chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. On 26-JUL-2012 the patient was vaccinated with first dose of GARDASIL 120 Y (dose unit, route, lot # and expiry date unknown). On 08-SEP-2013 and 13-FEB-2014, patient received second and third dose of GARDASIL respectively. No adverse symptoms reported. The outcome of the patient received GARDASIL on 26-JUL-2012, 09-AUG-2013 and 13-FEB-2014 and no adverse event was unknown. No further information provided. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 32 year old female patient. On 10-FEB-2014 the patient was vaccinated with a first dose of PNEUMOVAX 23 (25/0.5 Y) lot # J004747 (expiry date July 2014), intramuscular in the arm. The nurse stated that the patient experienced pain in her arm after receiving the first dose on 10-FEB-2014. The pain was in the outer aspect of the patient's arm and the patient could not pick up her child or lift her arm. The outcome of pain in her arm was reported as recovered/resolved on 13-FEB-2014. Causality assessment was not provided. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 10 year old patient. On an unknown date the patient was vaccinated inadvertently with VAQTA, injection, 1 ml, (strength, dose number, lot number and expiry date unknown) intramuscularly. No adverse effects reported. The outcome of 1 ml dose administered and no adverse effects was unknown. No further information provided. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune disorder
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 50 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose number, route, lot number and expiry date unknown). On an unknown date in her 50's the patient developed autoimmune like reaction similar to rheumatoid arthritis after receiving ZOSTAVAX. The outcome of autoimmune like reaction similar to rheumatoid arthritis was unknown. No further information was provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Product quality issue
Clinical narrative: This spontaneous report as received from physician assistant via company representative refers to a 13 year old female patient. on an unknown date of 2013, the patient was vaccinated with first dose of GARDASIL, (strength, dose unit, route, lot# and expiry date unknown). On 09-DEC-2013, patient received second dose of GARDASIL, with recalled lot number J007354 and expiry date 20-FEB-2016 by her mother. No concomitant medications were administered. On same day while injecting, the level of pain felt with second dose was more severe than the first dose of GARDASIL. It was reported that injection site did not appear unusual. On an unknown date of December 2013 (within two weeks), patient had subsided and fully recovered from pain and no treatment was given for events. The outcome of level of pain was more severe than the 1st dose and appearance of the injection site did not appear unusual was reported as recovered/resolved. No further AE information was provided. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased immune responsiveness
Clinical narrative: This spontaneous report was received from a Nurse refers to a 22 year old female patient. On an unkonwn date, the patient was vaccinated with VARIVAX (Merck) 0.5 ml subcutaneous and was also vaccinated with M-M-R II (dose, route and frequency was not reported). It was reported that on an unknown date, the result of unspecified tests on unspecified dates was that the patient did not have adequate immunity from VARIVAX (Merck) and M-M-R II. On an unkonwn date, the patient was administered with the third dose of VARIVAX (Merck) 0.5 ml subcutaneous. The outcome of the event did not have adequate immunity was unknown. The reporter did not provide the causality between the event and the suspect drugs. This case is linked to the case 1402USA009677 (same reporter link). Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient with high cholesterol. Patient had no other drug allergies. On 14-FEB-2014 the patient was vaccinated with ZOSTAVAX via 0.65 ml with lot # J007211 and expiry date 20-SEP-2014, (strength, dose number unknown) subcutaneously to prevent shingles. On 16-FEB-2014, last night patient developed a round red hot hard lump at the injection site. On 17-FEB-2014, patient called and informed the pharmacist via the phone and was instructed by pharmacist to apply ice. No laboratory test was performed. The outcome of developed a round red hot hard lump and the injection site was reported as not recovered/not resolved. No further information was provided. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient. The patient had no pertinent medical history and drug reactions/allergies. On 20-JAN-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # reported as J011337, Exp date 13-DEC-2014), subcutaneously (dose unspecified). Concomitant therapy included unknown number of unspecified medications. The patient was prescribed SOLU-MEDROL for an unspecified reason on 25-JAN-2014 (treatment for the adverse event was also reported as no). No lab diagnostics studies were performed. The outcome of the event was unkonwn. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 45 year old female patient. On 20-JAN-2014 the patient's husband was vaccinated with a dose of ZOSTAVAX, (lot # reported as J011337, Exp date 13-DEC-2014), subcutaneously (dose unspecified). The healthy patient was diagnosed with the shingles only a few days after (estimated as January 2014) her husband received the ZOSTAVAX. The patient began to experience a rash and discomfort, went to her primary care physician who diagnosed her with shingles. Patient was currently being treated with valacyclovir, gabapentin and acetaminophen, VICODIN for pain. The outcome of the events was unknown. This is one of several reports received from the same reporter. 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 licensed practical nurse refers to a patient of unknown age. On 17-FEB-2014, the patient was vaccinated with GARDASIL dose 3, .5 ml, intramuscular. The nurse was reporting that the patient was administered the first dose of GARDASIL in December 2010, the second dose of GARDASIL in February 2011, and the third dose of GARDASIL on 17-FEB-2014. No adverse effects were reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Nurse refers to a 22 year old female patient. On 17-FEB-2014, the patient was vaccinated with fourth dose of VARIVAX (Merck) 0.5 ml subcutaneous in one arm and PROQUAD (Merck) (dose and frequency was not reported) instead of M-M-R II in the other arm. No adverse events were reported. No further information was provided. This case is linked to the case 1402USA008801 (same reporter link). Additional information has been requested.
Age: 0.53
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC13, RV5
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: None - pt found unresponsive and deceased 2/20/14 approximately 5 AM.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Chills, Fatigue, Injection site cellulitis, Injection site erythema
Clinical narrative: Swelling / redness at injection site. Fever, chills, fatigue. Cellulitis at and around injection site. "Chest tightness".
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Swelling / redness at injection site. Fever, chills, fatigue. Cellulitis at and around injection site. "Chest tightness".
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Arm swollen, red, warm.
Age: 47.0
Sex: M
Vaccine: ANTH, HEP, RAB, TYP, YF
Symptoms: Blood pressure fluctuation, Lung disorder, Myalgia, Pulse abnormal, Vertigo
Clinical narrative: Episodes of vertigo, myalgias, vacillating BP and pulse occur 5-20 times per day, lasting for 5 minutes to a few hours. Symptoms began after receiving immunizations in 2002. His trainee immunizations were repeated at the same time because his immunization record was lost. Upon arriving, he was hospitalized for 12 days for a lung condition. Since then multiple specialists and workups have not yielded a diagnosis. He is under care. He was to provide a record of his immunizations, but has not as yet.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Incomplete course of vaccination
Clinical narrative: Per Mother: He had severe abdominal pain for 2 weeks after receiving his first and second GARDASIL shots. Refused the third on 2-19-14. 1st: 08-12-13 Lot # H021608. 2nd: 10-15-13 Lot # H021608.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Local reaction
Clinical narrative: This spontaneous report as received from a medical assistant of physician via company representative refers to a 12 month old infant (gender unspecified). This case is referring one infant out of the twins who developed a red lump at the injection site after administration of VARIVAX (Merck). Patients medical history, drug reactions and allergies were reported as none. On an unknown date, the patient was vaccinated with VARIVAX (Merck) Subcutaneous Injection, (lot number: J006732, expiry date: 30-MAY-2015), 0.5 ml, subcutaneous in the right thigh for vaccination. Concomitant therapy reported as none. The medical assistant reported 12 month old infant developed a red lump at the injection site after administration of VARIVAX (Merck). The infant was evaluated at a urgent care facility and were diagnosed with a local reaction from the vaccine. The patients are scheduled to be evaluated by the physician on 13-FEB-2014. No treatment was given for the event. No lab diagnostic studies were performed. No product quality complaint was involved. The outcome of the event was unknown. The reporters causality assessment for the event local reaction from the vaccine with the therapy of VARIVAX (Merck) was not reported. No further information provided. This case is linked with case 1402USA007653 as sibling report. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Practice Manager refers to a patient of unknown age and gender. On 19-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000492, exp. date: 19-FEB-2014) 0.65 ml, subcutaneously that expired. No adverse effects were reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Local reaction
Clinical narrative: This spontaneous report as received from a medical assistant of physician via company representative refers to a 12 month old infant (gender unspecified). This case is referring one infant out of the twins who developed a red lump at the injection site after administration of VARIVAX (Merck). Patients medical history, drug reactions and allergies were reported as none. On an unknown date, the patient was vaccinated with VARIVAX (Merck) subcutaneous injection, (lot number: J006732, expiry date: 30-MAY-2015), 0.5 ml, subcutaneous in the right thigh. Concomitant therapy reported as none. The medical assistant reported 12 month old infant developed a red lump at the injection site after administration of VARIVAX (Merck). The infant was evaluated at a local urgent care facility and were diagnosed with a local reaction from the vaccine. The patients are scheduled to be evaluated by the physician on 13-FEB-2014. No treatment was given for the event. No lab diagnostic studies were performed. No product quality complaint was involved. The outcome of event was unknown. The reporters causality assessment for the event local reaction from the vaccine with the therapy of VARIVAX (Merck) was not reported. No further information provided. This case is linked with case 1402USA009360 as sibling report. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Pallor
Clinical narrative: Pt. received vaccine, got very pale, c/o chest pain. BP 120/80, Sprite/ammonia offered. Placed in wheelchair and taken to ER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Culture throat negative, Erythema, Local swelling, Streptococcus test negative, Swelling face
Clinical narrative: Redness and swelling to cheeks and dorsum of hands.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Feeling hot, Loss of consciousness, Pallor, Syncope
Clinical narrative: Given Hepatitis A vaccine right arm. No reaction. Gave HPV vaccine #3 left arm, syncope in chair, pallor. Regained consciousness spontaneously.  Given ice pack to cool (pt. c/o feeling hot) and fluids (water).
Age: 32.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Dizziness, Pruritus, Rash
Clinical narrative: PT states she felt itchy and light headed before she developed rash on her arms legs and face. PT took Benadryl 25mg to relieve the itching but symptoms just progressed.
Age: 45.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Inflammation, Injection site discharge, Injection site vesicles, Local swelling, Neck mass
Clinical narrative: Noticed a lump on the left side of my neck, about an hour later there was another lump right above the first one.  As the day went on the swelling continued to get worse.  Also the location of the smallpox vaccine has turn into multiple blisters. It just wouldn't stop oozing. I finally called my doctor and made an appt for the next day.  By the time I got to my doctor the next day the right side of my neck was swollen.  The inflammation was traveling down my arm.
Age: 45.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Swelling
Clinical narrative: Noticed a lump on the left side of my neck, about an hour later there was another lump right above the first one.  As the day went on the swelling continued to get worse.  Also the location of the smallpox vaccine has turn into multiple blisters. It just wouldn't stop oozing. I finally called my doctor and made an appt for the next day.  By the time I got to my doctor the next day the right side of my neck was swollen.  The inflammation was traveling down my arm.
Age: 48.0
Sex: M
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Deafness unilateral, Eyelid function disorder, Hemiparesis, Hypoaesthesia
Clinical narrative: Left side facial droop, left side body weakness especially left arm and leg numbness, unable to close left eye, difficulty eating and drinking. hearing loss all on left side.  Eventually diagnosed as Bells Palsy.
Age: 48.0
Sex: M
Vaccine: VARCEL
Symptoms: Impaired work ability, Laboratory test normal, VIIth nerve paralysis
Clinical narrative: Left side facial droop, left side body weakness especially left arm and leg numbness, unable to close left eye, difficulty eating and drinking. hearing loss all on left side.  Eventually diagnosed as Bells Palsy.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: States she received flu vaccine 2/4/14 and had pain in right arm during week. States pain started moving to right shoulder on 2//9/2014 - states when she moves right arm it hurts. Denies arm being puffy/swollen.
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, X-ray
Clinical narrative: Joint pain on my left foot, right knee cap, my two elbows, and finger next to little finger.
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Discomfort, Feeling abnormal
Clinical narrative: Joint pain on my left foot, right knee cap, my two elbows, and finger next to little finger.
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Insomnia, Myalgia, Pain, X-ray
Clinical narrative: Joint pain on my left foot, right knee cap, my two elbows, and finger next to little finger.
Age: 11.0
Sex: F
Vaccine: DPP, MEN
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, headache over last 5 hours. Treatment so far is Advil and fluids.  Dr visit later today.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Full blood count normal, Local swelling
Clinical narrative: Localized swelling to left arm and elbow.  No s/s of infection, NL CBC.  Tx with Ace wrap and observation.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Rash, redness and swelling at injection site. Diagnosed as cellulitis. Treated with antibiotics x 7 days.
Age: 60.0
Sex: F
Vaccine: DTP
Symptoms: Headache, Myalgia, Pain
Clinical narrative: Deep muscle pain and pain on entire left side, headache.
Age: 1.47
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, MMRV
Symptoms: Rash, Rash maculo-papular, Rash pustular, Urticaria
Clinical narrative: 2/20/14 Presented to ED with maculo papular rash entire body with few pustules present. RN states, child acts like they are in her throat also. Started breaking out 2/10 in the arm on face and started worsen last nite. More so this am. Was given picture of child shows "huge welts" like rash. BENADRYL 6.25 cc po. Prelone 10.2 cc po.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and fever to injection site.
Age: 54.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Arthralgia, Computerised tomogram, Dyspnoea, Faecal incontinence, Fall
Clinical narrative: On Oct 10, 2013 - received flu vaccination. Around Nov 7, 2013 - started experiencing numbess pain/burning in hands/feet. Progressing were weakness legs, arms, incontinent stool; short of breath. Fell on face due to weakness in legs. Dec 2, 2013 - ED visit -> CAT scan, MRI -> neurology consult -> Dx GBS 1/16/14.
Age: 54.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: On Oct 10, 2013 - received flu vaccination. Around Nov 7, 2013 - started experiencing numbess pain/burning in hands/feet. Progressing were weakness legs, arms, incontinent stool; short of breath. Fell on face due to weakness in legs. Dec 2, 2013 - ED visit -> CAT scan, MRI -> neurology consult -> Dx GBS 1/16/14.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Skin reaction
Clinical narrative: Pain, erythema around injection site, induration. Lesion approx. size of a goose egg.
Sex: U
Vaccine: HPV4
Symptoms: Encephalitis
Clinical narrative: This spontaneous report as received from an unspecified nurse via a Company Representative refers to a pediatric patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date the patient was vaccinated with a dose of GARDASIL, intramuscular (lot number was not provided). It was unspecified if the patient had received more than one dose in the series or if this was the first administration in the series. The reporting nurse mentioned that the patient had been diagnosed with encephalitis, shortly after the patient was vaccinated with GARDASIL. The patient was reported to be hospitalized at an unspecified facility, at the time of this report (approximately in February 2014). The outcome of encephalitis was unknown. No reporter causality was provided. Encephalitis was considered medically significant upon internal review. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female medical assistant of unknown age who on an unknown date, received a 3 dose series of RECOMBIVAX HB (doses, routes and lot numbers not reported) and had negative titers for hepatitis B. At the time of the report, the patient's outcome was unknown. The relatedness for negative titers for hepatitis B and RECOMBIVAX HB was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Vaccination site abscess sterile
Clinical narrative: This case was reported by a pharmacist and described the occurrence of vaccination site abscess sterile in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown details). At an unspecified time after vaccination with ENGERIX B, the subject experienced vaccination site abscess sterile (described as "sterile-site abscess"). No further details were provided at the time of reporting. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Age: 42.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Rash
Clinical narrative: Day after vaccines, patient had rash on legs and stomach lasting 1-2 days.  No fever, no other complaints.  Resolved without intervention.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza B virus test positive
Clinical narrative: Positive flu test after Fluarix vaccine on 10/23/2013 (Flu B).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Tenderness
Clinical narrative: Edema and erythema right arm (MCV4) vaccine site 50x50. Tender to touch. Injection site feels warm.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Injection site mass, Injection site nodule, Irritability
Clinical narrative: Nodule/mass and irritability on the R thigh.
Age: 26.0
Sex: M
Vaccine: YF
Symptoms: Dizziness, Pyrexia
Clinical narrative: Light-headedness, fever.
Age: 67.0
Sex: F
Vaccine: MEA
Symptoms: Back pain, Nausea, Pyrexia, Vomiting
Clinical narrative: Severe N/V, fever, BA.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Influenza, Influenza virus test, Pain, Rhinorrhoea
Clinical narrative: Influenza type B. Chills, sneezing, runny nose, body aches.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Sneezing
Clinical narrative: Influenza type B. Chills, sneezing, runny nose, body aches.
Age: 1.52
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Rash with hives and centered on the Pentacel site.
Age: 81.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Client called complaining of severe muscular pain in left deltoid every night in middle of night without any relief from pain medication. He ices and gets relief from that.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Dyspnoea, Muscle spasms, Pain, Rash erythematous
Clinical narrative: Pt describes at ten days post vaccine "intense chest and upper back/shoulder muscle spasms, pain and SOB" requiring pain medication and a visit to the ER. Subsequently experiencing an itching/burning head to toe rash and red bumps lasting about a week. Then it took "a few more weeks before the dry patches cleared up".   No report of fever.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Pt describes at ten days post vaccine "intense chest and upper back/shoulder muscle spasms, pain and SOB" requiring pain medication and a visit to the ER. Subsequently experiencing an itching/burning head to toe rash and red bumps lasting about a week. Then it took "a few more weeks before the dry patches cleared up".   No report of fever.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Flushing, Heart rate increased, Rash pruritic
Clinical narrative: Patient reports that within thirty minutes after receiving the vaccine she experienced an increased heart rate, flushing, dizziness and a subsequent itchy collarbone rash.  All symptoms gone by morning.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood test normal, Chest X-ray abnormal, Hyperhidrosis, Ocular hyperaemia
Clinical narrative: Profuse sweating starting on 12/22/2013 in the early morning and continuing periodically through today, 2/20/2014. Worse sweating is in the bed at night. Also no energy. My immune system is down and came down with pneumonia on 1/15/2014 also pink eye in both eyes. Treated with antibiotics for 10 days the pneumonia and pink eye disappeared but the sweats and severe lack of energy still continues through today 2/20/2014. Have had a battery of blood tests and all came out normal. Dr. now scheduling chest CT. Did have chest xrays that showed I contracted the pneumonia on 1/18/2014.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: Profuse sweating starting on 12/22/2013 in the early morning and continuing periodically through today, 2/20/2014. Worse sweating is in the bed at night. Also no energy. My immune system is down and came down with pneumonia on 1/15/2014 also pink eye in both eyes. Treated with antibiotics for 10 days the pneumonia and pink eye disappeared but the sweats and severe lack of energy still continues through today 2/20/2014. Have had a battery of blood tests and all came out normal. Dr. now scheduling chest CT. Did have chest xrays that showed I contracted the pneumonia on 1/18/2014.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Onset redness, swelling and pain in left arm 8 days after injection.  Progressive worsening over next 24 hours.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Induration
Clinical narrative: Erythema, warmth and induration inferior and posterior to deltoid muscle, worsening each day until came in 1/16/2014.  Rx cephalexin with resolution.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local swelling at site of inejction and erythema on left thigh.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal distension, Dyspnoea, Laboratory test normal, Pain, Staphylococcal infection
Clinical narrative: Couldn't breathe ended in hospital and port was removed. Staph infection and trouble breathing and swelling in stomach, Disease Control called.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Pt. given Adult Hep A vaccine instead of Childrens dose.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Off label use
Clinical narrative: Adult given, children's Hep-B vaccine re-vaccinated with adult dose.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dyskinesia, Gaze palsy, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Mom was withi pt in exam room he had rec'd the vaccine (sitting on side of exam table), had syncopal episode - pale, diaphoretic, frontal BP 80/42. When we tried to sit him up - started to jerk and eyes rolled back in his head. Repeated BP, gave sips of sugary soda - after 1 hr. color returned to pink, alert and oriented, BP normal and d/c home.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient complains of sore arm for last 4 wks since flu vaccine was given.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: (L) deltoid swollen, itchy.
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Fall, Seizure like phenomena, Syncope
Clinical narrative: Within 5 minutes of injection, he fainted and fell on the floor. Symptoms appeared like seizure. Paramedic came within 5 minutes of incident.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 68 year old male patient. The patient's current conditions or medical history were not reported. On an unknown date in 2008, the patient was vaccinated with ZOSTAVAX (dose, route, lot and expiration date were not reported). In August-2013, the patient acquired shingles. At the time of the report the outcome for shingles was unknown. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a 56 year old female patient. The patient's medical history included "mild case of shingles 4 to 6 weeks prior to received ZOSTAVAX. No drug reactions or allergies were reported. On 06-FEB-2014, the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous for "shingles prevention". Approximately on 08-FEB-2014 (also reported as "48 hours later after receiving vaccination), the patient had vesicular rash reaction and discoloration of the skin at the injection site area that was 6x3 inches sizes after receiving ZOSTAVAX. The reporter stated that the patient's vesicular rash reaction resolved without treatment, but discoloration around the injection site still present and not resolved. No treatment was given for the adverse event. No lab diagnostics studies were performed. On an unspecified date, the patient sought medical attention, contacted the primary physician. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Anti-platelet antibody negative, Contusion, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Petechiae
Clinical narrative: Began to notice petechia on lower extremities bilaterally along with bruising on arms and abdominal area. Platelets found to be 3000.  Admitted to hospital 10/7. Hematology consult felt flu shot precipitated Idiopathic thrombocyopenic purpura.  Given 1 unit platelets and IVIG.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Platelet count decreased
Clinical narrative: Began to notice petechia on lower extremities bilaterally along with bruising on arms and abdominal area. Platelets found to be 3000.  Admitted to hospital 10/7. Hematology consult felt flu shot precipitated Idiopathic thrombocyopenic purpura.  Given 1 unit platelets and IVIG.
Age: 95.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Influenza like illness, Myalgia
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of muscle pain in a 95-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 24 September 2013 at 15:00 the subject received a dose of FLULAVAL (.5 ml, intramuscular, left deltoid). On 25 September 2013, 1 day after vaccination with FLULAVAL, the subject experienced muscle pain (described as "extreme muscle aches"), weakness, mild congestion (nos) (described as "congestion"), dizziness, fever, chills and flu-like symptoms. The nurse practitioner reported that the "congestion is the worst problem." The nurse practitioner reported that she was "very concerned" about the subject. The nurse practitioner wanted the subject to "go to the emergency room" but the patient did not want to go. At the time of reporting the events were worse. The nurse practitioner reported that "the events were all getting worse." The healthcare professional considered the events were probably related to vaccination with FLULAVAL. The nurse practitioner reported another case with FLULAVAL. See case A1044908A for details on the other case.
Age: 95.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of muscle pain in a 95-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 24 September 2013 at 15:00 the subject received a dose of FLULAVAL (.5 ml, intramuscular, left deltoid). On 25 September 2013, 1 day after vaccination with FLULAVAL, the subject experienced muscle pain (described as "extreme muscle aches"), weakness, mild congestion (nos) (described as "congestion"), dizziness, fever, chills and flu-like symptoms. The nurse practitioner reported that the "congestion is the worst problem." The nurse practitioner reported that she was "very concerned" about the subject. The nurse practitioner wanted the subject to "go to the emergency room" but the patient did not want to go. At the time of reporting the events were worse. The nurse practitioner reported that "the events were all getting worse." The healthcare professional considered the events were probably related to vaccination with FLULAVAL. The nurse practitioner reported another case with FLULAVAL. See case A1044908A for details on the other case.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Influenza like illness, Myalgia
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of muscle pain in a 47-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 25 September 2013 the subject received a dose of FLULAVAL (.5 ml, unknown details). On 26 September 2013, 1 day after vaccination with FLULAVAL, the subject experienced muscle pain (described as "extreme muscle aches"), weakness, mild congestion (nos) (described as "congestion"), dizziness, fever, chills and flu-like symptoms. The nurse practitioner reported that the "congestion is the worst problem." At the time of reporting the events were worse. The nurse practitioner reported that "the events were all getting worse." The healthcare professional considered the events were probably related to vaccination with FLULAVAL. The nurse practitioner reported another case with FLULAVAL. See case A1044907A for details on the other case.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of muscle pain in a 47-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 25 September 2013 the subject received a dose of FLULAVAL (.5 ml, unknown details). On 26 September 2013, 1 day after vaccination with FLULAVAL, the subject experienced muscle pain (described as "extreme muscle aches"), weakness, mild congestion (nos) (described as "congestion"), dizziness, fever, chills and flu-like symptoms. The nurse practitioner reported that the "congestion is the worst problem." At the time of reporting the events were worse. The nurse practitioner reported that "the events were all getting worse." The healthcare professional considered the events were probably related to vaccination with FLULAVAL. The nurse practitioner reported another case with FLULAVAL. See case A1044907A for details on the other case.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia oral, Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of tongue numbness in a 29-year-old female subject who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On 21 October 2013 the subject received 1st dose of FLULAVAL TETRA (.5 ml, unknown, right arm). On 23 October 2013, 2 days after vaccination with FLULAVAL TETRA, the subject experienced tongue numbness, erythema and swelling. The subject received FLULAVAL TETRA on 21 October 2013 as part of a worksite clinic. The reporting healthcare professional received a voicemail from the female subject on 23 October 2013 stating she had experienced redness, swelling, and tongue numbness. Details as whether the redness and swelling were local or systemic were not provided. The subject inquired if FLULAVAL TETRA contained propylene glycol, but the reporting healthcare professional was unaware if the subject had a reaction to this ingredient. At the time of reporting the outcome of the events were unspecified.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Mobility decreased, Neurological examination, Nuclear magnetic resonance imaging
Clinical narrative: Severe pain as soon as flu vaccine was injected in right arm at injection site, with shooting pain in entire right arm. There has been no treatment and severe pain continues. There is difficult and limited movement where there was none before the vaccine. There was no pain in right arm before Vaccine was injected. Pain is also in my right hand now. I can no longer use my hand and arm to do certain things now.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Severe pain as soon as flu vaccine was injected in right arm at injection site, with shooting pain in entire right arm. There has been no treatment and severe pain continues. There is difficult and limited movement where there was none before the vaccine. There was no pain in right arm before Vaccine was injected. Pain is also in my right hand now. I can no longer use my hand and arm to do certain things now.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a pharmacy manager via a company representative refers to a 50 year old female patient. On 10-FEB-2014 the patient was vaccinated with ZOSTAVAX, (lot#, expiration date, dose, frequency, route and indication not reported). The unspecified patient experienced anaphylaxis after being administered ZOSTAVAX on 10-FEB-2014. The patient was taken to an unspecified emergency room and given BENADRYL (manufacturer unknown) and SOLU-MEDROL (manufacturer unknown). The patient was released from the emergency room on an unspecified date. The outcome of the event was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PER, VARZOS, FLUX, PER, VARZOS
Symptoms: Aphagia, Aphthous stomatitis, Biopsy, Blood test, Culture
Clinical narrative: This spontaneous report as received from a consumer's husband refers to a 62 years old female patient. It was reported that the patient had a healthy immune system and had no history of cold sores. On an unknown date, the patient was vaccinated with ZOSTAVAX, single dose injection. Other suspect therapies included AFLURIA and pertussis vaccine (unspecified) were administered within the same week as with ZOSTAVAX. No concomitants were reported. On 28-JAN-2014 (also reported as a few weeks later), the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. On an unknown date in 2014, the fever worsened and the patient developed symptoms of a Urinary tract infection (no UTI was confirmed) and severe discomfort in her throat, which included difficulty in swallowing. Patient visited to a walk-in clinic (unspecified), where she was prescribed LEVAQUIN. The patient then visited her physician. where she was examined. On an unknown date in 2014, the patient developed white tongue and canker sores in her mouth and she began to experience more severe problems in swallowing and was unable to eat or drink. The patient sought the attention of an Infectious Disease Specialist and on 04-FEB-2014; she went to the Emergency Room and was hospitalized on 04-FEB-2014. On an unknown date in 2014, lab diagnostics studies included blood, urine tests, endoscopy, cultures, biopsies were performed. She was diagnosed with unspecified herpes virus blisters in her throat. Patient received acyclovir by intravenous administration in hospital and CARAFATE to coat the ulcerations. BACTRIM and vancomycin were also given as treatment. She was discharged on 09-FEB-2014, and was reportedly able to eat and drink lightly, but was still uncomfortable. All the reported events were recovering/resolving. Causality assessment was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PER, VARZOS, FLUX, PER, VARZOS
Symptoms: Dysphagia, Endoscopy, Fluid intake reduced, Headache, Herpes virus infection
Clinical narrative: This spontaneous report as received from a consumer's husband refers to a 62 years old female patient. It was reported that the patient had a healthy immune system and had no history of cold sores. On an unknown date, the patient was vaccinated with ZOSTAVAX, single dose injection. Other suspect therapies included AFLURIA and pertussis vaccine (unspecified) were administered within the same week as with ZOSTAVAX. No concomitants were reported. On 28-JAN-2014 (also reported as a few weeks later), the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. On an unknown date in 2014, the fever worsened and the patient developed symptoms of a Urinary tract infection (no UTI was confirmed) and severe discomfort in her throat, which included difficulty in swallowing. Patient visited to a walk-in clinic (unspecified), where she was prescribed LEVAQUIN. The patient then visited her physician. where she was examined. On an unknown date in 2014, the patient developed white tongue and canker sores in her mouth and she began to experience more severe problems in swallowing and was unable to eat or drink. The patient sought the attention of an Infectious Disease Specialist and on 04-FEB-2014; she went to the Emergency Room and was hospitalized on 04-FEB-2014. On an unknown date in 2014, lab diagnostics studies included blood, urine tests, endoscopy, cultures, biopsies were performed. She was diagnosed with unspecified herpes virus blisters in her throat. Patient received acyclovir by intravenous administration in hospital and CARAFATE to coat the ulcerations. BACTRIM and vancomycin were also given as treatment. She was discharged on 09-FEB-2014, and was reportedly able to eat and drink lightly, but was still uncomfortable. All the reported events were recovering/resolving. Causality assessment was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PER, VARZOS, FLUX, PER, VARZOS
Symptoms: Oropharyngeal blistering, Oropharyngeal discomfort, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer's husband refers to a 62 years old female patient. It was reported that the patient had a healthy immune system and had no history of cold sores. On an unknown date, the patient was vaccinated with ZOSTAVAX, single dose injection. Other suspect therapies included AFLURIA and pertussis vaccine (unspecified) were administered within the same week as with ZOSTAVAX. No concomitants were reported. On 28-JAN-2014 (also reported as a few weeks later), the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. On an unknown date in 2014, the fever worsened and the patient developed symptoms of a Urinary tract infection (no UTI was confirmed) and severe discomfort in her throat, which included difficulty in swallowing. Patient visited to a walk-in clinic (unspecified), where she was prescribed LEVAQUIN. The patient then visited her physician. where she was examined. On an unknown date in 2014, the patient developed white tongue and canker sores in her mouth and she began to experience more severe problems in swallowing and was unable to eat or drink. The patient sought the attention of an Infectious Disease Specialist and on 04-FEB-2014; she went to the Emergency Room and was hospitalized on 04-FEB-2014. On an unknown date in 2014, lab diagnostics studies included blood, urine tests, endoscopy, cultures, biopsies were performed. She was diagnosed with unspecified herpes virus blisters in her throat. Patient received acyclovir by intravenous administration in hospital and CARAFATE to coat the ulcerations. BACTRIM and vancomycin were also given as treatment. She was discharged on 09-FEB-2014, and was reportedly able to eat and drink lightly, but was still uncomfortable. All the reported events were recovering/resolving. Causality assessment was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PER, VARZOS, FLUX, PER, VARZOS
Symptoms: Tongue discolouration, Urinary tract infection, Urine analysis
Clinical narrative: This spontaneous report as received from a consumer's husband refers to a 62 years old female patient. It was reported that the patient had a healthy immune system and had no history of cold sores. On an unknown date, the patient was vaccinated with ZOSTAVAX, single dose injection. Other suspect therapies included AFLURIA and pertussis vaccine (unspecified) were administered within the same week as with ZOSTAVAX. No concomitants were reported. On 28-JAN-2014 (also reported as a few weeks later), the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. On an unknown date in 2014, the fever worsened and the patient developed symptoms of a Urinary tract infection (no UTI was confirmed) and severe discomfort in her throat, which included difficulty in swallowing. Patient visited to a walk-in clinic (unspecified), where she was prescribed LEVAQUIN. The patient then visited her physician. where she was examined. On an unknown date in 2014, the patient developed white tongue and canker sores in her mouth and she began to experience more severe problems in swallowing and was unable to eat or drink. The patient sought the attention of an Infectious Disease Specialist and on 04-FEB-2014; she went to the Emergency Room and was hospitalized on 04-FEB-2014. On an unknown date in 2014, lab diagnostics studies included blood, urine tests, endoscopy, cultures, biopsies were performed. She was diagnosed with unspecified herpes virus blisters in her throat. Patient received acyclovir by intravenous administration in hospital and CARAFATE to coat the ulcerations. BACTRIM and vancomycin were also given as treatment. She was discharged on 09-FEB-2014, and was reportedly able to eat and drink lightly, but was still uncomfortable. All the reported events were recovering/resolving. Causality assessment was not provided. Additional information has been requested.