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Tenderness
Clinical narrative: This spontaneous case was initially received on 14-Oct-2015. The case report was received from a Health Professional and concerns a 76 years old female patient. Weight: 144 pounds, Height: 66 inches. At the time of the event the patient concomitantly suffered from Diabetes, High blood pressure and Penicillin allergy. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had this exact same adverse reaction soreness and swelling happen to her 40 years ago after receiving an unspecified pneumococcal vaccine. The patient received Influenza vaccine on 05-Oct-2015 - unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. PNEUMOVAX. On 05-Oct-2015, 4 hours after starting treatment with Unspecified flu shot the patient experienced Swelling [and tenderness] goes almost all the way to her left shoulder, [Swelling and] tenderness goes almost all the way to her left shoulder, Left arm started to swell at the site of injection, Left arm was very sore at the site of injection. Action taken: None. Ice, ibuprofen. For relevant test results see appropriate report section.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling, Tenderness
Clinical narrative: This spontaneous case was initially received on 14-Oct-2015. The case report was received from a Health Professional and concerns a 76 years old female patient. Weight: 144 pounds, Height: 66 inches. At the time of the event the patient concomitantly suffered from Diabetes, High blood pressure and Penicillin allergy. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had this exact same adverse reaction soreness and swelling happen to her 40 years ago after receiving an unspecified pneumococcal vaccine. The patient received Influenza vaccine on 05-Oct-2015 - unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. PNEUMOVAX. On 05-Oct-2015, 4 hours after starting treatment with Unspecified flu shot the patient experienced Swelling [and tenderness] goes almost all the way to her left shoulder, [Swelling and] tenderness goes almost all the way to her left shoulder, Left arm started to swell at the site of injection, Left arm was very sore at the site of injection. Action taken: None. Ice, ibuprofen. For relevant test results see appropriate report section.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Flushing
Clinical narrative: This spontaneous case was initially received on 23-Oct-2015. The case report was received from a(n) Non Health Professional and concerns a(n) 57 years old female patient. Weight: 143 pounds, Height: 64 inches. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Cranial pain. 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 22-Oct-2015 -22-Oct-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 23-Oct-2015, 2 days after starting/ treatment with AFLURIA the patient experienced flushing of face and neck (non serious, outcome: Not Recovered/ Not Resolved). For relevant test results see appropriate report section. Reporter's assessment.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash
Clinical narrative: This spontaneous case was initially received on 23-Oct-2015. The case report was received from a(n) Non Health Professional and concerns a(n) 57 years old female patient. Weight: 143 pounds, Height: 64 inches. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Cranial pain. 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 22-Oct-2015 -22-Oct-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 23-Oct-2015, 2 days after starting/ treatment with AFLURIA the patient experienced flushing of face and neck (non serious, outcome: Not Recovered/ Not Resolved). For relevant test results see appropriate report section. Reporter's assessment.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Feeling abnormal, Immediate post-injection reaction, Injected limb mobility decreased, Injection site nerve damage
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 34-year old female patient. On 03-Oct-2015, the patient received intramuscular AFLURIA injection (batch number U56106) in the left arm. On 03-Oct-2015, the patient reported that it burned more than usual going in. Over the next several days, the pain in her left arm worsened to the point of feeling injured 'by someone yanking her arm out of place'. For the week of 12-Oct-2015, the patient was on vacation and decided to continue to monitor her arm for symptoms during the vacation. For the first 2 weeks afterwards, the patient had hard time with basic arm motions (lifting, reaching, getting dressed) and at times it hurt to just move. There were also several nights where the patient experienced pain when laying on her side. 18-Oct-2015 was when she had extreme pain. On 20-Oct-2015, the patient went to the chiropractor who suspected that the shot went directly into the nerve in her upper arm. The chiropractor did some work on the arm and it felt better, although the patient was still experiencing symptoms. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious. Case correction 18-Apr-2016: AE 1 'suspects that shot went directly into a nerve in my upper arm' has been upgraded to serious. Case correction 03-May-2016: AE 5 verbatim changed from 'several nights where I experienced [pain] when laying on my side' to 'sleep disorder', no change in PT. The health authority reported the symptom: sleep disorder.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 34-year old female patient. On 03-Oct-2015, the patient received intramuscular AFLURIA injection (batch number U56106) in the left arm. On 03-Oct-2015, the patient reported that it burned more than usual going in. Over the next several days, the pain in her left arm worsened to the point of feeling injured 'by someone yanking her arm out of place'. For the week of 12-Oct-2015, the patient was on vacation and decided to continue to monitor her arm for symptoms during the vacation. For the first 2 weeks afterwards, the patient had hard time with basic arm motions (lifting, reaching, getting dressed) and at times it hurt to just move. There were also several nights where the patient experienced pain when laying on her side. 18-Oct-2015 was when she had extreme pain. On 20-Oct-2015, the patient went to the chiropractor who suspected that the shot went directly into the nerve in her upper arm. The chiropractor did some work on the arm and it felt better, although the patient was still experiencing symptoms. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious. Case correction 18-Apr-2016: AE 1 'suspects that shot went directly into a nerve in my upper arm' has been upgraded to serious. Case correction 03-May-2016: AE 5 verbatim changed from 'several nights where I experienced [pain] when laying on my side' to 'sleep disorder', no change in PT. The health authority reported the symptom: sleep disorder.
Sex: U
Vaccine: HPV4
Symptoms: Brain neoplasm, Headache, Product quality issue
Clinical narrative: This initial spontaneous report was received from a physician via a company representative reporting that one of her patients told her of another patient of unknown age and gender whose pertinent medical history, concomitant medications or concurrent conditions were not described. The reporter stated that on an unknown date, the patient was vaccinated with a dose of an unspecified vaccine; GARDASIL or GARDASIL 9 injection (dose, route, lot# and expiration date were not provided). On an unknown date, the patient began getting headaches and sought medical attention at a Neurologist who told that the vaccine GARDASIL or GARDASIL 9 had also caused a brain tumor. Product quality complaint (PQC) was involved. At the time of the report, the outcome of the event was unknown. The reporter causality between the event to the suspect therapies was not reported. All attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative has been updated.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a 63 year old female patient. The patient has received the flu shot in the past, specifically the AFLURIA vaccine, on 02-Oct-2014 and 08-Sep-2013, without any issues. The patient states she is "super sensitive to vaccines". She had gotten this reaction years ago. The following drug history information was reported: Unspecified vaccine (Indication: -, Reaction: Muscle soreness). Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for the Prevention of influenza on 11-Sep-2015, Batch no: U55406, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Left deltoid. Additional suspect drug (s):  ZOSTAVAX, (LIVE), Batch no: Unknown, Indication: not provided, Site: Right arm. Reaction(s)/ event (s) and outcome: On 11-Sep-2015, after starting / treatment with AFLURIA the patient experienced Muscle soreness in the left arm where AFLURIA was administered / Muscle soreness (non serious, outcome: Not Recovered / Not Resolved). As of 19-Oct-2015, the patient still has muscle soreness in the left arm where the AFLURIA was administered. The soreness is not felt all the time. When the patient lifts weights, she does not notice it. However, it is when she is laying down in the bed that she can feel it. She states it does not feel better or worse. Reporter's assessment: Not reported.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a 63 year old female patient. The patient has received the flu shot in the past, specifically the AFLURIA vaccine, on 02-Oct-2014 and 08-Sep-2013, without any issues. The patient states she is "super sensitive to vaccines". She had gotten this reaction years ago. The following drug history information was reported: Unspecified vaccine (Indication: -, Reaction: Muscle soreness). Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for the Prevention of influenza on 11-Sep-2015, Batch no: U55406, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Left deltoid. Additional suspect drug (s):  ZOSTAVAX, (LIVE), Batch no: Unknown, Indication: not provided, Site: Right arm. Reaction(s)/ event (s) and outcome: On 11-Sep-2015, after starting / treatment with AFLURIA the patient experienced Muscle soreness in the left arm where AFLURIA was administered / Muscle soreness (non serious, outcome: Not Recovered / Not Resolved). As of 19-Oct-2015, the patient still has muscle soreness in the left arm where the AFLURIA was administered. The soreness is not felt all the time. When the patient lifts weights, she does not notice it. However, it is when she is laying down in the bed that she can feel it. She states it does not feel better or worse. Reporter's assessment: Not reported.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Grip strength decreased, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a Health Professional and concerns a 63 years old male patient. Weight: not provided, Height: not provided. Concurrent medical condition (s), medical history and drug history: The patient has a medical history of High blood pressure and High cholesterol (both were treated with medications). 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 protection against influenza virus on 05-Nov-2015- 05-Nov-2015, Batch no: U51209, Route of administration: Intramuscular, Dose: 0.5 ml, Site: right arm. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On 06-Nov-2015, around 2-3 am, the patient experienced Arm was sore (non serious, outcome: Recovered/Resolved), Hand was swollen/ Hand swollen (non serious, outcome: Recovered/ Resolved), Hand hard to close/Difficulty to close his hand (non serious, outcome: Recovered/Resolved), Mobility decreased (non serious, outcome: Recovered/ Resolved). It was in the right hand, same arm as AFLURIA administered the previous day. Event treatment: The patient applied ice to hand/arm. He exercised the arm/hand. The symptoms resolved later in the day. For relevant test results see appropriate report section.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Rash pustular
Clinical narrative: This spontaneous case was initially received on 28-Oct-2015. The case report was received from a(n) Health Professional and concerns a(n) 65 year old male patient. The patient has a medical history of Shingles, High blood pressure and High cholesterol. The patient has no drug reactions/allergies. Her concomitant medications included sterile diluent (Lot number K024557, expiry 10-Oct-2016). The patient received AFLURIA on 14-Oct-2015, Batch no: U55806, Route of administration: not provided, Dose: 0.5 ml, Site: Opposite arm to ZOSTAVAX administration. Additional suspect drug(s): ZOSTAVAX, Batch no: L012478, Expiry: 10-Jul-2016. Route: Subcutaneous. On 15-Oct-2015, 2 days after starting treatment with AFLURIA the patient experienced a rash, ovular, 2 inches across by 1 inch with pustules at the edges that are flat and dry. The patient stated the rash was "not like usual shingles he had in the past". Reporter's assessment: non-serious.
Age: 50.0
Sex: M
Vaccine: YF
Symptoms: Endotracheal intubation, Multiple organ dysfunction syndrome, Seizure
Clinical narrative: Initial unsolicited report received from a nurse on 10-Dec-2015. This case involves a 50-year-old male patient, who was vaccinated with a dose of YF-VAX (batch number: UI369AA expiry date: 28-Feb-2019, dose, dose in series, route and site of administration were not reported) on 03-Dec-2015. No illness at the time of vaccination. Patient had no medical history, no allergies and concomitant medications were not reported. On 07-Dec-2015, four days after vaccination patient experienced seizures and on an unknown date, patient experienced multi organ failure. On 10-Dec-2015, patient was hospitalized and intubated. Laboratory investigations and corrective treatment were not reported. At the time of this report patient had not recovered from the events. Documents held by Sender: none. Follow up information received from a Nurse on 07 January 2016. It was reported that, the patient was vaccinated with 0.5ml dose of YF-VAX vaccine subcutaneously. Sender's Comments: Follow-up information received on 07 January 2016 does not change the previous medical assessment of this case. Multi-organ failure and convulsions are listed with YELLOW FEVER VACCINE. Further information on the details of the symptoms, concomitant medications, lab data confirming the diagnosis, etc. will be required for further assessment of this case. Based on the information available, no conclusion can be drawn.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV, FLU3
Symptoms: Malaise, Peripheral swelling, Rash, Rash erythematous, Skin warm
Clinical narrative: This health authority case was initially received on 22-Feb-2016. The case report was received from a Health Professional and concerns a 45 years old male patient. Weight: not provided, Height: not provided. Concurrent medical condition (s), medical history and drug history: The patient has a medical history of Sulfa allergy. The following drug history information was reported: Influenza (seasonal) vaccine (Indication: -, Reaction: Bell's palsy). 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 reported on 30-Dec-2015- unknown stop date, Batch no: U59208, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm. Additional suspect drug (s): On the same day the patient also received PNEUMOVAX  in the left arm, Indication: not provided. Both vaccines were administered in the left arm (medication error not explicitly reported). Reaction (s)/ event (s) and outcome: On 31-Dec-2015, 2 days after starting / treatment with AFLURIA the patient experienced swollen arm (non serious, outcome: Not Recovered/ Not Resolved), Arms had red rash (non serious, outcome: Not Recovered/ Not Resolved), Warm to touch (non serious, outcome: Not Recovered/ Not Resolved), Hasn't felt well (non serious, outcome: Not Recovered/ Not Resolved), Rash spreading around arm (non serious, outcome: Not Recovered/ Not Resolved). For relevant test results see appropriate report section.
Age: 35.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen 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 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 syringe 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 antigen and hepatitis C antibody. The outcome was unknown.
Age: 35.0
Sex: M
Vaccine: FLU3, 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 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 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 syringe 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 antigen and hepatitis C antibody. The outcome was unknown.
Age: 35.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Wrong technique in product usage process
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 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 syringe 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 antigen and hepatitis C antibody. The outcome was unknown.
Age: 33.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 33 year old patient (gender: unknown). 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 vaccine (10 doses/vial) were used to 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 antigen and hepatitis C antibody. The outcome was unknown.
Age: 33.0
Sex: U
Vaccine: FLU3, 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 33 year old patient (gender: unknown). 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 vaccine (10 doses/vial) were used to 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 antigen and hepatitis C antibody. The outcome was unknown.
Age: 33.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, 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 33 year old patient (gender: unknown). 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 vaccine (10 doses/vial) were used to 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 antigen and hepatitis C antibody. The outcome was unknown.
Age: 39.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 39 year old patient (gender: unknown). 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 inserted 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 vaccine (10 doses/vial) were used for 67 adult patients. 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 surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown.
Age: 39.0
Sex: U
Vaccine: FLU3, 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 39 year old patient (gender: unknown). 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 inserted 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 vaccine (10 doses/vial) were used for 67 adult patients. 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 surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown.
Age: 39.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: 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 39 year old patient (gender: unknown). 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 inserted 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 vaccine (10 doses/vial) were used for 67 adult patients. 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 surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown.
Age: 56.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 56 year old patient (gender unknown). 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 surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown.
Age: 56.0
Sex: U
Vaccine: FLU3, 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 56 year old patient (gender unknown). 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 surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown.
Age: 56.0
Sex: U
Vaccine: FLU3, 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 56 year old patient (gender unknown). 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 surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown.
Age: 56.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Incorrect product storage, Multiple use of single-use product
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 56 year old patient (gender unknown). 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 surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown.