chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Vaginal haemorrhage
Clinical narrative: This is a prospective pregnancy case. This 39-year-old female subject was enrolled in an open label study. The subject received FLUARIX QIV (intramuscular) .5 ml on 20th October 015. The subject received FLUARIX at week 8 of the pregnancy and during the first trimester of pregnancy. On 20th October 2015, 9 hrs after receiving FLUARIX, the subject developed vaginal bleeding (Non-serious). Additional event(s) including vaccine exposure during pregnancy. The outcome of vaginal bleeding was not recovered/not resolved. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. The investigator considered the vaginal bleeding to be possibly related to FLUARIX. Additional details were provided as follows: The patient received FLUARIX quadrivalent (batch number 33FF2, expiry date: 30th June 2016). The patient experienced vaginal bleeding which was described as light to moderate. At the time of reporting, the patient was visiting the emergency room because of the bleeding.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Vomiting
Clinical narrative: Vomiting from 5:00 am to 6:00 pm. Headache. Chills.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Soreness at injection site (Right arm) and whole body ache, soreness.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pain in upper right arm & shoulder - NO REDNESS/SWELLING/RASH - advised to follow CDC treatment protocol.
Age: 13.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Lethargy, Pyrexia
Clinical narrative: Extreme high fever 103.8 very lethargic.
Age: 13.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Activities of daily living impaired, Fatigue, Pyrexia
Clinical narrative: Extreme high fever 103.8 very lethargic.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain, Pruritus
Clinical narrative: Patient had redness at the site of injection, itchiness, and mild pain. Patient was counseled to try Benadryl for the the site reaction and acetaminophen for the pain.
Sex: F
Vaccine: FLU3
Symptoms: Depression
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of depression in a female patient who received influenza vaccine. On 20th October 2015, the patient received influenza vaccine unspecified. On 20th October 2015, less than a day after receiving influenza vaccine unspecified, the patient experienced depression. On an unknown date, the outcome of the depression was not recovered/not resolved. It was unknown if the reporter considered the depression to be related to influenza vaccine unspecified. Additional details were received as follows: The patient reported that, she received flu vaccine and since then she feels depressed. The patient reported, she believes that the flu vaccine might be the reason for the depression. The reporter stated that, she will call back within the business hours.
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to Influenza vaccine. Additional details were received as follows: The patient received Flu vaccine and experienced rash on the back of knee. The reporter refused to provide further information and advised to call back during business hours.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Stomatitis
Clinical narrative: Patient states she had a rash on both arms & sores in mouth. She has not followed up with us since.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Eye pruritus, Eye swelling, Ocular hyperaemia
Clinical narrative: Severely red, itchy, swollen eyes, inside and out. Took antihistamine (Claritin), NSAID (Naproxen), and flushed frequently with TheraTears.
Age: 1.9
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Extremely high fever of 106.8F.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Muscle spasms
Clinical narrative: Patient had swelling and redness at site of the shot. Patient said had cramping and diarrhea around 3 hours after receiving the shot.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Vertigo
Clinical narrative: Severe Vertigo, for the first 12 hours after onset. Dizziness still 2 days later.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Nausea, Pyrexia
Clinical narrative: Fever, nausea, dizziness.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Injection site swelling, Peripheral swelling
Clinical narrative: 15 minutes after receiving dizzy, lightheaded, sob pulse 140 R arm swollen from shoulder down to fingers lasted 4 hours after injections.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling abnormal, Throat tightness
Clinical narrative: Patient stated feeling a little off, redness developed on chest, and some tightness in the throat.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain and limited range of motion in the arm that the vaccine was administered. This reaction has continued throughout the two week period since the vaccination.
Age: 65.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Asthenia, Fatigue, Headache, Hypersomnia
Clinical narrative: Very bad headache, weak and tired. Went back to bed slept several hours, ate lunch, went back to bed for another 3 hours. Had Prevnar and Flulaval Quad vaccines.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Total body aching, hard, shaking chills, fever of 101 F, pounding headache x 14 hours.  Complete recovery to baseline by 24 hours post vaccination.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: From day one pain in arm (L) and cannot bend without pain. Not red or swollen. Patient states hurt when went in. Be definitely seeking treatment.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: 12-25-2012 numbness in hands and feet. 12-26 numbness in legs, unable to walk - 12-27 admitted to hospital numbness up to chest - discharged on 12-30. 12-31 back in E.R. Transported via ambulance to med center - IV Gamma gobulin 1-5 tran regional rehab.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash
Clinical narrative: Rash, redness, inflammation at injection site.
Sex: U
Vaccine: FLU3
Symptoms: Pain, Paraesthesia
Clinical narrative: Tingling, throbbing,
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Swelling
Clinical narrative: Cellulitis, swelling, treated with KEFLEX and BACTRIM (went to ER).
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Asthenia, Dysgraphia, Joint injection, Nuclear magnetic resonance imaging normal
Clinical narrative: PREVNAR 13 was given in right arm at approximately 4:15 PM. Patient woke between 3 AM and 4 AM. Right arm was very sore and painful, and had a Parkinson-like tremor that was not present before. Doctor was contacted; he suggested the tremor would probably subside over the next few weeks. He checked it 2 weeks later - no change. Have had MRI  and X-ray with no diagnosis. Dr. injected shoulder joint with cortisone/lidocaine with no positive result. Now nearly 4 months later, the tremor is still present, and constant. It is debilitating, making it difficult to write, eat, etc. Have to hold the arm down with other hand to stop the shaking.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Tremor, X-ray normal
Clinical narrative: PREVNAR 13 was given in right arm at approximately 4:15 PM. Patient woke between 3 AM and 4 AM. Right arm was very sore and painful, and had a Parkinson-like tremor that was not present before. Doctor was contacted; he suggested the tremor would probably subside over the next few weeks. He checked it 2 weeks later - no change. Have had MRI  and X-ray with no diagnosis. Dr. injected shoulder joint with cortisone/lidocaine with no positive result. Now nearly 4 months later, the tremor is still present, and constant. It is debilitating, making it difficult to write, eat, etc. Have to hold the arm down with other hand to stop the shaking.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Activities of daily living impaired, Anxiety, Back pain, Balance disorder
Clinical narrative: This 47 year old female applicant alleges onset of a number of symptoms which incapacitated her from continuing her work in a medical office. She alleges that she took the mandatory flu vaccination administered by PA at a medical office where she worked. Shortly thereafter she began having pins and needles and numbness in her hands, feet, fingers and toes with weakness in her legs that spread to her arms and hands, with dizziness that impaired her gait, plus difficulty speaking ("my tongue was messed up"). In addition she remembers having abdominal cramping pain, loss of control of bowels and bladder, rapid heart rate, low blood pressure, and difficulty breathing. These symptoms were associated with severe fatigue which has persisted and unsteady gait, poor concentration, decreased cognitive functioning, inability to drive due to dizziness, anxiety, depression, headaches, weight loss, incoordination, and lower extremity weakness. She indicates that during the most severe symptoms she had trouble being understood, likely due to effects on the tongue. Of all the above symptoms, she says she has persistent (1) dizziness, (2) being off balance, (3) numbness in the legs, arms and hand (on and off), (4) weakness in the legs, and (5) easily fatigued. She states that her physician has told her the symptoms are compatible with Guillain Barre Syndrome. Also her cognitive functions have been impaired she says because she now has trouble reading and understanding what she has read, a problem which she did not have before. Furthermore she has back pain at severity 6-7 on a 0/10 numeric rating scale of intensity, causing her to seek chiropractic care. The pain interferes with standing longer than 10-15 minutes, sitting longer than 30 minutes w/o moving, completing household chores, participating in social activities, religious activities, recreational activities, bending, standing, walking. The pain in the back is described as sharp, stabbing, and tingling and numbness. The pain interferes with her ability to stand and balance herself she says.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Cognitive disorder, Coordination abnormal, Depression, Disturbance in attention, Dizziness
Clinical narrative: This 47 year old female applicant alleges onset of a number of symptoms which incapacitated her from continuing her work in a medical office. She alleges that she took the mandatory flu vaccination administered by PA at a medical office where she worked. Shortly thereafter she began having pins and needles and numbness in her hands, feet, fingers and toes with weakness in her legs that spread to her arms and hands, with dizziness that impaired her gait, plus difficulty speaking ("my tongue was messed up"). In addition she remembers having abdominal cramping pain, loss of control of bowels and bladder, rapid heart rate, low blood pressure, and difficulty breathing. These symptoms were associated with severe fatigue which has persisted and unsteady gait, poor concentration, decreased cognitive functioning, inability to drive due to dizziness, anxiety, depression, headaches, weight loss, incoordination, and lower extremity weakness. She indicates that during the most severe symptoms she had trouble being understood, likely due to effects on the tongue. Of all the above symptoms, she says she has persistent (1) dizziness, (2) being off balance, (3) numbness in the legs, arms and hand (on and off), (4) weakness in the legs, and (5) easily fatigued. She states that her physician has told her the symptoms are compatible with Guillain Barre Syndrome. Also her cognitive functions have been impaired she says because she now has trouble reading and understanding what she has read, a problem which she did not have before. Furthermore she has back pain at severity 6-7 on a 0/10 numeric rating scale of intensity, causing her to seek chiropractic care. The pain interferes with standing longer than 10-15 minutes, sitting longer than 30 minutes w/o moving, completing household chores, participating in social activities, religious activities, recreational activities, bending, standing, walking. The pain in the back is described as sharp, stabbing, and tingling and numbness. The pain interferes with her ability to stand and balance herself she says.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Dysstasia, Faecal incontinence, Fatigue, Gait disturbance
Clinical narrative: This 47 year old female applicant alleges onset of a number of symptoms which incapacitated her from continuing her work in a medical office. She alleges that she took the mandatory flu vaccination administered by PA at a medical office where she worked. Shortly thereafter she began having pins and needles and numbness in her hands, feet, fingers and toes with weakness in her legs that spread to her arms and hands, with dizziness that impaired her gait, plus difficulty speaking ("my tongue was messed up"). In addition she remembers having abdominal cramping pain, loss of control of bowels and bladder, rapid heart rate, low blood pressure, and difficulty breathing. These symptoms were associated with severe fatigue which has persisted and unsteady gait, poor concentration, decreased cognitive functioning, inability to drive due to dizziness, anxiety, depression, headaches, weight loss, incoordination, and lower extremity weakness. She indicates that during the most severe symptoms she had trouble being understood, likely due to effects on the tongue. Of all the above symptoms, she says she has persistent (1) dizziness, (2) being off balance, (3) numbness in the legs, arms and hand (on and off), (4) weakness in the legs, and (5) easily fatigued. She states that her physician has told her the symptoms are compatible with Guillain Barre Syndrome. Also her cognitive functions have been impaired she says because she now has trouble reading and understanding what she has read, a problem which she did not have before. Furthermore she has back pain at severity 6-7 on a 0/10 numeric rating scale of intensity, causing her to seek chiropractic care. The pain interferes with standing longer than 10-15 minutes, sitting longer than 30 minutes w/o moving, completing household chores, participating in social activities, religious activities, recreational activities, bending, standing, walking. The pain in the back is described as sharp, stabbing, and tingling and numbness. The pain interferes with her ability to stand and balance herself she says.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Heart rate increased, Hypoaesthesia, Hypotension, Impaired driving ability
Clinical narrative: This 47 year old female applicant alleges onset of a number of symptoms which incapacitated her from continuing her work in a medical office. She alleges that she took the mandatory flu vaccination administered by PA at a medical office where she worked. Shortly thereafter she began having pins and needles and numbness in her hands, feet, fingers and toes with weakness in her legs that spread to her arms and hands, with dizziness that impaired her gait, plus difficulty speaking ("my tongue was messed up"). In addition she remembers having abdominal cramping pain, loss of control of bowels and bladder, rapid heart rate, low blood pressure, and difficulty breathing. These symptoms were associated with severe fatigue which has persisted and unsteady gait, poor concentration, decreased cognitive functioning, inability to drive due to dizziness, anxiety, depression, headaches, weight loss, incoordination, and lower extremity weakness. She indicates that during the most severe symptoms she had trouble being understood, likely due to effects on the tongue. Of all the above symptoms, she says she has persistent (1) dizziness, (2) being off balance, (3) numbness in the legs, arms and hand (on and off), (4) weakness in the legs, and (5) easily fatigued. She states that her physician has told her the symptoms are compatible with Guillain Barre Syndrome. Also her cognitive functions have been impaired she says because she now has trouble reading and understanding what she has read, a problem which she did not have before. Furthermore she has back pain at severity 6-7 on a 0/10 numeric rating scale of intensity, causing her to seek chiropractic care. The pain interferes with standing longer than 10-15 minutes, sitting longer than 30 minutes w/o moving, completing household chores, participating in social activities, religious activities, recreational activities, bending, standing, walking. The pain in the back is described as sharp, stabbing, and tingling and numbness. The pain interferes with her ability to stand and balance herself she says.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain, Paraesthesia, Paraesthesia oral, Reading disorder
Clinical narrative: This 47 year old female applicant alleges onset of a number of symptoms which incapacitated her from continuing her work in a medical office. She alleges that she took the mandatory flu vaccination administered by PA at a medical office where she worked. Shortly thereafter she began having pins and needles and numbness in her hands, feet, fingers and toes with weakness in her legs that spread to her arms and hands, with dizziness that impaired her gait, plus difficulty speaking ("my tongue was messed up"). In addition she remembers having abdominal cramping pain, loss of control of bowels and bladder, rapid heart rate, low blood pressure, and difficulty breathing. These symptoms were associated with severe fatigue which has persisted and unsteady gait, poor concentration, decreased cognitive functioning, inability to drive due to dizziness, anxiety, depression, headaches, weight loss, incoordination, and lower extremity weakness. She indicates that during the most severe symptoms she had trouble being understood, likely due to effects on the tongue. Of all the above symptoms, she says she has persistent (1) dizziness, (2) being off balance, (3) numbness in the legs, arms and hand (on and off), (4) weakness in the legs, and (5) easily fatigued. She states that her physician has told her the symptoms are compatible with Guillain Barre Syndrome. Also her cognitive functions have been impaired she says because she now has trouble reading and understanding what she has read, a problem which she did not have before. Furthermore she has back pain at severity 6-7 on a 0/10 numeric rating scale of intensity, causing her to seek chiropractic care. The pain interferes with standing longer than 10-15 minutes, sitting longer than 30 minutes w/o moving, completing household chores, participating in social activities, religious activities, recreational activities, bending, standing, walking. The pain in the back is described as sharp, stabbing, and tingling and numbness. The pain interferes with her ability to stand and balance herself she says.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Speech disorder, Urinary incontinence, Weight decreased
Clinical narrative: This 47 year old female applicant alleges onset of a number of symptoms which incapacitated her from continuing her work in a medical office. She alleges that she took the mandatory flu vaccination administered by PA at a medical office where she worked. Shortly thereafter she began having pins and needles and numbness in her hands, feet, fingers and toes with weakness in her legs that spread to her arms and hands, with dizziness that impaired her gait, plus difficulty speaking ("my tongue was messed up"). In addition she remembers having abdominal cramping pain, loss of control of bowels and bladder, rapid heart rate, low blood pressure, and difficulty breathing. These symptoms were associated with severe fatigue which has persisted and unsteady gait, poor concentration, decreased cognitive functioning, inability to drive due to dizziness, anxiety, depression, headaches, weight loss, incoordination, and lower extremity weakness. She indicates that during the most severe symptoms she had trouble being understood, likely due to effects on the tongue. Of all the above symptoms, she says she has persistent (1) dizziness, (2) being off balance, (3) numbness in the legs, arms and hand (on and off), (4) weakness in the legs, and (5) easily fatigued. She states that her physician has told her the symptoms are compatible with Guillain Barre Syndrome. Also her cognitive functions have been impaired she says because she now has trouble reading and understanding what she has read, a problem which she did not have before. Furthermore she has back pain at severity 6-7 on a 0/10 numeric rating scale of intensity, causing her to seek chiropractic care. The pain interferes with standing longer than 10-15 minutes, sitting longer than 30 minutes w/o moving, completing household chores, participating in social activities, religious activities, recreational activities, bending, standing, walking. The pain in the back is described as sharp, stabbing, and tingling and numbness. The pain interferes with her ability to stand and balance herself she says.
Sex: M
Vaccine: PNC13
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age and ethnicity received a single dose of PREVNAR 13 on an unspecified date. Medical history and concomitant medications were not reported. The patient died from Guillain-Barre syndrome on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.
Age: 78.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Blood test, Fluid overload, Full blood count abnormal, Metabolic function test abnormal, Swelling
Clinical narrative: This is a spontaneous report a contactable Practice manager who reported on behalf of physician. A 78-year-old male patient received PREVNAR 13 (NDC number: 0005-1971-01, Lot number: L84631, Expiry date: 1 Feb 2017), intramuscular in the right deltoid on 11Sep2015 at 0.5 ml single dose and FLUZONE (NDC number: 49281-397-88, Lot number: UI4278A, Expiry date: 28 Mar 2016, Manufacturer: Sanofi Pasteur) intramuscular in the left deltoid on the same date at high dose of 0.5. Medical history included diabetes mellitus, hypertension, leukaemia, anxiety, blood pressure abnormal, blood cholesterol increased and chronic kidney disease. Concomitant medication included JANUVIA, lisinopril, XANAX, NORVASC, COREG, fenofibrate, PRAVACHOL. The next day patient had swelling over his entire body then the patient was hospitalized due to fluid overload and he cannot fit into his clothes. The patient also experienced full blood count abnormal and metabolic function test abnormal on 06Oct2015. The patient underwent lab tests and procedures on 06Oct2015 which included blood test: unspecified, full blood count: abnormal, metabolic function test: abnormal. The patient did not recover from the event fluid overload while the outcome of the other adverse events was unknown. Therapeutic measures were taken as a result of the events swelling and fluid overload and included LASIX.
Age: 78.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Blood test, Condition aggravated, Fluid retention, Full blood count abnormal, Leukaemia
Clinical narrative: This is a spontaneous report a contactable Practice manager who reported on behalf of physician. A 78-year-old male patient received PREVNAR 13 (NDC number: 0005-1971-01, Lot number: L84631, Expiry date: 1 Feb 2017), intramuscular in the right deltoid on 11Sep2015 at 0.5 ml single dose and FLUZONE (NDC number: 49281-397-88, Lot number: UI4278A, Expiry date: 28 Mar 2016, Manufacturer: Sanofi Pasteur) intramuscular in the left deltoid on the same date at high dose of 0.5. Medical history included diabetes mellitus, hypertension, leukaemia, anxiety, blood pressure abnormal, blood cholesterol increased and chronic kidney disease. Concomitant medication included JANUVIA, lisinopril, XANAX, NORVASC, COREG, fenofibrate, PRAVACHOL. The next day patient had swelling over his entire body then the patient was hospitalized due to fluid overload and he cannot fit into his clothes. The patient also experienced full blood count abnormal and metabolic function test abnormal on 06Oct2015. The patient underwent lab tests and procedures on 06Oct2015 which included blood test: unspecified, full blood count: abnormal, metabolic function test: abnormal. The patient did not recover from the event fluid overload while the outcome of the other adverse events was unknown. Therapeutic measures were taken as a result of the events swelling and fluid overload and included LASIX.
Age: 78.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Metabolic function test abnormal, Swelling
Clinical narrative: This is a spontaneous report a contactable Practice manager who reported on behalf of physician. A 78-year-old male patient received PREVNAR 13 (NDC number: 0005-1971-01, Lot number: L84631, Expiry date: 1 Feb 2017), intramuscular in the right deltoid on 11Sep2015 at 0.5 ml single dose and FLUZONE (NDC number: 49281-397-88, Lot number: UI4278A, Expiry date: 28 Mar 2016, Manufacturer: Sanofi Pasteur) intramuscular in the left deltoid on the same date at high dose of 0.5. Medical history included diabetes mellitus, hypertension, leukaemia, anxiety, blood pressure abnormal, blood cholesterol increased and chronic kidney disease. Concomitant medication included JANUVIA, lisinopril, XANAX, NORVASC, COREG, fenofibrate, PRAVACHOL. The next day patient had swelling over his entire body then the patient was hospitalized due to fluid overload and he cannot fit into his clothes. The patient also experienced full blood count abnormal and metabolic function test abnormal on 06Oct2015. The patient underwent lab tests and procedures on 06Oct2015 which included blood test: unspecified, full blood count: abnormal, metabolic function test: abnormal. The patient did not recover from the event fluid overload while the outcome of the other adverse events was unknown. Therapeutic measures were taken as a result of the events swelling and fluid overload and included LASIX.
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Inadequate aseptic technique in use of product
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received PREVNAR 13 via an unspecified route of administration at 0.5ml single in deltoid (unknown in which arm) on an unspecified date. Reporting Pharmacist administered the suspect vaccine. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced cellulitis. The patient was claiming the pharmacist used a dirty needle to administer the suspect vaccine. The outcome was unknown.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Haemoglobin decreased, Malaise, Transfusion
Clinical narrative: This is a spontaneous report from a non-contactable nurse (the patient). A patient of unspecified age, gender and ethnicity received on the same day (date unknown) PREVNAR 13 at a single dose  and flu vaccine (manufacturer unknown) at an unknown dose both via an unspecified route of administration, on unknown date. Relevant medical history myelodysplastic syndrome, ongoing. Concomitant medications were not reported. The day after the vaccination, hemoglobin went from 8.7 to 6.9 (unit not provided) and he/she was not feeling well. The patient had a transfusion for hemoglobin decreased. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. An adult female patient (over 50 years as reported) of an unspecified ethnicity received a single dose of PREVNAR 13, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced cellulitis on an unspecified date with outcome of unknown.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Dysphagia, Headache, Immediate post-injection reaction
Clinical narrative: Initial unsolicited report received from a consumer on 15 October 2015. This case involves an 81-year-old female patient who was vaccinated with a dose of FLUZONE HD (Batch number, dose, dose in series, expiry date were not reported) via intramuscular route in left deltoid on 06 October 2015. The patient did not have any illness at the time of vaccination or any pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medications were not reported. On 06 October 2015, few seconds (immediately) following the vaccination, the patient had experienced pain in left deltoid. Three days following the vaccination, the patient had severe pain in the left arm that shot up to her neck and to the top of head. She had severe pain in her neck, difficulty swallowing, had a generalized pain and weakness throughout the body. Patient had difficulty getting in and out of bed and felt incapacitated. Laboratory data and corrective treatment were not reported. The patient had not recovered from the events. Upon medical review, the case was considered as serious due to important medical event: having difficulty getting in and out of bed/feels incapacitated. List of documents held by sender: none.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 15 October 2015. This case involves an 81-year-old female patient who was vaccinated with a dose of FLUZONE HD (Batch number, dose, dose in series, expiry date were not reported) via intramuscular route in left deltoid on 06 October 2015. The patient did not have any illness at the time of vaccination or any pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medications were not reported. On 06 October 2015, few seconds (immediately) following the vaccination, the patient had experienced pain in left deltoid. Three days following the vaccination, the patient had severe pain in the left arm that shot up to her neck and to the top of head. She had severe pain in her neck, difficulty swallowing, had a generalized pain and weakness throughout the body. Patient had difficulty getting in and out of bed and felt incapacitated. Laboratory data and corrective treatment were not reported. The patient had not recovered from the events. Upon medical review, the case was considered as serious due to important medical event: having difficulty getting in and out of bed/feels incapacitated. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial unsolicited report received from a non-health care professional (office staff) via company representative on 17 October 2015. This case involves an elderly patient (age and gender unknown) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route, dose in series and site of administration were not reported) on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date following the vaccination, the patient experienced severe health problems and severe symptoms. It was reported that patient was required to be hospitalized for treatment. Lab data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Blood cholesterol, Cellulitis
Clinical narrative: This is a spontaneous report obtained from a contactable Health Care Professional through a Pfizer sales representative. The Health Care Professional reported for a patient on behalf of physician. A 61 year old female patient received, on 08Oct2015, intramuscular PREVNAR 13 (Lot. M03211, Expiration date: 31Mar2017, NDC number: 00005197105) 0.5 ml, single dose. The patient received concomitantly Flu vaccine on the opposite arm. Relevant medical history included hypertension. On 09Oct2015, the patient experienced cellulitis. Relevant laboratory data included blood cholesterol on 08Oct2015 (unspecified result). In response to the adverse event treatment was received (BACTRIM 800 mg, tablet). The patient did not recover from the event at time of this report. The adverse event, cellulitis, was considered related to PREVNAR 13.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female (age: 87; units unknown) patient of unknown ethnicity received PREVNAR 13 at single dose on an unspecified date. After vaccination, her arm turned red and was swollen and hot. She went to the emergency room and was diagnosed with cellulitis and was given an antibiotic. Her arm was very red all the way to her elbow 10 days after the shot on an unknown date. Outcome was unknown.
Sex: U
Vaccine: MEN
Symptoms: Pain, Vaccination complication
Clinical narrative: Initial unsolicited report received from a consumer on 11 October 2015. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of Meningococcal vaccine (batch number, dose, route, cycle in series and site of administration was not reported, manufacturer unknown) on an unspecified date (when patient's son was 3 months old). It was reported that the patient received all vaccines in past. It was reported that the patient had a stroke a few years ago. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient almost died, and he had a lot of painful side effects. It was reported that "I was told you can NEVER get it again, but I have read people saying they did". Patient reports that patient had stroke (unspecified) a few years ago and also suspects to have had it again. Lab data and corrective treatments were not reported. Outcome of events was not reported. This case considered serious due to life threatening event: stroke. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Pericardial effusion
Clinical narrative: Initial unsolicited report received from a physician on 13 October 2015. This case involves a male patient (age not reported) who was vaccinated with a dose of Influenza vaccine / flu shot (manufacturer: unknown, batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date (several years ago). The patient's medical history and concomitant medications were not reported. On an unknown date, one week following the vaccination, the patient had developed fluid around the heart. Laboratory data was not reported. The patient was treated with unspecified medication and released. The outcome of the event was not reported. Upon medical review, the case was considered as serious due to important medical event: fluid around the heart. List of documents held by sender: none.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Hyperhidrosis, Myalgia, Pyrexia, Tremor
Clinical narrative: Muscle aches, joint pain, sweating, shaking, vomiting, fever.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Muscle aches, joint pain, sweating, shaking, vomiting, fever.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Pruritus
Clinical narrative: Cellulitis reported by patient and itching near the injection site.
Age: 27.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Nausea, Neck pain, Vertigo
Clinical narrative: Neck and Headache. Next Day (Oct. 28): Throbbing headache, nausea, and vertigo.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Sudden sore throat, no fever; 10/27 2 degree fever; 10/28 no fever, but sore throat continues. Tylenol, ice pack on head, liquids. See doctor 10/30, first available appointment. Missed 5 days work.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Asthenia, Differential white blood cell count normal, Full blood count normal, Headache, Liver function test normal
Clinical narrative: Began 30 minutes after receiving vaccines with weakness and headache.  Than approximately one hour later passed out for around 5 minutes followed by frequent vomiting.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Urine analysis normal, Vomiting
Clinical narrative: Began 30 minutes after receiving vaccines with weakness and headache.  Than approximately one hour later passed out for around 5 minutes followed by frequent vomiting.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt had extreme pain in arm and limited mobility.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram, Electroencephalogram, Hypoaesthesia, Lumbar puncture, Malaise
Clinical narrative: Pt reported not feeling well the evening after the vaccine, within 7 days his legs were weak, 14 days out his muscles were sore and crampy. After 20 days his hands and feet were numb and legs were very weak. The PT proceeded to the ED and was referred to a larger hospital for evaluation. The PT was hospitalized for 3 days, discharged and is now following up with physical therapy and a neurologist.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms, Muscular weakness, Myalgia, Nuclear magnetic resonance imaging
Clinical narrative: Pt reported not feeling well the evening after the vaccine, within 7 days his legs were weak, 14 days out his muscles were sore and crampy. After 20 days his hands and feet were numb and legs were very weak. The PT proceeded to the ED and was referred to a larger hospital for evaluation. The PT was hospitalized for 3 days, discharged and is now following up with physical therapy and a neurologist.
Sex: F
Vaccine: FLU3
Symptoms: Faeces discoloured, Haematochezia
Clinical narrative: Initial unsolicited report received from a consumer on 15 October 2015. This case involves a [age unknown] female patient who was vaccinated with a [route and dose in series were not reported] dose of FLUZONE HD [batch number, expiry date and site of administration were not reported) on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced dark, bloody stool. Lab data and corrective treatment were not reported. The outcome of event was unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Condition aggravated, Impaired driving ability, Multiple sclerosis relapse
Clinical narrative: Initial unsolicited report received from a consumer on 30 September 2015. Addendum 26-Oct-2015, upon second medical examination another event Multiple sclerosis had to be coded, which makes the case serious and processed accordingly. This case involves a female patient (age not reported) who was vaccinated with a dose of flu shot (batch number, dose, route and site of administration was not reported) on an unspecified date. Patient's medical history included multiple sclerosis. The patient was taking AUBAGIO (dose: 7mg x 1 mo then 14mg via oral route four times a day) concomitantly for multiple sclerosis. On an unspecified date, following the vaccination, the patient had a relapse of existing condition. Presently the patient reported that she was not able to drive. Lab data and corrective treatments were not reported. The outcome of event was unknown. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Swelling, redness to (L) arm with know at site of injection. Treated with KEFLEX (antibiotic) 500 mg 1 three times daily x 7 days,
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Rash
Clinical narrative: Pt presented with red swelling near and around injection site on 10/21 the evening she received vaccine. Pt saw MD on 10/23 and he suspected cellulitis and gave pt antibiotic and now 10/28 rash has gone away.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Malaise, Nasal congestion, Pain
Clinical narrative: Vaccine administered b/c 3-4pm 10/27. Pt. states she started to feel ill at 8-9 pm. With chills (couldn't get warm) nasal stuffiness, aches. "Hard to catch "breath". Did not seek medical tx.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient complained of a pain in the arm (left) used to administer vaccine which he continued to experience for > 3 weeks after administration.
Age: 1.03
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives on both arms - 5 hr. after vaccines given.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Cough, Diarrhoea, Fatigue, Pain
Clinical narrative: Since 10/19/15, pt c/o having cough, diarrhea, Lt arm pain, back pain, achy and fatigue. Pt was given DEPO-MEDROL 60mg IM, codeine-guaifenesin, albuterol inhaler at appt on 10/22/15. On 10/19/15 pt received knee injection of MARCAINE and KENALOG.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Since 10/19/15, pt c/o having cough, diarrhea, Lt arm pain, back pain, achy and fatigue. Pt was given DEPO-MEDROL 60mg IM, codeine-guaifenesin, albuterol inhaler at appt on 10/22/15. On 10/19/15 pt received knee injection of MARCAINE and KENALOG.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration, Injection site pain
Clinical narrative: Developed dark, tender, painful bruising around injection site.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Electrocardiogram, Throat irritation
Clinical narrative: Patient stated she felt a burning sensation in her chest radiating to her throat that lasted less than a minutes. Radiated to her back, no SOB. Came on about 15 minutes after vaccine and lasted less than a minute. Evaluated by MD, EKG done.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Feeling cold, Headache, Myalgia, Piloerection
Clinical narrative: Approximately 7 hours after influenza vaccine, developed the following symptoms in the specified order: symptoms developed acutely within 1-1.5 hours. Whole body chills/goose bumps; whole body myalgias; severe headache; severe sleepiness. Temperature taken (after drinking hot tea and having taken a hot bath) was 101.2 degrees F, 15 minutes later, temp was 100.4 degrees F. Slept 12 hours straight, awoke - temp 96.5 degrees F; chills and myalgias gone - mild residual headache and sleepiness. All symptoms gone after 48 hours. This the 1st time ever experiencing these symptoms after a flu shot.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Somnolence
Clinical narrative: Approximately 7 hours after influenza vaccine, developed the following symptoms in the specified order: symptoms developed acutely within 1-1.5 hours. Whole body chills/goose bumps; whole body myalgias; severe headache; severe sleepiness. Temperature taken (after drinking hot tea and having taken a hot bath) was 101.2 degrees F, 15 minutes later, temp was 100.4 degrees F. Slept 12 hours straight, awoke - temp 96.5 degrees F; chills and myalgias gone - mild residual headache and sleepiness. All symptoms gone after 48 hours. This the 1st time ever experiencing these symptoms after a flu shot.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Vomiting
Clinical narrative: Received flu shot on 10/22/15 became diaphoretic and dizzy. B/P 130/42 AP 60 at 3:46 pm. Then 118/82 AP 60 at 4:10 pm. Sent home via taxi. Called that eve, had vomited. Called again that eve and next AM - back to work no problems.
Age: 81.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Severe pain in left shoulder at the site of the injection.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Smallpox vaccination site has remained protruded and red for over 2 years since administration.  Vaccination site is on patient's left arm.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 0.75
Sex: F
Vaccine: FLUX, HEP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomit and diarrhea.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Discomfort, Laboratory test, Pyrexia, Vaccination site swelling
Clinical narrative: Patient was seen on 10/21/15 for an office visit and flu shot.  On Thursday 10/22/15 patient starting to experience fever and chills.  On 10/23/15 around 5 PM she was at a store and felt the fever and chills again.  Also she experienced like her chest neck and shoulders were being crushed. During these episodes the left shoulder area where the vaccine was administered was hot to the touch and swollen about the size of a half dollar. When she woke up on Saturday 10/24/15 she experienced another episode and at that point she went to the ER.  She was given saline through IV and labwork was performed.  No Medications were given to her.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site warmth
Clinical narrative: Patient was seen on 10/21/15 for an office visit and flu shot.  On Thursday 10/22/15 patient starting to experience fever and chills.  On 10/23/15 around 5 PM she was at a store and felt the fever and chills again.  Also she experienced like her chest neck and shoulders were being crushed. During these episodes the left shoulder area where the vaccine was administered was hot to the touch and swollen about the size of a half dollar. When she woke up on Saturday 10/24/15 she experienced another episode and at that point she went to the ER.  She was given saline through IV and labwork was performed.  No Medications were given to her.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Erythema, Pain
Clinical narrative: Pain/burning sensation; soreness/redness.
Age: 59.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given incorrect vaccination. Pt was properly screened prior to vaccination. Pt is over the age of 50 years and was given the LAIV Flumist vaccination which is licensed for ages 2 years 0 49 years.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Severe Nausea vomiting chills with sudden onset lasting 5 hours and then gone.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Heart rate increased, Hyperphagia, Nausea, Thirst
Clinical narrative: After flu vaccination patient states she felt dizzy, nauseous, and had an itchy throat and briefly had rapid heart beat. When assessed not obvious signs of distress. Vital signs were checked by nurse and also had an increased intake of water and food.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: After flu vaccination patient states she felt dizzy, nauseous, and had an itchy throat and briefly had rapid heart beat. When assessed not obvious signs of distress. Vital signs were checked by nurse and also had an increased intake of water and food.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Eye swelling, Feeling abnormal, Injection site reaction, Skin tightness
Clinical narrative: Says that her eye starting itching the evening after she received her vaccine.  By the next morning, eye was swollen and arm was "tight" where she had received injection.  Also says that she just felt bad the following day.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Pyrexia, Respiratory tract infection
Clinical narrative: Hoarseness, slight cough; mild at first; fever 1-2 days later; became secondary infection (respiratory); required antibiotic.