chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Nuclear magnetic resonance imaging normal, Pyrexia, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: biopsy-proven disseminated Zoster. treated with valacyclovir, responding well.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: biopsy-proven disseminated Zoster. treated with valacyclovir, responding well.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: LEFT UPPER ARM RED, WARM, SWOLLEN AT INJECTION SITE.
Age: 1.11
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Irritability, Pallor, Rash erythematous, Rash maculo-papular, Respiratory tract congestion
Clinical narrative: Fussy, congestion, rash (prominent 3-5mm maculopapular rash that are erythematous and blanching with 'stuck-on' appearance over face and trunk. No involvement of palms/soles).
Age: 1.89
Sex: F
Vaccine: IPV
Symptoms: Crying, Decreased appetite, Fatigue, Irritability, Pain in extremity
Clinical narrative: Fever ranging 101.9-102.7, Fussiness, Aching legs, Tired, loss of appetite, wouldn't bare weight, kept telling me "owie feet" and crying.
Age: 1.89
Sex: F
Vaccine: IPV
Symptoms: Pyrexia, Weight bearing difficulty
Clinical narrative: Fever ranging 101.9-102.7, Fussiness, Aching legs, Tired, loss of appetite, wouldn't bare weight, kept telling me "owie feet" and crying.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Appendicitis perforated, Decreased appetite, Diarrhoea, Small intestinal obstruction, Surgery
Clinical narrative: 06/27/15 Child was brought to urgent care with decreased appetite, diarrhea and vomiting. Transported to ER via 911. Admitted at hospital. Dx-small bowel obstruction. 06/28/15-Transferred to another hospital undergone surgical intervention due to ruptured appendicitis.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: 06/27/15 Child was brought to urgent care with decreased appetite, diarrhea and vomiting. Transported to ER via 911. Admitted at hospital. Dx-small bowel obstruction. 06/28/15-Transferred to another hospital undergone surgical intervention due to ruptured appendicitis.
Age: 0.85
Sex: U
Vaccine: FLUX
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This non-serious medically confirmed report (initial receipt 03-SEP-2014) concerns a 10 month and 6 day old patient. On the 05-OCT-2011, the patient received influenza injectable trivalent vaccine (manufacturer and batch number not provided). The patient was 10 months and 6 days old. Outcome was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This non-serious medically confirmed report (initial receipt 09-Oct-2013) concerns a patient in the 80's. On the 27-Sep-2013, the patient received AFLURIA (batch number not reported). On the 09-Oct-2013, the patient received a 2nd dose of AFLURIA. No adverse effects were reported. Outcome was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: This non-serious medically confirmed report (initial receipt 10-Sep-2014) concerns a female patient. On an unspecified date, 6 years ago, the patient received a flu shot (manufacturer and batch number not reported). On an unspecified date after receiving the vaccine, the patient developed hives. Outcome was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: This consumer spontaneous report (initial receipt 10-Sep-2014), concerns a female patient, who had a medical history of two brain injuries and five unspecified chronic conditions, and had drug reactions/allergies of penicillin, latex, chlorine, silicone, acetaminophen, codeine and ezetimibe. The patient was taking concomitant medications of phenytoin, clonazepam, sertraline, salbutamol sulphate and montelukast. On an unspecified date, the patient received unspecified influenza vaccine (manufacturer and batch number not reported). On an unspecified date, the patient experienced a mild reaction after receiving the unspecified flu vaccine. The outcome was unknown.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site extravasation
Clinical narrative: This spontaneous medically confirmed report (initial receipt 12-SEP-2014) concerns a 32-year-old male patient. The patient had a medical history of diabetes. On 12-SEP-2014, the patient received intramuscular AFLURIA (batch number T50407, expiry date 30-JUN-2015) at 0.5 ml. On 12-SEP-2014, while removing the needle from the patient's arm, some of the vaccine came out of the injection site and ran down the patient's arm. This resulted in the patient not receiving a full dose of vaccine. The patient did not experience any adverse reaction due to the event. The outcome was not reported. Reporter's comments: The reporter assessed the events as non-serious.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This non-serious medically confirmed report (initial receipt 11-SEP-2014) concerns a 59-year-old female patient. The patient tolerated AFLURIA in the past. on 11-SEP-2014, the patient received subcutaneus AFLURIA (batch number T58006, expiry date 06-JUN-2015) 0.5 ml. On 11-SEP-2014, after receiving the vaccine, the patient noted that the vaccine was administered with 5/8 inch needle. The patient suspected that she received a subcutaneous dose of the vaccine. No adverse reaction was experienced since the administration of vaccine. The outcome was recovered on 11-SEP-2014. Reporter's comments: The reporter assessed the events as medication error, non-serious and unrelated to the influenza vaccine.  Batch record review for lot T580096 noted: Batch records and QA batch review checklists for the seed lot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seed lot, MPH, formulated bulk vaccine and finished product lot T58006 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seed lot, MPH, formulated bulk vaccine and finished product process stages associated with lot T58006 were reviewed, and all results were satisfactory with no out of specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically derived process control limits. In conclusion, there were no batch related issues identified that may have caused the adverse events reported.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous medically confirmed report (initial receipt 13-SEP-2014) concerns a 54-year-old male patient. On 13-SEP-2014, the patient received intramuscular AFLURIA (batch number T57305, expiry date MAY 2015) at a dose of 0.5 ml. On 13-SEP-2014, immediately after the injection, the patient developed a large red and swollen area at the injection site. The pharmacist applied ice to the area which lessoned the reaction and helped to reduce some of the swelling. The outcome was reported as not yet recovered. Reporter's comments: The reporter assessed the events as non-serious and considered the causality as probable with the use of AFLURIA.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pruritus, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: This non-serious medically confirmed report (initial receipt 13-SEP-2014) concerns a 62-year-old female patient. On 13-SEP-2014, the patient received intramuscular AFLURIA (batch number T57305, expiry date AUG-2015) at a dose of 0.5 ml. On 13-SEP-2014, immediately after administering the injection, the patient was scratching her arm in the waiting   area of the pharmacy. The pharmacist discovered that the patient had an itchy red rash and hives on the arm of the injection site. No other adverse reactions like shortness of breath or swelling were noted. The rash and hives were spreading quickly. The patient was treated with Epipen and the rash disappeared 10 minutes after the injection of epinephrine. The outcome was reported as recovered on 12-SEP-2014. Reporter's comments: The reporter assessed the events as non-serious and considered the causality as probably with the use of AFLURIA.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: This non-serious medically confirmed report (initial receipt 17-SEP-2014) concerns an approximately 50 year old female patient who was generally healthy with no co-morbidities. The patient had received flu vaccines in the past. On the 17-SEP-2014, the patient received the AFLURIA  vaccine (batch number not reported) 0.5 ml via the intramuscular route. The pharmacist who was administering the vaccine on the 17-SEP-2014 stated that she was unable to depress the plunger from the pre-filled syringe. The syringe plunger stopped moved and the pharmacist (who had administered vaccines before) was afraid to use the additional force. The pharmacist removed the syringe and could still see visible liquid in the syringe. The patient did not receive the full amount of intended vaccine. The patient appeared fine and remained in the pharmacy at least another 10 minutes with no problems, in which the patient's appeared fine and remained in the pharmacy at least another 10 minutes with no problems, in which the patient's husband received the AFLURIA injection from the same box without any issues. The patient was not re-vaccinated. Outcome was recovered.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Influenza like illness, Injection site erythema, Nasopharyngitis
Clinical narrative: This non-serious spontaneous consumer report (initial receipt 17-SEP-2014) concerns a 50-year-old male patient. The patient had a medical history of allergy to pollen and dust. Approximately in SEP-2013, the patient received FLUZONE and had experienced flu-like symptoms (same as that experienced this year). The patient reported to have experienced more achiness in the joints with FLUZONE and not with AFLURIA. He had no drug allergies. On 15-SEP-2014, the patient received intramuscular AFLURIA (batch number not provided) at 0.5 ml. On 15-SEP-2014, approximately four hours after AFLURIA pre-filled syringe administration, the patient experienced flu-like symptoms which included post-nasal drip, redness at the injection site (not persistent) and extreme fatigue. The patient took three ibuprofen (ADVIL) on the night of AFLURIA administration because he had a feeling that he was coming down with cold. The patient also experienced red eyes (not persistent). He stated that 90 percent of the symptoms had subsided but the post-nasal drip and fatigue were persisting. The outcome was reported as not yet recovered, however the red eyes and redness at the injection site were not persisting. Reporter's comments: The reporter assessed the events as non-serious.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Upper-airway cough syndrome
Clinical narrative: This non-serious spontaneous consumer report (initial receipt 17-SEP-2014) concerns a 50-year-old male patient. The patient had a medical history of allergy to pollen and dust. Approximately in SEP-2013, the patient received FLUZONE and had experienced flu-like symptoms (same as that experienced this year). The patient reported to have experienced more achiness in the joints with FLUZONE and not with AFLURIA. He had no drug allergies. On 15-SEP-2014, the patient received intramuscular AFLURIA (batch number not provided) at 0.5 ml. On 15-SEP-2014, approximately four hours after AFLURIA pre-filled syringe administration, the patient experienced flu-like symptoms which included post-nasal drip, redness at the injection site (not persistent) and extreme fatigue. The patient took three ibuprofen (ADVIL) on the night of AFLURIA administration because he had a feeling that he was coming down with cold. The patient also experienced red eyes (not persistent). He stated that 90 percent of the symptoms had subsided but the post-nasal drip and fatigue were persisting. The outcome was reported as not yet recovered, however the red eyes and redness at the injection site were not persisting. Reporter's comments: The reporter assessed the events as non-serious.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Eye irritation, Fatigue, Influenza like illness, Respiratory tract congestion
Clinical narrative: This spontaneous consumer report (initial receipt 17-SEP-2014) concerns a 58-year-old female patient. On 15-SEP-2014, the patient received intramuscular AFLURIA (batch number not provided) at 0.5 ml. On 15-SEP-2014, approximately four hours after AFLURIA pre-filled syringe  administration, the patient experienced flu-like symptoms which included congestion, burning and feverish eyes, heavy fatigue and achy joints. The outcome was reported as recovered on 17-SEP-201. Reporter's comments: The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 18-Sep-2014) concerns female patient. On 16-Sep-2014, the patient received intramuscular AFLURIA (batch number not provided) at 0.5 ml. On 16-Sep-2014 the patient had an allergic reaction to AFLURIA. The outcome was reported as unknown.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Peripheral swelling
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 18-Sep-2014) concerns 45-year-old female patient. No vaccine was given concomitantly. The patient received a Flu vaccine last year (identity unknown) without complaints. On 16-Sep-2014, the patient received intramuscular AFLURIA, (batch number not provided) at 0.5 ml. On 16-Sep-2014, the patient had an allergic reaction AFLURIA. She developed redness at the injection site and swollen arm on the arm of AFLURIA injection. The outcome was reported as unknown. Reporter comments: The reporter stated that the events were due to AFLURIA.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Fatigue, Influenza like illness, Pain, Pain in extremity
Clinical narrative: This spontaneous consumer report (initial receipt 19-SEP-2014) concerns a female patient. The patient had a medical history of suppressed immune system and colitis. She had drug reaction/allergies to amoxicillin, sulfa, metronidazole, infliximab and azathioprine. The patient received flu shot in 2008 and experienced same symptoms (refer to case 2014045212). On an unspecified date in 2013, the patient received flu shot (manufacturer and batch number not provided) in the opposite arm. She  concomitantly received PNEUMOVAX23 (batch number: J007059). On an unspecified date in 2013, on the second day after vaccination, the patient experienced body aches, 103 degree temperature, fatigue and general flu like symptoms that lasted for about a day. her arm was sore for two days.  The outcome was recovered. Reporter's comments: The reporter stated that the patient experienced same symptoms after each PNEUMOVAX23 injection.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, No adverse event, Syringe issue
Clinical narrative: This spontaneous medically confirmed report (initial receipt 22-SEP-2014) concerns a 58-year-old female patient. The patient had a medical history of allergy to latex. On 22-SEP-2014, the patient received intramuscular AFLURIA (batch number T59306) at a dose of 0.5 ml. On 22-SEP-2014, immediately after administration (around 8:00 PM), the pre-filled syringe shattered. No harm occurred to the patient after AFLURIA administration. The reporter had inspected the AFLURIA pre-filled syringe before administration and there was nothing about the appearance of the pre-filled syringe that could identify the shattering ability. Outcome was reported as unknown. Reporter's comments: The pharmacist stated that the shattering was caused by the syringe and not due to the technique.
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site swelling, Nasopharyngitis, Rhinorrhoea
Clinical narrative: This spontaneous medically confirmed report (initial receipt 23-SEP-2014) concerns a female patient. The patient had a medical history of allergy to "ampillin". The patient was not pregnant and was not receiving any concomitant blood thinners, diabetes medications or steroids. The patient received influenza shots in the past (for 10 years), without any reactions. On 11-SEP-2014, the patient received intramuscular AFLURIA injection (batch number T57005) in the left arm at a dose of 0.5 ml annually. On 11-SEP-2014, after vaccination, the patient developed a black marking. The patient developed a raised marking in the vaccine's injection site. The patient had a very fair skin and this was the first time it was noticed, therefore it may/may not have been there entire time. The marking was described as the head of an Energizer battery. It was black in color and about the size of a dime. It was not painful to touch. The marking does not appear red and there was no abscess or fluid. The patient could see the injection site where a black pinpoint was visible. There was no bruise. The patient had no fever or signs of infection. On 13-Sep-2014, the patient developed cold symptoms (runny nose) that resolved itself. The pharmacist reported that the patient might have received flu before the flu shot and it was manifesting now. As of 23-Sep-2014, the black marks had not faded or increased/decreased in size. The outcome was reported as not yet recovered.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue
Clinical narrative: This medically confirmed health authority (initial receipt 537914) concerns 52 year-old male patient. The patient had medical history of mild reactive airway disease (RAD), intermittent asthma (x12 years), actinic keratosis, suspected glaucoma (in 2011, the patient wads unclear with the exact nature of this ocular condition which was followed annually), herpes zoster ophthalmicus (17-OCT-2011) involving lesions on left side of his face, eyelid and left side of his scalp, chicken pox (when he was three months old), male pattern baldness (stated that his hair were thinning) and benign lipoma right shoulder (in SEP-2011). The patient's concomitant medication included salbutamol. On 24-MAY-2013, the patient received an influenza vaccination (TIV) (manufacturer or batch number not reported) as a condition of employment. On an unspecified date, about 10 days after vaccination, the patient developed fatigue which lasted for about 2 weeks. On 13-SEP-2013, the patient received intramuscular AFLURIA (batch number 08649211A) in the right arm (refer to case 2014045233). The outcome was recovered.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Erythema, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 19-JAN-2015) concerns a 60 year-old female patient who had AFLURIA last year (2013) without any issues. On 11-OCT-2014, the patient received intramuscular AFLURIA (batch number 10049221B). It was unknown which arm AFLURIA was injected as per the patient's medical chart. On an unspecified date in OCT-2014, the patient experienced arm pain and visited an urgent care centre for the arm pain. The patient was treated with cephalexin and hydrocortisone cream. On 10-DEC-2014, the patient visited the family medical practice and complained of arm pain which was only at the injection site, not both arms. The patient described she had difficulty lifting her arm and this is the fist time she had issues with AFLURIA. The patient also had swelling, redness and discomfort. The outcome was not yet recovered. Reporter's comments: The reporter was not aware of the patient's past medical history of arm injuries or if patient received multiple injections on 11-OCT-2014. The reporter assessed the events as related to AFLURIA.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 19-JAN-2015) concerns a 60 year-old female patient who had AFLURIA last year (2013) without any issues. On 11-OCT-2014, the patient received intramuscular AFLURIA (batch number 10049221B). It was unknown which arm AFLURIA was injected as per the patient's medical chart. On an unspecified date in OCT-2014, the patient experienced arm pain and visited an urgent care centre for the arm pain. The patient was treated with cephalexin and hydrocortisone cream. On 10-DEC-2014, the patient visited the family medical practice and complained of arm pain which was only at the injection site, not both arms. The patient described she had difficulty lifting her arm and this is the fist time she had issues with AFLURIA. The patient also had swelling, redness and discomfort. The outcome was not yet recovered. Reporter's comments: The reporter was not aware of the patient's past medical history of arm injuries or if patient received multiple injections on 11-OCT-2014. The reporter assessed the events as related to AFLURIA.
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Chest X-ray normal, Cough, Fatigue, Malaise, Pain in extremity
Clinical narrative: This medically confirmed report received via a sales representative (initial receipt 26-MAR-2014) concerns a female patient. Her current illness was reported as prophylaxis. On an unspecified date, the patient received a high dose flu vaccine (manufacturer and batch number not reported), ZOSTAVAX  (batch number J000429, expiry date 10-APR-2014) and PNEUMOVAX (batch number J007059, expiry date: 14-JUL-2014) on the same day. On an unspecified date following the administration of the vaccines, the patient developed a cough, felt fatigued and felt sick. Her lungs hurt from the coughing. The patient developed pain in her arm. The patient sought medical attention and went for a chest x-ray, in which the results were negative. Outcome was not reported. Reporter's comments: The health authority assessed the case as non-serious. Causality assessment was not provided. The authority reported term was "chest x-ray normal".
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Pulmonary pain
Clinical narrative: This medically confirmed report received via a sales representative (initial receipt 26-MAR-2014) concerns a female patient. Her current illness was reported as prophylaxis. On an unspecified date, the patient received a high dose flu vaccine (manufacturer and batch number not reported), ZOSTAVAX  (batch number J000429, expiry date 10-APR-2014) and PNEUMOVAX (batch number J007059, expiry date: 14-JUL-2014) on the same day. On an unspecified date following the administration of the vaccines, the patient developed a cough, felt fatigued and felt sick. Her lungs hurt from the coughing. The patient developed pain in her arm. The patient sought medical attention and went for a chest x-ray, in which the results were negative. Outcome was not reported. Reporter's comments: The health authority assessed the case as non-serious. Causality assessment was not provided. The authority reported term was "chest x-ray normal".
Age: 43.0
Sex: F
Vaccine: FLUC3
Symptoms: Flushing, Injection site erythema, Urticaria, Vaccination site pain, Vaccination site reaction
Clinical narrative: Case number PHEH2013US021884 in an initial spontaneous report received from a consumer (health care professional) on 16 OCT 2013. This report refers to a 43-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly on 14 OCT 2013. On the same date, she began to experience hives and flushing on her face and neck. Her vaccination site about the size of a 3x5 inch card became swollen,  hot, red and very painful. The outcome of the events was reported as condition unchanged. No further information was provided.
Age: 43.0
Sex: F
Vaccine: FLUC3
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHEH2013US021884 in an initial spontaneous report received from a consumer (health care professional) on 16 OCT 2013. This report refers to a 43-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly on 14 OCT 2013. On the same date, she began to experience hives and flushing on her face and neck. Her vaccination site about the size of a 3x5 inch card became swollen,  hot, red and very painful. The outcome of the events was reported as condition unchanged. No further information was provided.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This non-serious medically confirmed spontaneous (initial receipt 16-JAN-2015) concerns an unknown demographics patient. On 23-SEP-2014, the patient received intramuscular AFLURIA (batch number T58806) 0.5 ml once. On an unspecified date, the patient began experiencing soreness and swelling at the injection site shortly after receiving the vaccine which persisted at the time of reporting. The outcome was not yet recovered. Reporter comments: The reporter assessed the events as non-serious.
Age: 12.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US021111 is an initial spontaneous report received from a health care professional on 08 OCT 2013. This report refers to a 12-year-old patient of unknown gender who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly on 07 OCT 2013. No adverse event was reported following this administration error.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure via direct contact, No adverse event, Syringe issue, Underdose
Clinical narrative: This non-serious medically confirmed report (initial receipt 13-OCT-2014) concerns a 61 year old female patient. ON the 10-OCT-2014, the patient received AFLURIA (batch number: T57005) 0.5 ml annually via the intramuscular route. As the pharmacist was preparing and administering the AFLUIRA injection, while pressing the plunger of the vaccine's syringe, the solution leaked from the syringe and went down the patient's arm. The pharmacist checked the syringe and was positive that everything was tightly screwed in. The syringe appeared different from other syringe, the pharmacist was not sure if the patient received the correct dose. The patient was fine and would return to the pharmacy for re-vaccination. Outcome was unknown.
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 06-OCT-2014) concerns a male patient. On 06-OCT-2014, the patient was administered excursioned AFLURIA (batch number: T50507). AFLURIA pre-filled syringe was kept at 57 degrees Fahrenheit for 48 hours and was administered to the patient. Outcome was not reported. Reporter's comments: The reporter believed that the patient was fine.
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Lymphadenopathy
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a female adult patient. On an unspecified date in 2013, the patient received AFLURIA injection (batch number not provided). On an unspecified date following the vaccination, the patient experienced swelling of lymph nodes and pain in collar bone area. The outcome was not reported. Linked to case 2015048070.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash and urticaria pruritis.
Sex: F
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a female patient. On an unspecified date in 2013, the patient received a flu vaccine (manufacturer and batch number not reported). On an unspecified date in 2013, the patient developed a headache that lasted one month. Outcome was not reported Linked to 2015048093
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: The patient believed that he did not receive the full 0.5 ml AFLURIA dose because some liquid was leaking from the syringe. The patient was fine. The nurse administering the vaccine stated the patient received the full dose, the syringe was not leaking. Outcome was not reported. Reporter's comments: The reporter stated that the patient was fine.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site urticaria, Pruritus
Clinical narrative: This non-serious medically confirmed report (initial receipt 03-OCT-2014) concerns a 78 year old non-pregnant female patient. On the 26-SEP-2014, the patient received AFLURIA (batch number 10248111A) 0.5 ml annually. On the 26-SEP-2014, the patient immediately afterwards experienced a wheal at the injection site with redness and itching This spread to the rest of the arm and across the chest. The patient's primary health care provider was aware and the patient had returned so the reaction could be evaluated. Outcome was unknown.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: This non-serious medically confirmed report (initial receipt 03-OCT-2014)  concerns a 39 year old female patient. On the 11-SEP-2014 at 16:00, the patient received AFLURIA (batch number 10249211A) 0.5 ml annually via the intramuscular route. ON the 11-SEP-2014 at 18:00, two hours later, the patient experienced a wheal at the injection site, with redness and itching. The patient took paracetamol which helped alleviate the symptoms. The symptoms  resolved midday within 24-28 hours. Outcome was recovered on 13-SEP-2014
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: This medically confirmed spontaneous report (initial receipt 03-OCT-2014) concerns a 40-year-old female patient. On 17-SEP-2014 at 10:00 AM, the patient received AFLURIA injection (batch number: 10249211A) at 0.5 ml annually via intramuscular route. On 17-SEP-201, one hour after vaccination, the patient experienced a wheal at injection site with redness and itching. The patient had not sought treatment. The symptoms resolved next morning. The outcome was reported as recovered on 18-SEP-2014.
Sex: F
Vaccine: FLU3
Symptoms: Exposure via direct contact, Eye irrigation, Syringe issue
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 03-OCT-2014) concerns a female patient (nurse). On 03-OCT-2014, the patient received AFLURIA (batch number not provided). On 03-OCT-2014, the vaccine was withdrawn into the syringe. During the administration, the needle came off the syringe and the serum sprayed into the administering nurse's eye. The nurse went into the restroom to flush out her eye. Her eyes seemed fine and there was not a problem at the time of reporting. Outcome was unknown.  Linked to TC-1165 (patient report).
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious medically spontaneous report (initial receipt 02-OCT-2014) concerns a four years and 6 months old male patient. On 26-SEP-2014, the patient received AFLURIA (batch number not provided) 0.5 ml. Outcome was unknown. Reporter's comments: This was discovered during a hospital audit database. The reporter believed the child was fine and he has not returned to the institution.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 02-OCT-2014) concerns an 81-year-old male patient. On 02-OCT-2014, the patient received excursioned AFLURIA (batch number: 09949211A) via intramuscular route. The AFLURIA multidose vial was kept in room temperature for about 12-14 hours. The refrigerator temperature read 55 degree Fahrenheit, but the reporter did not believe that it was accurate. Outcome was not reported. Reporter's comments: The reporter stated that th patient was fine.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: This medically confirmed spontaneous report initial receipt (13-JAN-2015) concerns a 3 year old male patient. The patient received seasonal influenza vaccine in the past and was able to tolerate the previus vaccination: on 16-JAN-2014, the patient received FLUZONE and a booster of FLUZONE (batch number U4712AA) on 03-MAR-2014. There was no reports of patient harm after receiving FLUZONE. The patient was not taking any other medication, vitamins or herbal supplements. On 13-JAN-2014 at 11:00 AM, the patient received intramuscular AFLURIA (batch number T50307) at 0.5 ml. The same day, the patient also received Hep A vaccine (batch number not reported). Both the vaccines were administered on different shoulders.  On 13-JAN-2015, the patient developed fever at 103F with associated vomiting and shivering/chills that started the night after AFLURIA administration. The temperature was taken by the thermometer orally and axillary. The patient was treated with acetaminophen (Children's Tylenol) to help reduce fever. The outcome was reported as recovering (improved). Reporter comments: The patient required consultation with a doctor. No review at hospital emergency department or hospital was done.
Sex: F
Vaccine: FLU3
Symptoms: Injury, Syringe issue
Clinical narrative: This medically confirmed spontaneous report (initial receipt 02-OCT-2014) concerns a female patient. On 30-SEP-2014, the patient was administering AFLURIA pre-filled syringe (batch number: T57606) to a student. During the administration, AFLURIA syringe hub broke. The nurse was believed to be injured as she filed an incident report. The reporter believed that there was no administrative error from the nurse. Outcome was not reported.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Headache, Pain, Rash, Skin warm
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 71 year-old female patient who had no known current illness at the time of vaccination. Her medical history included allergy to salicylate. Concomitant medications included methocarbamol, levothyroxine and phenytoin. On 02-OCT-2014, the patient received intramuscular AFLURIA (batch number T58906) in the right arm. ON 02-OCT-2014, the night of the vaccination, the patient developed a headache. ON 03-OCT-2014, the patient developed swollen, burning rash one inch below the injection site. The rash was hot to touch and painful when touched. Patient stated that it did not itch. The outcome was unknown. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 71 year-old female patient who had no known current illness at the time of vaccination. Her medical history included allergy to salicylate. Concomitant medications included methocarbamol, levothyroxine and phenytoin. On 02-OCT-2014, the patient received intramuscular AFLURIA (batch number T58906) in the right arm. ON 02-OCT-2014, the night of the vaccination, the patient developed a headache. ON 03-OCT-2014, the patient developed swollen, burning rash one inch below the injection site. The rash was hot to touch and painful when touched. Patient stated that it did not itch. The outcome was unknown. Reporter's comments: The regulatory authority assessed the case as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This medically confirmed spontaneous report (initial receipt 29-SEP-2014) concerns a female patient. On 16-SEP-2o14, the patient received AFLURIA (batch number not provided). On an unknown date, two days post vaccination, the patient experienced aching pain in her whole left arm which was not just at the injection site. The patient treated herself with naproxen but it did not work. The patient will try using Advil (ibuprofen) for the pain. Outcome was reported as unknown.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 30-SEP-2014) concerns a 53-year-old male patient. On 30-SEP-2014, the patient received AFLURIA (batch number T50507) less than 0.5 ml once intramuscularly. AFLURIA had been stored correctly,. On 30-SEP-2014, during the vaccination, the plunger was depressed completely as the vaccine entered into the patient's arm. After removing the syringe from the patient's arm, the reporter noticed that there was still vaccine in the syringe despite the plunger was depressed completely. The plunger of the pre-filled syringe could not be manipulated further to expel the remaining vaccine. This resulted the patient not receiving a full 0.5 ml dose of the vaccine. The patient did not experience any adverse reactions due to administration. Outcome was reported as recovered on 30-SEP-2014. Reporter's comments: The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Injection site extravasation, No adverse event, Underdose
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 30-SEP-2014) concerns a female patient. On 30-SEP-2014, the patient received AFLURIA (batch number T50707)  less than 0.5 ml once intramuscularly. AFLURIA had been stored correctly. ON 30-SEP-2014, while the nurse was administering the vaccine into the patient's arm, the nurse noticed that some of the vaccine came out of the injection site. Consequently, the patient did not receive the whole dose of vaccine. No adverse reactions have been reported since administration Outcome was reported as received on 30-SEP-2014. Reporter's comments: The reporter assessed the case as non-serious.
Age: 1.58
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: This consumer report (initial receipt 08-Oct-2014) concerns a 1 year and 7 months old female patient who had not received H1N1 vaccine. On 07-Oct-2014, the patient received intramuscular AFLURIA, (batch number not reported) at 0.5 ml. On 08-Oct-2014, 05:00 AM, the patient developed fever at 101.3 degree Fahrenheit (measured via mouth). The fever went down to 101 degree Fahrenheit after the administration of TYLENOL. One hour later, the patient received MOTRIN and the fever was reduced to 99 Fahrenheit. The fever persisted with no other associated symptoms and no seizures occurred. The patient did not consult with the doctor, or presented at the emergency department or hospital. The outcome was reported as not yet recovered.
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: This medically confirmed spontaneous report (initial receipt 26-SEP-2014) concerns a female patient. On 24-SEP-2014, the patient received AFLURIA (batch number not provided) intramuscularly. On 24-SEP-2014, the patient experienced a rash all over her body. The patient's primary care provider was aware and gave her something to treat the rash. She felt much better on 26-SEP-2014. Outcome was reported resolving on 26-SEP-2014.  Reporter's comments: The reporter assessed the causality as possible in relation to AFLURIA.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Pain, Pain in extremity
Clinical narrative: This medically confirmed spontaneous report (initial receipt 26-Sep-2014) concerns a 82 year-old female patient who had a FLUZONE flu shot last year and was fine. On 19-Sep-2014, the patient received AFLURIA (batch number T5930, 0.5mL x 1) intramuscularly in the left arm for the prevention of influenza. No other injections were given. On 19-Sep-2014, the patient experienced pain at the injection site (left arm) when she visited the pharmacy on 26-Sep-2014. She also reported that she had been experiencing the pain for a week now, since she got the AFLURIA shot. Her arm was extremely sore and painful. The pain was dull, but hurts the patient to the point where she was not able to sleep at night. She did not specify what makes the pain better or worse. Outcome was reported ongoing.
Age: 49.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Back pain, Injection site pain, Neck pain, Pain in extremity, Pruritus
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt: 15-Sep-2014) concerns a 49-year-old female patient. The patient's concomitant medication topiramate, VICODIN, hydrochlorothiazide, omeprazole, colestipol, 'Klcon' and daily vitamins. On 23-Aug-2013, the patient received intramuscular AFLURIA (batch number R52206) and intramuscular ADACEL, both in the left arm. On 01-Feb-2014, the patient experienced severe pain in the arm, neck and back. The pain in the arm area where the shots were given goes up to shoulder. The patient cannot sleep on that side and cannot reach for anything with that arm. The pain was getting bad. The patient underwent an X-ray which showed itching. The patient wondered if there was nerve damage. The outcome was reported as missing.
Age: 49.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: X-ray abnormal
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt: 15-Sep-2014) concerns a 49-year-old female patient. The patient's concomitant medication topiramate, VICODIN, hydrochlorothiazide, omeprazole, colestipol, 'Klcon' and daily vitamins. On 23-Aug-2013, the patient received intramuscular AFLURIA (batch number R52206) and intramuscular ADACEL, both in the left arm. On 01-Feb-2014, the patient experienced severe pain in the arm, neck and back. The pain in the arm area where the shots were given goes up to shoulder. The patient cannot sleep on that side and cannot reach for anything with that arm. The pain was getting bad. The patient underwent an X-ray which showed itching. The patient wondered if there was nerve damage. The outcome was reported as missing.
Sex: U
Vaccine: FLUX, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site nodule, Rash morbilliform, Rash rubelliform
Clinical narrative: This medically confirmed spontaneous report (initial receipt 17-OCT-2014) was received via a sales representative and involves an infant. On an unspecified date, the patient received a flu vaccine (manufacturer and batch number not reported), MMR II (batch number J014875) via the subcutaneous route, VARIVAX (batch number not reported), PREVNAR (batch number not reported) and HIB (batch number not reported). ON an unspecified date, the patient developed an MMR-like rash over the back and truck area. It was not specified whether the rash looked like measles, mumps or rubella specifically. The patient also developed a node at the injection site. Outcome was not recovered.
Age: 1.0
Sex: F
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: This non-serious medically confirmed report (initial receipt 17-Oct-2014) concerns a one year old female patient. The patient's daycare centre reported a possible case of chickenpox in another child attending daycare. On the 07-Oct-2014, the patient received an unspecified influenza vaccine (manufacturer and batch number not reported), HAVRIX (batch number not reported), MMR II (batch number not reported) and VARIVAX (batch number not reported) 0.5mL via the subcutaneous route for vaccination. On the 08-Oct-2014, the patient developed two red raised bumps on her face. On the 09-Oct-2014, the patient developed one raised red bump on her chest. Outcome was not recovered.
Age: 69.0
Sex: U
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Myalgia, Pain, Pain in extremity
Clinical narrative: This non-serious consumer report (initial receipt 14-Oct-2014) concerns a 69 year old female patient who received the flu shot for the past ten years. The patient visits her doctor annually for check ups. On the 20-Sep-2014, the patient received AFLURIA (batch number not reported) for the prevention of influenza in the left arm. About three weeks prior to the 14-Oct-2014, the patient developed sharp pains across the back shoulder when lying down. The patient described it as a twang. The patient was not horrible and was not a big deal however did not go away. Initially the patient thought the she had slept in an awkward position but knew something was wrong because her back muscles continued to feel sore. Recently, the pain left her back region and radiated down her left arm towards her fingertips. Treatment included topical BENGAY to treat the pain at night only which somewhat helped. When putting on a shirt, she only used her right arm because she felt sharp pain when raising the left arm above her head. This is the first time she has experienced this after the flu shot. Outcome was not recovered.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Urticaria
Clinical narrative: This non-serious medically confirmed report (initial receipt 13-Oct-2014) concerns a 50 year old female patient who had a medical history of chronic sinus disorder and allergies. Her concomitant medications included an unknown sinus/congestion medications and an unknown medication for hot flashes. The patient had the flu vaccine in the past. On the 08-Oct-2014 during the school day (mid-day), the patient received AFLURIA (batch number T59607) 0.5 mL annually via the intramuscular route for the prevention of influenza. AFLURIA was stored correctly. On the 08-Oct-2014, later that evening when the patient arrived home from work, the patient broke out in hives. On Friday 10-Oct-2014, the patient developed hoarseness. Later on Friday, the patient sought medical treatment from her primary care provided. Treatment included a steroid shot. The doctor told the patient that it may had been a potential drug interaction because this is the first time the patient was on the unknown sinus/congestion medication and unknown medication for hot flashes (it was unknown when the patient commenced these medications). After the injection, the hives and hoarseness resolved. The patient was fine on the 13-Oct-2014. Outcome was recovered on 10-Oct-2014.
Sex: M
Vaccine: FLUX
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious medically confirmed report (initial receipt 13-Oct-2014) concerns a male patient. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported) via the intramuscular route for the protection against seasonal influenza virus. The patient received only a partial dose of the vaccine. No adverse reaction was reported. Outcome was recovered.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This non-serious medically confirmed report (initial receipt 13-Oct-2014) concerns a 48 year old female patient who had no relevant medical history. On the 13-Oct-2014, the patient received AFLURIA (batch number T51108) 0.5 mL once via the intramuscular route for protection against seasonal influenza virus. The vaccine that was administered was stored at about 70F for 72 hours, which was a medication error. No adverse reaction had been reported since administration. Outcome was reported as recovered.
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: This non-serious medically confirmed report (initial receipt 13-Oct-2014) concerns a female patient who has an allergy to tree nuts and oils. On an unspecified date, the patient received AFLURIA (batch number not reported) for the prevention of influenza. On an unspecified day after receiving AFLURIA vaccine, the patient developed an hives and urticarial reaction (hives) at the injection site. The doctor did not treat the hives and it resolved by itself in 24 hours. Outcome was recovered.