chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician referring to a female patient of unknown age, who was pregnant. Her last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. On 02-MAY-2016 the patient was inadvertently administered with a dose of GARDASIL 9 (lot #L043213, dose, expired date and route were unknown) (drug administration error, exposure during pregnancy). No concomitant therapy was reported. The pregnancy outcome was unknown. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown demographics. No patient's concurrent conditions or medical history were provided. On an unknown date, those patient's were vaccinated with improperly stored doses of VARIVAX injection (lot # L046885 with expiry date: 23-NOV-2017; strength, dose, route and site of administration were unspecified). The administered vaccines underwent the temperature excursion of 26.7 degrees Fahrenheit for 2 hours 24 minutes. There was previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Acne, Injection site reaction
Clinical narrative: This spontaneous report has been received from a female consumer of unknown age referring to herself. Concurrent or historical condition was not provided. On an unspecified date of November 2015 the patient was vaccinated with a dose of GARDASIL (dose, route, lot number and expired date unknown). On an unspecified date of November 2015 the patient developed one pimple-like bump near the injection site. The outcome of the event was unknown. The causality was not provided. Additional information is not expected as no contact information was provided. Additional information is not expected as no contact information was provided.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash
Clinical narrative: Pain extending down arm from injection site to hand, fingers. Bumps/rash also appeared. Started day of injection (6/1/16) and continuing through today. Patient has been icing/taking ibuprofen. Saw a doctor and was prescribed antibiotic.
Age: 12.0
Sex: M
Vaccine: HPVX, MEN, TDAP
Symptoms: Burning sensation, Discomfort, Erythema, Pruritus, Swelling
Clinical narrative: Itching, discomfort, burning, swelling, red area. Erythema 10cm x 15cm diameter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-APR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot # L035508, expiration date 12-MAY-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. No concurrent conditions or medical history was provided. On an unspecified date in May 2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot # L037560 with expiry date: 29-SEP-2017) and a dose of M-M-R II injection (lot # L027431 with expiry date: 22-JUL-2017; strength, dose, route and site of administration were unspecified for both). The administered vaccine underwent the temperature excursion at 50 degrees Fahrenheit for 3.5 hours. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot # report as M012495, expiration date 09-OCT-2017). There was no adverse effect reported. The administrated dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot reported as M012495, expiration date 09-OCT-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # K015946, expiration date 23-SEP-2016 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 16-APR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L034724, expiration date 09-DEC-2016 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 11-APR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L034724, expiration date 09-DEC-2016 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 48.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 48-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 29-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (in deltoid, route of administration, dose number, lot number reported as L035449, expiry date: 26-JAN2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-APR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot # L035508, expiration date 12-MAY-2017). There was no adverse effect reported. The administrated dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-APR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot # L035508, expiration date 12-MAY-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-APR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot # L035508, expiration date 12-MAY-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 46.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 46-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 30-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (in deltoid, route of administration: intramuscularly, dose number not reported, lot number: L038499, expiry date: 26-JUN-2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Asthenia, Fatigue, Injected limb mobility decreased, Injection site pain
Clinical narrative: Extreme Fatigue, Head-to-toe muscle aching, couldn't get out of bed without help due to weakness, eventual bright red rash on arm at injection site:  hot to the touch and very sore.  Had no use of injected arm for 48 hours. Generally felt very ill for two days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site warmth, Malaise, Myalgia, Rash erythematous
Clinical narrative: Extreme Fatigue, Head-to-toe muscle aching, couldn't get out of bed without help due to weakness, eventual bright red rash on arm at injection site:  hot to the touch and very sore.  Had no use of injected arm for 48 hours. Generally felt very ill for two days.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Large red itchy rash at site of injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash, Rash pruritic
Clinical narrative: Injection site red, swollen, painful. By 05/14/2016 rash began on back and side. Painful and itchy.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Arrhythmia, Cardiac murmur, Hyporesponsive to stimuli, Seizure, Urine analysis
Clinical narrative: Seizures, decrease in response times, decrease in response to name, heart murmur and arrhythmia.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Injection site pain
Clinical narrative: No rash or erythema.  Patient states they had arm pain near injection site radiating to breast area.  Happened within one week of getting vaccine and persisting now for two weeks after.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient (associate of store) received Pnemovax 23 vaccination on right arm IM on 6/3/16. On 6/5/16 patient came in the pharmacy reporting redness, warm and tenderness on upper right arm with minor swelling starting the night after the injection. No other sympotms in other areas of body. Patient was advised to monitor swelling and pain and redness. He was instructed to use ice packets / cold compress and he is taking ibuprofen for pain. Patient was explained to that this is a mild reaction and his symptoms will be reported. HE was asked to monitor his symptoms and report any symptoms worsens or contact dr if any more severe reaction occurs. Reaction is also reported to VAERS.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L025598 with expiration date 13-JAN-2017 and lot # L037924 with expiration date 22-JUN-2017, oral, dose unspecified), which was exposed to temperature excursion 30 Fahrenheit degree (F) for 10 total cumulative hours. It was also reported that there was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (lot # K011325 with expiration date 08-APR-2017 and lot # L040459 with expiration date 06-APR-2017, dose and route unspecified), which was exposed to temperature excursion 30 Fahrenheit degree (F) for 10 total cumulative hours. It was reported that there was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test, Injection site vesicles, Peripheral swelling
Clinical narrative: Severe arm swelling - blisters at injection site. Looks like allergy. Received IV therapy and oral antibiotics.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Pyrexia
Clinical narrative: This medically confirmed spontaneous report (initial receipt 08-Jan-2015) concerns a 20 year-old male patient who received the flu shot (non-CSL product) in the past without any issues. The patient did not take any concomitant medications, and had no history of febrile reactions to any vaccines, including previous flu shots. He did not receive other recent immunisations. On 07-Jan-2015, in the evening, the patient received intramuscular AFLURIA (batch number 09949221A) 0.5mL annually. This was the first time he received AFLURIA. On 08-Jan-2015, in the morning, the patient reported that he experienced 102 degrees Fahrenheit (oral) after the AFLURIA administration. The patient believed that AFLURIA caused his fever and that he now has the flu. The patient will see his physician later on 08-Jan-2015 for further assessment. The outcome was reported as unknown. Reporter's comments: The reporter counseled the patient on flu incubation periods and antibody responses, reported that the fever was related to the AFLURIA, and reported that the patient could have received H1N1 vaccine at another pharmacy (there were none listed in the patient's pharmacy profile) at the reporter's pharmacy. Follow-up (16-Jan-2015): Clinical course, AE start date and outcome. Follow-up information received on 23-Sep-2015 from the health authority: VAERS case ID: 586919. The previous case 2015047841 had the key ingredient changed to 'FLUVAX - thiomersal', consequently this new case has been created. Case 2015047841 will be nullified. Reporter's comments: The regulator reported the AE onset of 08-Jan-2015 and assessed the events as non-serious. Case correction (29-Oct-2015): Reopened case to correct the date of last received information. It was inadvertently entered as 08-Jan-2015, should have been 23-Sep-2015.
Age: 47.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 23-Nov-2015) concerns a 47 year-old male patient. His concomitant medications included acetaminophen, amlodipine, clindamycin, enoxaparin, and insulin aspart. The patient was admitted to medicine for suspected cellulitis, potential DVT (deep vein thrombosis). On 16-Dec-2014, following admission, the patient received AFLURIA injection (batch number 'D1352') and PNEUMOVAX (batch number K008927). Both vaccines were given via the intramuscular route on the right arm. On 16-Dec-2014, 24 hours after administration, the patient was febrile to 102.9 degrees, his right arm was tender, warm, erythematous around the injection site. The fever abated over the following day. The patient was hospitalised for 5 days. The outcome was unknown. VAERS case ID: 590844 Reporter's comments: The health authority assessed the case as serious (led to hospitalisation) and reported the term 'cellulitis'.
Age: 47.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 23-Nov-2015) concerns a 47 year-old male patient. His concomitant medications included acetaminophen, amlodipine, clindamycin, enoxaparin, and insulin aspart. The patient was admitted to medicine for suspected cellulitis, potential DVT (deep vein thrombosis). On 16-Dec-2014, following admission, the patient received AFLURIA injection (batch number 'D1352') and PNEUMOVAX (batch number K008927). Both vaccines were given via the intramuscular route on the right arm. On 16-Dec-2014, 24 hours after administration, the patient was febrile to 102.9 degrees, his right arm was tender, warm, erythematous around the injection site. The fever abated over the following day. The patient was hospitalised for 5 days. The outcome was unknown. VAERS case ID: 590844 Reporter's comments: The health authority assessed the case as serious (led to hospitalisation) and reported the term 'cellulitis'.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: This health authority case was initially received on 23-NOV-2015. The case report was received from a(n) Health Professional and concerns a(n) 32 years old female patient. Weight: not provided, Height: not provided. Concurrent medical condition(s), medical and drug history: At the time of the event the patient concomitantly suffered from Depression. The patient has a medical history of Penicillin, Keflex. The following drug history information was reported: Penicillin (Indication - Reaction: Allergy) and Keflex (Indication - Reaction: Allergy). 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 in the right arm, Indication not reported  on 15-SEP-2015 - unknown stop date, Batch no: U54406, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): On the same day the patient received PNEUMOVAX in the left arm, Indication: not provided. Reaction(s)/event(s) and outcome: On 16-SEP-2015, 2 days after starting/treatment with AFLURIA the patient experienced left arm was swollen where if she touched her arm there would be an indent (non serious, outcome: Recovered/Resolved). The patient took 2 tablets of diphenhydramine 25 mg. Upon examination on 17-SEP-2015, her arm was not swollen and it was not red.  For relevant test results see appropriate report section. Reporter's assessment: Not provided.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 23-Nov-2015. The case report was received from a (n) Health Professional and concerns a (n) 20 years old female patient. The patient had no current illness, medical history or medications 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 AFLURIA in the left arm for indication not reported. on 05-Sep-2015- unknown stop date, Batch no: U56406, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 17-Sep-2015, 1 week 6 days after starting/ treatment with AFLURIA the patient experienced Pain in her arm from the shoulder at the site of injection to the elbow (non serious, outcome: Unknown), (Pain gets continuously worse and) the patient cannot move her arm (non serious, outcome: Unknown), Injection site pain (non serious, outcome: Unknown). For relevant test results see appropriate report section.
Age: 67.0
Sex: U
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site movement impairment, Pain
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 23-Nov-2015. The case report was received from a (n) Health Professional and concerns a (n) 67 years old patient with unknown gender. Weight: not provided, Height: not provided. Concurrent medical condition (s), medical history and drug history: The patient has a medical history of PCN (penicillin), CECLOR, LAMISIL and HTN (hypertension). The following drug history information was reported: Penicillin (Indication: -, Reaction: Allergy), CECLOR (Indication: -, Reaction: Allergy) and LAMISIL (Indication: -, Reaction: Allergy). 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 in the left arm for indication not reported on 08-Nov-2014 - unknown stop date, Batch no: T52308, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 10-Nov-2014, 3 days after starting / treatment with AFLURIA the patient experienced Pain (non serious, outcome: Unknown), Decreased mobility left shoulder (injection site: left arm) (non serious, outcome: Unknown), Injection site movement impairment (non serious, outcome: Unknown). For relevant test results see appropriate report section.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Diarrhoea, Headache, Nausea, Pain, Pain in extremity
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 52 years old female patient. The patient received AFLURIA on 18-Sep-2015 - unknown stop date, Batch no: 11049211A, Route of administration: Intramuscular, Dose: Site: left arm (LA). No additional drugs suspected. On 19-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced Felt tired and run down, [Redness and] swelling from elbow to shoulder, Redness [and swelling] from elbow to shoulder. VAERS ID: 596787. Reporter's assessment: Non-serious.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Headache, Nausea, Pain, Pain in extremity
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 52 years old female patient. The patient received AFLURIA on 18-Sep-2015 - unknown stop date, Batch no: 11049211A, Route of administration: Intramuscular, Dose: Site: left arm (LA). No additional drugs suspected. On 19-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced Felt tired and run down, [Redness and] swelling from elbow to shoulder, Redness [and swelling] from elbow to shoulder. VAERS ID: 596787. Reporter's assessment: Non-serious.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Erythema, Fatigue, Peripheral swelling
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 52 years old female patient. The patient received AFLURIA on 18-Sep-2015 - unknown stop date, Batch no: 11049211A, Route of administration: Intramuscular, Dose: Site: left arm (LA). No additional drugs suspected. On 19-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced Felt tired and run down, [Redness and] swelling from elbow to shoulder, Redness [and swelling] from elbow to shoulder. VAERS ID: 596787. Reporter's assessment: Non-serious.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain, Tenderness
Clinical narrative: This health authority case was initially received on 23-NOV-2015. This case report was received from a(n) Health Professional and concerns a(n) 56 years old female patient. The patient had no current illness. 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 15-SEP-2015 - unknown stop date, Batch no: U55506, Route of administration: Unknown, Dose: 0.5 ml. Additional suspect drug(s): On the same day, the patient also received PNEUMOVAX. Both vaccine were administered in the left arm (medication error not explicitly reported). Reaction(s)/event(s) and outcome: On 15-SEP-2015, 1 day after starting/treatment with AFLURIA the patient experienced Upper arm tenderness radiating to neck and shoulder (non serious, outcome: Not Recovered/Not Resolved), Difficulty lifting arm past elbow level (non serious, outcome: Not Recovered/Not Resolved), Hurts to lay on that side with pain when lifting (non serious, outcome: Not Recovered/Not Resolved), Mobility decreased (non serious, outcome: Not Recovered/Not Resolved). For relevant tests results see appropriate report section. Reporter's assessment: Non serious.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Rash
Clinical narrative: This health authority case was initially received on 23-SEP-2015. The case report was received from a Health Professional and concerns a 66 year old female patient. The patient had no illness at the time of vaccination and no medical history. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 17-SEP-2015  - unknown stop date, Batch no: U55806, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): PREVNAR13 and ZOSTAVAX. Reaction(s)/event(s) and outcome: On 18-SEP-2015, 2 days after starting/treatment with AFLURIA the patient experienced (arm pain, redness and swelling around injection site, then) blisters/Blisters started to go away the next morning/Now (4 days post injection) line where blisters were is still visible (non serious, outcome: Recovered/Resolved), Arm pain, redness and swelling around injection site, then blisters)/Now (4 days post injection) pain continues to a lesser extent (non-serious, outcome Recovered/Resolved), (arm pain, redness and swelling around injection site, then blisters)/Now (4 days post injection) redness continues to a lesser extent (non-serious, outcome: Recovered/Resolved), (arm pain, redness and swelling around injection site, then blisters) (non serious, outcome: Recovered/Resolved, Rash appears to be resolving on its own (non serious, outcome; Recovered/Resolved. VAERS ID: 593522. Reporter's assessment: Non-serious.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Peripheral swelling
Clinical narrative: This health authority case was initially received on 23-Nov-2015. This case was received from a Health Professional and concerns a 56 year old female patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of possible allergy to eggs. The patient had no 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 17-Sep-2015 - unknown stop date, Batch no: U56807, Route of administration: Intramuscular, Dose: 0.5 ml: Site: right arm (RA). Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 17-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced trouble breathing (non serious, outcome: Recovered / Resolved), arm swelled up (non serious, outcome: Recovered / Resolved). VAERS ID: 596868. Reporter's assessment: Non-serious.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot
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 28 year old female patient. The patient has no medical history. Concomitant medications include SPRINTEC. The patient had no illness at the time of vaccination. The patient received AFLURIA on 22-Sep-2015 - unknown stop date, Batch no: U57907, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm (LA). No additional drugs suspected. On 22-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced Felt [lightheaded and] faint, Felt lightheaded [and faint], Felt hot. She was given some water, she requested a Coke, she requested to lie down on the bench. The injection site was inspected, there was no visible reaction. After about 30 min, her husband came and picked her up. VAERS ID: 596883. Reporter's assessment: Non-serious.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Feeling abnormal, Heart rate increased, Paraesthesia, Paraesthesia oral
Clinical narrative: This health authority case was initially received on 23-Sep-2015. The case report was received from a Health Professional and concerns a 19 year old female patient. The patient has a medical history of 'thyroid condition'. Concomitant medications at the time of vaccination are unknown. The patient had no illness at the time of vaccination. The patient received AFLURIA on 17-Sep-2015, Batch no: 11049211A, Route of administration: Intramuscular, Dose: Site: right arm (RA). No additional drugs suspected. On 17-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced tingling on her upper lip and neck area, blood pressure and pulse were elevated, felt weird, and red blotches on her chest. Emergency medical services (EMS) attended to the patient. VAERS ID: 596935. Reporter's assessment: Non-serious.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular
Clinical narrative: This health authority case was initially received on 23-Sep-2015. The case report was received from a Health Professional and concerns a 19 year old female patient. The patient has a medical history of 'thyroid condition'. Concomitant medications at the time of vaccination are unknown. The patient had no illness at the time of vaccination. The patient received AFLURIA on 17-Sep-2015, Batch no: 11049211A, Route of administration: Intramuscular, Dose: Site: right arm (RA). No additional drugs suspected. On 17-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced tingling on her upper lip and neck area, blood pressure and pulse were elevated, felt weird, and red blotches on her chest. Emergency medical services (EMS) attended to the patient. VAERS ID: 596935. Reporter's assessment: Non-serious.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Rash
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 54 year old female patient. The patient had no known illness at the time of vaccination. The patient received AFLURIA on 15-Sep-2015 - unknown stop date, Batch no: U54506, Route of administration: 'SYR', Dose: 0.5 ml, Site: right arm (RA). No additional drugs suspected. On an unknown date two days after vaccination with AFLURIA, the patient experienced Rash near injection site, Soreness at injection site. VAERS ID: 596996. Reporter's assessment: Non-serious.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Sensory disturbance
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 53 year old female patient. The patient received AFLURIA on 23-Sep-2015 - unknown stop date, Batch no: 11449221A, Route of administration: not provided, Route: 'SYR', Site: left arm (LA). No additional drugs suspected. On 23-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced Felt pain in (L) forearm, and hard sharp, shooting in nature. Denies any weakness or numbness. No rash or allergic reaction, denies CP/SOB/dizzy. VAERS ID: 596999. Reporter's assessment: Non-serious.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
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 53 year old female patient. The patient received AFLURIA on 23-Sep-2015 - unknown stop date, Batch no: 11449221A, Route of administration: not provided, Route: 'SYR', Site: left arm (LA). No additional drugs suspected. On 23-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced Felt pain in (L) forearm, and hard sharp, shooting in nature. Denies any weakness or numbness. No rash or allergic reaction, denies CP/SOB/dizzy. VAERS ID: 596999. Reporter's assessment: Non-serious.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling, Pain, Tenderness
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 24 year old male patient. The patient has no medical history and had no illness at the time of vaccination. The patient received AFLURIA on 23-Sep-2015, Batch no: U54806, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm (LA). No additional drugs suspected. On 23-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced swelling in armpit, 7/10 constant pain, and extremely tender. VAERS ID: 597118. Reporter's assessment: Non-serious.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Hyperhidrosis, Pallor
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 42 year old female patient. The patient has a medical history of codeine allergy. The patient had no illness or concomitant medications at the time of vaccination. The following drug history information was reported: Codeine (Indications: -, Reaction: Allergy). The patient received their first dose of AFLURIA on 24-Sep-2015 - unknown stop date, Batch no: U56907, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm (LA). No additional drugs suspected. On 24-Sep-2015, 1 day after starting/treatment with AFLURIA the patient experienced Trouble breathing, Weakness, Sweating, Loss of colour. VAERS ID: 597171. Reporter's assessment: Non-serious.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Dizziness, Dry mouth, Dyspnoea, Nausea
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 49 year old female patient. The patient has no medical history. The patient had no illness and no applicable concomitant medications at the time of vaccination. The patient received AFLURIA on 24-Sep-2015 - unknown stop date, Batch no: U56807, Route of administration: Intramuscular, Dose: 0.5 ml. PNEUMOVAX. On 24-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced Trouble breathing, Tightness in chest, Dizzy, Dry mouth, Nausea. VAERS ID: 597186. Reporter's assessment: Non-serious.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea, Ocular hyperaemia
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional on concerns a 47 year old female patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 24-Sep-2015 - unknown stop date, Batch no: U59208, Route of administration: Intramuscular, Dose: 0.5 ml, Site: right arm (RA) Additional suspect drug(s): No additional drugs suspected. Reaction(s)/events(s) and outcome: On 24-Sep-2015, 2 to 3 hours post vaccination with AFLURIA, the patient experienced difficulty breathing (non serious, outcome: Recovered / Resolved), Hoarseness (non serious, outcome: Recovered / Resolved), Red eyes (non serious, outcome: Recovered / Resolved). VAERS ID: 597189. Reporter's assessment: Non-serious.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Nausea, Pallor
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 19 year old male patient. The patient has no pre-existing health conditions and no concomitant medications at the time of vaccination. The patient had no illness, 'did not feel sick or was not running a fever' at the time of vaccination. The patient received AFLURIA on 24-Sep-2015, Batch no: U56807, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm (LA). No additional drugs suspected. On 24-Sep-2015, 1 day after starting treatment with AFLURIA the patient was weak, visibly pale, and nauseous. VAERS ID: 597219. Reporter's assessment: Non-serious.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Oropharyngeal pain, Pain, Pyrexia
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 49 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 22-Sep-2015 - unknown stop date, Batch no: 11049211A, Route of administration: Intramuscular, Dose: Site: right arm. No additional drugs suspected. On 22-Sep-2015, 1 day after starting/treatment with AFLURIA the patient experienced Light headed X 2 days, Fever 103, Achy, Sore throat. Reporter's assessment: Non-serious. VAERS ID: 597384. Case correction (04-Mar-2016): Assessment for AE4 corrected to unlisted.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Eye pain, Fatigue, Headache
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 60 year old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had no current illness or medical history or lab data. The patient received AFLURIA on 22-Sep-2015 - unknown stop date, Batch no: not provided, Route of administration: not provided, Dose: Route: SYR, site: left arm. No additional drugs suspected. On 23-Sep-2015, 2 day after starting treatment with AFLURIA the patient experienced Pain in the eyes, Fever, Chills, Headache, Fatigue, Dizziness, Pain in neck, Pain in shoulder. For relevant test results see appropriate report section. Reporter's assessment: non serious. VAERS ID: 597387.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pyrexia
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 60 year old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had no current illness or medical history or lab data. The patient received AFLURIA on 22-Sep-2015 - unknown stop date, Batch no: not provided, Route of administration: not provided, Dose: Route: SYR, site: left arm. No additional drugs suspected. On 23-Sep-2015, 2 day after starting treatment with AFLURIA the patient experienced Pain in the eyes, Fever, Chills, Headache, Fatigue, Dizziness, Pain in neck, Pain in shoulder. For relevant test results see appropriate report section. Reporter's assessment: non serious. VAERS ID: 597387.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pyrexia
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 34 years old 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 22-Sep-2015 - unknown stop date, Batch no: 11049211A, Route of administration: Intramuscular, Dose: Site: Left arm. No additional drugs suspected. On 22-Sep-2015, within a few hours of receiving AFLURIA the patient experienced No energy for 2 days, Achiness, Fever 102-103. For relevant test results see appropriate report section. Reporter's assessment: Non serious. VAERS ID: 597388.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Infection, Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: This medically confirmed health authority report (initial receipt 23-Nov-2015) concerns a 53 year old female patient. The patient had medical history diabetes and had no current illness. Her concomitant medications included amlodipine, linagliptin, mesalamine, pantoprazole, cyclosporine, propranolol, montelukast, ropinorole hydrochloride, Lisinopril and potassium chloride. On 22-Sep-2015, the patient received intramuscular AFLURIA injection (batch number U56807) in the left arm. On 22-Sep-2015, the patent developed cellulitis in the left arm from the shot. The area was red and hot to touch. The patient was currently taking antibiotics for infection. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious. VAERS ID: 597408.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Dizziness, Headache, Paraesthesia, Pyrexia
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 57 years old female patient. Weight: not provided, Height: not provided. Concurrent medical history of allergy to penicillin and allergy to gluten. The following drug history information was reported: Penicillin (Indication: -, Reaction: Allergy). The patient had no current illness. 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 not reported on 25-Sep-2015- unknown stop date, Batch no: not provided, Route of administration: not provided, Dose: no information provided. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On 25-Sep-2015, 1 day after starting/ treatment with AFLURIA the patient experienced some mental confusion (non serious, outcome: Unknown), Extreme dizziness (non serious, outcome: Unknown), Vomiting (non serious, outcome: Unknown), Slight headache at lower back of the neck (non serious, outcome: Unknown), Low fever (non serious, outcome: Unknown), Some tingling in extremities (non serious, outcome: Unknown), Blurred vision (non serious, outcome: Unknown). For relevant test results see appropriate report section.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred, Vomiting
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 57 years old female patient. Weight: not provided, Height: not provided. Concurrent medical history of allergy to penicillin and allergy to gluten. The following drug history information was reported: Penicillin (Indication: -, Reaction: Allergy). The patient had no current illness. 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 not reported on 25-Sep-2015- unknown stop date, Batch no: not provided, Route of administration: not provided, Dose: no information provided. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On 25-Sep-2015, 1 day after starting/ treatment with AFLURIA the patient experienced some mental confusion (non serious, outcome: Unknown), Extreme dizziness (non serious, outcome: Unknown), Vomiting (non serious, outcome: Unknown), Slight headache at lower back of the neck (non serious, outcome: Unknown), Low fever (non serious, outcome: Unknown), Some tingling in extremities (non serious, outcome: Unknown), Blurred vision (non serious, outcome: Unknown). For relevant test results see appropriate report section.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Headache, Myalgia, Nausea
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 47 years old 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 22-Sep-2015 - unknown stop date, Batch no: 11049211A, Route of administration: Intramuscular, Dose: Site: left arm. No additional drugs suspected. On 22-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced Dizzy, Headache, N (and V), (N and) V, Sore throat, Fever 101, Achy muscles, No energy times 2 days. For relevant test results see appropriate report section. Reporter's assessment: Non serious. VAERS ID: 597479. Case correction (04-Mar-2016): Assessment for AE 5 (sore throat) changed to unlisted.