chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.23
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 21-OCT-2013 at 15:00 the patient was administered with a MMR II (lot number J002505, expiry date 28-FEB-2015) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date the MMR II was exposed approximately for 9.5 hours at temperature of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:25 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7 degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Adverse drug reaction, Staphylococcal infection
Clinical narrative: This spontaneous report as received from a female dental hygienist (also the patient) of unknown age via field representative. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown, reported as assumed to be PNEUMOVAX23 in the arm. Dose, lot and expiry date were not reported. The patient received an unspecified pneumonia shot (pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown, reported as assumed to be PNEUMOVAX23) and an unspecified flu vaccine on the same arm on the same day, and then developed a staph infections. The patient took an unspecified antibiotic as treatment for the infection and then developed an unspecified adverse reaction to the antibiotic. The patient was recovering from the event staph infections at the time of report. The outcome of unspecified adverse reaction to the antibiotic was unknown. The patient had sought medical attention though not specified how. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient. On 19-OCT-2013 at 11:00, the patient was administered with M-M-R II (lot number H018184, expiry date 05-OCT-2014) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date M-M-R II was exposed approximately for 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17: 14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:26 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7 degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Age: 1.03
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 16-OCT-2013 at 09:30 the patient was administered with a MMR II (lot number H018184, expiry date 05-OCT-2014) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date the MMR II was exposed approximately for 9.5 hours at temperature of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:25 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7 degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site pain, Neuritis, Pain in extremity
Clinical narrative: Pt came to the pharmacy on 11-16-13 and stated that she developed "neuritis" 2 weeks after receiving the flu shot. Pain initiated from the left shoulder in the back and radiated down the left arm. Symptoms started on 11-13 and lasted for 3-4ds - pt took 1 dose of EXCEDRIN - pt stated that she is 80-90% recovered at this time. Advise pt to see personal physician for follow up.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 08-OCT-2013, at 10:00 the patient was administered with a MMR II (lot number H01814, expiry date 05-OCT-2014) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date the MMR II was exposed approximately for 9.5 hours at temperature of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:25 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7 degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Device malfunction, Fatigue, Gait disturbance, Hydrocephalus
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of difficulty thinking in a 77-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included bleeding ulcer, gastroesophageal reflux disease, gout, high blood pressure, hydrocephalus and shunt placed. Concurrent medications included Lisinopril, PRILOSEC, Triamterene + hydrochlorothiazide and Allopurinol. On 28 September 2013 at 11:00 the subject received 1st dose of FLULAVAL (unknown details, left deltoid). On 1 October 2013, 3 days after vaccination with FLULAVAL, the subject experienced difficulty thinking, prolonged recovery, walking difficulty and fatigue. The subject reported that the "progress with my hydrocephalus with shunt placement slowed down since my flu shot". The subject reported that he was "not walking as well, unable to pick up feet, taking smaller steps". This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Mental impairment
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of difficulty thinking in a 77-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included bleeding ulcer, gastroesophageal reflux disease, gout, high blood pressure, hydrocephalus and shunt placed. Concurrent medications included Lisinopril, PRILOSEC, Triamterene + hydrochlorothiazide and Allopurinol. On 28 September 2013 at 11:00 the subject received 1st dose of FLULAVAL (unknown details, left deltoid). On 1 October 2013, 3 days after vaccination with FLULAVAL, the subject experienced difficulty thinking, prolonged recovery, walking difficulty and fatigue. The subject reported that the "progress with my hydrocephalus with shunt placement slowed down since my flu shot". The subject reported that he was "not walking as well, unable to pick up feet, taking smaller steps". This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved.
Age: 1.1
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 month old patient. On 14-NOV-2013 the patient was received with a first dose of VARIVAX (Merck) (injection, strength, lot#, dose, route and duration were unspecified) and PROQUAD (formulation, strength, lot#, dose, route and duration were unspecified). No adverse symptoms reported. Patient had sought unspecified medical attention. The outcome was unknown. Additional information has been requested.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Bacterial test negative, Diarrhoea, Haematochezia, Incomplete course of vaccination, Laboratory test normal
Clinical narrative: This case was reported by a healthcare professional (medical assistant) and described the occurrence of blood in stool (guaiac positive) in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DTaP-HepB-IPV; GlaxoSmithKline; unknown; unknown given on 15 October 2013; Hib (non-gsk); Sanofi; unknown; unknown given on 15 October 2013; PCV (non-gsk); Wyeth Labs; unknown; unknown given on 15 October 2013. On 15 October 2013 at 10:10 the subject received 1st dose of ROTARIX (1 ml, oral). By 18 October 2013, "within 3 days" after vaccination with ROTARIX, the subject experienced diarrhea and vomiting. On 21 October 2013, 6 days after vaccination with ROTARIX, the subject experienced blood in stools and guaiac positive stool. On 25 October 2013, 10 days after vaccination with ROTARIX, the subject experienced an elevated white count. This case was assessed as medically serious by GSK. Relevant test results included the following: On 21 October 2013, the subject had a guaiac test with result of positive. On 25 October 2013, the subject had a white cell count that was elevated at 22,000. On 28 October 2013, the subject was evaluated at the office and the guaiac was negative. On 1 November 2013, a repeat white cell count was within normal range. In 2013, per the reporter, "stool studies were also run" and results were "negative (salmonella, shigella, campylobacter)." At the time of reporting the event of diarrhea was improved. The events of blood in stools and guaiac positive stool, vomiting, and elevated white count were resolved. On 28 October 2013, the subject was evaluated and "the diarrhea and stool had been getting better, improved but was still loose." On 1 November 2013, a repeat blood test showed that the white cell count had returned to within normal range. The vaccination course with ROTARIX was discontinued. "The physician had determined that this was probably a reaction specifically to ROTARIX, the series has been discontinued." The healthcare professional considered the events were probably related to vaccination with ROTARIX.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Occult blood positive, Vomiting, White blood cell count increased
Clinical narrative: This case was reported by a healthcare professional (medical assistant) and described the occurrence of blood in stool (guaiac positive) in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DTaP-HepB-IPV; GlaxoSmithKline; unknown; unknown given on 15 October 2013; Hib (non-gsk); Sanofi; unknown; unknown given on 15 October 2013; PCV (non-gsk); Wyeth Labs; unknown; unknown given on 15 October 2013. On 15 October 2013 at 10:10 the subject received 1st dose of ROTARIX (1 ml, oral). By 18 October 2013, "within 3 days" after vaccination with ROTARIX, the subject experienced diarrhea and vomiting. On 21 October 2013, 6 days after vaccination with ROTARIX, the subject experienced blood in stools and guaiac positive stool. On 25 October 2013, 10 days after vaccination with ROTARIX, the subject experienced an elevated white count. This case was assessed as medically serious by GSK. Relevant test results included the following: On 21 October 2013, the subject had a guaiac test with result of positive. On 25 October 2013, the subject had a white cell count that was elevated at 22,000. On 28 October 2013, the subject was evaluated at the office and the guaiac was negative. On 1 November 2013, a repeat white cell count was within normal range. In 2013, per the reporter, "stool studies were also run" and results were "negative (salmonella, shigella, campylobacter)." At the time of reporting the event of diarrhea was improved. The events of blood in stools and guaiac positive stool, vomiting, and elevated white count were resolved. On 28 October 2013, the subject was evaluated and "the diarrhea and stool had been getting better, improved but was still loose." On 1 November 2013, a repeat blood test showed that the white cell count had returned to within normal range. The vaccination course with ROTARIX was discontinued. "The physician had determined that this was probably a reaction specifically to ROTARIX, the series has been discontinued." The healthcare professional considered the events were probably related to vaccination with ROTARIX.
Sex: U
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist, via company representative, refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with second dose of PNEUMOVAX23 (lot #, dose, site and route of administration not reported). The patient had received PNEUMOVAX23, five years previously. On an unknown date the patient experienced bad, bad rash after receiving PNEUMOVAX23. The patient sought medical attention  saw the pharmacist. The outcome of bad, bad rash was unknown. The relatedness between PNEUMOVX23 and event was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Information was received from a nurse practitioner regarding a 15 year old female, no known allergies, who was vaccinated with a first dose of  GARDASIL on 22-JUL-2011. The patient received a second dose of GARDASIL (Lot #672547/1745AA) (Expiration: 13-SEP-2014) on 17-JUL-2012. After receiving the vaccination, on 17-JUL-2012, a urine pregnancy test was positive. The patient has non relevant medical history or concomitant medications. On 17-JUL-2012, a blood test to confirm pregnancy was sent out and the results are pending. As of 17-JUL-2012, the patient planned to finish the series and the outcome of the exposure in utero is unknown. It was noted the patient was vaccinated with Tdap (manufacturer not specified) on an unknown date, but is not current on any other vaccinations. Follow-up information was received as due date was approximately April 2013. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: This spontaneous report as received from   a consumer refers to her daughter, a 10 year old female patient with no drug reactions/allergies. On an unknown date a few years ago, the patient was vaccinated with first dose of PNEUMOVAX23 (lot#, expiration date, dose, route, indication not reported). PNEUMOVAX23 (lot#, expiration date, dose, route, indication not reported). PNUEMOVAX23 was prescribed to the patient's unspecified coexisting "severe lung condition". The patient had no adverse experience from her initial dose of PNEUMOVAX23 or from unspecified previous flue shots (manufacturer unknown) which were administered on unspecified previous dates. On 05-NOV-2013 the patient was vaccinated with second dose of PNEUMOVAX23 (lot #, expiration date, dose, indication not reported, "injection" on the arm) and a dose of influenza virus vaccine (manufacturer unknown) (lot#, expiration date, dose, route, indication not reported on the other arm). Concomitant therapies included ADVAIR, FLOVENT, and NASONEX. On approximately 05-NOV-2013 ("about 36 hours after PNEUMOVAX23 injection on 06-NOV-2013" the patient experienced fever of 101-102 degrees Fahrenheit and, at the PNEUMOVAX23 injection site, a red circle which "measures about 2 inches in diameter". The patient had sought medical attention by speaking with an unspecified physician. No lab test was done. The patient was treated with ibuprofen for her fever, which was reported to "temporarily reduce the fever", but the fever had "always returned when the ibuprofen wore off" and at the time of the report, the patient was still experiencing both fever and the injection site redness. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via field representative refers to a 66 year old male patient. The medical history of the patient was unknown. On an unknown date in October-2012, (reported as in beginning of October-2012 on an unspecified date), the patient was vaccinated with ZOSTAVAX vial, subcutaneously for shingles preventions (lot number, expiry date, dose and route unspecified). The concomitant medications were not reported. On 18-OCT-2012, the patient experienced shingles. The outcome and causality was not provided. The physician stated that patient as on 12-NOV-2013, had shingles again. The outcome of shingles as of 12-NOV-2013 was not recovered. The causality was not provided. No product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The reporter stated that the patient was vaccinated with three doses of GARDASIL (lot #, strength, dose, route and site of administration not reported), on 15-APR-2013, 04-SEP-2013 and 06-NOV-2013. No adverse effect reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Contusion, Fatigue, Muscular weakness, Pain in extremity, Ultrasound Doppler normal
Clinical narrative: This spontaneous report as received from a consumer refers to the 24 year old daughter. Patient's pertinent medical history included diabetes. Drug reactions/allergies were reported as none. On 17-SEP-2013 the patient was vaccinated with the first dose of GARDASIL. Concomitant therapies included NOVOLOG, LEVEMIR and Influenza Virus Vaccine (manufacturer unknown). On an unknown date in 2013 the patient experienced muscle weakness, bruising, leg pain, fatigue and bad left arm pain after receiving her first dose of GARDASIL. On an unknown date the patient underwent Doppler test and no negative effects observed. The outcome of muscle weakness, fatigue, bad left arm pain, leg pain and bruising was reported as not recovered/not resolved. The patient sought medical attention and visited the physician but no treatment was rendered for the events. It was unknown if whether the patient will continue on to get the rest of the doses in the GARDASIL series. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 13 year old male patient. On an unknown date approximately in 2001 (reported as approximately 1 year of age) the patient received the first dose of MMR II (dose, route and lot# unknown) and on an unknown date approximately in 2013 (reported as just recently) at the age of 13 years the patient received his second dose of MMR II (dose, route and lot# unknown). No adverse effect reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous pregnancy report as received from a consumer (the patient's husband) refers to a 25 year old female patient with no pertinent medical history and no drug reactions or allergies. On an unspecified dates, the patient was vaccinated with the first and the second dose of GARDASIL (dose, lot number and route were not provided). On 22-OCT-2013 the patient was vaccinated with third dose of GARDASIL (dose, lot number and route were not reported). There was no concomitant medications. The patient done at home pregnancy test and found out that she was pregnant, also reported that she found out last week, in an approximately November 2013, that she was 8 weeks pregnant. The patient's last menstrual period (LMP) was in an approximately September 2013. There was no treatment given for the patient's event. The patient did not seek medical attention. At the time of report, the patient outcome was unknown (outcome pending). Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an immunization program refers an patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL (route, site, dose, strength not reported, lot # H021861, exp. date: 09-OCT-2015). This is one of severeal reports received from the same source (linked MARRS#: 1310USA014881, 1310USA014883, 1310USA014888, 1310USA014891, 1311USA000056, 1311USA000071, 1310USA015417, 1310USA014897, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014866, 1310USA014861, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064,  1311USA000020, 1311USA000021, 1311USA000040, 1310USA015096, 1311USA000022, 1310USA015101, 1311USA000053, 1310USA014853, 1311USA000075, 1310USA014895, 1311USA000059, 1310USA015119, 1310USA015113, 1311USA004931, 1311USA000065, 1310USA014853, 1311USA000739). Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Pt c/o of shoulder pain that started day after flu shot. Pain gets worse when lifting. Advised pt to go to doctor - (Pain still present 11/15/13).
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Left arm hurting and swollen all the way to hand swollen and hurting.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 58 year old male patient. When he took dapsone his "02 levels drop".  On 07-NOV-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # J004080, expiration date 22-AUG-2014) injections, 0.5 ml once, subcutaneous in the arm for "recommended vaccination". Concomitant therapies included Symbicort, losartan potassium (manufacturer unknown), Omeprazole, Simvastatin (manufacturer unknown and Lorazepam. There was no pertinent medical history. On 07-NOV-2013 the patient developed a fever, fatigue and the injections site was red, painful to the touch and swollen after receiving PNEUMOVAX23. The reaction was "almost leading to cellulitis in the arm". Lab diagnostic studies were not performed. The patient was being seen by the physician on 08-NOV-2013. No treatment was given for the events. The patient was not recovered from the events at the time of reporting.
Sex: U
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a medical assistant refers to 6 unspecified patients with unknown ages and unknown genders. On unknown dated the patients were vaccinated with PNEUMOVAX23 (route, dose, lot# and expiration date unknown). The medical assistant reported a patient developed fevers, fatigues and the injection sites were red, painful to the touch and swollen after receiving PNEUMOVAX23. The reactions were almost leading to cellulitis in the arm (capture in MARRS# 1311USA004305). The medical assistant also reported that 6 other unspecified patients had the "exact same" reactions after receiving PNEUMOVAX23. The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Lethargy, Nausea, Pyrexia
Clinical narrative: Fever, nausea, lethargy. Pt admit to hospital.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Heart rate increased, Hypersensitivity, Malaise, Nausea
Clinical narrative: Case number PHEH2013US023545 an initial spontaneous report received from a consumer on 08 Nov 2013. This report refers to a 58-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) intramuscularly on an unknown date, 4 years ago. It was reported that she was so sick after getting the flu shot. She had symptoms of heart beating fast and blurry vision within 10 minutes of getting the flu shot. She also had nausea and was totally sick. She felt awful the whole day during day and night and had a high fever. She took TYLENOL. About a week later she went to doctor and took an antibiotic. The physician told her that she probably had an allergic reaction to something in the flu vaccine. The event outcome was unknown. She skipped a year and then took flu shot in the last year and the vaccine was well tolerated. The seriousness and causality was not reported.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Vaccination complication, Vision blurred
Clinical narrative: Case number PHEH2013US023545 an initial spontaneous report received from a consumer on 08 Nov 2013. This report refers to a 58-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) intramuscularly on an unknown date, 4 years ago. It was reported that she was so sick after getting the flu shot. She had symptoms of heart beating fast and blurry vision within 10 minutes of getting the flu shot. She also had nausea and was totally sick. She felt awful the whole day during day and night and had a high fever. She took TYLENOL. About a week later she went to doctor and took an antibiotic. The physician told her that she probably had an allergic reaction to something in the flu vaccine. The event outcome was unknown. She skipped a year and then took flu shot in the last year and the vaccine was well tolerated. The seriousness and causality was not reported.
Sex: U
Vaccine: FLU4
Symptoms: Dementia, Laboratory test
Clinical narrative: Initial report was received from a nonhealthcare professional on 07 November 2013. An unidentified patient (date of birth, age and gender not reported) had received an injection of FLUZONE QIV (lot number, route, site and date not reported) and an unspecified amount of time later experienced dementia. The reporter was trying to find out if there have been reports of dementia occurring after FLUZONE QIV. No other information was provided. Outcome was not reported. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 36.0
Sex: F
Vaccine: FLUN4
Symptoms: Chest discomfort, Cough, Headache, Pain, Respiratory tract congestion
Clinical narrative: STARTED WITH HEADACHE THAT NIGHT, ON 11/17 I WOKE UP WITH CONGESTION AND SNEEZING, BY EVENING I WAS COUGHING 11/18 WOKE UP WITH WORSENED COUGH, CHEST TIGHTNESS AND BODY ACHES
Age: 36.0
Sex: F
Vaccine: FLUN4
Symptoms: Sneezing
Clinical narrative: STARTED WITH HEADACHE THAT NIGHT, ON 11/17 I WOKE UP WITH CONGESTION AND SNEEZING, BY EVENING I WAS COUGHING 11/18 WOKE UP WITH WORSENED COUGH, CHEST TIGHTNESS AND BODY ACHES
Age: 35.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site streaking, Injection site warmth
Clinical narrative: Patient had a softball size swollen area with a knot in the center on his left arm, could not move left arm at all for 3 days, left arm soreness lasting 7 days; bedfast for 72 hours; site was warm to the touch, red streaks and bruising; patient had fever of not less than 103 degrees F for 72 hours after injection; fever persisted with acetaminophen treatment.
Age: 35.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Local swelling, Nodule, Pain in extremity, Pyrexia
Clinical narrative: Patient had a softball size swollen area with a knot in the center on his left arm, could not move left arm at all for 3 days, left arm soreness lasting 7 days; bedfast for 72 hours; site was warm to the touch, red streaks and bruising; patient had fever of not less than 103 degrees F for 72 hours after injection; fever persisted with acetaminophen treatment.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Facial pain, Headache, Hypoaesthesia, Pain in jaw, Paraesthesia
Clinical narrative: About 24 hours after flu vaccine, developed tingling/pain on left side of face that radiated to back of head. Pain similar to a trigeminal neuralgia. 48 hours later, the tingling/numbness was in both side of face with dull headache. About 5 days later, the tingling/numbness subsided but there was a pain in lower jaw, pain with chewing
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Eye irritation, Heart rate increased, Oropharyngeal pain
Clinical narrative: Increased heartrate, sore throat and eye irritation.
Age: 34.0
Sex: F
Vaccine: FLU3, HEP, TDAP, VARCEL
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Shortness of breath, tenderness at site, erythema and hot at site along with swelling and raised area. Patient also reports tingling down right arm and muscle aches.
Age: 34.0
Sex: F
Vaccine: FLU3, HEP, TDAP, VARCEL
Symptoms: Myalgia, Paraesthesia
Clinical narrative: Shortness of breath, tenderness at site, erythema and hot at site along with swelling and raised area. Patient also reports tingling down right arm and muscle aches.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: CRAMPING. THEN ABOUT 9:00 PM, SEVERE CRAMPS. AT 10:00PM-DIARRHEA.  CRAMPS IN WAVES, THEN DIARRHEA AGAIN AT 11:00. CRAMPS IN WAVES, THEN DIARRHEA AGAIN AT 12:00AM.  MORE CRAMPING, THEN THEY EASED AND I FINALLY WENT TO SLEEP.  AM PERFECTLY FINE THIS MORNING.  MY HUSBAND AND I ATE THE EXACT SAME THINGS THIS WEEKEND AND HE WAS FINE SO NOT FOOD RELATED.  I WAS FINE BEFORE 8:00PM.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Musculoskeletal pain
Clinical narrative: Pain to shoulder area 15 minutes after injection.Pain escalated to 9/10 and inability to use arm with pain continuing for months.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Pyrexia, Rhinorrhoea
Clinical narrative: After receiving the flu vaccine on Monday child started having a fever 102 degrees F no other symptoms then on Friday started with mild runny nose and slight cough.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Rash pruritic, Rash vesicular, Skin lesion, Viral test negative
Clinical narrative: Onset rash - itchy, burning on axilla, scapular of same arm received vaccination, 3 days later noticed 3rd area rash. On back (L) side. Onset several hours after injection. Notes rash in 3 separate areas. No other symptoms. Lesions in 3 isolated clusters (L) back and axilla - vesicular appearing patch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Musculoskeletal discomfort
Clinical narrative: This spontaneous report was received from approximately 60 year old female consumer refers to herself. The consumer was sensitive to codeine and Percocet. The patient had no pertinent medical history and no concomitant medications. On 31-OCT-2013 the patient was vaccinated with ZOSTAVAX, single vaccination intramuscular for prevention of shingles. On 31-OCT-2013, following the vaccination the patient experienced some mild discomfort in her neck, shoulder and upper arm that continued on and off into the next day. The patient was treated with essential oils and the patient did not seek medical attention. No laboratory diagnostics studies performed. The patient was not hospitalized. The consumer believed that the vaccine might have been exposed to temperatures higher than the recommended temperature guidelines for the vaccine. There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Erythema, edema, heat and tenderness KINRIX injection site (R) arm.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hypoaesthesia, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itchiness at injection site (L deltoid).  2 weeks post injection this patient also c/o muscle pain, numbness and tingling in the left arm. If one touched her left arm, she feels she feels chills down that arm, the pain radiates to the left side of her neck around to the shoulder blade.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Myalgia, Neck pain, Paraesthesia
Clinical narrative: Redness, swelling, itchiness at injection site (L deltoid).  2 weeks post injection this patient also c/o muscle pain, numbness and tingling in the left arm. If one touched her left arm, she feels she feels chills down that arm, the pain radiates to the left side of her neck around to the shoulder blade.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Pharyngeal oedema
Clinical narrative: Throat swelling, difficulty swallowing.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Erythema, edema, heat and tenderness in (R) FA. surrounding KINRIX injection site.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Arrhythmia, Blood thyroid stimulating hormone, Borrelia test negative, Bradycardia, Condition aggravated
Clinical narrative: Initial report received from a healthcare professional who is the patient's mother on 06 November 2013. A 13-year-old male patient received an intramuscular injection in the left arm of FLUZONE, lot number U2847AA, on 23 October 2008. The patient's chart states he received FLUVIRIN by Novartis but a lot number for FLUZONE was charted. On 09 November 2008, also reported as 09 November 2013, the patient developed muscle spasms, hiccup type movement in abdomen and neck jerking. The patient was evaluated by a physician when symptoms progressed per mother on 09 November 2008. Laboratory tests were negative for a Lyme blood test, no invasive tests for neurological, followup cardiac test for sinus arrhythmia an EKG, TSH and heart rate (HR) 40. The patient was referred to pediatric neurologists on an unreported date. The neurologists report states: Potential Tourettes, chronic motor tic, developmental condition he will outgrow. Possible onset dystonia. Possibly due to tick bite in 2006-07, possibly due to traumatic injury. Pediatrician health summary 20 November 2008: Cardiac arrhythmia, contusion chest wall, flu vaccination, dizziness, and twitch. Reporter states son is now 18 years old and in college and in her opinion still experiences motor tics but not overtly noticed by patient. The patient has no complaints about these or any symptoms to his mother at this time. Past medical history included being diagnosed with a cardiac arrhythmia in 2006, a contusion of the chest wall from people piling on top of him, a tick bite in 2006 or 2007, fatigue, iron deficiency anemia, an abnormal thyroid stimulating hormone (TSH) and bone fractures. The patient outcome is unknown. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Dizziness, Dyskinesia, Electrocardiogram, Hiccups
Clinical narrative: Initial report received from a healthcare professional who is the patient's mother on 06 November 2013. A 13-year-old male patient received an intramuscular injection in the left arm of FLUZONE, lot number U2847AA, on 23 October 2008. The patient's chart states he received FLUVIRIN by Novartis but a lot number for FLUZONE was charted. On 09 November 2008, also reported as 09 November 2013, the patient developed muscle spasms, hiccup type movement in abdomen and neck jerking. The patient was evaluated by a physician when symptoms progressed per mother on 09 November 2008. Laboratory tests were negative for a Lyme blood test, no invasive tests for neurological, followup cardiac test for sinus arrhythmia an EKG, TSH and heart rate (HR) 40. The patient was referred to pediatric neurologists on an unreported date. The neurologists report states: Potential Tourettes, chronic motor tic, developmental condition he will outgrow. Possible onset dystonia. Possibly due to tick bite in 2006-07, possibly due to traumatic injury. Pediatrician health summary 20 November 2008: Cardiac arrhythmia, contusion chest wall, flu vaccination, dizziness, and twitch. Reporter states son is now 18 years old and in college and in her opinion still experiences motor tics but not overtly noticed by patient. The patient has no complaints about these or any symptoms to his mother at this time. Past medical history included being diagnosed with a cardiac arrhythmia in 2006, a contusion of the chest wall from people piling on top of him, a tick bite in 2006 or 2007, fatigue, iron deficiency anemia, an abnormal thyroid stimulating hormone (TSH) and bone fractures. The patient outcome is unknown. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms, Muscle twitching, Tic
Clinical narrative: Initial report received from a healthcare professional who is the patient's mother on 06 November 2013. A 13-year-old male patient received an intramuscular injection in the left arm of FLUZONE, lot number U2847AA, on 23 October 2008. The patient's chart states he received FLUVIRIN by Novartis but a lot number for FLUZONE was charted. On 09 November 2008, also reported as 09 November 2013, the patient developed muscle spasms, hiccup type movement in abdomen and neck jerking. The patient was evaluated by a physician when symptoms progressed per mother on 09 November 2008. Laboratory tests were negative for a Lyme blood test, no invasive tests for neurological, followup cardiac test for sinus arrhythmia an EKG, TSH and heart rate (HR) 40. The patient was referred to pediatric neurologists on an unreported date. The neurologists report states: Potential Tourettes, chronic motor tic, developmental condition he will outgrow. Possible onset dystonia. Possibly due to tick bite in 2006-07, possibly due to traumatic injury. Pediatrician health summary 20 November 2008: Cardiac arrhythmia, contusion chest wall, flu vaccination, dizziness, and twitch. Reporter states son is now 18 years old and in college and in her opinion still experiences motor tics but not overtly noticed by patient. The patient has no complaints about these or any symptoms to his mother at this time. Past medical history included being diagnosed with a cardiac arrhythmia in 2006, a contusion of the chest wall from people piling on top of him, a tick bite in 2006 or 2007, fatigue, iron deficiency anemia, an abnormal thyroid stimulating hormone (TSH) and bone fractures. The patient outcome is unknown. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Rash maculo-papular
Clinical narrative: Myalgias, maculopapular rash on thighs. Treatment: BENADRYL, TYLENOL, Ibuprofen.
Age: 3.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Papule, Pruritus, Scab, Skin lesion
Clinical narrative: Several discrete papules within 3 inches of injection site. Within 48 hours lesions itched, scabbed and resolved within one week. No fever, arm swelling, or other symptoms.
Age: 56.0
Sex: F
Vaccine: FLUC3
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Low grade fever, chills, vomiting, nausea.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Eye swelling, Injected limb mobility decreased, Joint stiffness, Ocular hyperaemia
Clinical narrative: Within 1 hour of shot eyes red, swollen, vision blurred. Throat started to close. Administered BENADRYL every 3 to 4 hours for two days. Continued pain and decrease range of motion in arm shot given joint pain and stiffness as well.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Throat tightness, Vision blurred
Clinical narrative: Within 1 hour of shot eyes red, swollen, vision blurred. Throat started to close. Administered BENADRYL every 3 to 4 hours for two days. Continued pain and decrease range of motion in arm shot given joint pain and stiffness as well.
Age: 0.51
Sex: M
Vaccine: DTAP, FLU3, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Apparent life threatening event, Pyrexia
Clinical narrative: Febrile illness, ALTE.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Headache
Clinical narrative: Stomach ache and headache.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Cardiopulmonary bypass, Death, Dyspnoea, Influenza, Oropharyngeal pain
Clinical narrative: Initial report was received on 07 November 2013 from a nonhealth care provider from an unverified internet source. A 14 year-old female patient (date of birth not reported) had received on an unspecified date in August 2012 a Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and five months later on 08 January 2013 "died from complications of infection with Influenza Type A". The patient was evaluated at and urgent care with a bad sore throat, treated with Prednisone and was sent home. The sore throat evolved into a serious fever that included shortness of breath and wheezing. The patient's lungs filled with fluid and was hospitalized. The patient had a heart and lung bypass with an "ACMO" machine and blood transfusions. Diagnostic and laboratory testing were not reported. The patient's outcome was fatal. Documents held by sender: none.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Pulmonary oedema, Pyrexia, Transfusion, Wheezing
Clinical narrative: Initial report was received on 07 November 2013 from a nonhealth care provider from an unverified internet source. A 14 year-old female patient (date of birth not reported) had received on an unspecified date in August 2012 a Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and five months later on 08 January 2013 "died from complications of infection with Influenza Type A". The patient was evaluated at and urgent care with a bad sore throat, treated with Prednisone and was sent home. The sore throat evolved into a serious fever that included shortness of breath and wheezing. The patient's lungs filled with fluid and was hospitalized. The patient had a heart and lung bypass with an "ACMO" machine and blood transfusions. Diagnostic and laboratory testing were not reported. The patient's outcome was fatal. Documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Acute disseminated encephalomyelitis, Altered state of consciousness, CSF oligoclonal band present, CSF protein increased, Endotracheal intubation
Clinical narrative: 15 6/12 y/o female developed lower extremity pain progressing to weakness with altered level of consciousness started 10/6/13 11 days after vaccinations. Admitted to PICU on 10/9/13 and required intubation/mechanical ventilation. MRI of head/spine showed multiple areas of inflammation. Treated with high dose steroids and IVIG for ADEM, with elevated CSF protein and oligoclonal bands. Extubated after 5 days. Transferred to rehab on 10/23 with slow progress of muscle strength and abilities.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Immunoglobulin therapy, Inflammation, Intensive care, Mechanical ventilation, Muscular weakness
Clinical narrative: 15 6/12 y/o female developed lower extremity pain progressing to weakness with altered level of consciousness started 10/6/13 11 days after vaccinations. Admitted to PICU on 10/9/13 and required intubation/mechanical ventilation. MRI of head/spine showed multiple areas of inflammation. Treated with high dose steroids and IVIG for ADEM, with elevated CSF protein and oligoclonal bands. Extubated after 5 days. Transferred to rehab on 10/23 with slow progress of muscle strength and abilities.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity
Clinical narrative: 15 6/12 y/o female developed lower extremity pain progressing to weakness with altered level of consciousness started 10/6/13 11 days after vaccinations. Admitted to PICU on 10/9/13 and required intubation/mechanical ventilation. MRI of head/spine showed multiple areas of inflammation. Treated with high dose steroids and IVIG for ADEM, with elevated CSF protein and oligoclonal bands. Extubated after 5 days. Transferred to rehab on 10/23 with slow progress of muscle strength and abilities.
Age: 70.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Balance disorder, Blood test normal, Defaecation urgency, Dysuria, Incoherent
Clinical narrative: Fever, uncontrolled urination and stool cannot keep balance, incoherence vomiting happened the next day after receiving the FLUZONE HD and PNEUMOVAX.
Age: 70.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, uncontrolled urination and stool cannot keep balance, incoherence vomiting happened the next day after receiving the FLUZONE HD and PNEUMOVAX.
Sex: U
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Initial report was received from a non-healthcare professional on 07 November 2013. A patient (age, date of birth and gender not reported) had received an intramuscular injection of FLUZONE HIGH-DOSE (lot number, site and date not reported) and an unspecified amount of time later developed a full body rash and was hospitalized for 5 days. No further information was provided. Outcome was unknown. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Conjunctivitis infective, Face and mouth X-ray abnormal, Face injury, Facial bones fracture, Headache
Clinical narrative: Initial report received from a consumer who is the patient's parent on 07 November 2013. A female patient (age and date of birth not provided), received FLUZONE, lot number UH910AC intramuscularly into the left deltoid on 06 October 2013. The patient had no illness at the time of vaccination and has no pre-existing allergies or medical conditions. Three hours after vaccination, the patient passed out and hit her nose. It is unknown how long patient was passed out. The patient had her nose x-rayed and had a fracture. The patient began putting on weight and gained 17 # (pounds) in 4 days. The patient's face was swollen. The patient developed pink eye on 18 October 2013 and had a severe headache and had nausea. The symptoms resolved on an unreported date. Further details are not available at the time of this report. Outcome was recovered. Documents held by sender: None.