chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 80 years old female patient. The patient was vaccinated on April 2012 with 0.65 mL dose of subcutaneous injection of ZOSTAVAX, broke out on 17-OCT-2012 into a rash and was diagnosed with shingles. The patient received treatment with acyclovir. The patient sought unspecified medical attention. The outcome of the event was unknown. The relatedness of the event with subcutaneous injection of ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This spontaneous report as received from a physician refers to 2 patients of unknown ages. The patients were vaccinated with a dose of ZOSTAVAX (lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that on an unknown date, the patients experienced a local reaction at the injection site. The outcome of local reaction at the injection site was unknown. The relatedness for local reaction at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Activities of daily living impaired, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: This spontaneous report as received from certified medical assistant (CMA) concerning to a 6 years old male patient with no drug allergies or reactions and no pertinent medical history. The patient received the first dose of HAVRIX in November 2011. On 01-OCT-2012, the patient was vaccinated with the second dose of 0.5 ml VAQTA (lot no. 0669AE, exp date: 07-DEC-2014). No other co-suspects were reported. Concomitant medications included FLUZONE. On the same date, the patient experienced fever of 104 degrees F, 1 day after onset of therapy, fatigue, loss of appetite, diarrhea, nausea and headache. The patient could not go to school. The patient was treated alternated taking acetaminophen and ibuprofen. The patient sought medical attention office visit. There were no laboratories diagnostic test performed. On 04-OCT-2012, the patient recovered from all the adverse events. Fever of 104 degrees f, fatigue, loss of appetite, diarrhea, nausea and headache considered disabling by the reporter. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from certified medical assistant (CMA) concerning to a 6 years old male patient with no drug allergies or reactions and no pertinent medical history. The patient received the first dose of HAVRIX in November 2011. On 01-OCT-2012, the patient was vaccinated with the second dose of 0.5 ml VAQTA (lot no. 0669AE, exp date: 07-DEC-2014). No other co-suspects were reported. Concomitant medications included FLUZONE. On the same date, the patient experienced fever of 104 degrees F, 1 day after onset of therapy, fatigue, loss of appetite, diarrhea, nausea and headache. The patient could not go to school. The patient was treated alternated taking acetaminophen and ibuprofen. The patient sought medical attention office visit. There were no laboratories diagnostic test performed. On 04-OCT-2012, the patient recovered from all the adverse events. Fever of 104 degrees f, fatigue, loss of appetite, diarrhea, nausea and headache considered disabling by the reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced welt associated with the ZOSTAVAX administration site. The patient complained that it really bother her for about 7 days. The outcome of welt associated with the ZOSTAVAX administration site was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 44 years old female patient (who is also physician) with no medical history or drug reactions/allergies. The patient was vaccinated subcutaneously in the left arm with a 0.5 ml dose of VARIVAX (merck) on 05-OCT-2012. Lot number 0660AE (in validation) and exp. date 14-MAR-2014. No other co-suspects were reported. Concomitant medications included: SYNTHROID and another unspecified medication. On 17-OCT-2012 the patient developed a red golf ball size rash on the left arm at the injection site. On 18-OCT-2012 the patient had one vesicle at the same location of the red golf ball size rash. The patient sought medical attention by phone call and office visit. No laboratory tests were performed. Treatment included ice and TYLENOL. The outcome of red golf ball size rash on the left arm at the injection site and vesicle at the same location of the red golf ball size rash was reported as recovering/resolving. The relatedness for red golf ball size rash on the left arm at the injection site and vesicle at the same location of the red golf ball size rash was unknown for VARIVAX (Merck). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced welt associated with ZOSTAVAX administration site. The patient complained that it really bother her about 7 days administration site was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced welt associated with ZOSTAVAX administration site. The outcome of welt associated with ZOSTAVAX administration site was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 71 years old male patient with no drug reactions or allergies. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX on 17-OCT-2012 (Lot # H013018, expiration date 09-OCT-2012) SQ on 17-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 17-OCT-2012, the patient developed four little welts around injection site along with itching about 10-15 minutes after receiving ZOSTAVAX. After the patient was administered, he was in the waiting area just for an observation and patient complained to pharmacist that the injection site was itching and when the pharmacist examined the patient, she noticed four white welts around the injection site. The patient left the pharmacy soon after and when the pharmacist called the patient to follow up, patient's wife reported that welts had gotten little bigger in size but no other symptoms were reported. The patient did not receive treatment for the adverse events. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced welt associated with ZOSTAVAX administration site. The outcome of welt associated with the ZOSTAVAX administration site was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced welt associated with the ZOSTAVAX administration site. The outcome of welt associated with the ZOSTAVAX administration site was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced welt associated with the ZOSTAVAX administration site. The outcome of welt associated with ZOSTAVAX administration site was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from approximately 66 years old male patient regarding himself. Pertinent medical history was none. The patient was allergic to Sulfa drugs. On 28-JUN-2012, the patient was vaccinated with ZOSTAVAX. Dosing details and the lot number were not reported. Concomitant medications included RAMIPRIL and CRESTOR. Approximately on 13-AUG-2012 (reported as a month ago) the patient experienced a spot on his arm that itches between his wrist and elbow after about 2 months of getting ZOSTAVAX. No medical attention was sought. No treatment information was reported. No lab diagnostics studies performed. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with expired PNEUMOVAX 23 (lot # 669776/0614AA, exp date 27-SEP-2012) on 12-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Injection site haematoma
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a male patient over the age of sixty years old. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # not reported) in the forearm that caused an injection site reaction "last week", on approximately 16-OCT-2012. The reaction was described as a large deep bruise. It was also stated that the patient was administered ZOSTAVAX in forearm rather then in the deltoid region. Patient returned to his physician (unspecified by reporter) and was prescribed an antibiotic (product and manufacturer unspecified). The outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced welt associated with the ZOSTAVAX administration site. The outcome of welt associated with the ZOSTAVAX administration site was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with MMR II (route, dose and lot # not reported) when she was a child. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the recent titer was negative, no adverse effect reported. At the reporting time, the outcome of event was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced welt associated with the ZOSTAVAX administration site. The outcome of welt associated with the ZOSTAVAX administration site was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients (gender unspecified). No concomitant medications were reported. The nurse reported that on an unknown date some doses of ZOSTAVAX (lot # not reported) had been transported using dry ice and the temperature might have gone down below -58 F and these doses might have been administered to an unknown number of patients. No adverse effects were reported. Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Contusion, Injection site haematoma
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 years old male patient. The patient had none pertinent medical history. The patient had none drug allergies. On 20-OCT-2012 the patient was vaccinated intramuscularly in right arm with PNEUMOVAX 23 (lot # not reported) from another Pharmacy. Concomitant medications were reported as none. On 21-OCT-2012 the patient developed pain at his right arm pit. Additionally, he developed a dark red, purplish bruise of his entire right forearm and at the crease of his right elbow into his bicep area. The patient sought for medical attention by stopping by at pharmacy. No treatment was given. Lab diagnostics studies performed were reported as none. The outcome was reported as not recovered. Additional information has been requested.
Age: 1.51
Sex: F
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an 18 months old female patient. On 05-OCT-2012 the patient was vaccinated in her right arm with M-M-R II (lot # 669032/0255AA, expiration date 21-FEB-2013). Other suspect therapies included VARIVAX (Merck). Concomitant medications included a flu vaccine (manufacturer unspecified). On 21-OCT-2012 the patient broke out in a rash. It was reported that the patient "had full body rashes, but no itching". It was unspecified whether the patient sought for medical attention. The outcome was unknown. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a female patient of unknown age. The healthcare professional reported that the patient's daughter was vaccinated with a dose of VARIVAX (merck) (lot number H007141, expiration date not provided) on 06-OCT-2012 and the patient developed shingles approximately one month later on approximately 06-SEP-2012. At the time of the report, the patient was recovering from the event of shingles. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 1 years old male patient. On 12-OCT-2012 the patient was vaccinated with 0.5 ml M-M-R II (lot # reported as 1644Z, expiration date unspecified). Concomitant medications included PREVNAR, HIB and a flu vaccine (manufacturer's unspecified). On 12-OCT-2012 the patient "had full body rashes, but no itching". It was unspecified if the patient sought for medical attention. On an unspecified date the patient recovered. This is one of several reports received from the same source. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This spontaneous report as received from an about 50 years old female pharmacist via a company representative refers to herself. On 10-OCT-2012 or 11-OCT-2012 the patient was vaccinated subcutaneously with single dose of 0.65 ml ZOSTAVAX (lot # not reported). It was reported that when the patient was vaccinated with ZOSTAVAX, her "right arm at the injection site was itching and there was redness and a raised induration that lasted 3 to 4 days". It was unspecified whether the patient sought for medical attention. On an unspecified date the patient was recovered. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning to a patient who, on an unspecified day, was vaccinated with an improperly stored dose of MMR II which was exposed to 67 F for 63 hours. No adverse effect reported. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Oedema peripheral, Rash erythematous
Clinical narrative: This spontaneous report as received from a Pharmacist refers to a 72 years old patient with unknown demographics. On 22-SEP-2012, the patient was vaccinated with ZOSTAVAX (dose, route and lot# were unspecified). Pertinent medical history, drug reactions and allergies were unspecified. Concomitant medications were unspecified. On 22-SEP-2012 within hours after receiving ZOSTAVAX, the patient experienced red rash and arm became swollen. The patient was treated with ice pack and a topical ointment ARNICA. The outcome of arm became swollen and red rash was reported as recovering/resolving. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 5 years old male patient. The patient was vaccinated with ZOSTAVAX (lot number not reported) on 23-OCT-2012. No concomitant medications were reported. The patient received a dose of ZOSTAVAX on 23-OCT-2012 instead of his second dose of VARIVAX (Merck). The patient received his first dose of VARIVAX (Merck) (lot number not reported) in March 2008. No adverse symptoms reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old male patient with prostate cancer and not receiving any immunosuppressive treatment. The patient was vaccinated subcutaneously in the ventral aspect of his right forearm with 0.65 ml ZOSTAVAX (Lot number H012523, expiration date 09-OCT-2013) on 19-OCT-2012. No other co-suspects were reported. Concomitant medications included FLOMAX and CLARAVIS. On 19-OCT-2012 the patient experienced injection site pain at the moment of receipt of the dose of ZOSTAVAX. And the following day on 20-OCT-2012, the patient developed redness and swelling at the injection site. His injection site reaction progressed to developing a rash in the area of the redness and swelling. The patient had consulted physician for medical attention. BENADRYL was given for treatment. At the time of this report, his pain, redness, swelling and rash was reported as recovering/resolving. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: 10/17/2012 8:00 PM low grade fever. 10/18/2012 approximately 10 PM noted raised & infuriated area at injection sight on right arm the size of "a golf ball, attempted to photograph. 10/19/2012 contacted pharmacy & spoke with pharmacy manager. 11:35 AM evaluated at Urgent Care physician who found R. Forearm posterior... With mid tricep area below... 4x4 cared raised induration...Afterwards returned to pharmacy & spoke with pharmacy manager. He photographed injection site with his and my mobile phone cameras. Stated vaccine given eith 5/8 inch needle, reaction was normal, use of warm compresses & Tylenol. 10/24/2012 evaluated by PCP. Slight redness with itching persists.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: 10/17/2012 8:00 PM low grade fever. 10/18/2012 approximately 10 PM noted raised & infuriated area at injection sight on right arm the size of "a golf ball, attempted to photograph. 10/19/2012 contacted pharmacy & spoke with pharmacy manager. 11:35 AM evaluated at Urgent Care physician who found R. Forearm posterior... With mid tricep area below... 4x4 cared raised induration...Afterwards returned to pharmacy & spoke with pharmacy manager. He photographed injection site with his and my mobile phone cameras. Stated vaccine given eith 5/8 inch needle, reaction was normal, use of warm compresses & Tylenol. 10/24/2012 evaluated by PCP. Slight redness with itching persists.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: 10/17/2012 8:00 PM low grade fever. 10/18/2012 approximately 10 PM noted raised & infuriated area at injection sight on right arm the size of "a golf ball, attempted to photograph. 10/19/2012 contacted pharmacy & spoke with pharmacy manager. 11:35 AM evaluated at Urgent Care physician who found R. Forearm posterior... With mid tricep area below... 4x4 cared raised induration...Afterwards returned to pharmacy & spoke with pharmacy manager. He photographed injection site with his and my mobile phone cameras. Stated vaccine given eith 5/8 inch needle, reaction was normal, use of warm compresses & Tylenol. 10/24/2012 evaluated by PCP. Slight redness with itching persists.
Age: 33.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Asthenia, Injection site pain, Lethargy
Clinical narrative: Severe pain in arm where shot was administered. Lethargic and weak feeling throughout body.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash papular, Skin irritation
Clinical narrative: PT STATES STARTED AS LITTLE RED BUMPS ON L ARM, SPREADING TO BILATERAL ARMS AND BACK. IRRITATION AND ITCHING STARTED A COUPLE DAYS AFTER VACCINATION.  PT WAS PRESCRIBED HYDROXYZINE. RETURNED TO CLINIC A COUPLE DAYS AFTER INITIAL REACTION, WITH NO IMPROVEMENTS. NO HX ADVERSE REACTIONS IN THE PAST AND NO ALLERGIES TO EGGS, GLUTEN, LATEX, ETC. NO TROUBLE BREATHING. PT WILL BE PRESCRIBED MEDICATION DURING THE REMAINDER OF DEPLOYMENT AND VERBALIZED UNDERSTANDING TO REPORT TO THE CLINIC UPON ANY OTHER SYMPTOMS.
Age: 82.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Shingles on head, neck and going into ear.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Palpitations, Pruritus
Clinical narrative: Severe reaction resulting in 911 call and paramedic transport to hospital. Numbness, racing heart, shortness of breath, itching.
Age: 57.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Abdominal distension, Hypoaesthesia, Hypoaesthesia oral, Pharyngeal oedema, Swelling
Clinical narrative: Profound numbness of face, tongue, extremities.  Feeling of fullness/swelling in upper chest and throat. Symptoms lasted 12 hours. No rash.  No shortness of breath, nor wheezing.
Age: 57.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Hypoaesthesia, Tongue disorder
Clinical narrative: Profound numbness of face, tongue, extremities.  Feeling of fullness/swelling in upper chest and throat. Symptoms lasted 12 hours. No rash.  No shortness of breath, nor wheezing.
Age: 32.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Trouble breathing, heart felt like it was going to beat out of chest, dizziness.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Dysphagia, Dyspnoea, Injection site erythema, Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: Throat swelling; Trouble swallowing and breathing; Fever; Redness in my eyes, especially on the side of the injection; Redness around injection site. Treated with Benadryl.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Throat swelling; Trouble swallowing and breathing; Fever; Redness in my eyes, especially on the side of the injection; Redness around injection site. Treated with Benadryl.
Age: 23.0
Sex: F
Vaccine: FLUX, TD
Symptoms: Blood test, Chest X-ray, Cough, Migraine, Pyrexia
Clinical narrative: MIGRAINE HEADACHE, FEVER OF 103, CONGESTION, LINGERING COUGH LASTING 6 WEEKS.
Age: 23.0
Sex: F
Vaccine: FLUX, TD
Symptoms: Respiratory tract congestion, Urine analysis
Clinical narrative: MIGRAINE HEADACHE, FEVER OF 103, CONGESTION, LINGERING COUGH LASTING 6 WEEKS.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: SWELLING AT INJECTION SITE. SWELLING HAS COME DOWN AS OF 10/27/12.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Malaise, Muscular weakness, Nausea
Clinical narrative: Arm shot was given in went numb immediately after and stayed numb and felt very heavy for 15 or more minutes.  About an hour later, both legs experienced numbness and weakness.  Next day, still felt numbness in legs and arm. Awoke at night with body aches and general ill feeling. Third day, arm shot was given was achy and numb, had nausea and blurry vision.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Sensation of heaviness, Vision blurred
Clinical narrative: Arm shot was given in went numb immediately after and stayed numb and felt very heavy for 15 or more minutes.  About an hour later, both legs experienced numbness and weakness.  Next day, still felt numbness in legs and arm. Awoke at night with body aches and general ill feeling. Third day, arm shot was given was achy and numb, had nausea and blurry vision.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Cough
Clinical narrative: PATIENT STATES THAT AROUND BEDTIME (10/26/12) SHE BEGAN SUFFERING FROM TERRIBLE CHILLS. SHE STATES THE CHILLS LASTED THROUGHOUT THE NIGHT. IN THE MORNING HER TEMPERATURE WAS ~99 DEGREES. UPON FOLLOW UP HER TEMPERATURE IS APPROX 100 DEGREES AT 3:45PM (10/27/12). THE PATIENT ALSO STATES THAT SHE HAS HAD A COUGH SINCE THE VACCINE.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Myalgia, Pain, Pain in extremity
Clinical narrative: During administration, pain, numbness and tingling down medial aspect of forearm into 4th and 5th digits. Lasted approx 1 minute. Later that evening developed pain in left muscle/shoulder near injection site. Tender to touch and very painful to rotate arm. Unable to sleep on left side and will wake up if I roll onto that side. Ten days after vaccination, developed a raised, itchy rash on body. Total of approx 20 raised areas over skin. Still having the same amount of pain and symptoms in arm 17 days later.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Rash pruritic, Tenderness
Clinical narrative: During administration, pain, numbness and tingling down medial aspect of forearm into 4th and 5th digits. Lasted approx 1 minute. Later that evening developed pain in left muscle/shoulder near injection site. Tender to touch and very painful to rotate arm. Unable to sleep on left side and will wake up if I roll onto that side. Ten days after vaccination, developed a raised, itchy rash on body. Total of approx 20 raised areas over skin. Still having the same amount of pain and symptoms in arm 17 days later.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Cardiac function test, Chest X-ray, Computerised tomogram head
Clinical narrative: Difficulty Breathing, Hoarseness, wheezing, fast heart beat and dizziness.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Differential white blood cell count, Dizziness, Dysphonia, Dyspnoea, Electrocardiogram
Clinical narrative: Difficulty Breathing, Hoarseness, wheezing, fast heart beat and dizziness.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Heart rate increased, International normalised ratio, Laboratory test, Myoglobin blood
Clinical narrative: Difficulty Breathing, Hoarseness, wheezing, fast heart beat and dizziness.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Prothrombin time, Troponin I, Wheezing
Clinical narrative: Difficulty Breathing, Hoarseness, wheezing, fast heart beat and dizziness.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Decreased appetite, Headache, Injection site discolouration, Injection site nodule, Oropharyngeal pain
Clinical narrative: Swelling of body, feet, hands, legs, fever, full body ache, kidneys inflamed, hurts to move, throat sore, hurts to try and talk, severe head ache, pale, can't keep food down, don't want to eat. Knots and arm turn white at injection site.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pallor, Pyrexia, Swelling, Urinary tract inflammation
Clinical narrative: Swelling of body, feet, hands, legs, fever, full body ache, kidneys inflamed, hurts to move, throat sore, hurts to try and talk, severe head ache, pale, can't keep food down, don't want to eat. Knots and arm turn white at injection site.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Swelling of body, feet, hands, legs, fever, full body ache, kidneys inflamed, hurts to move, throat sore, hurts to try and talk, severe head ache, pale, can't keep food down, don't want to eat. Knots and arm turn white at injection site.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Was painful, swollen and red in color. The redness started to travel down the arm. Somewhat itchy and annoying.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper
Clinical narrative: Stomach cramps for over 12 hours.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Immediate post-injection reaction, Influenza like illness, Mobility decreased
Clinical narrative: EXTREME immediate pain, feeling as if I'd pass out.. immediate increased nasal secretions within 10 minutes of receiving vaccine, followed by extreme pain for entire day, complete shoulder front and back of shoulder radiating halfway up neck pain, severe fatigue followed the next day with inability to get out of bed, moderate flu like symptoms.. chills x three weeks but no fever, unable to use or lift arm due to pain, muscles felt like overused as if every muscle in shoulder was pulled.. unable to lay on that side, unable to lift anything, and use of arm limited as of 10/27/12 and continues.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle fatigue, Musculoskeletal pain, Pain, Presyncope, Rhinorrhoea
Clinical narrative: EXTREME immediate pain, feeling as if I'd pass out.. immediate increased nasal secretions within 10 minutes of receiving vaccine, followed by extreme pain for entire day, complete shoulder front and back of shoulder radiating halfway up neck pain, severe fatigue followed the next day with inability to get out of bed, moderate flu like symptoms.. chills x three weeks but no fever, unable to use or lift arm due to pain, muscles felt like overused as if every muscle in shoulder was pulled.. unable to lay on that side, unable to lift anything, and use of arm limited as of 10/27/12 and continues.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Large red area around injection site.  Blisters.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dyspnoea, Fatigue, Injection site erythema, Injection site haematoma
Clinical narrative: Dizziness first evening. Next morning woke with shoulder pain, trouble breathing and fatigue. Used heating pad on shoulder still having trouble breathing. Rested all day. Felt relief next day. Then had a large 2-3" itchy, red blotchy area at injection site. Itchiness lasted 3 days. Still have a bruise type area remaining but itching is gone. I have had many flu shots and NEVER had any reaction whatsoever. This is a complete mystery.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pruritus, Injection site rash, Musculoskeletal pain
Clinical narrative: Dizziness first evening. Next morning woke with shoulder pain, trouble breathing and fatigue. Used heating pad on shoulder still having trouble breathing. Rested all day. Felt relief next day. Then had a large 2-3" itchy, red blotchy area at injection site. Itchiness lasted 3 days. Still have a bruise type area remaining but itching is gone. I have had many flu shots and NEVER had any reaction whatsoever. This is a complete mystery.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Blood culture, Blood test, Chest X-ray, Chills, Culture urine
Clinical narrative: Fever (up to 103.0), body aches, tachycardia, headache, nausea, chills, fatigue, and loss of appetite for 2+ weeks. Seeked medical attention on Oct. 26. Awaiting results now from blood work, urine sample, chest X-ray, blood cultures, and flu swab.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Decreased appetite, Fatigue, Headache, Influenza virus test, Metabolic function test
Clinical narrative: Fever (up to 103.0), body aches, tachycardia, headache, nausea, chills, fatigue, and loss of appetite for 2+ weeks. Seeked medical attention on Oct. 26. Awaiting results now from blood work, urine sample, chest X-ray, blood cultures, and flu swab.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Pyrexia, Tachycardia
Clinical narrative: Fever (up to 103.0), body aches, tachycardia, headache, nausea, chills, fatigue, and loss of appetite for 2+ weeks. Seeked medical attention on Oct. 26. Awaiting results now from blood work, urine sample, chest X-ray, blood cultures, and flu swab.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Injection site pain, Pruritus, Rhinorrhoea, Wheezing
Clinical narrative: Extreme runny nose...tightness in chest....wheezing....some itching...soreness around shot area.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Feeling abnormal, Feeling of body temperature change, Nausea
Clinical narrative: I experienced the sudden onset of dizziness, hot and cold chills, and nausea. I felt strange and decided to retire for the night.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Could not lift my left arm over head to remove my sweater that same evening.  I had acute shoulder pain on side where the shot was given.  The shot was given high in my left deltoid.  I continue to have the pain in my left upper arm and shoulder.  Should becomes stiff during the night.   This is chronically painful but not disabling or an emergency.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Myalgia, Oropharyngeal pain
Clinical narrative: Sore throat and muscle aches, diarrhea.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
Clinical narrative: I was approximately 6.5 weeks pregnant when I was administered the flu vaccine.  My baby stopped growing and never got bigger than 6.5 weeks along.  I was diagnosed with a miscarriage a few weeks later. The heartbeat stopped and embryo never grew past that point.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Red mark w/ itching, pain at injection site.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Oedema peripheral
Clinical narrative: 10/27/12 at 4:00pm swollen lips, puffy fingers, possible swollen tongue.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Raised red area around vaccine administration site on shoulder. The site is also warm and painful.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Dizzy, nauseated.
Age: 67.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Mass, Oedema peripheral, Pruritus, Rash
Clinical narrative: Patient called on 10/27/12 and said her left arm was swollen, red, and itching. She said the area was 3 inches big and there was a lump under the skin. It starting bothering her on 10/26/12 but only when she was sitting around doing nothing (not busy). She started putting AVEENO lotion on the rash and she said it did help the itching.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Redness, inflammation at the site of injection of about 2-3 inches in diameter.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Headache, Pain in extremity, Rash erythematous, Skin warm
Clinical narrative: 8 PM 10/12/12: Patient had a throbbing headache, a temperature of 104.2 degrees F and a small red spot. AM 10/13/12: Temperature 102.4 degrees F, small red spot developed into a large welt on arm of injection. PM 10/13/12: Temperature decreased to 101 degrees F, found large welt became thick, hot to touch and painful. Her arm was very sore. AM 10/14/12: Temperature 99.1 degrees F and large welt remains the same. 10/15/12: No treatment because welt disappeared.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urticaria
Clinical narrative: 8 PM 10/12/12: Patient had a throbbing headache, a temperature of 104.2 degrees F and a small red spot. AM 10/13/12: Temperature 102.4 degrees F, small red spot developed into a large welt on arm of injection. PM 10/13/12: Temperature decreased to 101 degrees F, found large welt became thick, hot to touch and painful. Her arm was very sore. AM 10/14/12: Temperature 99.1 degrees F and large welt remains the same. 10/15/12: No treatment because welt disappeared.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Sweating and fever.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Nausea
Clinical narrative: Gave FLUZONE High dose at 1:30 PM on 10/19. Pt. experienced nausea, diarrhea, dizziness at 7:00 PM and did not fully recover till 3 PM the following day.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient was vaccinated with her first dose of GARDASIL, 0.5 ml, intramuscular (lot number not reported) in September 2011. No other co-suspects were reported. No concomitant medications were reported. On 24-OCT-2012, that day, the patient might receive her second dose of GARDASIL, 0.5 ml, intramuscular (lot number not reported). No adverse effect reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: MMR
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 years old female patient without drug reactions/allergies. The patient was vaccinated with MMR II (dose, route and lot# not reported) 2 weeks ago, about on 24-SEP-2012. It was reported that the patient who received MMR II at an unspecified hospital was on BACTRIM on 09-OCT-2012. The reason why the patient was on BACTRIM was unknown. The pharmacist stated the patient had been on BACTRIM before but not chronically. At the time of report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Abdominal pain upper, Arthralgia, Condition aggravated, Feeling abnormal, Headache
Clinical narrative: Increasing and debilitating body aches, fatigue, nausea, pain and weakness in legs, brain fog lasting to varying degrees for 3 months.  Doctor had no treatment other than Lyme antibiotics, herbal supplements and rest.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Lyme disease, Night sweats, Pyrexia
Clinical narrative: Increasing and debilitating body aches, fatigue, nausea, pain and weakness in legs, brain fog lasting to varying degrees for 3 months.  Doctor had no treatment other than Lyme antibiotics, herbal supplements and rest.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Fatigue, Feeling abnormal, Muscular weakness, Nausea, Pain
Clinical narrative: Increasing and debilitating body aches, fatigue, nausea, pain and weakness in legs, brain fog lasting to varying degrees for 3 months.  Doctor had no treatment other than Lyme antibiotics, herbal supplements and rest.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Pain in extremity
Clinical narrative: Increasing and debilitating body aches, fatigue, nausea, pain and weakness in legs, brain fog lasting to varying degrees for 3 months.  Doctor had no treatment other than Lyme antibiotics, herbal supplements and rest.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Arthralgia, Asthenia, Behcet's syndrome, Fatigue
Clinical narrative: Diagnosed with Behcet's Disease. Chronic arthritic joint pain, weakness, headaches, memory loss, chronic fatigue, severe headaches.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Headache
Clinical narrative: Diagnosed with Behcet's Disease. Chronic arthritic joint pain, weakness, headaches, memory loss, chronic fatigue, severe headaches.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Activities of daily living impaired, Dizziness, Feeling hot, Flushing
Clinical narrative: Mom called after hours telecommunications for office practice to inform clinician that patient had a prolonged episode of tremors/shaking which continued in same intensity for at least an hour then gradually started to diminish over the next couple hours until resolution. Asymptomatic by mid afternoon/evening. Patient describes being alert at the time but unable to control the shaking. Felt a hot sensation, and had flushed cheeks as noted by her dance instructor and other dancers. Brief period of time whereby she did not dance, but was able to do some activity while continuing the tremor. Denies chest pain nor difficulty breathing. Had a headache, some transient dizziness, and a stomach ache. Felt stomach ache could be related to menstrual cramps she had at the time. Had breakfast that morning. Did not have any seizure activity, No LOC. At the time of occurrence, mom informed but did not connect that her symptoms could be related to the influenza vaccine. Called telecommunications at 7:01 pm on 10/27/2012 to report event. Discussed bringing patient to the ER, but mom felt symptoms resolved by the time. Mom described plans to consult with patient's primary provider.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Tremor
Clinical narrative: Mom called after hours telecommunications for office practice to inform clinician that patient had a prolonged episode of tremors/shaking which continued in same intensity for at least an hour then gradually started to diminish over the next couple hours until resolution. Asymptomatic by mid afternoon/evening. Patient describes being alert at the time but unable to control the shaking. Felt a hot sensation, and had flushed cheeks as noted by her dance instructor and other dancers. Brief period of time whereby she did not dance, but was able to do some activity while continuing the tremor. Denies chest pain nor difficulty breathing. Had a headache, some transient dizziness, and a stomach ache. Felt stomach ache could be related to menstrual cramps she had at the time. Had breakfast that morning. Did not have any seizure activity, No LOC. At the time of occurrence, mom informed but did not connect that her symptoms could be related to the influenza vaccine. Called telecommunications at 7:01 pm on 10/27/2012 to report event. Discussed bringing patient to the ER, but mom felt symptoms resolved by the time. Mom described plans to consult with patient's primary provider.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Pt developed Mildly erythematous, raised, umbilicated (some) papules on hands (palms fingers, wrists) and elbows.  Consulted CDC and felt to be "benign, Accrual papulovesicular eruption".
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cough, Oedema peripheral, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Left arm was very swollen and tender next day. He may have had low grade fever later the same day that he got it. Had sore throat, cough, some rhinorrhea, achiness which cleared by 10/26/2012.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rhinorrhoea, Tenderness
Clinical narrative: Left arm was very swollen and tender next day. He may have had low grade fever later the same day that he got it. Had sore throat, cough, some rhinorrhea, achiness which cleared by 10/26/2012.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Injection site pain, Skin warm
Clinical narrative: Pain at injection site. Large (2 inch diameter) area that is red, hard and warm to touch.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Redness, itching, warm-to-touch; beginning the evening of the day of vaccination and becoming progressively worse over 24 hours. Self-treated with diphenhydramine oral.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Suddenly had a fever over 99 degrees and developed hives significant in size. The hives would disappear and then reappear on another part of his body, but the hives appeared all over him at once. A single hive could reach the size of one half of his entire leg from hip to ankle.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dizziness, Eye discharge, Eye swelling, Fatigue
Clinical narrative: Felt like lumps developed in throat that hurt, started wheezing, and slight nasal congestion.  2 hours after that my eyes swelled, had green discharge from them, throat continued to hurt and congestion worsened.  Felt extremely fatigues, went to bed and slept for 3 hours, woke up with eyes partially closed and red, sore throat went away and had slight congestion.  Went back to bed and slept for another 7 hours.  Got up and went to work.  Starting feeling dizzy, stomach got upset 2 hours afterwards, started vomiting.  There was only 1 incident of vomiting.  Drove back home and slept another 3 hours.  Felt queasy the rest of the day.  Went to bed and felt much better on Sunday morning as I'm typing this.