chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Full blood count normal, Glycosylated haemoglobin normal, Hemiparesis, Hypoaesthesia, Laboratory test normal
Clinical narrative: Pt. was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt. developed hot tingling sensation in L face involving cheek down to chin as well as LUE/LLE weakness; no other neuro sxs reported. EKG performed and pt. send to ED for stroke evaluation. Pt. was seen in ED and stroke alert called. Not determined a TIA candidate per neurology. Pt. was admitted and found to have L facial droop, L facial numbness, and L hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt. stated feeling good but still having trouble with words. On ER call 5/31/13, pt. reported worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (no aphasic speech) but otherwise normal and CT/MRI was negative. Pt. was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt. reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Muscular weakness, Nausea, Neurological examination abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Pt. was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt. developed hot tingling sensation in L face involving cheek down to chin as well as LUE/LLE weakness; no other neuro sxs reported. EKG performed and pt. send to ED for stroke evaluation. Pt. was seen in ED and stroke alert called. Not determined a TIA candidate per neurology. Pt. was admitted and found to have L facial droop, L facial numbness, and L hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt. stated feeling good but still having trouble with words. On ER call 5/31/13, pt. reported worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (no aphasic speech) but otherwise normal and CT/MRI was negative. Pt. was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt. reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia, Speech disorder, Transient ischaemic attack, Troponin I normal, VIIth nerve paralysis
Clinical narrative: Pt. was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt. developed hot tingling sensation in L face involving cheek down to chin as well as LUE/LLE weakness; no other neuro sxs reported. EKG performed and pt. send to ED for stroke evaluation. Pt. was seen in ED and stroke alert called. Not determined a TIA candidate per neurology. Pt. was admitted and found to have L facial droop, L facial numbness, and L hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt. stated feeling good but still having trouble with words. On ER call 5/31/13, pt. reported worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (no aphasic speech) but otherwise normal and CT/MRI was negative. Pt. was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt. reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Injection site erythema, Injection site joint pain, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately 72 year old female patient with no drug reactions or allergies. On 18-JAN-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number H01809 and expiry date: January 2014), subcutaneously in the left deltoid. No concomitant medications were reported. Approximately on an unknown date in 2013, after the vaccination, the patient experienced redness at the injection site which was described as being 8 centimeter (cm) in diameter. The patient was then admitted to unspecified hospital with pneumonia and developed arm and shoulder pain in left arm and left shoulder. Approximately on an unknown date in 2013, X-rays were performed in the hospital, but showed nothing. Approximately on an unknown date in 2013, the patient was discharged. After discharge, the patient experienced inability to lift arm and limited arm mobility, for which she was taking physical therapy for, but discontinued due to lack of pain and function improvement and financial concerns. She continued to have congestion, could not keep throat clear and that she could not sing anymore. The symptoms were unchanged 6 months after the injection. The patient sought medical attention (seeing physician monthly), but treatment information was not available. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia, Respiratory tract congestion, Throat irritation, X-ray normal
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately 72 year old female patient with no drug reactions or allergies. On 18-JAN-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number H01809 and expiry date: January 2014), subcutaneously in the left deltoid. No concomitant medications were reported. Approximately on an unknown date in 2013, after the vaccination, the patient experienced redness at the injection site which was described as being 8 centimeter (cm) in diameter. The patient was then admitted to unspecified hospital with pneumonia and developed arm and shoulder pain in left arm and left shoulder. Approximately on an unknown date in 2013, X-rays were performed in the hospital, but showed nothing. Approximately on an unknown date in 2013, the patient was discharged. After discharge, the patient experienced inability to lift arm and limited arm mobility, for which she was taking physical therapy for, but discontinued due to lack of pain and function improvement and financial concerns. She continued to have congestion, could not keep throat clear and that she could not sing anymore. The symptoms were unchanged 6 months after the injection. The patient sought medical attention (seeing physician monthly), but treatment information was not available. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Catheterisation cardiac normal, Computerised tomogram thorax normal, Echocardiogram normal, Electrocardiogram abnormal, Eosinophil count increased
Clinical narrative: Developed myocarditis following smallpox immunization. Also, hypereosinophilia which was attributed to a reactive mechanism following the immunization. Received appropriate care and is doing well. Currently building physical conditioning as tolerated.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Eosinophilia, Myocarditis, Troponin increased, Vaccination complication
Clinical narrative: Developed myocarditis following smallpox immunization. Also, hypereosinophilia which was attributed to a reactive mechanism following the immunization. Received appropriate care and is doing well. Currently building physical conditioning as tolerated.
Sex: F
Vaccine: TDAP
Symptoms: Myocarditis
Clinical narrative: Initial report was received on 05 June 2013 from a health care professional. A female patient (date of birth not reported) had received on 29 May 2013 ADACEL (lot number, route and site of administration not reported) and on 04 June 2013, developed myocarditis. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional (physician) on 04 June 2013. A five year old male patient received his 5th dose of DAPTACEL in the Dtap series on 14 May 2013 into the left deltoid, route not reported (Batch C4346BA). The patient also received a MMR vaccine, Manufacturer Merck, (Batch H015826) into the right deltoid, route not reported on 14 May 2013. The reporter denied that the patient had any concomitant medications or medical history. The patient experienced a site reaction (side not reported) of redness, swelling and tenderness resembling cellulitis. The patient was examined by a physician on 16 May 2013 and treated with KEFLEX, ice compresses and Ibuprofen, details not provided. Laboratory tests were not reported. The patient recovered on an unreported date. No further details were available at the time of this report. Documents held by sender: None.
Sex: U
Vaccine: HEP
Symptoms: Abnormal behaviour, Central nervous system lesion, Condition aggravated, Mental disorder, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: This case was reported by a consumer (mother of the subject) via a pharmaceutical company and described the occurrence of brain lesion in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. 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 brain lesion (described as "lesion on the frontal lobe"), change in behavior and psychiatric patient. Per the subject's mother, the subject "had behavioral changes after receiving ENGERIX B. The patient is in a psychiatric facility." No further adverse event information was provided. Contact information for follow up was not provided, therefore, the case has been closed. This case was assessed as medically serious by GSK. Relevant test results included a nuclear magnetic resonance imaging of brain (MRI). The results of the MRI "showed a lesion on the frontal lobe." At the time of reporting the outcome of the events were unspecified.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Paraesthesia
Clinical narrative: This spontaneous report from a consumer refers to her husband, an about 56 year old male patient with "blood pressure", no drug allergies. On 04-APR-2013 the consumer was vaccinated with a dose of ZOSTAVAX (dose and route was unknown). Concomitant therapies included cholesterol and beta blocker, blood pressure. On 14-APR-2013, the consumer called in and reporting that her husband got a case of the shingles 10 days after she received ZOSTAVAX. It started out with stingeling sensation and did mature to full blown shingles including blisters. The shingles came on his stomach wrapped to the back. Unspecified treatment was given. Lab diagnostics studies was performed. The outcome of shingles was unknown. Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning a 15 month old male patient. On 07-JUN-2013, the patient was inadvertently vaccinated with both a dose of PROQUAD (Merck) (lot number, expiry date, dose and route unspecified) and a dose of MMR II (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. It was reported that on an unknown date in January 2013 and on 12-JUN-2013 the patient was vaccinated with a first and a second doses of GARDASIL (doses, lot numbers and route was not reported) respectively. No adverse event reported. Additional information has been requested.
Age: 0.65
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient (age when first adverse event occurred was not reported currently at the time of the report patient had 17 years) with no drug allergies and no pertinent medical history. On 21-NOV-1995 the patient was vaccinated with RECOMBIVAX HB, 5 mcg/0.5 ml, first dose 0.5 ml, intramuscular (lot number was not reported). On 10-JAN-1996 the patient was vaccinated with RECOMBIVAX HB, 5 mcg/0.5 ml, second dose 0.5 ml, intramuscular (lot number was not reported). On 02-JUL-1996 the patient was vaccinated with RECOMBIVAX HB, 5 mcg/0.5 ml, third dose 0.5 ml, intramuscular (lot number was not reported). No history of concomitant medication. On an unknown date the patient had titers drawn at an unspecified site and results showed he failed to seroconvert. The patient sought medical attention by parent, who called physician's office. The patient outcome of failed to seroconvert was not reported. The relatedness between event and RECOMBIVAX HB was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a medical assistant (also reported as a healthcare worker) concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, after receiving ZOSTAVAX, the patient experienced an unspecified reaction. The patient sought medical attention (office visit). The outcome of unspecified reaction was unknown. The reporter enquired on behalf of the physician regarding the ingredients in ZOSTAVAX of it has neomycin and formaldehyde. The relatedness for the unspecified reaction was unknown for ZOSTAVAX. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Pruritus, Rash macular, Skin warm
Clinical narrative: 6/17/13 mom called reporting 6 hrs after patient received a KINRIX on 6/14/13 she broke out in red blotches all over her body. She was itchy. Blotches on neck, face, legs, stomach, arms. Mom states the arm where KINRIX given was red and itchy, warm to touch. Mom gave 3 doses of BENADRYL in a 24 hrs period and blotchiness resolved. Arm redness and warmth resolved by 6/17/13.
Age: 52.0
Sex: M
Vaccine: YF, YF
Symptoms: Myalgia
Clinical narrative: 3 days after receiving yellow fever vaccine "in his triceps", had significant pain in muscles of arm, back, scapula, neck and chest.
Age: 52.0
Sex: M
Vaccine: YF, YF
Symptoms: Asthenia, Chest pain, Hypoaesthesia, Musculoskeletal pain, Myalgia
Clinical narrative: 3 days after receiving yellow fever vaccine "in his triceps", had significant pain in muscles of arm, back, scapula, neck and chest.
Age: 52.0
Sex: M
Vaccine: YF, YF
Symptoms: Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: 3 days after receiving yellow fever vaccine "in his triceps", had significant pain in muscles of arm, back, scapula, neck and chest.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Blood test abnormal, Computerised tomogram normal, Infection, Local swelling, Trismus
Clinical narrative: Mom states child developed "lock jaw", unable to open mouth with swelling in the neck area. Private MD directed child to go to ED, he was administered steroids, blood tests and CAT scan completed. Child was provided antibiotics and he showed some improvement in ability to open mouth.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Computerised tomogram normal, Laboratory test normal, Local swelling, Streptococcus test negative, Trismus
Clinical narrative: Mom states child developed "lock jaw", unable to open mouth with swelling in the neck area. Private MD directed child to go to ED, he was administered steroids, blood tests and CAT scan completed. Child was provided antibiotics and he showed some improvement in ability to open mouth.
Age: 1.51
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC13, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: At about 7:30 my son started to get a fever we treated it with Motrin and then at 10 pm he started to reach another high fever so we gave him Tylenol and put him to bed at 1:45 am I had a gut feeling to go and check on my son and I found him in his crib in the middle of a seizure. Every doctor I spoke to in the emergency room last night points to this as the reason for my sons seizure. He was transported via ambulance to the hospital last night.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Local reaction, Palpitations, Swelling
Clinical narrative: Local reaction of redness and swelling. On and off episodes of dizziness and heart palpatations.
Age: 25.0
Sex: M
Vaccine: ADEN_4_7, FLU3, MNQ, TD
Symptoms: Dysphagia, Swollen tongue
Clinical narrative: Tongue swelling, difficulty swallowing. 25mg Benadryl given IM at 10:35 AM.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope, Tuberculin test
Clinical narrative: Initially received Influenza Vaccine, then went and had a PPD administered. Approximately 5 minutes later she became faint and passed out. Administered Ammonia and woke up immediately. Able to drink some juice and ate crackers.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Vaccine given without complication in right deltoid.  Patient noted that she didn't feel the injection at the time of administration.  Within 1-2 hours of administration, patient complained of soreness in deltoid where injection given.  Overnight, pain in upper extremity worsened.  Pain noted with movement of extremity or pressure to area.  Patient used heat to area and ibuprofen for symptom control.  Symptoms continued without improvement.  On 6/13/13, patient was evaluated by MD.  No redness at site, no swelling, no induration, no localized reaction noted.  Patient complaint of pain was several inches below the site of injection.  No pain at site of injection.  Patient was unable to abduct right upper extremity without excruciating pain.  No sign of infection or localized reaction at site.  MD recommended to continue ibuprofen po every 6-8 hours and heat to area.  On 6/14/13 pain and ability to abduct right upper extremity improved.  On 6/16/13 symptoms had resolved completely.  No residual effects noted.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Abdominal pain, Dermatitis allergic, Eczema, Laboratory test abnormal, Muscle spasms
Clinical narrative: Fever, leg spasms/cramps within a few hours and daily/hourly for the next 18 months approximately, then about monthly to every 2 months since; rash, screaming & abdominal pain within a few hours then on and off over the next 18 months; hives began a few weeks later, which is on and off with no apparent cause since injection; extreme skin sensitivity to any soaps, chemicals, sun etc, including severe eczema which never occurred prior, monthly to every few months since injection. Medical doctors claimed it was unrelated, even up through facility's legal dept.  I finally found a nutritionist/chiropractor about 18 months after the injection who was able to detect toxins in his body, which we treated with organically bound minerals and organic detox vitamins/minerals.  Within a few days symptoms subsided significantly and he was able to sleep through the night for the first time in 18 months.  Now the symptoms are very rare, but his skin sensitivities and rashes persist.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Rash, Screaming, Urticaria
Clinical narrative: Fever, leg spasms/cramps within a few hours and daily/hourly for the next 18 months approximately, then about monthly to every 2 months since; rash, screaming & abdominal pain within a few hours then on and off over the next 18 months; hives began a few weeks later, which is on and off with no apparent cause since injection; extreme skin sensitivity to any soaps, chemicals, sun etc, including severe eczema which never occurred prior, monthly to every few months since injection. Medical doctors claimed it was unrelated, even up through facility's legal dept.  I finally found a nutritionist/chiropractor about 18 months after the injection who was able to detect toxins in his body, which we treated with organically bound minerals and organic detox vitamins/minerals.  Within a few days symptoms subsided significantly and he was able to sleep through the night for the first time in 18 months.  Now the symptoms are very rare, but his skin sensitivities and rashes persist.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Child fainted in waiting room after HPV and MCV4 & Tdap given. Taken to TX room. Placed in Trendelenburg position, Pulse 60 and regular, and examined by clinic doctor. Given juice and peanut butter crackers after 15 minutes. Alert and color pink. Ambulated to car with mom and RN at 12 PM.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Itching that started few minutes after the vaccine was given. Pt. reoprted it was very itchy and is bothering her. There was localized redness around the injection site. Itching was decreased substantially.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Pt was walking to car in garage facility, and she suddenly felt light headed and fainted.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Coma, Culture, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Guillain Barre Syndrome.  Tingling in fingers and toes. Progressed to muscle weakness.  Emergency room. IgG started. Respirator for 3 monthes. Coma for 1 month. Painful physical therapy until present.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Pain, Paraesthesia
Clinical narrative: Guillain Barre Syndrome.  Tingling in fingers and toes. Progressed to muscle weakness.  Emergency room. IgG started. Respirator for 3 monthes. Coma for 1 month. Painful physical therapy until present.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain, Pyrexia
Clinical narrative: Pain, redness, fever, Dr DX cellulitis, RX of Keflex/ 10 days.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: PT FELT THAT THE SITE OF INJECTION WAS SWOLLEN, RED, HOT TO THE TOUCH AND COVERED A 4"x 2" AREA. IT WAS RAISED AND IT WAS HARD. PT ALSO HAD A HEADACHE. THE SXs STARTED TO SUBSIDE AT APPROX 9AM ON MONDAY (6/17/13).
Age: 0.23
Sex: M
Vaccine: HIBV
Symptoms: Body temperature increased, Crying, Differential white blood cell count normal, Febrile convulsion, Full blood count normal
Clinical narrative: He suffered three febrile seizures. 1600, 1800, 1900 followed by 11 hours of sleep that was so deep he did not move or nurse. Seizures included trunk spams and shaking of the hands and becoming straight like a board followed by "passing out". His temp was 101 for most of the day, shot up to 103 for less than a half hour. (Using hospital grade temporal lobe thermometer) He cried harder than he had with colic and I could not get him calm. No nursing for this period.
Age: 0.23
Sex: M
Vaccine: HIBV
Symptoms: Loss of consciousness, Muscle spasms, Posture abnormal, Tremor
Clinical narrative: He suffered three febrile seizures. 1600, 1800, 1900 followed by 11 hours of sleep that was so deep he did not move or nurse. Seizures included trunk spams and shaking of the hands and becoming straight like a board followed by "passing out". His temp was 101 for most of the day, shot up to 103 for less than a half hour. (Using hospital grade temporal lobe thermometer) He cried harder than he had with colic and I could not get him calm. No nursing for this period.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Crying, Decreased appetite, Irritability, Pyrexia, Screaming
Clinical narrative: Baby woke up from nap crying and screaming. This is not usual behavior for the baby. He was unusually upset and fussy for the rest of the day. He had a fever of 101.3 and we gave his children's Tylenol. He didn't have much of an appetite that evening either.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dysaesthesia, Electromyogram abnormal, Herpes zoster, Laboratory test normal
Clinical narrative: This spontaneous report as received from a physician refers to his wife, a 65 year old female patient. The patient's medical history included peripheral neuropathy and fibromyalgia, also she allergy to tetracycline and RECOMBIVAX HB. On APRIL 2008 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Concomitant therapies included prednisone. On 09-APR-2013 the patient experienced chest tightness, a "rash suggestive of shingles" and dysesthesia. The patient spent one night in hospital in MAY 2013 for chest tightness. The reporter reported that the patient has an allergy to RECOMBIVAX HB in the form of pain and fatigue that lasted 6 months (MARRS#1306USA007772). The patient did the Electromyogram test, and it showed peripheral neuropathy in arms and legs. The patient also did Brain MRI and the routine labs, the tests were normal. The outcome of shingles was reported as recovered but the patient was still left with dysesthesia. The outcome of the chest tightness was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This spontaneous report as received from a physician refers to his wife, a 65 year old female patient. The patient's medical history included peripheral neuropathy and fibromyalgia, also she allergy to tetracycline and RECOMBIVAX HB. On APRIL 2008 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Concomitant therapies included prednisone. On 09-APR-2013 the patient experienced chest tightness, a "rash suggestive of shingles" and dysesthesia. The patient spent one night in hospital in MAY 2013 for chest tightness. The reporter reported that the patient has an allergy to RECOMBIVAX HB in the form of pain and fatigue that lasted 6 months (MARRS#1306USA007772). The patient did the Electromyogram test, and it showed peripheral neuropathy in arms and legs. The patient also did Brain MRI and the routine labs, the tests were normal. The outcome of shingles was reported as recovered but the patient was still left with dysesthesia. The outcome of the chest tightness was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a female consumer refers of unknown age who refers to herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported). It was reported that after receiving the vaccine, on an unknown date the patient experienced redness and pain at the injection site. The outcome of redness and pain at the injection site was unknown. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an approximately 76 year old female patient. On 04-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as J000430 and 10-APR-2014 respectively, dose and route unspecified). No concomitant medications were reported. Approximately on an unknown date in June 2013, the patient developed a red rash about an inch in diameter at the injection site, but the red rash was without pain or itching. The patient sought medical attention (contact pharmacist). No treatment was given. It was unspecified if any lab tests were performed. The patient was not recovered from the events at the time of report. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients that might have been vaccinated with a doses of GARDASIL (doses and lot number not reported) that were exposed to -1C for 24 hours on 15-MAY-2013 and these same doses were previously exposed to 0C for a total of 48 hours. No adverse reactions had been reported. Additional information has been requested.
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Information has been received from a patient's husband, for (Merck) VARIVAX, Pregnancy Registry product, concerning his wife female who on 16-AUG-2011 was vaccinated with a dose of (Merck) VARIVAX (lot number, dose and site of administration not reported). Secondary suspect vaccines included a dose of MMR (manufacturer unknown) (lot number, dose and site of administration not reported), a dose of IPV (unspecified) and a dose of DPT. There was no concomitant medication. On 21-OCT-2011, three days ago, the patient tool a home pregnancy test and learned she was pregnant. They were looking for a physician to see here. His wife had no symptoms from the vaccinations. No treatment was given for the adverse event. The patient did not seek medical attention. The patient's LMP and EDD was not provided. Follow-up information has been received from the reporting husband. His wife gave birth naturally to a healthy baby girl. The baby girl's birth and his wife's pregnancy were without complications. Birth weight was unknown. Baby girl had no congenital anomalies and was "perfect". Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngeal oedema
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 24 year old female patient with no drug allergies or medical history reported. On 20-NOV-2012 the patient was vaccinated with the first dose of GARDASIL (lot#0459AE, Exp. 13-DEC-2014) intramuscularly in the left deltoid. Concomitant medication included: unspecified "oral birth control". On 22-JAN-2013 the patient was vaccinated with the second dose of GARDASIL (lot # H017698, Exp. 02-JUL-2015) intramuscularly in the left deltoid. The patient called the physician's office the next day stating that "she went to the emergency room on the evening of 22-JAN-2013 because she felt like her throat was swelling up". The emergency room was unspecified. No lab diagnostics studies was performed. The patient stated that the unspecified emergency room physician said "the reaction was mild, not severe, and sent her home with BENADRYL". The outcome of felt like her throat was swelling up was reported as recovered/resolved on an unknown date. Additional information has been requested.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a 98 year old female patient with oxycodone allergy and cardizem allergy. The patient's medical history included hypertension. On 17-DEC-2007, the patient was vaccinated with a dose of ZOSTAVAX (lot # 658396/0967U, expiry: 25-DEC-2008), 0.5 ml (reported as 0.5 cc) in the left arm. Concomitant therapies included COREG 1.25 mg twice a day (bid) and isradipine 5 mg once daily (qd). On 10-JUN-2013, the patient experienced herpes zoster-dermatome CN-5th. Other systemic symptoms included headache. Patient had no recent exposure to chickenpox or shingles. The outcome of herpes zoster was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Rash
Clinical narrative: This spontaneous report was received from a pharmacy student concerning a female patient of unknown age. On 31-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. Approximately on an unknown date in June 2013 (reported as within a few days after receiving ZOSTAVAX, the patient developed a mildly, painful rash on her flank about the size of a fist. The patient sought medical attention (called to pharmacy). No treatment was given. No lab tests were performed. The patient was not recovered from the event at the time of report. The relatedness for the event was unknown for ZOSTAVAX. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site pruritus, Vaccination site induration, Vaccination site inflammation, Vaccination site pain, Vaccination site swelling
Clinical narrative: Large raised inflamed area, firm spot in area of vaccine. Very hot and itchy. Uncomfortable when pressed on. Cool compresses and ibuprofen as directed.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Vaccination site warmth
Clinical narrative: Large raised inflamed area, firm spot in area of vaccine. Very hot and itchy. Uncomfortable when pressed on. Cool compresses and ibuprofen as directed.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Henoch-Schonlein purpura, Vasculitis
Clinical narrative: Vasculitis. Henoch Schonlein Purpura.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Skin reaction, Skin warm, Tenderness
Clinical narrative: The patient had a localized reaction 15 x 10 cm round reaction, red, hot, tender, well demarcated. This occurred today.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Induration, Rash generalised, Rash papular
Clinical narrative: Erythema and induration 3-4cm in diameter also papulovesicular rash all over body each 1-2mm, induration felt warm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Area around admin site is red and inflamed with pain. Redness and swelling began about 27 hours after vaccine administration, and has increased over past 24 hours.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local rxn w/ swelling and erythema entire upper arm where vaccine administered.
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Left upper arm pain to palpatation over deltoid and tricep. Symptom is aggravated by use. MRI - has been ordered.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy, Mass, Mobility decreased, Pain
Clinical narrative: 6/6/13 - Pain (8/10) on day of vaccination which interfered with sleep. 6/8 - "clavicle lymph node" swollen and tender (8/10); unable to raise arm. Treated with ibuprofen. No swelling or tenderness at injection site. 6/11 - took last ibuprofen. 6/12 - Treated with KEFLEX by another MD (curbside, no labs drawn). 6/14/13 - "100% better except for lump on (L) clavicle".
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Sleep disorder
Clinical narrative: 6/6/13 - Pain (8/10) on day of vaccination which interfered with sleep. 6/8 - "clavicle lymph node" swollen and tender (8/10); unable to raise arm. Treated with ibuprofen. No swelling or tenderness at injection site. 6/11 - took last ibuprofen. 6/12 - Treated with KEFLEX by another MD (curbside, no labs drawn). 6/14/13 - "100% better except for lump on (L) clavicle".
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Chest X-ray normal, Chest pain, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: 15-30 sec after receiving vaccines, pt became pale and unresponsive. Placed in trendelenburg. Lasted 5-10 sec during which time he had 2 tonic-clonic movements then was repsonsive. Remained supine for 15 min. Given juice and crackers and sat up. After 1-2 mins, became pale again. Complained of abd and chest pain, BP 106/60, HR 70/min. Ambulance called.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Pallor, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: 15-30 sec after receiving vaccines, pt became pale and unresponsive. Placed in trendelenburg. Lasted 5-10 sec during which time he had 2 tonic-clonic movements then was repsonsive. Remained supine for 15 min. Given juice and crackers and sat up. After 1-2 mins, became pale again. Complained of abd and chest pain, BP 106/60, HR 70/min. Ambulance called.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Mother reported after 24 hrs she developed a fever of 101 and her arm was very swollen. Fever lasted for 4 days. Treatment at home, mother then said after nurse asked her again if she ever remembered a rxn and she thought she had a rxn in 2010 to something, and it was probably the DTaP.
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site nodule
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient received a dose of ZOSTAVAX at a unspecified pharmacies and developed a "baseball size knot" at the injection site at an unspecified time. The patient was unable to move the arm. The outcome of events was unknown. Lot number 000444 is an invalid lot number for ZOSTAVAX. This is one of two reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Injection site pain, Nausea, Pallor
Clinical narrative: As recipient was receiving injection of GARDASIL, she felt pain and then just started to mumble and repeat her words. She turned pale and slumped forward. She did not lose consciousness. Got nauseous and pale about 5 minutes later and a little lightheaded. Put her head between her legs and she felt better after about 5-10 minutes. GARDASIL was 3rd injection.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to his brother of unknown age. In November 2007 the patient was vaccinated with a dose of ZOSTAVAX (lot number not provided). On 02-APR-2013 the patient came down with shingles. He had one of the worst cases the reporter had seen over the years working as a nurse. It was on his left mid back wrapping around the front of his rib cage about 12 inch wide. The areas were finally healing but he was still having to take a narcotic for pain every six hours with not a whole lot of relief. They had tried the xylocaine patches but they had not helped at all. They thought it supposed to be a one dose vaccine but obviously for the patient it was not effective after five years. At the time of the report the outcome of shingles was recovered and pain was not recovered. Additional information has been requested.
Sex: U
Vaccine: BCG
Symptoms: Multiple use of single-use product
Clinical narrative: This spontaneous report was received from a healthcare worker referring to 3 patients of unknown ages and genders. On an unknown date, the patients were placed on therapy with TICE (dose, frequency and indication not reported). Healthcare worker reporting that the pharmacy is possibly using one single vial of TICE to treat 3 patients at a time. Healthcare worker did not know what dose the patients were receiving. He stated he was not aware of any PQC issue. Healthcare worker was not certain if the pharmacy was actually using the vials of TICE in this manner or if he misunderstood the pharmacist. No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender, with no pertinent medical history reported. On 23-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (dose and route not specified). No other suspect therapies or concomitant medications were reported. The pharmacist reported that on an unknown date the patient developed a red rash on the opposite side of the body from where the injection site of ZOSTAVAX was. The red rash was reported to be on the patient's chest and opposite arm that did not receive ZOSTAVAX. It was not reported how the rash did look like. The pharmacist reported that the patient went to an unknown physician who prescribed "some type of hydrocortisone cream (not specified)". The patient also reported this event to the unknown pharmacy were the ZOSTAVAX was administered. The outcome of the red rash was unknown at the time of the report. The reporting pharmacist did not assess the causality between red rash and ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Swelling
Clinical narrative: This spontaneous report as received from a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (intramuscular) dose 3. Dose and lot number were not reported. On an unknown date, after the patient had received the third dose in series, the patient experienced nausea and swelling. The patient visited due to the events the emergency room (ER). The outcome of nausea and swelling was unknown. Reporter causality was not reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Pruritus
Clinical narrative: Patient received KINRIX and PROQUAD vaccinations at our clinic on 6/12/13. They were both given on the left arm. His mother brought him in 6/13/13 to show us a local reaction on the upper left arm. It was reddened and slightly swollen. He was itching, mom was instructed to give children's BENADRYL and cold compress and contact his physician if it did not improve.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Arm where injection was given was swollen.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Diarrhoea, Influenza like illness, Listless, Malaise, Muscle spasms
Clinical narrative: On the morning of Monday, 22 Apr 13, I felt flu like symptoms as far as body aches and listlessness, I just didn't feel well. No chills - no fever. On Tuesday 23 April 13, I was awakened by severe cramps and severe diarrhea. Had appt w/ doctor, he prescribed IMODIUM (2mg). It stops the urge to go but when it comes time I still have diarrhea. Today is 21 May 13 and I still have diarrhea. I've tried to plug it up w/ pizza, bread, bananas, cheese/cracker to no avail.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Pain, Sleep disorder
Clinical narrative: On the morning of Monday, 22 Apr 13, I felt flu like symptoms as far as body aches and listlessness, I just didn't feel well. No chills - no fever. On Tuesday 23 April 13, I was awakened by severe cramps and severe diarrhea. Had appt w/ doctor, he prescribed IMODIUM (2mg). It stops the urge to go but when it comes time I still have diarrhea. Today is 21 May 13 and I still have diarrhea. I've tried to plug it up w/ pizza, bread, bananas, cheese/cracker to no avail.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient presented with rash on 6/13/13 on back of left shoulder. Approx 5 inches by 4 inches. Patient said no pain associated w/rash. Mild itching. Told to use diphenhydramine cream by pharmacist.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Rash macular, Skin lesion
Clinical narrative: Increased irritability x 4 days post vaccines. Low grade fever on and off x 3 days. Erythematous macules lesions on trunk. On day 9 post vaccines.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Paraesthesia, Pruritus, Viral test
Clinical narrative: 5-20-13: pt received shingles vaccination on (L) deltoid. 6-12-13 pt return to clinic with 7 days Hx of (R) upper chest localized burning, tingling, itchy sensation, mild in nature, no rash.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Area of injection became red and swollen.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Localized rash on area around injection site. Pt took BENADRYL - rash subsided. 4" x 6" area tender to touch.
Age: 5.0
Sex: M
Vaccine: MNQ
Symptoms: Gait disturbance, Pain in extremity, Tenderness
Clinical narrative: Seen by me on June 6, 2013 at 4 PM for pain in both legs and limping of one day duration. Mild tenderness on the back of both knees, no swelling of ankles, knees or hips, movement normal in all joints, no weakness in both legs. Rest of neurological examination: Normal. Advice to give ADVIL one teaspoon every 6 hours, apply BENGAY locally and advice to come to office next day. I called mother next day at 5 PM. Child was doing okay, no pain in legs, walking well without limping. ADVIL was stopped and advice to come to office if pain comes again. Spoke to mother again on June 11. Every thing is okay, no more pain or limping since June 6.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling - cellulitis. Warm to touch site - all in (R) arm.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistance refers to a patient of unknown age and gender. The reporter noted that the patient had received their second dose of GARDASIL (strength, dose and lot number were not reported) on an unspecified date. On 11-JUN-2013 the patient was vaccinated with the third dose of GARDASIL (strength, dose and lot number were not reported) to complete the vaccine series. This third dose is being administered outside of the prescribing information. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to unspecified number of patients of unknown age. On unknown dates, the patients were vaccinated with ZOSTAVAX (dose, route and lot number not reported). It was reported that an unspecified number of patients developed shingles after receiving ZOSTAVAX. The outcome of the adverse events was unknown. Additional information is not expected.