chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever of 103. Vomiting.  Headache.  Soreness and redness at injection site.  Went to emergency room. Diagnosed with cellulitis. Admitted to hospital for IV antibiotic treatments on 11/16/2013. Discharged on 11/18/2013 to continue oral antibiotic course.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Fever of 103. Vomiting.  Headache.  Soreness and redness at injection site.  Went to emergency room. Diagnosed with cellulitis. Admitted to hospital for IV antibiotic treatments on 11/16/2013. Discharged on 11/18/2013 to continue oral antibiotic course.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea
Clinical narrative: Coughing fits, severe enough to take my breath and keep me from breathing.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash generalised, Rash pruritic, Skin warm, Swelling
Clinical narrative: Rash developed on face, by 8:00 AM (11/14/2013) rash had spread to torso and arms. Rash moved down my body, I was covered from head to toe by 8:00 AM the 16th of November. The rash began to fade yesterday November 18th, in the same way it spread, (Head to Toe) The rash felt hot/feverish, and included some swelling.  My temperature was between 99 and 100. I still have the rash on my abdomen, legs, and feet. As the rash subsides it itches.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site haematoma, Injection site injury
Clinical narrative: The pharmacist who administered the vaccine injected it into the subcutaneous tissues of the left deltoid region instead on intramuscularly into the deltoid.  The injection site and the surrounding have a deep tissue injury resulting in a hematoma and erythema.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site laceration, Injection site nodule, Injection site swelling
Clinical narrative: Pt. came into pharmacy 11/19/13 and complained about reaction to ZOSTAVAX vaccine given on 11/14/13. I observed area very swollen, red and skin ruptured around site of injection, she said area had a nodule filled with fluid and burst, Dr. gave pt BACTRIM DS to prevent infection.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Pt. came into pharmacy 11/19/13 and complained about reaction to ZOSTAVAX vaccine given on 11/14/13. I observed area very swollen, red and skin ruptured around site of injection, she said area had a nodule filled with fluid and burst, Dr. gave pt BACTRIM DS to prevent infection.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Fasciitis, Injected limb mobility decreased, Pain in extremity, Rotator cuff syndrome, Scar
Clinical narrative: Patient complaint left arm pain next day. Visited doctor then orthopedic surgeon now doing PT. Pt stated patient lost 40% range of motion in left arm. Patient still doing therapy and still no results.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound scan abnormal
Clinical narrative: Patient complaint left arm pain next day. Visited doctor then orthopedic surgeon now doing PT. Pt stated patient lost 40% range of motion in left arm. Patient still doing therapy and still no results.
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Pt. started experiencing pain around the injection site in 24 hrs. In 48 hrs, about 4-5 inch, slightly raised red spot (irregular borders) formed. She mentioned that she was seen by her doctor and received 14-day doxycycline as a result. After 10 days, pt is almost completely recovered.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash, itchy after injection.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Patient was in the "hall" after receiving flu and HPV vaccines. She fainted and her head hit the wall. She awakened after a few seconds. She was able to ambulate to an exam room with help. She was placed in a supine position with her legs elevated. She was oriented x3. After eating a cracker with peanut butter and a popsicle she set up and was not dizzy walked to car independently.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother called and stated that the nurse called her and told her the R arm where injection was given was red and swollen and seemed to be gettng worse. Mother referred to PCP or ER.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Appendicectomy, Blister, Fatigue, Herpes zoster, Listless
Clinical narrative: This spontaneous report as received from a 73 year old male consumer refers to himself. In September 2007, the patient was vaccinated with a dose of ZOSTAVAX, (lot#, and strength not reported), injection. Concomitant therapies included lisinopril, omeprazole (manufacturer unknown) and aspirin (manufacturer unknown)/biannual KENALOG shot. In approximately November 2012 (a year ago), the patient experienced appendectomy. On 08-NOV-2013, the patient developed a rash and was diagnosed with shingles. Consumer said that the rash was very red, with pustules, but only one pustule itches and describes his skin as tight, tender, blistered and that it was starting to feel like sunburn. He was also listless and fatigued, and had more frequent urination. The patient mentioned additionally said that SUDAFED made him dizzy. No lab diagnostics studies were performed. The patient sought medical attention by saw healthcare professional (HCP). Triamcinolone ointment and valacyclovir pills were given to treat the events. The outcome of the event was unknown. Upon internal review, the event appendectomy was considered to be medically significant. This is one of the several reports refer to the same patient. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain of skin, Pollakiuria, Pruritus, Rash erythematous, Rash pustular
Clinical narrative: This spontaneous report as received from a 73 year old male consumer refers to himself. In September 2007, the patient was vaccinated with a dose of ZOSTAVAX, (lot#, and strength not reported), injection. Concomitant therapies included lisinopril, omeprazole (manufacturer unknown) and aspirin (manufacturer unknown)/biannual KENALOG shot. In approximately November 2012 (a year ago), the patient experienced appendectomy. On 08-NOV-2013, the patient developed a rash and was diagnosed with shingles. Consumer said that the rash was very red, with pustules, but only one pustule itches and describes his skin as tight, tender, blistered and that it was starting to feel like sunburn. He was also listless and fatigued, and had more frequent urination. The patient mentioned additionally said that SUDAFED made him dizzy. No lab diagnostics studies were performed. The patient sought medical attention by saw healthcare professional (HCP). Triamcinolone ointment and valacyclovir pills were given to treat the events. The outcome of the event was unknown. Upon internal review, the event appendectomy was considered to be medically significant. This is one of the several reports refer to the same patient. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin tightness
Clinical narrative: This spontaneous report as received from a 73 year old male consumer refers to himself. In September 2007, the patient was vaccinated with a dose of ZOSTAVAX, (lot#, and strength not reported), injection. Concomitant therapies included lisinopril, omeprazole (manufacturer unknown) and aspirin (manufacturer unknown)/biannual KENALOG shot. In approximately November 2012 (a year ago), the patient experienced appendectomy. On 08-NOV-2013, the patient developed a rash and was diagnosed with shingles. Consumer said that the rash was very red, with pustules, but only one pustule itches and describes his skin as tight, tender, blistered and that it was starting to feel like sunburn. He was also listless and fatigued, and had more frequent urination. The patient mentioned additionally said that SUDAFED made him dizzy. No lab diagnostics studies were performed. The patient sought medical attention by saw healthcare professional (HCP). Triamcinolone ointment and valacyclovir pills were given to treat the events. The outcome of the event was unknown. Upon internal review, the event appendectomy was considered to be medically significant. This is one of the several reports refer to the same patient. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Had developed herpes zoster 3 days after the injection.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Rash, Rash generalised, Urticaria
Clinical narrative: Pt stated he had a rash on his body since he got the flu vaccine. He has been taking OTC benadryl ever since but the rash is still not going away. He is allergic to eggs but marked "no" to that question on the VAR form. He reported this to the pharmacy on 11/18/13. Rash on arms with redness and hives. Pt will see PCP.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Allergy test negative, Erythema, Pyrexia, Rash, Skin warm
Clinical narrative: Rash, swelling, red hot, fever, Primary care doctor sent her emergency room in hospital Dr gave her cephalexin, VICODIN, and MEDROL
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Rash, swelling, red hot, fever, Primary care doctor sent her emergency room in hospital Dr gave her cephalexin, VICODIN, and MEDROL
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Bilateral rash on back, unilateral rash on neck right side.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: 1 day after providng immunization the patient returned with a large red welt at the site of injection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: Patient reported back 2 days after vaccine with a very large red welt.
Age: 82.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was accidentally given the DTaP vaccine instead of the Tdap vaccine. Patient was notified of mistake. No adverse reaction to date.
Age: 16.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Dizziness, Dyskinesia, Full blood count, Iron binding capacity total, Loss of consciousness
Clinical narrative: Felt dizzy after the shot and pass out for few 5 seconds. With jerky moves of arm and regained consciousness. Also notice pallor by parent. No treatment given.C
Age: 16.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Metabolic function test, Pallor, Thyroxine, Tri-iodothyronine, Vitamin D
Clinical narrative: Felt dizzy after the shot and pass out for few 5 seconds. With jerky moves of arm and regained consciousness. Also notice pallor by parent. No treatment given.C
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Feeling cold, Paraesthesia
Clinical narrative: Sudden strange cold feeling. Feeling of pins and needles on tongue and lips. Occurred about 1 hr. after the shot. Responded to diphenhydramine.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Induration, Pain in jaw, Skin warm, Swelling face
Clinical narrative: Left cheek and jaw swole within 1 hour of vacc. Hot and hard to touch. Swelling responded to massage and dissipated within 18 hours. Sore jaw for about 24 hours.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Limb discomfort, Pain in extremity
Clinical narrative: Pain in arm, numbness in hand and numbness that radiated to chest. Saw an orthopedic MD 2 weeks after shot and is in physical therapy. Called pharmacy day after shot to inquire about discomfort in arm but never called back until today 11/19 to report issue.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: Patient received ZOSTAVAX vaccine on 11/11. On 11/14 patient stated her arm was swollen, red, and hard. Patient went to her physician and a prescription antibiotics (Zithromax) was given to her as precaution.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Pain, Skin irritation
Clinical narrative: Has red know on arm at injection, sore area (also has irritated area on the inner part of elbow, not sure if related).
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Joint range of motion decreased, Paraesthesia
Clinical narrative: Felt like funny bone was hit although the needed hit no bone; tingling and numbness in arm; now cannot raise arm.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site infection
Clinical narrative: Pt stated that they go an infection at the site of injection. The vaccines were given on 11/15/13 and patient call the pharmacy to say her doctor gave her a 10 day treatment of antibiotics on 11/18/13.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Pallor, Rash erythematous, Rash pruritic
Clinical narrative: Local non indurated itchy blanching red rash which improved with BENADRYL developed 2 days after vaccine at site of DTaP-IPV.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site streaking
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient. In approximately 2013 9reported as "past couple weeks") the patient was vaccinated with a 0.65 ml single dose of ZOSTAVAX by injection route (lot # and exp date were not reported). Pharmacist said (in 2013) after getting ZOSTAVAX, the patient had a "red line that went down her arm" from the injections site. The line was resolved in a couple days" (in 2013). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous report has been received from a pharmacist who heard the information from another pharmacist via a sales representative concerning to a patient of unknown age and gender. Current conditions, medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, lot# and route were not provided). Concomitant medication was not reported. In approximately November 2011 (reported as two years ago), the patient developed herpes zoster ophthalmicus after receiving ZOSTAVAX. The outcome of the adverse events was unknown. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. On 05-NOV-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (lot number and expiry date were reported as H012579 and 28-SEP-2013 respectively, dose and route unspecified). No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report refers to a 11 month old baby reported by nurse. On 02-MAR-2000, the baby was vaccinated with VARIVAX (Merck), subcutaneous. On 02-MAR-2000, the baby received first dose of VARIVAX 11 days before they were 12 months old and second dose on 21-SEP-2009. The outcome was unknown. No adverse effects reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from an approximately 59 year old female patient regarding herself. There was no pertinent medical history and no drug reactions/allergies. Approximately on 17-OCT-2013 (reproted as about 3 weeks ago), the patient was vaccinated with 0.65 milliliter (ml) (reported as standard dose) of ZOSTAVAX (lot number and expiry date unspecified), subcutaneously . Other suspect therapy included influenza virus vaccine (manufacturer unknown) (lot number, expiry date, dose and route unspecified) administered approximately on 17-OCT-2013 (reported as on the date of ZOSTAVAX vaccination). No concomitant therapy was reported. Approximately on 20-OCT-2013 (reported as 3-4 days later), after the vaccination, the patient developed shingles outbreak. Approximately on 20-OCT-2013 (reported as 3-4 days later), she developed the conditions on her forehead and in her hair. The patient sought medical attention (called the physician's office). The patient had received an unspecified treatment for the conditions. No lab tests were performed. The patient was recovering at the time of report. The relatedness for shingles outbreak was unknown for ZOSTAVAX and influenza virus vaccine (manufacturer unknown). Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Asthenia, Choking, Dysphagia, Dyspnoea
Clinical narrative: Initial report received on 11-NOV-2013 from a consumer (the patient herself): A 65-year-old female patient with a medical history of allergies to preservatives, sulfa drugs and some aminoglycosides and with seasonal allergies, who denied any illness at time of vaccination, had received inadvertently a second intramuscular dose of FLUZONE (Sanofi Pasteur Inc., batch number UH436AB, site of administration not reported) on 14-SEP-2011. She had received a first dose of influenza vaccine (manufacturer, batch number, route and site of administration not reported) in January 2011 and had no problems. On 19-SEP-2011, i.e. 5 days after vaccination, the patient stated her vocal cords were not working right, stated they go into spasm, she had trouble getting air into her lungs, trouble swallowing and claimed she had had an 80 lb weight loss since. The patient has been evaluated by multiple physicians and had no formal diagnosis. In FEB 2012, Botox was used as corrective treatment unsuccessfully. In FEB 2012, Botox was used as corrective treatment unsuccessful. In FEB 2013, ear, nose, throat specialist treated her with vocal cord scraping and Botox. Neurologists, cardiologists, pulmonologists cannot find anything wrong with the patient. MRI was negative. Oxygen saturation was at 97% on room air. At the time of the report, the outcome was reported as unknown.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea exertional, Gastrooesophageal reflux disease, Imaging procedure, Influenza like illness, Interstitial lung disease
Clinical narrative: Initial report received on 11-NOV-2013 from a consumer (the patient herself): A 65-year-old female patient with a medical history of allergies to preservatives, sulfa drugs and some aminoglycosides and with seasonal allergies, who denied any illness at time of vaccination, had received inadvertently a second intramuscular dose of FLUZONE (Sanofi Pasteur Inc., batch number UH436AB, site of administration not reported) on 14-SEP-2011. She had received a first dose of influenza vaccine (manufacturer, batch number, route and site of administration not reported) in January 2011 and had no problems. On 19-SEP-2011, i.e. 5 days after vaccination, the patient stated her vocal cords were not working right, stated they go into spasm, she had trouble getting air into her lungs, trouble swallowing and claimed she had had an 80 lb weight loss since. The patient has been evaluated by multiple physicians and had no formal diagnosis. In FEB 2012, Botox was used as corrective treatment unsuccessfully. In FEB 2012, Botox was used as corrective treatment unsuccessful. In FEB 2013, ear, nose, throat specialist treated her with vocal cord scraping and Botox. Neurologists, cardiologists, pulmonologists cannot find anything wrong with the patient. MRI was negative. Oxygen saturation was at 97% on room air. At the time of the report, the outcome was reported as unknown.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Laboratory test abnormal, Pharyngeal erythema, Pharyngeal oedema, Pyrexia, Rhinorrhoea
Clinical narrative: Initial report received on 11-NOV-2013 from a consumer (the patient herself): A 65-year-old female patient with a medical history of allergies to preservatives, sulfa drugs and some aminoglycosides and with seasonal allergies, who denied any illness at time of vaccination, had received inadvertently a second intramuscular dose of FLUZONE (Sanofi Pasteur Inc., batch number UH436AB, site of administration not reported) on 14-SEP-2011. She had received a first dose of influenza vaccine (manufacturer, batch number, route and site of administration not reported) in January 2011 and had no problems. On 19-SEP-2011, i.e. 5 days after vaccination, the patient stated her vocal cords were not working right, stated they go into spasm, she had trouble getting air into her lungs, trouble swallowing and claimed she had had an 80 lb weight loss since. The patient has been evaluated by multiple physicians and had no formal diagnosis. In FEB 2012, Botox was used as corrective treatment unsuccessfully. In FEB 2012, Botox was used as corrective treatment unsuccessful. In FEB 2013, ear, nose, throat specialist treated her with vocal cord scraping and Botox. Neurologists, cardiologists, pulmonologists cannot find anything wrong with the patient. MRI was negative. Oxygen saturation was at 97% on room air. At the time of the report, the outcome was reported as unknown.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Scan, Sensation of foreign body, Sleep disorder, Sneezing, Spasmodic dysphonia
Clinical narrative: Initial report received on 11-NOV-2013 from a consumer (the patient herself): A 65-year-old female patient with a medical history of allergies to preservatives, sulfa drugs and some aminoglycosides and with seasonal allergies, who denied any illness at time of vaccination, had received inadvertently a second intramuscular dose of FLUZONE (Sanofi Pasteur Inc., batch number UH436AB, site of administration not reported) on 14-SEP-2011. She had received a first dose of influenza vaccine (manufacturer, batch number, route and site of administration not reported) in January 2011 and had no problems. On 19-SEP-2011, i.e. 5 days after vaccination, the patient stated her vocal cords were not working right, stated they go into spasm, she had trouble getting air into her lungs, trouble swallowing and claimed she had had an 80 lb weight loss since. The patient has been evaluated by multiple physicians and had no formal diagnosis. In FEB 2012, Botox was used as corrective treatment unsuccessfully. In FEB 2012, Botox was used as corrective treatment unsuccessful. In FEB 2013, ear, nose, throat specialist treated her with vocal cord scraping and Botox. Neurologists, cardiologists, pulmonologists cannot find anything wrong with the patient. MRI was negative. Oxygen saturation was at 97% on room air. At the time of the report, the outcome was reported as unknown.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Speech disorder, Tardive dyskinesia, Visual impairment, X-ray
Clinical narrative: Initial report received on 11-NOV-2013 from a consumer (the patient herself): A 65-year-old female patient with a medical history of allergies to preservatives, sulfa drugs and some aminoglycosides and with seasonal allergies, who denied any illness at time of vaccination, had received inadvertently a second intramuscular dose of FLUZONE (Sanofi Pasteur Inc., batch number UH436AB, site of administration not reported) on 14-SEP-2011. She had received a first dose of influenza vaccine (manufacturer, batch number, route and site of administration not reported) in January 2011 and had no problems. On 19-SEP-2011, i.e. 5 days after vaccination, the patient stated her vocal cords were not working right, stated they go into spasm, she had trouble getting air into her lungs, trouble swallowing and claimed she had had an 80 lb weight loss since. The patient has been evaluated by multiple physicians and had no formal diagnosis. In FEB 2012, Botox was used as corrective treatment unsuccessfully. In FEB 2012, Botox was used as corrective treatment unsuccessful. In FEB 2013, ear, nose, throat specialist treated her with vocal cord scraping and Botox. Neurologists, cardiologists, pulmonologists cannot find anything wrong with the patient. MRI was negative. Oxygen saturation was at 97% on room air. At the time of the report, the outcome was reported as unknown.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Dyspnoea, Muscle spasms, Nuclear magnetic resonance imaging normal, Vocal cord disorder
Clinical narrative: Initial report received on 11-NOV-2013 from a consumer (the patient herself): A 65-year-old female patient with a medical history of allergies to preservatives, sulfa drugs and some aminoglycosides and with seasonal allergies, who denied any illness at time of vaccination, had received inadvertently a second intramuscular dose of FLUZONE (Sanofi Pasteur Inc., batch number UH436AB, site of administration not reported) on 14-SEP-2011. She had received a first dose of influenza vaccine (manufacturer, batch number, route and site of administration not reported) in January 2011 and had no problems. On 19-SEP-2011, i.e. 5 days after vaccination, the patient stated her vocal cords were not working right, stated they go into spasm, she had trouble getting air into her lungs, trouble swallowing and claimed she had had an 80 lb weight loss since. The patient has been evaluated by multiple physicians and had no formal diagnosis. In FEB 2012, Botox was used as corrective treatment unsuccessfully. In FEB 2012, Botox was used as corrective treatment unsuccessful. In FEB 2013, ear, nose, throat specialist treated her with vocal cord scraping and Botox. Neurologists, cardiologists, pulmonologists cannot find anything wrong with the patient. MRI was negative. Oxygen saturation was at 97% on room air. At the time of the report, the outcome was reported as unknown.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Weight decreased
Clinical narrative: Initial report received on 11-NOV-2013 from a consumer (the patient herself): A 65-year-old female patient with a medical history of allergies to preservatives, sulfa drugs and some aminoglycosides and with seasonal allergies, who denied any illness at time of vaccination, had received inadvertently a second intramuscular dose of FLUZONE (Sanofi Pasteur Inc., batch number UH436AB, site of administration not reported) on 14-SEP-2011. She had received a first dose of influenza vaccine (manufacturer, batch number, route and site of administration not reported) in January 2011 and had no problems. On 19-SEP-2011, i.e. 5 days after vaccination, the patient stated her vocal cords were not working right, stated they go into spasm, she had trouble getting air into her lungs, trouble swallowing and claimed she had had an 80 lb weight loss since. The patient has been evaluated by multiple physicians and had no formal diagnosis. In FEB 2012, Botox was used as corrective treatment unsuccessfully. In FEB 2012, Botox was used as corrective treatment unsuccessful. In FEB 2013, ear, nose, throat specialist treated her with vocal cord scraping and Botox. Neurologists, cardiologists, pulmonologists cannot find anything wrong with the patient. MRI was negative. Oxygen saturation was at 97% on room air. At the time of the report, the outcome was reported as unknown.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Culture, Exposure to vaccinated person, Orthopoxvirus test positive, Polymerase chain reaction, Skin lesion
Clinical narrative: This case was received on 12 November 2013 via a third party query tool search on the VAERS database, under reference number 495510. A 20-year-old female patient was exposed to secondary transmission of a smallpox vaccination site of her boyfriend an unspecified date. The patient's boyfriend received an injection of ACAM2000 (SP Biologics Co. lot number not reported) between 30 May 2013 and 02 June 2013. Although, the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient found a lesion on her neck on 22 June 2013 and found secondary lesion on 25 June 2013. Cultures were done on 27 June 2013. No herpes simplex virus DNA was detected by realtime PCR assay, no varicella-zoster virus DNA was detected on and non-variola orthopox virus DNA was detected on 28 June 2013. The patient's outcome was unknown. Documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Varicella virus test negative, Viral test negative
Clinical narrative: This case was received on 12 November 2013 via a third party query tool search on the VAERS database, under reference number 495510. A 20-year-old female patient was exposed to secondary transmission of a smallpox vaccination site of her boyfriend an unspecified date. The patient's boyfriend received an injection of ACAM2000 (SP Biologics Co. lot number not reported) between 30 May 2013 and 02 June 2013. Although, the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient found a lesion on her neck on 22 June 2013 and found secondary lesion on 25 June 2013. Cultures were done on 27 June 2013. No herpes simplex virus DNA was detected by realtime PCR assay, no varicella-zoster virus DNA was detected on and non-variola orthopox virus DNA was detected on 28 June 2013. The patient's outcome was unknown. Documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Fatigue, Malaise, Orthopoxvirus test positive, Paraesthesia, Polymerase chain reaction
Clinical narrative: This case was received on 12 November 2013 via a third party query tool search on the VAERS database, under reference number 495510. A 20-year-old female patient was exposed to secondary transmission of a smallpox vaccination site of her boyfriend an unspecified date. The patient's boyfriend received an injection of ACAM2000 (SP Biologics Co. lot number not reported) between 30 May 2013 and 02 June 2013. Although, the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient found a lesion on her neck on 22 June 2013 and found secondary lesion on 25 June 2013. Cultures were done on 27 June 2013. No herpes simplex virus DNA was detected by realtime PCR assay, no varicella-zoster virus DNA was detected on and non-variola orthopox virus DNA was detected on 28 June 2013. The patient's outcome was unknown. Documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Pyrexia, Rash pustular, Secondary transmission
Clinical narrative: This case was received on 12 November 2013 via a third party query tool search on the VAERS database, under reference number 495510. A 20-year-old female patient was exposed to secondary transmission of a smallpox vaccination site of her boyfriend an unspecified date. The patient's boyfriend received an injection of ACAM2000 (SP Biologics Co. lot number not reported) between 30 May 2013 and 02 June 2013. Although, the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient found a lesion on her neck on 22 June 2013 and found secondary lesion on 25 June 2013. Cultures were done on 27 June 2013. No herpes simplex virus DNA was detected by realtime PCR assay, no varicella-zoster virus DNA was detected on and non-variola orthopox virus DNA was detected on 28 June 2013. The patient's outcome was unknown. Documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Culture negative, Herpes simplex serology negative, Orthopoxvirus test positive, Polymerase chain reaction, Secondary transmission
Clinical narrative: This case was received on 12 November 2013 via a third party query tool search on the VAERS database, under reference number 495510. A 20-year-old female patient was exposed to secondary transmission of a smallpox vaccination site of her boyfriend an unspecified date. The patient's boyfriend received an injection of ACAM2000 (SP Biologics Co. lot number not reported) between 30 May 2013 and 02 June 2013. Although, the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient found a lesion on her neck on 22 June 2013 and found secondary lesion on 25 June 2013. Cultures were done on 27 June 2013. No herpes simplex virus DNA was detected by realtime PCR assay, no varicella-zoster virus DNA was detected on and non-variola orthopox virus DNA was detected on 28 June 2013. The patient's outcome was unknown. Documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Skin lesion, Varicella virus test negative
Clinical narrative: This case was received on 12 November 2013 via a third party query tool search on the VAERS database, under reference number 495510. A 20-year-old female patient was exposed to secondary transmission of a smallpox vaccination site of her boyfriend an unspecified date. The patient's boyfriend received an injection of ACAM2000 (SP Biologics Co. lot number not reported) between 30 May 2013 and 02 June 2013. Although, the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient found a lesion on her neck on 22 June 2013 and found secondary lesion on 25 June 2013. Cultures were done on 27 June 2013. No herpes simplex virus DNA was detected by realtime PCR assay, no varicella-zoster virus DNA was detected on and non-variola orthopox virus DNA was detected on 28 June 2013. The patient's outcome was unknown. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Decreased vibratory sense, Injection site anaesthesia
Clinical narrative: Immediate pain with inoculation on upper arm to elbow. Hot painful arm. Spread down arm to fingers by end of week sensory affected. Position in space, light and deep touch. Patient felt as if arm was asleep to wrist by 10-8-13. Whole arm affected by 10/9/13. Finger tips with normal feeling 10-13-13. Up to wrist for normal feeling but back to finger tips pot football game as spectator. Neurologist visited 10/28/13. Feeling to elbow - 11-10-13.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Immediate pain with inoculation on upper arm to elbow. Hot painful arm. Spread down arm to fingers by end of week sensory affected. Position in space, light and deep touch. Patient felt as if arm was asleep to wrist by 10-8-13. Whole arm affected by 10/9/13. Finger tips with normal feeling 10-13-13. Up to wrist for normal feeling but back to finger tips pot football game as spectator. Neurologist visited 10/28/13. Feeling to elbow - 11-10-13.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Sensory disturbance
Clinical narrative: Immediate pain with inoculation on upper arm to elbow. Hot painful arm. Spread down arm to fingers by end of week sensory affected. Position in space, light and deep touch. Patient felt as if arm was asleep to wrist by 10-8-13. Whole arm affected by 10/9/13. Finger tips with normal feeling 10-13-13. Up to wrist for normal feeling but back to finger tips pot football game as spectator. Neurologist visited 10/28/13. Feeling to elbow - 11-10-13.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Lymphadenopathy, Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old male patient. Patient's current condition includes hypothyroidism. He had no drug reactions/allergies. On 30-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot # J001005, expiry date: 24-APR-2014, single dose, subcutaneous). Concomitant medications included thyroid supplement. On 04-NOV-2013, the patient developed a right periorbital rash and left cervical lymphadenopathy. No treatment was given for the event. No lab diagnostic studies were performed. The patient sought medical attention by visiting the pharmacy. The patient told the pharmacist that the rash was beginning to improve. The outcome of left cervical lymphadenopathy is unknown. Patient was directed to contact his healthcare provider. No PQC was involved. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Lymphadenopathy, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old male patient. Patient's current condition includes hypothyroidism. He had no drug reactions/allergies. On 30-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot # J001005, expiry date: 24-APR-2014, single dose, subcutaneous). Concomitant medications included thyroid supplement. On 04-NOV-2013, the patient developed a right periorbital rash and left cervical lymphadenopathy. No treatment was given for the event. No lab diagnostic studies were performed. The patient sought medical attention by visiting the pharmacy. The patient told the pharmacist that the rash was beginning to improve. The outcome of left cervical lymphadenopathy is unknown. Patient was directed to contact his healthcare provider. No PQC was involved. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood test abnormal, Colitis ulcerative, Colonoscopy abnormal, Diarrhoea, Fatigue
Clinical narrative: Pt had flu shot on 10/7/13 and day after (10/8) began with diarrhea. Pt saw PCP on 10/21/13 for diarrhea, decreased solid intake and weight loss.
Age: 17.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Haematochezia, Muscle spasms, Night sweats, Pyrexia, Stool analysis abnormal
Clinical narrative: Pt had flu shot on 10/7/13 and day after (10/8) began with diarrhea. Pt saw PCP on 10/21/13 for diarrhea, decreased solid intake and weight loss.
Age: 17.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: White blood cell count increased, X-ray gastrointestinal tract normal
Clinical narrative: Pt had flu shot on 10/7/13 and day after (10/8) began with diarrhea. Pt saw PCP on 10/21/13 for diarrhea, decreased solid intake and weight loss.
Age: 17.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Decreased appetite, Diarrhoea, Weight decreased
Clinical narrative: Pt had flu shot on 10/7/13 and day after (10/8) began with diarrhea. Pt saw PCP on 10/21/13 for diarrhea, decreased solid intake and weight loss.
Age: 0.04
Sex: M
Vaccine: HEP, HEP
Symptoms: Death
Clinical narrative: This spontaneous report as received from the patient's mother and a physician (Medical Examiner) refers to a 15 day old male patient. On 04-NOV-2013 the patient was vaccinated with a dose of RECOMBIVAX HB injection, "one dose" for "recommendation" (lot# J006511, expiration date 28-JAN-2016, route "injection" as reported). There was no concomitant medication or pertinent medical history. The patient passed away at home and was transported to a medical center. The infant was pronounced dead in the Emergency Room at 7:25am on 05-NOV-2013. The mother requested a lot check of RECOMBIVAX HB her son received, and the expiration date was 25-JAN-2016 or 28-JAN-2016, the writing of the expiration date was ineligible so the reporter was unsure of the exact expiration date. The physician reported the following information from his post mortem examination of this infant. This was a 15 day old infant that was found unresponsive. No jaundice was noted and no outward evidence of ascites was seen. The physician stated that a 2-3 cc blood sample was sent for toxicology testing. An autopsy could not be performed because of the parents' religious beliefs. The physician stated his cursory exam found no evidence of congenital malformation, physical abuse, no fluid in abdomen. The physician did extract a "couple" milliliter (ML)'s of fluid from chest cavity and was sent to toxicology (results pending). The physician found the baby to be "heavier/bigger" (weight not specified) then other babies that age. Mother had no diabetes or gestational diabetes during pregnancy. The cause of death decision was pending no death certificate available. Additional information has been requested.
Age: 0.04
Sex: M
Vaccine: HEP, HEP
Symptoms: Death neonatal, Large for dates baby, Toxicologic test, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from the patient's mother and a physician (Medical Examiner) refers to a 15 day old male patient. On 04-NOV-2013 the patient was vaccinated with a dose of RECOMBIVAX HB injection, "one dose" for "recommendation" (lot# J006511, expiration date 28-JAN-2016, route "injection" as reported). There was no concomitant medication or pertinent medical history. The patient passed away at home and was transported to a medical center. The infant was pronounced dead in the Emergency Room at 7:25am on 05-NOV-2013. The mother requested a lot check of RECOMBIVAX HB her son received, and the expiration date was 25-JAN-2016 or 28-JAN-2016, the writing of the expiration date was ineligible so the reporter was unsure of the exact expiration date. The physician reported the following information from his post mortem examination of this infant. This was a 15 day old infant that was found unresponsive. No jaundice was noted and no outward evidence of ascites was seen. The physician stated that a 2-3 cc blood sample was sent for toxicology testing. An autopsy could not be performed because of the parents' religious beliefs. The physician stated his cursory exam found no evidence of congenital malformation, physical abuse, no fluid in abdomen. The physician did extract a "couple" milliliter (ML)'s of fluid from chest cavity and was sent to toxicology (results pending). The physician found the baby to be "heavier/bigger" (weight not specified) then other babies that age. Mother had no diabetes or gestational diabetes during pregnancy. The cause of death decision was pending no death certificate available. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Consciousness fluctuating, Hypotonia, Seizure like phenomena
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old female patient. The patient's drug reactions/allergies included macrolide antibiotics, fluoroquinolones, sulfa antibiotics, lidocaine, and codeine. On 13-NOV-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # J007786, exp date 25-SEP-2014), (route, dose and strength not reported). On 13-NOV-2013, approximately 30 to 45 seconds after the PNEUMOVAX23 was administered the patient "slumped over in a chair and exhibited seizure like activity". The seizure like activity lasted about 1 minute and patient was in and out of consciousness. The patient then exhibited seizure like activity again for an unspecified period of time at which point an unspecified ambulance was called and the patient was taken to hospital. The pharmacist stated that the patient was given oxygen by the ambulance squad. It is unknown if the patient was admitted to the hospital. The outcome of the events was unknown. The patient had unspecified adverse reactions to unspecified flu vaccines in the past (Captured in MARRS#1311USA008340). Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Blood pressure fluctuation, Dizziness, Dysstasia, Feeling hot
Clinical narrative: 12 hours after shot - broke out in sweating, hot, so dizzy couldn't stand up - blood pressure dropped 85/54 - 12 hours later broke out in hives. Through heart off - blood pressure made big swings from very high to very low for several days.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Urticaria
Clinical narrative: 12 hours after shot - broke out in sweating, hot, so dizzy couldn't stand up - blood pressure dropped 85/54 - 12 hours later broke out in hives. Through heart off - blood pressure made big swings from very high to very low for several days.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 14-NOV-2013 the patient was vaccinated with MMR II (lot # 1251AA and expiry date 01-AUG-2013), (dose 0.5 milliliters), subcutaneous. Expired dose of MMR II was administered to the patient on that day. No adverse effects were reported. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 month old male patient. On 15-NOV-2013 the patient was vaccinated with ROTATEQ vial, 2 ml, oral. Lot number was reported as 0056AE and expiry date 12-SEP-2013. The patient had received an expired dose of ROTATEQ. No adverse effect was reported Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 04-NOV-2013, the patient was vaccinated with MMR II (lot number reported as J000154 with expiry date 09-JAN-2015 and J003623 with expiry date 22-MAR-2015) (route of administration was not reported). On 04-NOV-2013, an unspecified number of MMR II which reached a temperature of 10c for 31 hours might have been administered to an unspecified number of patients. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Maternal exposure before pregnancy, No adverse event
Clinical narrative: This spontaneous report refers to a patient of unknown age who is also a pharmacist. On an unknown date the patient was exposed to ZOSTAVAX vial 19400 PFU (dose, lot, expiry date unknown). In the past, the pharmacist had got some of the ZOSTAVAX solution on her skin while priming a needle prior to administration to a patient. The pharmacist had never experienced any adverse effect as a result of getting the ZOSTAVAX solution on her hands, and she has not notified her healthcare professional and did not seek medical attention. Recently, on an unknown date in approximately 2013, the pharmacist discovered that she was pregnant. Last menstrual period was approximately 2013, EDC, EDD could not be estimated. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: MMRV
Symptoms: Accidental exposure to product, Eye pruritus, Eyelid function disorder, Ocular hyperaemia, Product quality issue
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 26 years old female patient, who is a healthcare worker. The patient had no pertinent medical history and no drug reactions/allergies. On 08-NOV-2013, when the healthcare worker was draw up the vial of PROQUAD (Merck) (Lot # J007863, Exp date: 28-DEC-2014), was entered to remove the dose of PROQUAD (Merck), the dose sprayed all over and got in the patient's right eye. Patient's concomitant medication included "birth control pills". On 08-NOV-2013 the patient experienced redness in the eye and had difficulty opening the eye. On 11-NOV-2013 the patient experienced eye itches. The patient also stated that she was not experienced an any other adverse effects on 11-NOV-2013. PQC filed for pressure irregularity of PROQUAD (Merck). Patient stated that immediately after PROQUAD (Merck) solution "sprayed into her eye", she consulted medical attention, and her eye was flushed every 15 minutes with water as treatment on the day the event occurred on 08-NOV-2013. She denied any loss of vision or any other adverse effect. No lab diagnostics studies performed. The outcome of the events was reproted as not recovered/not resolved. Additional information has been requested.