chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Nausea, Pyrexia, Swelling, Tenderness
Clinical narrative: 0.5 mL given IM in left deltoid at approximately 8:30 am. There was a large localized reaction on the LA-erythema, swelling, and tenderness. Subjective fever, afebrile today. Nausea, malaise, HA, arthralgia, severe left shoulder pain, decreased ROM. Circle drawn around spot, told to return if extends. Told to ice and use BENADRYL prn.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 08-MAY-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent an unkonwn number of excursion hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Age: 14.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Registered Nurse referring to a 14 year old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 20-JUL-2015 the patient was inadvertently vaccinated with ZOSTAVAX (lot#, dose, route not reported) instead of VARIVAX. Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from an unspecified health professional via other company (#64664) referring to a 50 year old male patient. Information regarding relevant medical history and concurrent condition were not reported. On 21-MAY-2015, the patient was vaccinated with PNEUMOVAX 23 (dose and route not reported, lot # K020215, expiration date 31-MAY-2016) at a regular office visit. Information regarding concomitant medications was not reported. The patient called the office on 22-MAY-2015 to report that he could barely move his arm and he was in a lot of pain. This was the same arm he received the PNEUMOVAX 23. It was not swollen or red. The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Information has been received from an unspecified health professional via other company (#64664) referring to a 53 year old female patient. Information regarding relevant medical history and concurrent condition were not reported. On 11-MAY-2015 the patient was vaccinated with PNEUMOVAX 23 (dose and route not reported, lot # K020215, expiration date 31-MAY-2016) at routine office visit. When she received the vaccine, the patient's arm was extremely painful. She could not lift her arm. The patient was given DEPO-MEDROL shot for symptoms and was told to follow up if not better. The outcome of the events was unknown. This is one of several reports received from the same source Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning a 5 month old patient of unknown gender. On an unknown date at 5 months of age, the patient was vaccinated with their first dose of oral, ROTATEQ (dose and lot# not provided). No adverse experiences was reported. 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 registered nurse and refers to an unspecified number of patient of unknown age and gender. On unknown dates, since 01-JUN-2015, the patients were vaccinated with unspecified number of improperly stored doses of VARIVAX lot # K005426. No adverse effects were reported. The outcome of incorrect product storage was unknown. This case was linked to 1507USA010868 and 1507USA004524 as it was received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 08-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot was received from a registered nurse and refers to an unspecified number of patient of unkonwn age and gender. On unknown dates, since 01-JUN-2015, the patients were vaccinated with unspecified number of improperly stored doses of PROQUAD (Merck) lot # K025761. No adverse effects were reported. The outcome of incorrect product storage was unknown. This case was linked to 1507USA010869 and 1507USA004524 as it was received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. On 07-JUL-2015 the patient was vaccinated with improperly stored doses of PROQUAD (Merck) lot # K025761. No adverse effects were reported. The outcome of incorrect product storage was unknown. This case was linked to 1507USA010868 and 1507USA010869 as it was received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a 62 year old female patient. On the 19-Aug-2014, the patient received AFLURIA (batch number T58006) in the left arm. On the 19-Aug-2014, the patient developed swelling that started about six inches below the injection site and severe pain at the arm that was injected (left). The patient also developed redness. It was still going two days after administration. Outcome was not reported. Reporter comments: The regulator reported the case as non-serious. Batch record review for lot T58006 noted: Batch records and QA batch review checklists for the seedlot, 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 seedlot, 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 seedlot, MPH, formulated bulk vaccine and finished product 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. Follow-up (23-Apr-2015): Batch record review results.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a 54 year old female patient who had a medical history of Crohn's disease. On the 19-Aug-2014, the patient received AFLURIA (batch number T580060 dose 1 via the intramuscular route. On the 19-Aug-2014, on the day of the vaccination, the patient vomited. Outcome was unknown.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Anger, Asthenia, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a 39 year old female patient who had a medical history of ADD, a history of paraesthesia, paraparesis and PTSD. Concomitant medications included lisdexamfetamine and mirtazepine. The patient had developed left and right hand paralysis after a previous influenza vaccine (see 2014046401). On the 04-Sep-2014, the patient received AFLURIA (batch number T57606) dose 3, in the left arm via the intramuscular route. On the 04-Sep-2014, the patient developed pain and soreness in the left shoulder and arm area, weakness in the area surrounding the shot administration and limited range of motion. All of these lasted through the next day and were improving. The patient developed a noticeable mood problem of anger and irritability, same onset time and duration. This had not resolved. Outcome was not recovered.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Irritability, Mood altered
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a 39 year old female patient who had a medical history of ADD, a history of paraesthesia, paraparesis and PTSD. Concomitant medications included lisdexamfetamine and mirtazepine. The patient had developed left and right hand paralysis after a previous influenza vaccine (see 2014046401). On the 04-Sep-2014, the patient received AFLURIA (batch number T57606) dose 3, in the left arm via the intramuscular route. On the 04-Sep-2014, the patient developed pain and soreness in the left shoulder and arm area, weakness in the area surrounding the shot administration and limited range of motion. All of these lasted through the next day and were improving. The patient developed a noticeable mood problem of anger and irritability, same onset time and duration. This had not resolved. Outcome was not recovered.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Cough, Headache, Myalgia, Nausea
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-OCT-2014) concerns a 54 year old male patient. Concomitant medications included fluvoxamine. On the 05-SEP-2014, the patient received AFLURIA (batch number T56905) in the right arm via the intramuscular route. On the 05-SEP-2014, the patient developed a fever, joint and muscle pain (through the entire body), nausea, headache and cough. All symptoms lasted about 12 hours. Treatment included ibuprofen. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-OCT-2014) concerns a 54 year old male patient. Concomitant medications included fluvoxamine. On the 05-SEP-2014, the patient received AFLURIA (batch number T56905) in the right arm via the intramuscular route. On the 05-SEP-2014, the patient developed a fever, joint and muscle pain (through the entire body), nausea, headache and cough. All symptoms lasted about 12 hours. Treatment included ibuprofen. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Paraesthesia oral, Throat tightness
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a 24 year old male patient. Concomitant medications included paracetamol extra strength, a multi vitamin and fish oil. On the 06-Sep-2014, the patient received AFLURIA (batch number 'T59406') dose 1, in the left arm via the intramuscular route. On the 06-Sep-2014, the patient developed tingling lips, chest tightness, a course throat and a tight throat. The patient took 1000mg of paracetamol within an hour of getting the shot. Subsequently after lunch, he returned to the clinic and notified the staff of his symptoms. He was given 50mg of oral diphenhydramine. The patient's vital signs were stable and he was monitored. The patient had no other signs or symptoms of infection. Outcome was reported as recovered.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dry eye, Dysphonia, Eye pruritus, Fatigue
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a 62 year old female patient who had a medical history of hypertension, type 2 diabetes and intraocular hypertension. Concomitant medications included bimatoprost, dorzolamide, timolol, metformin, metoprolol and lisinopril. The patient developed a fever with a previous influenza seasonal vaccine (2014046404). On the 06-Sep-2014, the patient received AFLURIA (batch number '33332001401') in the left arm via the intramuscular route. On the 06-Sep-2014, the patient developed symptoms of a scratchy throat and hoarseness and dry, itchy eyes. After about one hour, chills and fever began. The fever maxed out at 102 degrees and continued throughout the night. Upon waking at 7am, hives began and continued until about one hour after administration of a capsule of 25mg diphenhydramine. Fatigue and muscle aches continued throughout the date on the 07-Sep-2014. Outcome was reported as recovered.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia, Throat irritation, Urticaria
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a 62 year old female patient who had a medical history of hypertension, type 2 diabetes and intraocular hypertension. Concomitant medications included bimatoprost, dorzolamide, timolol, metformin, metoprolol and lisinopril. The patient developed a fever with a previous influenza seasonal vaccine (2014046404). On the 06-Sep-2014, the patient received AFLURIA (batch number '33332001401') in the left arm via the intramuscular route. On the 06-Sep-2014, the patient developed symptoms of a scratchy throat and hoarseness and dry, itchy eyes. After about one hour, chills and fever began. The fever maxed out at 102 degrees and continued throughout the night. Upon waking at 7am, hives began and continued until about one hour after administration of a capsule of 25mg diphenhydramine. Fatigue and muscle aches continued throughout the date on the 07-Sep-2014. Outcome was reported as recovered.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye swelling, Ocular hyperaemia, Swelling
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-OCT-2014) concerns a 66 year old female patient who had no current illness at the time of vaccination. On the 04-SEP-2014, the patient received AFLURIA (batch number 09649211A (thiomersal-containing) in the left arm via the intramuscular route. On the 04-SEP-2014, the patient presented to the clinic at 16:15 and stated she was experiencing shortness of breath, difficulty swelling (sic), eyes were red and swollen. The patient was examined by a Nurse Practitioner, and called EMS (Emergency Medical Service) but the patient declined any treatment. The patient left the clinic ambulatory. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-OCT-2014) concerns a 62 year old female patient who had a medical history of DM (diabetes mellitus), pain, a sleep disorder and had surgical removal of the pancreas. On the 03-SEP-2014, the patient received AFLURIA (batch number T58006) in the left arm via the intramuscular route. The patient concomitantly received PNEUMOVAX (batch number J005011) date 1 via the intramuscular route in the right arm. On the 03-SEP-2014, the patient complained of pain in the shoulder after the injection (IM, left arm). She was information that it was likely not an ADR (adverse drug reaction) due to location. Outcome was unknown. Reporter comments: The regulator reported the case as non serious and reported the term injection site pain. Batch record review for lot T58006 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 process stages associated with lot T58006 were review 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 issued identified that may have caused the adverse events reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Pharyngeal hypoaesthesia, Urticaria
Clinical narrative: This medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a 29-year-old female patient. The patient had medical history of allergy to iodine and shellfish. The patient had received flu shot in the past without any reaction. At the time of vaccination, the patient was not ill. Her concomitant medications included salbutamol sulphate, beclometasone dipropionate, secretide and fluticasone propionate. On 08-Sep-2014, the patient received intramuscular AFLURIA (batch number 10249211A) in the right arm. On 08-Sep-2014, the patient started complaining of her throat feeling numb and having a hard time swallowing. She stated that when she woke up the next morning, she had two hives on the back of her neck. The patient was immediately treated with 1 cc of methylprednisolone and injections of diphenhydramine (50 mg, 0.5 cc) as well as a nebulizer treatment with albuterol (0.83%). The outcome was reported as recovered.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-OCT-2014) concerns a 38 year old female patient. On the 09-SEP-2014, the patient received AFLURIA (batch number not reported) in the left arm via the intramuscular route. On the 09-SEP-2014, the patient developed violent chills, fatigue, muscle aches, severe headache, nausea, pain at the injection site and soreness. Outcome was reported as recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-OCT-2014) concerns a 38 year old female patient. On the 09-SEP-2014, the patient received AFLURIA (batch number not reported) in the left arm via the intramuscular route. On the 09-SEP-2014, the patient developed violent chills, fatigue, muscle aches, severe headache, nausea, pain at the injection site and soreness. Outcome was reported as recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a 62 year old male patient. Concomitant medications included gabapentin, rosuvastatin, pantoprazole, metformin, sertraline and trazodone. The patient received the flu shot every year and always developed a mild reaction (see 2014046391). On the 19-Sep-2014, the patient received AFLURIA (batch number '333320001401') in the left arm via the intramuscular route. On the 09-Sep-2014, the patient developed a severe classic flu-like symptoms, particularly uncontrollable shivering, followed a few hours later by a sensation of running a high fever. The patient also developed general body aches. Treatment included aspirin, however it did not mitigate the symptoms. The patient made every effort to remain hydrated. Outcome was reported as recovered.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Electrocardiogram normal, Fatigue, Headache, Pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-OCT-2014) concerns a 65 year old female patient who had a medical history of asthma and no current illness at the time of vaccination. Ont he 10-SEP-2014, the patient received AFLURIA (batch number 09749221A) in the left arm via the intramuscular route. On the 10-SEP-2014, the patient developed an extreme headache, tremors, cold extremities, trouble breathing, body aches and fatigue. An EKG (electrocardiogram) was normal.. Outcome was unknown. Reporter's comments: The regulator reported the case as non-serious and reported the term "electrocardiogram normal".
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral coldness, Tremor
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-OCT-2014) concerns a 65 year old female patient who had a medical history of asthma and no current illness at the time of vaccination. Ont he 10-SEP-2014, the patient received AFLURIA (batch number 09749221A) in the left arm via the intramuscular route. On the 10-SEP-2014, the patient developed an extreme headache, tremors, cold extremities, trouble breathing, body aches and fatigue. An EKG (electrocardiogram) was normal.. Outcome was unknown. Reporter's comments: The regulator reported the case as non-serious and reported the term "electrocardiogram normal".
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a 47 year old female patient who had a medical history of allergic conjunctivitis. On the 12-Sep-2014, the patient received AFLURIA (batch number T59807) in the left arm via the intramuscular route. On the 12-Sep-2014, the patient developed fever, pain throughout the body and a swollen arm in the area of injection. Outcome was recovered.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site reaction, Injection site warmth, Rash, Rash erythematous
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-OCT-2014) concerns a 51 year old female patient. On the 09-SEP-2014, the patient received AFLURIA (batch number T57505) dose 1, in the right arm via the intramuscular route. The patient concomitantly received PNEUMOVAX, batch number K004483) in the right arm via the intramuscular route. On the 11-SEP-2014, two days after the administration, the patient developed a worsening erythematous indurated painful rash which was approximately a 25 cm area which extended down from the injection site and was warm to touch. The patient did not have any systemic symptoms of fever. Treatment included oral sulfamethoxazole/trimethoprim.  Outcome was reported as not recovered. Reporter comments: The regulator reported the as non-serious.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest pain, Electrocardiogram normal
Clinical narrative: This medically confirmed health authority report (initial receipt: 02-Dec-2014) concerns a 53 year old female patient. On 12-Sep-2014, the patient received intramuscular AFLURIA (batch number: T57205) in the arm. On 12-Sep-2014, approximately 30 minutes post vaccination, the patient experienced chest pain. The patient described the pain to be 6/10 with the initial blood pressure reading at 130/103. The patient was treated with two doses of ASA 81 and the pain and blood pressure subsided a little bit. This was followed by a brief relief and 'int.' pain. The patient underwent EKG which was normal. The outcome was reported as unknown.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 49 year old female patient. On the 21-Aug-2014, the patient received AFLURIA (batch number T58006) in the right arm. On the 21-Aug-2014, the patient developed shoulder pain. The patient went to see the prescriber and Medical Doctor (MD) who said it was possible tendonitis due to possible influenza vaccine administration into the bursa. Outcome was unknown.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Ear pain, Myalgia
Clinical narrative: This medically confirmed health authority report (initial receipt: 02-Dec-2014) concerns a 28-year-old female patient. The patient's concomitant medication included prenatal vitamins. The patient had no current illness. On 16-Sep-2014, the patient receive intramuscular AFLURIA (batch number: T59707) in the left arm. On 16-Sep-2014, within an hour of vaccination, the patient experienced severe muscle aches in shoulders, radiating to the neck and head with bilateral ear pain and bilateral ankle pain. The outcome was reported as unknown.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 43-year-old female patient who had no known current illness and concomitant medications at the time of vaccination. Her medical history included allergies to ADVIL. On 16-Sep-2014, the patient received intramuscular AFLURIA (batch number T57806) in the left arm. On 16-Sep-2014, the patient experienced itching, rash and swelling at the injection site. The outcome was not reported.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Swelling
Clinical narrative: This medically confirmed health authority report (initial receipt: 02-Dec-2014) concerns a 75 year old female patient. On 06-Sep-2014, the patient received AFLURIA (batch number: "TS8006") in the arm (route: 'SYR'). On 06-Sep-2014, one hour after the vaccination, the patient experienced redness and swelling at the injection site. The side effects peaked at day 8. The reported no pain at any point. There was still internal swelling that felt like a lump. Slight redness was still visible. The outcome was reported as not recovered. Reporter's comments: The health authority assessed the events as non-serious. Batch record review for lot T58006 noted: Batch records and QA batch review checklists for the seedlot, 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 seedlot, 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.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 66 year old female patient who had a medical history of diabetes and osteoporosis. Concomitant medications included doxycycline, albuterol and ipratropium. One week prior to injection, the patient had a staph infection of the skin at a remote site. On the 17-Sep-2014, the patient received AFLURIA (batch number 09549211A) via the intramuscular route in the right arm, dose 1. The patient also received PNEUMOVAX  (batch number K004542) via the intramuscular route in the right arm. On the 17-Sep-2014, the patient developed swelling, redness and pain at the local site (right deltoid) and the a regional area (chest and trapezius) area. The patient also developed a headache. The outcome was unknown.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 34 year old male patient. On the 17-SEP-2014, the patient received AFLURIA (batch number T57005) via the intramuscular route in the left arm. On the 17-SEP-2014, the patient fainted after the shot was administered. The patient was not in any distress before, directly after or the next day. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 32 year old female patient. On the 17-SEP-2014, the patient received AFLURIA (batch number T57005) via the intramuscular route in the left arm. On the 17-SEP-2014, the patient fainted and recovered. No additional adverse events were reported. Outcome was not reported. Reporter comments: The regulator reported the case as non-serious.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 37 year old female patient who had a medical history of RA (Rheumatoid Arthritis) and spondiosis [sic]. Concomitant medications included prednisone. On the 16-Sep-2014, the patient received AFLURIA (batch number T57005) via the intramuscular route in the arm. On the 16-Sep-2014, the same day after receiving the influenza vaccine, the patient broke out in hives. Treatments that were recommended were over-the-counter diphenhydramine and steroids. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Influenza like illness, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt: 02-DEC-2014) concerns a 61 year old female patient. The patient's concomitant medication included nifedipine, levothyroxine and simvastatin. The patient had no current illness or medical history. On 19-SEP-2014, the patient received intramuscular AFLURIA (batch number: 33332001401) in the left arm. On 19-SEP-2014, the patient experienced severe flu-like symptoms, uncontrolled shivering with cold for 2.5 hours and fever of 102 degrees. The outcome was reported as recovered. Reporter's comments: The health authority assessed the events as non-serious.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Paraesthesia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 43 year old male patient who had tree nut allergies and asthma. The patient had no current illness and was not taking medications at the time of vaccination. On the 20-Sep-2014, the patient received AFLURIA syringe (batch number T59306), dose 1, in the left arm. On the 20-Sep-2014, the patient developed facial numbness, tingling, redness on the face and neck area treated with 50mg of diphenhydramine. Outcome was recovered.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 56 year old female patient who had no medical history and no current illness at the time of vaccination. On the 16-Sep-2014, the patient received AFLURIA (batch number 099492221a) via the intramuscular route in the right arm. The patient also received ZOSTAVAX (batch number J014812) via the subcutaneous route in the right arm). On the 17-Sep-2014, the patient developed an injection site reaction- red, raised, oval, hot-to-touch and itchy of around four to six inches. No treatment was required. Outcome was unknown.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 62 year old female patient who had a medical history of acid reflux and depression. Concomitant medications included omeprazole and citalopram. The patient had no current illness at the time of vaccination. On the 19-SEP-2014, the patient received ALFURIA (batch number not reported). On the 20-SEP-2014, the patient developed hives. Outcome was not recovered. Reporter Comments: The regulator reported the case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Muscle contractions involuntary, Muscular weakness, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 59 year old female patient. The patient had medical history of supraventricular tachycardia. On 18-SEP-2014, the patient received AFLURIA injection (batch number T57906) in the left arm. On 18-SEP-2014, immediately upon injection, the patient experienced a loss of muscle control and pain and numbness in the left arm. The symptoms improved within minutes and within 24  hours the only remaining symptom was some muscle weakness. The patient refused medical care. The outcome was reported as recovered. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injected limb mobility decreased, Injection site rash, Oropharyngeal pain, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 44 year old female patient. On the 18-Sep-2014, the patient received AFLURIA (batch number T50907) via the intramuscular route in the right arm. The patient also received PNEUMOVAX (batch number K004281) via the intramuscular route in the left arm. On the 18-Sep-2014, the patient had developed a sore throat and fatigue since immunisation. The left arm had been very sore and could barely lift it. The patient complained of five to six nickel sized bumps around the injection site of the left arm. Outcome was unknown.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Headache, Muscle spasms, Muscular weakness, Nasal congestion
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 15-year old male patient. The patient had medical history of seasonal allergies and asthma. His concomitant medications included- montelukast, cetirizine hydrochloride and salbutamol. On 15-Sep-2014, the patient received intramuscular AFLURIA (batch number- T57606) in the left arm. On 22-Sep-2014, the patient experienced severe headache, muscle spasms in lower body, weakness in legs, running nose combined with congestion. The following day, he developed soreness particularly in the arm in which the dose was administered. The patient underwent laboratory blood works and the results were awaited. The patient was TYLENOL Cold and Flu combined with diphenhydramine. The outcome was reported a not recovered. Reporter comments: The health authority assessed the events as non-serious.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 15-year old male patient. The patient had medical history of seasonal allergies and asthma. His concomitant medications included- montelukast, cetirizine hydrochloride and salbutamol. On 15-Sep-2014, the patient received intramuscular AFLURIA (batch number- T57606) in the left arm. On 22-Sep-2014, the patient experienced severe headache, muscle spasms in lower body, weakness in legs, running nose combined with congestion. The following day, he developed soreness particularly in the arm in which the dose was administered. The patient underwent laboratory blood works and the results were awaited. The patient was TYLENOL Cold and Flu combined with diphenhydramine. The outcome was reported a not recovered. Reporter comments: The health authority assessed the events as non-serious.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 70 year old female patient. On 18-Sep-2014, the patient received intramuscular AFLURIA (batch number: T58406) in the arm ('AR'). The same day, she also received intramuscular PNEUMOVAX (batch number: K004281) in the arm ('AR'). On 18-Sep-2014, the patient experienced redness and swelling at the site. By the second day, the swelling was down and there was no more pain or itching. The outcome was reported as recovered. Reporter comments: The health authority assessed the events as non-serious.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain
Clinical narrative: This medically confirmed health authority report (initial receipt: 02-Dec-2014) concerns a 23-year old female patient. The patient had medical history of rash with penicillin (PCN) and azithromycin. Her concomitant medication included CILEST. On 18-Sep-2014, the patient received intramuscular AFLURIA (batch number 09949211A) in the left arm. On 19-Sep-2014, the patient experienced sore neck from back to front on right side. On 21-Sep-2014 evening, it subsided. No treatment was given. The outcome was reported as resolved. Reporter's comments: The health authority assessed the events as non-serious.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Peripheral swelling, Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 65 year old male patient. On the 23-Sep-2014, the patient received AFLURIA (batch number '157105') via the intramuscular route in the left arm. The patient also received PNEUMOVAX  (batch number K004281) via the intramuscular route in the left arm. On the 23-Sep-2014, the patient developed a fever and swelling of the arm. The arm was immobile. Outcome was not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: This medically confirmed health authority report (initial receipt: 02-Dec-2014) concerns a 36-year old female patient. The patient had no medical history or current illness at the time of vaccination. On 19-Sep-2014, the patient received intramuscular AFLURIA injection (batch number: T50907) in the left arm. On 19-Sep-2014, the patient experienced numbness around her lips and the left jaw. The outcome was reported as resolved. Reporter's comments: The health authority assessed the events as non-serious.
Age: 57.0
Sex: U
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: This medically confirmed health authority report (initial receipt: 02-Dec-2014) concerns a 57 year old patient of unknown gender. The patient did not have current illness or medical history. On 08-Sep-2014, the patient received AFLURIA (batch number: T57305) in the left arm (route: 'SYR'). On 08-Sep-2014, the patient experienced numbness of left hand and pain at the injection site. The outcome was reported as not recovered.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Peripheral swelling, Skin warm
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 57 year old female patient who had a medical history with penicillin. The patient had no current illness at the time of vaccination. On the 18-SEP-2015, the patient received AFLURIA (batch number 09649221A) in the arm. On the 19-SEP-2015, the patient's arm became red, hot and swollen. It got worse by Saturday morning. The patient went to urgent care. The doctor gave her a sulfa antibiotic and  hydroxyzine antihistamine. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported the term "local swelling".
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Confusional state, Headache, Injection site reaction, Local reaction, Pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concers a 65 year old female patient who had a medical history of PCN and alprazolam allergy, hypertension, tremor, fasting hyperglycaemia, mood disorder, anxiety, GERD and hyperlipidaemia. Concomitant medications included venlafaxine, lisinopril, propranolol, gabapentin, omeprazole, propylene glycol, vitamin d and omega 3. On the 23-Sep-2014, the patient received AFLURIA (bath number "T57595') via the intramuscular route, dose 6 in the left arm. The patient also received PNEUMOVAX (batch number K004148) via the intramuscular route, dose 1 in the right arm. On the 23-Sep-2014, within five hours of receiving the Pneumovax vaccine, the patient developed a severe local reaction, H/A (headache), confusion and fever. 20 hours after the vaccine, the right deltoid had a mild local reaction and a mild headache and body aches. Outcome was not recovered.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concers a 65 year old female patient who had a medical history of PCN and alprazolam allergy, hypertension, tremor, fasting hyperglycaemia, mood disorder, anxiety, GERD and hyperlipidaemia. Concomitant medications included venlafaxine, lisinopril, propranolol, gabapentin, omeprazole, propylene glycol, vitamin d and omega 3. On the 23-Sep-2014, the patient received AFLURIA (bath number "T57595') via the intramuscular route, dose 6 in the left arm. The patient also received PNEUMOVAX (batch number K004148) via the intramuscular route, dose 1 in the right arm. On the 23-Sep-2014, within five hours of receiving the Pneumovax vaccine, the patient developed a severe local reaction, H/A (headache), confusion and fever. 20 hours after the vaccine, the right deltoid had a mild local reaction and a mild headache and body aches. Outcome was not recovered.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-DEC-2014) concerns a 37 year-o9ld female patient who had no known current illness at the time of vaccination. Her medical history included hypothyroidism. On 22-SEP-2014, the patient received intramuscular AFLURIA (batch number T51508) in the right arm. On 22-SEP-2014, the patient experienced severe itching and hives. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious and the patient presented at the "Emergency Room".
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 50 year old female patient who had a medical history of egg allergy (she could not eat egg whites). Concomitant medications included flaxseed oil, Calcium/magnesium and zinc vitamins, vitamin C, vitamin D and gamma-aminobutyric acid. The patient did not have any current illness that would have precluded her from receiving the flu shot. On the 26-Sep-2014, the patient received AFLURIA (batch number 'G9849211a') via the intramuscular route in the left arm. On the 26-Sep-2014, the patient developed severe chills, body aches, headaches, mild fever between 9PM and 11PM. Treatment included ibuprofen. Outcome was recovered.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Bone pain, Headache, Tremor
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-DEC-2014) concerns an 83 year old male patient. On the 12-SEP-2014 at 16:20 the patient received AFLURIA (batch number T58006) via the intramuscular route in the right arm. On the 12-SEP-2014 by 20:00, the patient experienced lots of shaking on the arms and legs. All his bones in his body were hurting and he also complained of a headache. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious. Batch record review for lot T58006 noted: Batch records an 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 processed control limits. In conclusion, there were no batch related issues identified that may have caused the adverse events reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Paraesthesia, Paraesthesia oral, Urticaria
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-Dec-2014) concerns a 36 year-old female patient who had a medical history of 'latex'. Concomitant medication included lurasidone. On 25-Sep-2014, the patient recovered intramuscular AFLURIA injection (batch number T57906) in the left arm. On 25-Sep-2014, within 3 minutes of the flu shot administration, the patient experienced tingling lips which appeared to be swollen. Symptoms progressed to tingling hands and hives over five minutes. Patient was given diphenhydramine 50mg capsule at 11:50 hours and taken to the emergency room. The outcome was unknown.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Tremor
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 61 year old female patient who had no medical history would prevent/contribute to the patient receiving vaccines. Concomitant medications included naproxen 500mg. Patient did not have any current illness at the time of vaccination. On the 27-Sep-2014, the patient received AFLURIA injection (batch number 10249211A [thiomersal-containing]) via the intramuscular route. On the 27-Sep-2014, the patient developed itching several hours after receiving the vaccination. Treatment included diphenhydramine. On the 28-Sep-2014, the patient had similar symptoms plus shaking. The patient took diphenhydramine and went to the local ER. The patient did not receive any additional therapies/effects. Outcome was recovered.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 56 year-old female patient who had no known current illness. On 25-Sep-2014, the patient received intramuscular AFLURIA (batch number T50307, dose 1) in the left arm. On the same day, the patient also received intramuscular PNEUMOVAX (batch K005797, dose 3) in the right arm. On 27-Sep-2014, the patient fever, body aches and flu symptoms. She also had redness and swelling at the injection site of the PNEUMOVAX on the right deltoid area. Outcome was recovered.