chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Screaming, Vomiting
Clinical narrative: This case was reported by a physician and by the same physician via a sales representative, and described the occurrence of high-pitched crying in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included haemophilus influenzae type b vaccine (non-gsk) ;Merck;unknown;unknown given on 28 August 2012; live attenuated human rotavirus vaccine ;GlaxoSmithKline;unknown;unknown given on 28 August 2012; pneumococcal vaccines (non-gsk) ;PFIZER;unknown;unknown given on 28 August 2012. The subject was solely breast-fed. On 28 August 2012 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, right thigh). On 28 August 2012, immediately after vaccination with PEDIARIX, the subject experienced fussiness and on 28 August 2012, 30 minutes after vaccination with PEDIARIX, the subject experienced high-pitched crying and screaming and was inconsolable, arching back and vomiting. The subject was treated at home with TYLENOL after the fussiness began. The high-pitched crying, screaming, inconsolable, arching back and vomiting lasted for 5.5 hours into the afternoon and evening of 28 August 2012. The fussiness continued until the next morning of 29 August 2012. The office also filed a VAERS form. The vaccination course with PEDIARIX was discontinued. The physician considered the events were probably related to vaccination with PEDIARIX due to the pertussis component and will no longer be giving the subject PEDIARIX.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 10-Sep-2012) concerns a female patient, who had an unspecified 'allergic reaction' to a flu shot (manufacturer, brand name and lot number were not provided) at some unspecified time in the past. The event outcome was not reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Facial pain, Neck pain, Pruritus
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 03-Oct-2012) concerns a 50-year-old female patient, who had no pertinent medical history or drug allergy. Concomitant medication include SYNTHROID. On 21-Sep-2012 the patient received AFLURIA (batch number: 06649221A) at a dose of 0.5 mL intramuscularly in the left arm. On 21-Sep-2012 the patient experienced a burning that went to the neck. On 22-Sep-2012 and 23-Sep-2012 it was very painful in the neck and it itched. The patient started feeling better but then she went on a trip and carried a bag on the left side where AFLURIA was given and experienced a burning sensation that was on the neck, shoulder and behind the left ear and moved behind the left eye and now hurting on an unspecified cheek bone on 03-Oct-2012. The patient sought medical attention. Treatment included paracetamol which helped some but symptoms were not improving. No lab diagnostic study was performed. The event outcome was not recovered.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Flushing
Clinical narrative: Just given influenza vaccine to employee, 2 minutes later can hear employee saying Help Me, Help Me walking back toward my office he stated that he was feeling flushed, SOB, and some chest discomforted. Employee was interviewed by NP and advised he to be checked out in Outpatient Clinic UC. Pulse went to 99. Diphenhydramine 50 mg once.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Condition aggravated, Eczema
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 24-Sep-2012) concerns a 72-year-old male patient, who had a medical history of eczema. He also had cellulitis / rash on leg and trunk prior to vaccination. On 21-Sep-2012 at 13:30 to 13:45 the patient received FLUVIRIN (batch number: 1204001) intramuscularly in left deltoid. At the same time he also received ZOSTAVAX (batch number: H011052) at a dose of 0.65 mL once subcutaneously in left arm. The patient now was having an exacerbation of eczema. He sought medical attention and had been prescribed prednisolone for the eczema exacerbation. The event outcome was not reported. Reporter's comment: On 13-Nov-2012 the physician confirmed no reports of vaccine reaction. She had been seeing the patient regularly since vaccine administration. The patient's skin condition was not due to vaccines. Follow up (13-Nov-2012): reporter's comment, medical history, suspect drugs (brand name, lot number, route/site, time of vaccination).
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Blood glucose normal, Blood pressure increased, Episiotomy, Gestational hypertension, Haemoglobin normal
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 18-Jun-2012) concerns a female patient, who was hypoglycemic and anemic. She had one previous pregnancy with no birth defect, still birth or miscarriage. The patient received a flu shot (manufacturer unknown) in the fall of 2011. The nurse commented that the patient had not been vaccinated in their office, so she did not know the exact date of vaccination, which flu vaccine the patient received or the batch number. On 10-Dec-2011 the patient had a positive pregnancy test. Her last menstrual period was 04-Nov-2011 and estimated delivery date is 10-Aug-2012. On 08-Feb-2012 the patient had an ultrasound scan for pregnancy verification and results were WNL (within normal limits). On 22-Mar-2012 the patient had a 20 weeks ultrasound scan for anatomy and results were WNL. On 12-Apr-2012, during the pregnancy, the patient also received Tdap vaccine. On 19-Apr-2012, she also received VARIVAX (batch number: 0835AA) injection at a dose of 0.5 mL subcutaneously. On 20-Apr-2012 she received VALTREX 1 g three times daily orally for 7 days (VALTREX was reported as a concomitant medication). On 31-Jul-2012, at 38 weeks 4 days of pregnancy, the patient delivered a live female infant, weighed 7 lb 12 oz. The infant was normal without congenital anomaly, other complications or abnormalities. There was no complication during pregnancy, however she had an elevated blood pressure (BP) at 37.3 weeks. There was no complication during labor/delivery except secondary laceration, episiotomy. The patient had normal routine pregnancy labs (GDDS (gestational diabetes screen), glucose, Hgb (hemoglobin), labs). PIH (pregnancy induced hypertension) labs were ordered at 37.3 weeks for elevated BP. The patient had UTI (urinary tract infection) during pregnancy. She had no other concurrent medical conditions. She was taking ondansetron, nitrofurantoin and omega 3 during this pregnancy. Follow up (02-Aug-2012): pregnancy outcome, obstetric information, other medication used during this pregnancy.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Maternal exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen normal, Urinary tract infection
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 18-Jun-2012) concerns a female patient, who was hypoglycemic and anemic. She had one previous pregnancy with no birth defect, still birth or miscarriage. The patient received a flu shot (manufacturer unknown) in the fall of 2011. The nurse commented that the patient had not been vaccinated in their office, so she did not know the exact date of vaccination, which flu vaccine the patient received or the batch number. On 10-Dec-2011 the patient had a positive pregnancy test. Her last menstrual period was 04-Nov-2011 and estimated delivery date is 10-Aug-2012. On 08-Feb-2012 the patient had an ultrasound scan for pregnancy verification and results were WNL (within normal limits). On 22-Mar-2012 the patient had a 20 weeks ultrasound scan for anatomy and results were WNL. On 12-Apr-2012, during the pregnancy, the patient also received Tdap vaccine. On 19-Apr-2012, she also received VARIVAX (batch number: 0835AA) injection at a dose of 0.5 mL subcutaneously. On 20-Apr-2012 she received VALTREX 1 g three times daily orally for 7 days (VALTREX was reported as a concomitant medication). On 31-Jul-2012, at 38 weeks 4 days of pregnancy, the patient delivered a live female infant, weighed 7 lb 12 oz. The infant was normal without congenital anomaly, other complications or abnormalities. There was no complication during pregnancy, however she had an elevated blood pressure (BP) at 37.3 weeks. There was no complication during labor/delivery except secondary laceration, episiotomy. The patient had normal routine pregnancy labs (GDDS (gestational diabetes screen), glucose, Hgb (hemoglobin), labs). PIH (pregnancy induced hypertension) labs were ordered at 37.3 weeks for elevated BP. The patient had UTI (urinary tract infection) during pregnancy. She had no other concurrent medical conditions. She was taking ondansetron, nitrofurantoin and omega 3 during this pregnancy. Follow up (02-Aug-2012): pregnancy outcome, obstetric information, other medication used during this pregnancy.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: This spontaneous consumer report (initial receipt: 07-Sep-2012) concerns a 74 year old female patient with a medical history of allergy to penicillin, phenobarbital; hyoscyamine; atropine and scopolamine combination, cefdinir, levofloxacin, gabapentin, sulfa, tiotropium and mometasone. Concomitant medications include omeprazole, estrogen and terbinafine. On 05-Sep-2012, the patient received AFLURIA (batch unspecified). On the same day, the patient also received PNEUMOVAX via intramuscular route. On the same day, after getting PNEUMOVAX and AFLURIA, the patient experienced extreme pain and itching in her arm and she could not move her arm. Her whole arm down to the elbow turned red. The patient was treated with ice packs, diphenhydramine and prednisone. The patient sought medical attention via a phone call and office visit. The event outcome was recovering.
Age: 60.0
Sex: F
Vaccine: FLUX, PNC, VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous consumer report (initial receipt: 19-Sep-2012) concerns a 60-year-old female patient, who had allergy to penicillin. On 18-Sep-2012 the patient received a flu vaccine (manufacturer, brand name and lot number were not provided). At the same time, she also received ZOSTAVAX injection at a dose of 0.65 mL subcutaneously and PREVNAR. On 18-Sep-2012, after her vaccination, the patient began to feel achy all over from her hands to her legs and arms. She did not seek medical attention. Treatment included ADVIL. The event outcome was recovering.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 05-Oct-2012) concerns a 52-year-old female patient. On 24-Sep-2012 the patient received flu vaccine (manufacturer, brand name and batch number were not provided). Concomitant she also received PNEUMOVAX (batch number: H010515) intramuscularly. Later that evening the patient was evaluated at an Emergency Room for severe swelling at the injection site and fever of 103 F (Fahrenheit). The event outcome was not reported.
Age: 22.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 18-Oct-2012) concerns a 22 year-old female patient, who had no pertinent medical history or drug allergy. On 14-Oct-2012 the patient received an unspecified flu vaccine (manufacturer, brand name and batch number were not provided). On the same day she also received PNEUMOVAX 23 injection for immune deficiency. Later that evening on 14-Oct-2012 the patient experienced pain at the injection site of PNEUMOVAX. The patient also developed a fever and chills 48 hours after receiving PNEUMOVAX and flu vaccine. The patient sought medical attention and was treated with unspecified pain medication. The event outcome was not recovered.
Age: 70.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Rash, Rash vesicular, Urticaria
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 17-Oct-2012) concerns a 70-year-old female patient, who had no pertinent medical history. About a week and a half ago, the patient received flu vaccine (manufacturer, brand name and batch number were not provided) in right arm. On the same day she also received ZOSTAVAX in left arm. About 3 days after vaccination the patient developed a vesicular, urticarial rash on her right shoulder and the right side of her neck. She sought medical attention and received unspecified topical cream for the events. The event outcome was not recovered.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Dizziness, Hyperhidrosis
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 08-Oct-2012) concerns a 60-year-old male patient, who had no pertinent medical history or drug allergies. On 06-Oct-2012 at 12:00 the patient received AFLURIA (batch number: P59908) at a dose of 0.5 mL injection intramuscularly. On 06-Oct-2012 at 18:00 the patient experienced coughing, dizziness, sweating, diarrhoea and felt like fainting. No lab diagnostic study was performed. The patient did not receive any treatment. He sought medical attention by phone call to the pharmacy. The event outcome was recovered on 07-Oct-2012 at 08:00.
Age: 57.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Feeling hot, Rash macular, Rash maculo-papular
Clinical narrative: This consumer report (initial receipt: 22-Oct-2012) concerns a 57 year-old female patient, who had a medical history of high cholesterol and AMD (Age-related Macular Degeneration). Concomitant medications include ALEVE, ZETIA, ibuprofen, vitamins and multivitamin with minerals. On 01-Oct-2012 the patient received an unspecified influenza vaccine (manufacturer, brand name and batch number were not provided) under the skin in the upper left arm. On the same day she might have also received a pneumonia vaccine (manufacturer and brand name unknown) and on 10-Sep-2012 she received a cortisone injection. The day after she received the vaccine her face was very red and blotchy and it felt hot and almost felt sun burned (although it was not sunburn). On 10-Oct-2012 she noticed a big black blotch on her left wrist extending about 6 inches up her arm. It began to appear as if it were clearing up until today (22-Oct-2012) - she stated that the area was a raised red patch with smaller red areas within it. Treatment included rubbing ice cubes on the area. The event outcome was not recovered. Reporter comment: The events might also have something to do with the cortisone injection (brand unknown) that patient received in her ankle.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 23-Oct-2012) concerns a female patient in her 70's, who was a cardiac patient. Early last week the patient received a flu vaccine (manufacturer, brand name and batch number were not provided). She also received ZOSTAVAX at a dose of 0.65 mL once subcutaneously as age based recommendation. She received both vaccines in opposite arms. Early last week after vaccination, the patient had an anaphylactic reaction. She went to a hospital where she was given epinephrine. She was admitted for 24 hours and then released. The hospital report stated that this may have been a reaction to neomycin, but only because that was mentioned in the prescribing information. The event outcome was recovered within 24 hours of getting the shot. Reporter's comment: On 23-Oct-2012 the reporter considered event to be serious due to hospitalisation or prolonged hospitalisation.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous consumer report (initial receipt: 02-Oct-2012) concerns a female patient, who had a medical history of breast cancer and allergy to azo-standard, azithromycin and SILVADENE. About 5 years ago (2007) the patient received a flu shot (manufacturer, brand name and batch number were not provided) and one vial dose of PNEUMOVAX 23 injection. About 5 years ago after vaccination, the patient reported her arm was sore for a couple of days. No lab diagnostic study was performed. The patient did not receive any treatment for the event. The event outcome was recovered.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Pain
Clinical narrative: This consumer report (initial receipt 23-Oct-2012) concerns a 59 year old female patient who has a medical history of an allergy/reaction to antibiotics. Concomitant medications included simvastatin and cetirizine. On 17-Oct-2012, the patient received flu vaccine (manufacturer unspecified, batch number not reported) in the left arm. On the same day the patient also received co-suspect drug, PNEUMOVAX 23 by injection (0.5mL dose) in the right arm intra`muscularly. On the 18-Oct-2012, the developed a high fever of 102F (Fahrenheit), severe chills, body aches, soreness and tenderness at the injection site. On 19-Oct-2012, 2 days following vaccination, her right upper arm (where PNEUMOVAX was administered) became red, hard and painful. On 20-Oct-2012, the patient was treated with cephalexin and ibuprofen. The patient outcome was not yet recovered at the time of reporting. Case correction (26-Oct-2012): Reported term of body aches to be changed to unlisted.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: This consumer report (initial receipt 23-Oct-2012) concerns a 59 year old female patient who has a medical history of an allergy/reaction to antibiotics. Concomitant medications included simvastatin and cetirizine. On 17-Oct-2012, the patient received flu vaccine (manufacturer unspecified, batch number not reported) in the left arm. On the same day the patient also received co-suspect drug, PNEUMOVAX 23 by injection (0.5mL dose) in the right arm intra`muscularly. On the 18-Oct-2012, the developed a high fever of 102F (Fahrenheit), severe chills, body aches, soreness and tenderness at the injection site. On 19-Oct-2012, 2 days following vaccination, her right upper arm (where PNEUMOVAX was administered) became red, hard and painful. On 20-Oct-2012, the patient was treated with cephalexin and ibuprofen. The patient outcome was not yet recovered at the time of reporting. Case correction (26-Oct-2012): Reported term of body aches to be changed to unlisted.
Age: 68.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Neuralgia, Pain in extremity
Clinical narrative: This consumer report (initial receipt 26-Oct-2012) concerns a 68 year old male patient who had a medical history of high blood pressure. Concomitant medications included lisinopril. On an unknown date "about 30 days ago" the patient received an unspecified flu shot (batch no. was not provided) injection subcutaneously in his left arm. He concomitantly received a ZOSTAVAX injection subcutaneously into his left arm also. About one week ago, he started to experience nerve pain on his left side, which traveled from his thigh down to his calf. He was seen by his doctor for the nerve pain. His doctor administered an unspecified steroid shot and prescribed hydrocodone/acetaminophen for the pain. He continued to take the hydrocodone/acetaminophen and stated that the steroid shot alleviated the pain greatly. He also experienced an injection site reaction, which consisted of swelling and redness. The outcome for the event of nerve pain was recovering because the steroid shot seemed to have "worn off" and the nerve pain had returned. He stated that "even with the pain medication, I still have some pain." The outcome for the injection site reactions were considered to be resolved as they "went away after a few days".
Age: 23.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Headache, Injection site swelling, Nausea, Pyrexia, Vomiting
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 02-Oct-2012) concerns a 23-year-old female patient, who had a medical history of depression, anxiety disorder, asthma and attention deficit-hyperactivity disorder. Concomitant medications included bupropion, topiramate, budesonide; formoterol fumarate combination and unspecified oral contraceptive. On 27-Sep-2012 the patient received a flu vaccine (manufacturer, brand name and batch number were not provided) intradermally (unapproved route of administration, not explicitly reported). On the same day the patient also received PNEUMOVAX 23 (batch number: 1850AA) at dose of 0.5 mL intramuscularly. On 27-Sep-2012 the patient developed a headache, fever, nausea and vomiting, and extreme swelling of her right arm at the PNEUMOVAX 23 injection site. The patient went to the Emergency Room where she was treated with an unspecified pain medication and was released after about 3 hours. Lab diagnostic study performed showed unspecified elevated white blood cell count. The event outcome was recovering.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: White blood cell count increased
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 02-Oct-2012) concerns a 23-year-old female patient, who had a medical history of depression, anxiety disorder, asthma and attention deficit-hyperactivity disorder. Concomitant medications included bupropion, topiramate, budesonide; formoterol fumarate combination and unspecified oral contraceptive. On 27-Sep-2012 the patient received a flu vaccine (manufacturer, brand name and batch number were not provided) intradermally (unapproved route of administration, not explicitly reported). On the same day the patient also received PNEUMOVAX 23 (batch number: 1850AA) at dose of 0.5 mL intramuscularly. On 27-Sep-2012 the patient developed a headache, fever, nausea and vomiting, and extreme swelling of her right arm at the PNEUMOVAX 23 injection site. The patient went to the Emergency Room where she was treated with an unspecified pain medication and was released after about 3 hours. Lab diagnostic study performed showed unspecified elevated white blood cell count. The event outcome was recovering.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Abdominal discomfort, Full blood count abnormal, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 02-Oct-2012) concerns a 23-year-old female patient, who had a medical history of depression, anxiety disorder, asthma and attention deficit-hyperactivity disorder. Concomitant medications included bupropion, topiramate, budesonide; formoterol fumarate combination and unspecified oral contraceptive. On 27-Sep-2012 the patient received a flu vaccine (manufacturer, brand name and batch number were not provided) intradermally (unapproved route of administration, not explicitly reported). On the same day the patient also received PNEUMOVAX 23 (batch number: 1850AA) at dose of 0.5 mL intramuscularly. On 27-Sep-2012 the patient developed a headache, fever, nausea and vomiting, and extreme swelling of her right arm at the PNEUMOVAX 23 injection site. The patient went to the Emergency Room where she was treated with an unspecified pain medication and was released after about 3 hours. Lab diagnostic study performed showed unspecified elevated white blood cell count. The event outcome was recovering.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Leukocytosis, Migraine, Nausea, Pyrexia, Vomiting
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 02-Oct-2012) concerns a 23-year-old female patient, who had a medical history of depression, anxiety disorder, asthma and attention deficit-hyperactivity disorder. Concomitant medications included bupropion, topiramate, budesonide; formoterol fumarate combination and unspecified oral contraceptive. On 27-Sep-2012 the patient received a flu vaccine (manufacturer, brand name and batch number were not provided) intradermally (unapproved route of administration, not explicitly reported). On the same day the patient also received PNEUMOVAX 23 (batch number: 1850AA) at dose of 0.5 mL intramuscularly. On 27-Sep-2012 the patient developed a headache, fever, nausea and vomiting, and extreme swelling of her right arm at the PNEUMOVAX 23 injection site. The patient went to the Emergency Room where she was treated with an unspecified pain medication and was released after about 3 hours. Lab diagnostic study performed showed unspecified elevated white blood cell count. The event outcome was recovering.
Age: 63.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pruritus, Rash pustular, Skin warm
Clinical narrative: This consumer report (initial receipt 24-Oct-2012) concerns a 63-year-old female patient, who had a medical history of chickenpox twice in her life, once as a baby and once after 30 years of teaching. On 29-Sep-2012 or 30 Sep-2012 the patient received flu vaccine (manufacturer and batch no. were not specified). On the same day in the opposite arm the patient received ZOSTAVAX (batch no. not specified). On 21-Oct-2012, the patient developed pustules around the left back portion of her neck and her neck felt warm. She also had itching. She applied BENADRYL gel to the area and the warmth and itching resolved. The pustules were disappearing.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Myalgia, Wrong technique in drug usage process
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 20-Sep-2012) concerns a 60-year-old male patient. On 20-Sep-2012 at 19:00 the patient received AFLURIA (batch number: P59107) 0.5 mL intramuscularly and PNEUMOVAX 23 (batch number: 0709AB) 0.5 mL intramuscularly that were mixed in the same syringe (total volume of 1 mL) and given as one injection. AFLURIA was supplied as a prefilled syringe and the dose of PNEUMOVAX 23 was drawn up into that AFLURIA prefilled syringe and added to the AFLURIA vaccine. The patient claimed to have felt that the vaccines worked fine and re-administration was not necessary. The patient experienced muscle soreness at injection site. Other than muscle soreness at injection site, no adverse event was reported. Reporter's comment: On 01-Nov-2012 the reporter considered event to be non serious. Follow up (01-Nov-2012): patient details (DOB, age), PNEUMOVAX (batch number, time of vaccination), AFLURIA (route of administration, time of vaccination), event summary description, reporter's comment, additional AE term.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This medically confirmed spontaneous report (initial receipt 15-Oct-2012) concerns a 59-year-old female patient, who had a medical history of hypertension and no previous drug allergies. On 06-Oct-2012, the patient received flu vaccine (manufacturer, brand name and batch number were not provided). On 13-Oct-2012 she received PNEUMOVAX 23 (batch number: H012650, exp: 27-Feb-2014) at a dose of 0.5 mL once intramuscularly in the same arm as flu vaccine. On 14-Oct-2012, the patient returned to the pharmacy complaining of soreness at injection site along with swelling around surrounding area. The pharmacist checked her blood pressure and it was 'fine'. The patient reported a little bit of sore and swelling went down. Compression did help. The patient sought medical attention by returning to the pharmacy. She was treated with paracetamol and cold compressions. The event outcome was not reported.
Age: 1.51
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Rash
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 23-Oct-2012) concerns a female child. On 05-Oct-2012 the patient received flu vaccine (manufacturer, brand name and batch number were not provided). On the same day she also received VARIVAX and MMR II (batch number: 0255AA). She received her vaccination in her right arm. On 21-Oct-2012 the patient broke out in a rash. The event outcome was not reported.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives on arms and torso shortly after administration of GARDASIL. BENADRYL given, hives resolved. Observed for 40 mins.
Age: 1.01
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Pyrexia
Clinical narrative: This consumer report (initial receipt 24-Oct-2012) concerns a 1-year-old female patient. Concomitant medications included ranitidine and multi-vitamins. On 15-Oct-2012, the patient received flu vaccine (manufacturer and batch no. were not specified) and VARIVAX. On 23-Oct-2012, the patient developed a fever of 101.6 degrees Fahrenheit. She had no other adverse reactions. The following morning the patient's temperature returned to a normal 98 degrees Fahrenheit. The patient's mother feared that her temperature might spike back up. Treatment included TYLENOL.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Amnesia, Blood test, Computerised tomogram
Clinical narrative: Patient claims that 1/2 hour post vaccination she had memory loss for 6 hours.
Age: 43.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose, Cold sweat, Disorientation, Electrocardiogram, Immediate post-injection reaction
Clinical narrative: At moment of injection with Fluzone Inradermal 0.1ML a slight sensation of pain in left shoulder was felt, followed by raised or localize swelling at injection zone, followed by systemic sensation throughout body which is best described as cold sweat, disorientation, feeling of cold arms and legs, followed by uncontrolled shaking (i.e. as if low blood sugar).
Age: 43.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling, Musculoskeletal pain, Peripheral coldness, Presyncope, Tremor
Clinical narrative: At moment of injection with Fluzone Inradermal 0.1ML a slight sensation of pain in left shoulder was felt, followed by raised or localize swelling at injection zone, followed by systemic sensation throughout body which is best described as cold sweat, disorientation, feeling of cold arms and legs, followed by uncontrolled shaking (i.e. as if low blood sugar).
Age: 43.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Dizziness, Erythema, Local swelling
Clinical narrative: At moment of injection with Fluzone Inradermal 0.1ML a slight sensation of pain in left shoulder was felt, followed by raised or localize swelling at injection zone, followed by systemic sensation throughout body which is best described as cold sweat, disorientation, feeling of cold arms and legs, followed by uncontrolled shaking (i.e. as if low blood sugar).
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Eczema, Exfoliative rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash described by dermatology 10/5/2012 erythematous non-indurated scaly and pruiritic patches of bilateral axilla. A&P: Eczematous skin changes of benign nature. Treated with steroid cream by derm, with Absorbine Jr then salicylate/sulfur shampoo.
Age: 56.0
Sex: M
Vaccine: FLU3, HEPAB, TDAP
Symptoms: Pain in extremity
Clinical narrative: Arm hurt down to the middle of the bone and didn't stop until the last couple of days.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Swelling and blister at site of injection.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in fingers. Resolved in about one week after symptoms started. Received influenza vaccine in 2010 and 2011 with no problems
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness unilateral, Nausea, Vertigo
Clinical narrative: Pt. given Sanofi Pasteur -FLUZONE- lot#UH729AB exp. 6/30/2013 flu vaccine in right deltoid via IM route on 12/18/2012. Next day experienced extreme vertigo causing nausea. Immediately went to ER, while in ER experienced hearing loss of right ear. Discharged home with appointment to see ENT specialist, specialist informed pt. that he has had 3 other incidents r/t to Flu vaccine this season. Pt. was given steroids, continues to take meclizine and ZOFRAN. Prednisone has partially reversed hearing loss.
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: This case is linked to Case Number 2013-00133. Initial information was received on 02 January 2013 from a consumer, who is also the patient's husband. A female patient (age not reported) with no reported medical history received a dose of FLUZONE Intradermal (sanofi pasteur) on 22 September 2012 (lot number and site of administration not reported). An unknown amount of time following vaccination, the patient developed Type A Influenza and "it was confirmed by her doctor earlier this week". The patient did not develop an itchy red bump. The patient's outcome was not reported. Documents held by sender: none.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Two days after vaccination, patient presented soreness, and swelling in the arm. Patient went to emergency room and they give AUGMENTIN 875mg and BENADRYL 25mg.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Cough, Tremor
Clinical narrative: Approx 2 hours after vaccine, patient developed chest tightness, unrelenting cough. Returned to office, treated with albuterol nebulizer. Developed shaking chills approx 6 hours after vaccine. Treated with BENADRYL & Prednisone. Doing well the next day.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Pneumonia
Clinical narrative: 12/17/12 Pt had pneumonia shot x 1 day ago. Pt c/o pain, redness at injection site and difficulty moving her arm (L). Pt was seen in ER 12/20/12. Pt seen 12/26/12 f/u - symptoms improving.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Lymphadenopathy
Clinical narrative: (L) cervical lymphadenopathy "golf-ball" size. Seen in Hospital Emergency 1/4/13.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Dyspnoea, Electrocardiogram, Oropharyngeal pain, X-ray
Clinical narrative: Shortness of Breath & Sore Throat.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Pain, Swelling
Clinical narrative: SORENESS, REDNESS, SWELLING, HEADACHE.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Induration, Mass, Pain
Clinical narrative: Localized redness, swelling, pain, hard lump, warmth, and bruising.  Has had reaction for less than 24hrs.  Reports that it was worse when she woke up this morning (01/10/2013).  Gave her 2 25mg diphenhydramine at pharmacy.  Referred to prescribing provider location for follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Localized redness, swelling, pain, hard lump, warmth, and bruising.  Has had reaction for less than 24hrs.  Reports that it was worse when she woke up this morning (01/10/2013).  Gave her 2 25mg diphenhydramine at pharmacy.  Referred to prescribing provider location for follow-up.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Vomiting
Clinical narrative: Diarrhea stomach pain, vomiting.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, Headache, Chills.  101.3 deg temp. Body ache. 24 hr period.  Took Tylonal extra strength to keep fever down, temp broke about 8 AM. Still have headache and body ache.
Age: 0.55
Sex: F
Vaccine: 6VAX-F
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Shot location of the DTap vaccine is really red around it as well as a hard lump under where the redness is.  She is running a 100.1 degree temperature so I have to keep giving Pediacare fever reducer every 4 hours.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Influenza virus test negative, Nausea, Pyrexia
Clinical narrative: Chills, fever of 101.7F, nausea, & headache.  This symptoms lasted approx. 36 hours.  We visited our physician the next morning.  Tested negative for the flu.  Rotated over the counter pain meds. to counter the symptoms listed above.
Age: 20.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling, induation, redness and pain at site of injection right tricep.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Erythema, Immediate post-injection reaction, Induration, Injection site pain
Clinical narrative: The vaccine did itch a little immediately, but that quickly stopped.  Later in the day, I noticed that my arm was sore if I touched the area.  The next morning when I showered, it was very painful to touch.  When I looked in the mirror, I could see that there was a swollen, hard, red area about four inches by two inches.  It was hot to the touch.  I considered going to a doctor, but I'm away from home and don't have a doctor in this area.  This area continued to grow.  By that night, it itched a lot.  On the third day, the red area had grown to about five inches by three inches, but the area was less defined.  Ice helps relieve the itching, but the pain had spread into my armpit.  The pain and itching have kept me awake each night.  Today, the fourth day after the vaccination, it is some improved.  The area is not as large and not as hard.  It is still warm to the touch. I have pain in my armpit, and it itches intensely.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Insomnia, Pruritus, Skin warm, Swelling
Clinical narrative: The vaccine did itch a little immediately, but that quickly stopped.  Later in the day, I noticed that my arm was sore if I touched the area.  The next morning when I showered, it was very painful to touch.  When I looked in the mirror, I could see that there was a swollen, hard, red area about four inches by two inches.  It was hot to the touch.  I considered going to a doctor, but I'm away from home and don't have a doctor in this area.  This area continued to grow.  By that night, it itched a lot.  On the third day, the red area had grown to about five inches by three inches, but the area was less defined.  Ice helps relieve the itching, but the pain had spread into my armpit.  The pain and itching have kept me awake each night.  Today, the fourth day after the vaccination, it is some improved.  The area is not as large and not as hard.  It is still warm to the touch. I have pain in my armpit, and it itches intensely.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: The vaccine did itch a little immediately, but that quickly stopped.  Later in the day, I noticed that my arm was sore if I touched the area.  The next morning when I showered, it was very painful to touch.  When I looked in the mirror, I could see that there was a swollen, hard, red area about four inches by two inches.  It was hot to the touch.  I considered going to a doctor, but I'm away from home and don't have a doctor in this area.  This area continued to grow.  By that night, it itched a lot.  On the third day, the red area had grown to about five inches by three inches, but the area was less defined.  Ice helps relieve the itching, but the pain had spread into my armpit.  The pain and itching have kept me awake each night.  Today, the fourth day after the vaccination, it is some improved.  The area is not as large and not as hard.  It is still warm to the touch. I have pain in my armpit, and it itches intensely.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test abnormal, Muscle spasms, Paraesthesia, Type IV hypersensitivity reaction
Clinical narrative: Muscle cramps, lower back, one thigh, one arm, one thumb, one toe,  pins and needles in limbs.  Course of prednisone. Also had reaction in 2005 and 2001 but did not connect them with flu shots at that time but timing was suspicious according to Dr records.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Musculoskeletal discomfort, Pruritus, Skin warm
Clinical narrative: Pt woke up morning of 1/10, 2 days post vaccination with redness (about 1" diameter) and a knotty feeling in the muscle.  Slightly itchy and warm to the touch.  Advised her to take Benadryl when she can.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Muscular weakness, Musculoskeletal pain, Paraesthesia
Clinical narrative: Pain in right shoulder and mid clavical area.  Weakness in right arm and recently, in the last week, numbness and tingling in all fingertips of  right hand (except pinky finger), especially while sleeping.  Limited range of motion in right shoulder/arm.  Have been taking x 2 Aleve morning and night without pain relief.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Cerebellar syndrome, Dizziness, Electromyogram abnormal
Clinical narrative: Presented with dizziness and falling, developed progressive weakness, sensory loss, dysmetria.  Was hospitalized and diagnosis made by neurologist with EMG confirmation - acute sensory neuronopathy (Guillain Barre Variant).  Received IVIG without significant improvement at follow up.  She is now nonambulatory and resides at long term acute care facility.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Guillain-Barre syndrome, Immunoglobulin therapy, Peripheral sensory neuropathy, Sensory loss
Clinical narrative: Presented with dizziness and falling, developed progressive weakness, sensory loss, dysmetria.  Was hospitalized and diagnosis made by neurologist with EMG confirmation - acute sensory neuronopathy (Guillain Barre Variant).  Received IVIG without significant improvement at follow up.  She is now nonambulatory and resides at long term acute care facility.
Age: 20.0
Sex: M
Vaccine: ANTH, FLU3, JEV1
Symptoms: Anaphylactic shock, Inappropriate schedule of drug administration
Clinical narrative: This medically confirmed report (initial receipt 29-Aug-2012) involves a 20 year old male who was enrolled in a retroactive surveillance study from a large database. Concomitant medications included prednisone, ranitidine, hydroxyzine HCl and epinephrine. The patient's past drug history includes IXIARO (batch number: JEV08L17), ACAM2000 (batch number: VV04-003A), MMR II (Batch number: 0763Y) and BIOTHRAX (Batch number: FAV235). On 24-Nov-2010, the patient received suspect vaccine, AFLURIA (CSL vaccine, Batch M51207). Co-suspect vaccines received on the same day include IXIARO (Batch JEV09L36A) and BIOTHRAX (Batch FAV242). On 24-Nov-2010, the same day as vaccinations, the patient had an anaphylactic shock however was diagnosed with 'other anaphylactic shock' as per ICD9-CM (International Classification of Diseases) code 995.0) on 03-Dec-2010 during an outpatient visit, without further specification. He received unspecified drug treatment. Patient outcome is unknown. Reporter comment: As per the decision of the drug safety monitoring board on 05-Jul-2012, the case was assessed as possibly related (may not be excluded, though not very likely). The causality assessment of possible is in relation to IXIARO only and not in relation to the concomitant vaccines. The reporter believes that the case does not constitute an adverse reaction for influenza vaccine. Note the reporter (pharmaceutical company) captured the additional event of 'Inappropriate schedule of vaccine administered' as preferred term due to a schedule deviation in relation to IXIARO - a second vaccination two months after the first. Follow-up (06-Sep-2012) and correction: Reporter comment on origin of report and product causality, correction to diagnosis date.
Age: 38.0
Sex: M
Vaccine: FLUX, JEV1
Symptoms: Convulsion
Clinical narrative: This medically confirmed report (received via a pharmaceutical company) involves a 38 year old male patient who was enrolled in a retroactive surveillance study. The information is derived from a large database. On 31-Aug-2010, the patient received suspect medication influenza vaccination (brand and batch number unknown). On the same day, the patient received co-suspect vaccine IXIARO. No other drugs were given. On 05-Sep-2010, 6 days after receiving vaccinations, during an outpatient visit, the patient was diagnosed with 'other convulsions' as per ICD9 CM code 780.39, without further specification. No therapy was initiated. The patient received a second dose of IXIARO on 26-Sep-2010. Outcome was not reported. Reporter comment: Causality assessed by the Drug Safety Monitoring Board (DSMB) on 05-Jul-2012 as possibly related. This causality assessment is related to IXIARO. There was no causality assessment on concomitant vaccines. the view from the pharmaceutical company reporter is that these cases do not constitute ADR cases for influenza vaccine. Patient received the second dose of IXIARO 3 weeks after their outpatient visit, indicating that the treating physician did not see any contraindication; there was no report on another convulsion (negative rechallenge for IXIARO). Follow-up (06-Sep-2012): Clarification of reporter causality, report type.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This spontaneous consumer report (initial receipt: 19-Sep-2012) concerns a 65-year-old female patient. Two years ago (2010) the patient received a flu shot (manufacturer, brand name and lot number were not provided). Two weeks after the shot, the patient came down with the flu. The event outcome was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 18-May-2012) concerns a female patient. On an unknown date the patient received an unspecified flu vaccine (manufacturer unspecified) and experienced Guillain-Barre syndrome. The event outcome was not reported. No further information could be provided by the reporter.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 18-May-2012) concerns a female patient. On an unknown date the patient received  an unspecified flu vaccine (manufacturer unspecified) and experienced Guillain-Barre syndrome. The event outcome was not reported. No further information could be provided by the reporter.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This medically confirmed spontaneous report (initial receipt 02-May-2012) concerns a female patient with a medical history of chronic inflammatory demyelinating polyneuropathy and allergy to flu vaccine. On an unspecified date many years ago, the patient received a flu vaccine and she became ill after receiving the vaccine. The patient was hospitalised as a result of this. The event outcome was recovered. Reporter's comments: On 02-May-2012, the reporter considered events serious due to hospitalisation.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hypersensitivity
Clinical narrative: This consumer report (initial receipt: 18-Oct-2012) concerns a 58-year-old female patient, who had a pertinent medical history of hay fever and an egg allergy. On an unknown date, the patient received a flu vaccine (manufacturer, brand name and batch number were not provided). The patient also received PNEUMOVAX 23 (batch number was not provided) injection on an unknown date. The patient developed an allergic reaction to PNEUMOVAX 23 and was treated with a shot of adrenaline (manufacturer unknown) by a physician. She was held at the physician's office for "about 8 hours" for observation. The patient reported that she had a similar reaction to a flu vaccine. The event outcome was not reported.