chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: YF
Symptoms: Asthenia, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: States starting itching all over after receiving yellow fever around 8 pm on 8/12/14 - call clinic on 8/13/14 - Had numerous complaints of headache dizziness, shortness of breath - weakness - no rash - or nausea. First to call 911/or have someone take to E.R. Dept. Spoke with patient 8/18/14 was evaluate in ER on 8/13/14 told reaction to yellow fever - no tx or medication. Call 911 on 8/14/14 because of elevated heart rate. Short breath was told vital stable no addition tx was not taken to E.R. spoke with patient 8/18/14 - Continue to complain of short of breath first to f/u with PCP.
Age: 23.0
Sex: F
Vaccine: YF
Symptoms: Laboratory test, Pruritus generalised
Clinical narrative: States starting itching all over after receiving yellow fever around 8 pm on 8/12/14 - call clinic on 8/13/14 - Had numerous complaints of headache dizziness, shortness of breath - weakness - no rash - or nausea. First to call 911/or have someone take to E.R. Dept. Spoke with patient 8/18/14 was evaluate in ER on 8/13/14 told reaction to yellow fever - no tx or medication. Call 911 on 8/14/14 because of elevated heart rate. Short breath was told vital stable no addition tx was not taken to E.R. spoke with patient 8/18/14 - Continue to complain of short of breath first to f/u with PCP.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Back pain, Chills, Full blood count, Local swelling
Clinical narrative: Pt received Tdap and PPD approx 10:45 AM on 9-2-2014. Pt reports awaking in night with shaking, chills, c/o weakness, low back pain, feels swollen at neck with no sore throat. Felt nausea with no vomiting.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Middle insomnia, Nausea, Tremor, Urine analysis
Clinical narrative: Pt received Tdap and PPD approx 10:45 AM on 9-2-2014. Pt reports awaking in night with shaking, chills, c/o weakness, low back pain, feels swollen at neck with no sore throat. Felt nausea with no vomiting.
Age: 22.0
Sex: F
Vaccine: HEPAB, HPV4, MMR, TDAP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient came to clinic on 8-26-14 for her second round of immigration vaccines. At this visit she stated she was 6 months pregnant and that she had been pregnant (thought had not known it at the time) on 4-10-14 when she received TDAP, Varicella, MMR, Flu and TWINRIX. She denies complication with her pregnancy at this time.
Age: 19.0
Sex: M
Vaccine: JEV1, RAB, TYP
Symptoms: Activities of daily living impaired, Ataxia, Incomplete course of vaccination, Nausea, Vertigo
Clinical narrative: Case number PHEH2014US012074, is an initial spontaneous report received from a physician on 13 Jun 2014, and with a follow up report received from physician on 28 Jul 2014 and a follow up received from physician on 25 Aug 2014. This report refers to a 19-year-old male patient. Relevant medical history was none and concomitant medications were not reported. Vaccination history included three doses of VIVOTIF on 30 May 2014, 01 Jun 2014 and 03 Jun 2014 respectively. He was vaccinated with first dose of pre-exposure series of RABAVERT (batch number: number: 534011A, expiration date: 30 Sep 2016) intramuscularly into the left arm deltoid on 05 Jun 2014 at 02:52 PM along with VIVOTIF fourth dose orally and IXIARO. On 06 Jun 2014, about 24 hours after vaccination, he experienced vertigo which continued to worsen and ataxia. He visited the urgent care and was treated with meclizine. He could not get off his couch for three days and had nausea but did not vomit. On 11 Jun 2014, he was able to get out of his house and vertigo started to dissipate. He visited a physician and had few residual symptoms. His balance was fine and he could turn his head. The patient completely recovered on 13 Jun 2014. The seriousness and causality of the events were not reported. He was due for his second dose of pre-exposure series of RABAVERT which was not administered yet at the time of this report (incomplete course of vaccination). Follow up report received from physician on 28 Jul 2014. Updated patient details, concomitant vaccination and outcome of events. Follow up received from physician on 25 Aug 2014: Updated patient demographics, RABAVERT batch number expiration date, time of vaccination, new event (ataxia) and other clinically relevant information.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Pruritus, Vomiting
Clinical narrative: Dizzy shortly after vaccine, developed pruritis Left arm and Left Lateral thorax 24-48 hrs after along with abdominal discomfort, one episode of vomiting, one bout of diarrhea.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The morning after receiving vaccine pt awoke 6:30 am to red, sore, swollen area at injection site. Area swelled for 5 inches surrounding site, sore, hot, red, itching for 4 days.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Swollen and rash around area of injection. Gave BENADRYL at home.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Red area around injection site cellulitis.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper deltoid swelling, erythema, pain, heat.
Age: 89.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Local reaction
Clinical narrative: Large local reaction with itching at site.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting projectile
Clinical narrative: Patient vomited about 3 hours after ROTATEQ was given. It was a projectile vomit. Patient then vomited again within a minute. No more episodes of vomiting occurred. No diarrhea.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Face injury, Fall, Head injury, Intensive care, Motor dysfunction
Clinical narrative: I broke out in hives, loss of motor functions. Fell down 10 step stairway. Split head open, back of head and bridge of nose. Later had fever of 106 degrees, then flight to hosp. in ICU for 3-4 days then released on 20th Aug. 14.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: I broke out in hives, loss of motor functions. Fell down 10 step stairway. Split head open, back of head and bridge of nose. Later had fever of 106 degrees, then flight to hosp. in ICU for 3-4 days then released on 20th Aug. 14.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction. Hot to touch, itchy, painful, red, raised, rash about 6 inches in diameter. Developed approximately 2 days after injection. Went to Emeg. Room diag. of cellulitis. BACTRIM DS x 10 and PERCOCET.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Injection site reaction. Hot to touch, itchy, painful, red, raised, rash about 6 inches in diameter. Developed approximately 2 days after injection. Went to Emeg. Room diag. of cellulitis. BACTRIM DS x 10 and PERCOCET.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction. Hot to touch, itchy, painful, red, raised, rash about 6 inches in diameter. Developed approximately 2 days after injection. Went to Emeg. Room diag. of cellulitis. BACTRIM DS x 10 and PERCOCET.
Age: 64.0
Sex: M
Vaccine: YF
Symptoms: Abdominal discomfort, Pyrexia
Clinical narrative: 8-23-14 Yellow fever vaccine. 8-26-14 Wife called our office reporting 2 day fever (100 degree F) with upset stomach. I referred her to VIS and encouraged seeking medical care. 8-27-14 spoke with wife. Pt is back at work never sought medical care.
Age: 63.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Burning sensation, Erythema, Pruritus, Rash, Skin exfoliation
Clinical narrative: Redness, itching, burning and very sore to touch. Scaly/bump.
Age: 63.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Tenderness
Clinical narrative: Redness, itching, burning and very sore to touch. Scaly/bump.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site oedema, Oropharyngeal pain, Pyrexia
Clinical narrative: 3cm circular erythematous edema at injection site, accompanied by nodularity and edema. Pt also reports sore throat and fever. All occurring within onset 12 days after vaccine administration.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Hyperaesthesia, Pain
Clinical narrative: Patient complained of full body aches/chills and skin sensitivity which lasted a few days after receiving the vaccine.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Pt experienced syncope after vaccine administration. Pt was altered for approx 1-2 min. Given water and laid with legs elevated. Refused juice or crackers. Vital signs stable.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: (R) thigh red and hard 24 hours after admin. UC on Sunday due to double in size.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Computerised tomogram head, Dyskinesia, Electroencephalogram, Infantile spasms, Laboratory test
Clinical narrative: Mom reported "jerking"movement of upper extremities and "staring" episodes - 2 episodes lasting 2-4 mins. approx 2 hrs after immunizations. Seen at ER for neuro admission. ACTH started; EEG sched for 9/9/14. Neurology appt. Infantile spasms.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Occult blood, Staring
Clinical narrative: Mom reported "jerking"movement of upper extremities and "staring" episodes - 2 episodes lasting 2-4 mins. approx 2 hrs after immunizations. Seen at ER for neuro admission. ACTH started; EEG sched for 9/9/14. Neurology appt. Infantile spasms.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye swelling, Ocular hyperaemia, Swelling
Clinical narrative: Patient presented to clinic at 4:15pm, stating she was experiencing shortness of breath & difficulty swelling, eyes were red & swollen. Examined by Nurse practitioner,  Called EMS, but patient declined any treatment. Left clinic ambulatory.
Age: 37.0
Sex: M
Vaccine: MNQ
Symptoms: Axillary mass, Pyrexia
Clinical narrative: Patient said that he developed fever the next day and lump developed under the left arm pit. Advised patient to have provider further evaluate situation.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site rash, Injection site urticaria, Pyrexia
Clinical narrative: Fever, rash - hives on both legs, small cluster of hives around site of injection. Diphenhydramine 12.5/5 ml - 1/2 tsp every 6 hours PRN for 48 hours.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis - seen in office 9/4/14 by CNP. Given BACTRIM DS 800-160 mg 1 tab BID x 10 days. Being reseen for f/u on 9/8/14 with CNP.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling, Pruritus
Clinical narrative: Employee received Influenza vaccine at approx. 1200 PM on 8/27/14 in the Employee Health Service office. He developed a swollen upper lip and mild itching sensation approx. 3 1/2-4 hrs after receiving the vaccination. He was treated with an antihistamine and given an ice pack.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Choking sensation, Haematocrit normal, Haemoglobin normal, Injection site swelling, Platelet count normal
Clinical narrative: Swelling to (R) deltoid at site of vaccination. Also had sensation of choking and throat closing. Approximately 2 days later.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Throat tightness, White blood cell count normal
Clinical narrative: Swelling to (R) deltoid at site of vaccination. Also had sensation of choking and throat closing. Approximately 2 days later.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Injection site reaction, Tuberculin test
Clinical narrative: Right arm injection site.
Age: 57.0
Sex: M
Vaccine: TYP, YF
Symptoms: Erythema, Headache, Vomiting
Clinical narrative: The patient noted red patch (R) inguinal fold 6 days after injection on 8/28/14. He has had several episodes of emesis intermittent headache as well.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dyspnoea, Hyperhidrosis, Malaise, Panic attack
Clinical narrative: Patient received shot at pharmacy. He was very nervous of needles.  After shot he became sweaty and said he wasn't feeling well. We fanned him, gave him an ice pack and some candy. He denied having trouble breathing twice, he denied tongue swelling or feeling itchy twice. He did not appear to have any visible signs of an allergic reaction. The technician and I both were convinced this was a panic attack. He was very worried about needles (was pacing back and forth before shot).  He sat there after the injection for about 10-15 minutes with his brother and father.  After this time and denying trouble breathing or tongue swelling, he said he felt better and was "fine".  He left with his father and brother.  Approximately 15 minutes later, the father called and wanted me to call the emergency room.  He said he was on his way there and wanted me to tell them what shot had been given.  He said he was having trouble breathing.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Medial tibial stress syndrome, Muscular weakness, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: My daughter had her first dose of GARDASIL the Summer of 2009, 2nd dose 12/2009 and third dose Spring of 2010. From 10/2009 through Spring of 2011, she experienced severe pain in her shins and legs. Her legs felt weak and heavy when she exercised. She had x-rays, MRI's and a variety of other tests to determine the problem. She was diagnosed with a stress fracture in one shin, but was experiencing the same pain in both shins, and continued to have these problems over a two year period, with no official diagnosis. After reading some reports about the GARDASIL drug we are now wondering if it could be the culprit during this time frame. We felt it was important to report her symptoms for this reason.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Sensation of heaviness, X-ray
Clinical narrative: My daughter had her first dose of GARDASIL the Summer of 2009, 2nd dose 12/2009 and third dose Spring of 2010. From 10/2009 through Spring of 2011, she experienced severe pain in her shins and legs. Her legs felt weak and heavy when she exercised. She had x-rays, MRI's and a variety of other tests to determine the problem. She was diagnosed with a stress fracture in one shin, but was experiencing the same pain in both shins, and continued to have these problems over a two year period, with no official diagnosis. After reading some reports about the GARDASIL drug we are now wondering if it could be the culprit during this time frame. We felt it was important to report her symptoms for this reason.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Inappropriate schedule of drug administration, Pain, Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a physician refers to a 25 year old female patient. The patient's medical history included hives (MARRS# 1409USA003495) following an administration of an unspecified Hepatitis B vaccine (RECOMBIVAX cannot be rule out) approximately in 1999 when she was 10 years old. On 28-AUG-2014 the patient was vaccinated with GARDASIL (lot # J009788, expiry 17-MAR-2016) dose 3, intramuscular. Concomitant therapies included ADDERALL, CELEXA and unspecified birth control. Physician reports that the patient received her third dose of GARDASIL yesterday, on 28-AUG-2014, which was "about a year after the administration of her first dose (2013) and second dose (approximately in August 2013) of GARDASIL. Physician reports that "last night" on 28-AUG-2014, following the vaccine administration the patient began to experience a red, severely itchy and painful rash on the palms of her hands, soles of her feet and groin area up to her abdomen, which appears to be vasculitis (disability). Physician states that no blisters are present, and they are not urticarial, they appear more vascular. Patient was treated with BENADRYL 50mg was administered on 29-AUG-2014 morning. No lab diagnostics studies were performed. The patient was having trouble walking because of the symptoms. The outcome of vasculitis was reported as not recovered/not resolved. The relatedness of the suspect therapy with the event was not provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic, Vasculitis
Clinical narrative: This spontaneous report was received from a physician refers to a 25 year old female patient. The patient's medical history included hives (MARRS# 1409USA003495) following an administration of an unspecified Hepatitis B vaccine (RECOMBIVAX cannot be rule out) approximately in 1999 when she was 10 years old. On 28-AUG-2014 the patient was vaccinated with GARDASIL (lot # J009788, expiry 17-MAR-2016) dose 3, intramuscular. Concomitant therapies included ADDERALL, CELEXA and unspecified birth control. Physician reports that the patient received her third dose of GARDASIL yesterday, on 28-AUG-2014, which was "about a year after the administration of her first dose (2013) and second dose (approximately in August 2013) of GARDASIL. Physician reports that "last night" on 28-AUG-2014, following the vaccine administration the patient began to experience a red, severely itchy and painful rash on the palms of her hands, soles of her feet and groin area up to her abdomen, which appears to be vasculitis (disability). Physician states that no blisters are present, and they are not urticarial, they appear more vascular. Patient was treated with BENADRYL 50mg was administered on 29-AUG-2014 morning. No lab diagnostics studies were performed. The patient was having trouble walking because of the symptoms. The outcome of vasculitis was reported as not recovered/not resolved. The relatedness of the suspect therapy with the event was not provided. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Swelling face
Clinical narrative: Facial swelling with rash on arms and legs 36-48 hrs following injection 9/8/14 - SOLUMEDROL 40 mg IM. Prednisone taper, hydroxyzine.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site rash
Clinical narrative: Pt had large 6 inch circular rash on right thigh.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Neck pain
Clinical narrative: Patient said she was experiencing pain radiating up her neck and in her chest and back. Had no trouble breathing.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site inflammation, Urticaria
Clinical narrative: The patient had some inflammation after the vaccine. She returned here 3 days later. The area of administration was black/blue and she had hives on her arms.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Anger, Arthralgia, Fatigue, Insomnia, Myalgia
Clinical narrative: Extreme fatigue, muscle aches, joint pain, trouble sleeping as I have gotten older the symptoms have gotten worse. Also, anger issues also.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Sleep study
Clinical narrative: Extreme fatigue, muscle aches, joint pain, trouble sleeping as I have gotten older the symptoms have gotten worse. Also, anger issues also.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Irritability, Tachycardia, Urticaria
Clinical narrative: Patient developed tiny little hives around mouth and 2 others over back and upper arms. No respiratory symptoms. She was a bit fussy and tachycardic HR 160. pOX 99 ROOM AIR. No oral edema. Patient calmed down spontaneously and observed for 15 minutes. HR down to 130. Hives-->  by 95% faded. Immunization given with latex free gloves.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Dizziness, Electrocardiogram, Hypoaesthesia oral, Pharyngeal oedema
Clinical narrative: The patient was about to ride in the car to go home from the clinic, when she complained to the daughter/companion that she feels dizzy. She was brought back to the clinic. Initial VS were: BP 157/60 and HR 39. She was transferred to the UC via a wheelchair. At 10:50, at the UC, patient was placed at OBS room. Initial VS were: BP:160/69, HR: 46, O2 sat at 95% at Room Air. UC doctor was notified. Patient complained that her upper lip was sleeping and that her throat felt swollen. IV access was started with difficulty. Patient was given Solumedrol 125 mg/IV at 1110 AM, Benadryl 50 mg/IV at 1115 AM. At 1115, pulse was noted at 38. Patient was transferred to the ER via 911.  At the ER, EKG was done and patient was given Pepcid 20 mg/IV and Solumedrol 125 mg/IV.  Patient was discharged stable at 14:52.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: The next morning after the flu shot, I had SEVERE diarrea and 102 deg. fever. Stayed in bed most of the day. Never had such a reaction before.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm red, swollen, warm to touch, stated had 'flu-like symptoms', headache on 9/6 + 9/7; MD appt. on 9/8.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: The day after getting his vaccine, patient complained of sweating and also having a fever. He felt these symptoms since the morning the day after the vaccine. Patient went to hospital ER where he left shortly after.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Tinnitus, Visual acuity reduced
Clinical narrative: Dizziness, sweating, ringing in ears, light headed, vision fading.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, General physical health deterioration, Lumbar puncture, Mental disorder, Neurological symptom
Clinical narrative: Basic paralysis within five days. Worsening neurological symptoms since. Now permanently disabled due to host of mental and physical problems. Still seeking answers and treatment.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Paralysis, Sleep study
Clinical narrative: Basic paralysis within five days. Worsening neurological symptoms since. Now permanently disabled due to host of mental and physical problems. Still seeking answers and treatment.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysgeusia
Clinical narrative: Patient experienced a metallic taste in mouth and feelings of dizziness. Instructed patient to sit down in store.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, headache, sore throat.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Lethargy, Rash, Varicella
Clinical narrative: Rash, irritability, lethargy.  Diagnosed with chicken pox.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Cough, Fatigue, Insomnia
Clinical narrative: Myalgias at onset, then chill that night, next day low grade fever to 100.5, then continuous malaise, severe fatigue, mild nausea and profound weakness. On day three a mild non-productive cough gradually improving after day 5 but persisting to day 7. Difficulty sleeping, Mild pharyngitis.  A rather severe viral like illness! No adenopathy,
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Myalgia, Nausea, Pharyngitis, Pyrexia
Clinical narrative: Myalgias at onset, then chill that night, next day low grade fever to 100.5, then continuous malaise, severe fatigue, mild nausea and profound weakness. On day three a mild non-productive cough gradually improving after day 5 but persisting to day 7. Difficulty sleeping, Mild pharyngitis.  A rather severe viral like illness! No adenopathy,
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Viral infection
Clinical narrative: Myalgias at onset, then chill that night, next day low grade fever to 100.5, then continuous malaise, severe fatigue, mild nausea and profound weakness. On day three a mild non-productive cough gradually improving after day 5 but persisting to day 7. Difficulty sleeping, Mild pharyngitis.  A rather severe viral like illness! No adenopathy,
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Soreness getting worse day by day and month by month leading to pain in the entire arm to the point of being unable to move it without pain. Even simple movements caused pain.  Finally in July I went to an orthopedic MD and he diagnosed it as bursitis and/or possible frozen shoulder.  With a cortisone shot and PT, I have made much improvement....however, I still have some pain and limited mobility.  I am scared to get another flu shot and may not this year due to this experience.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Chills, Headache
Clinical narrative: Chills, weakness, joint pain, headache, fever, stomach upset, nausea.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Chills, weakness, joint pain, headache, fever, stomach upset, nausea.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Pyrexia, Tremor, Vomiting
Clinical narrative: Patient's wife called the pharmacy around 2pm and complained that her husband has been "feeling sick" for the past 2 hours.  He has been vomiting, "has the shakes", and is running a high fever of 104 degrees F.  I told her to take him to the ER immediately.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Fatigue, Myalgia
Clinical narrative: Myalgias, joint pain, abdominal soreness, fatigue.  Symptomatic treatment: rest, ibuprofen.
Age: 0.23
Sex: F
Vaccine: PNC13, RV5
Symptoms: Irritability
Clinical narrative: Two days of fussiness following vaccinations.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Headache, Hyperhidrosis, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Within 5 minutes of receipt of vaccine patient reported nausea, dizziness, sharp pain in head and then syncope. Muscle stiffness observed during syncopal episode. He was also pale and diaphoretic.  He was unconscious approximately 10 to 15 seconds. Patient was placed in Trendelenburg position. Zofran was given sublingually for the nausea around 10AM. He had a general feeling of nausea until late in the evening. Patient did not report feeling "normal" until around 10:30 PM.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Nausea, Pallor, Syncope
Clinical narrative: Within 5 minutes of receipt of vaccine patient reported nausea, dizziness, sharp pain in head and then syncope. Muscle stiffness observed during syncopal episode. He was also pale and diaphoretic.  He was unconscious approximately 10 to 15 seconds. Patient was placed in Trendelenburg position. Zofran was given sublingually for the nausea around 10AM. He had a general feeling of nausea until late in the evening. Patient did not report feeling "normal" until around 10:30 PM.
Age: 0.9
Sex: F
Vaccine: PNC13
Symptoms: Irritability, Pyrexia
Clinical narrative: Three days of fever and fussiness.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient experienced swelling/pain in arm where injection occurred. Presented at hospital and received antibiotics.
Age: 39.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Intensive care
Clinical narrative: Patient experienced cellulitis like reaction that required hospitalization (ICU) and numerous antibiotics. Patient received vaccine on 9/2/14. Patient discharged from hospital on 9/8/14.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Large deep red welt in shot area about size of 50 cent piece then a secondary lighter red area also swollen and raised about 7 inches long lasted for 3 to 4 days.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Chills, Headache
Clinical narrative: Approximately four hours after receiving the HPV vaccine, pt began felling chills run up her leg and then travelled to the whole right side of her body. She then felt weak, got a headache and got chills over her whole body. Duration 1.5 hours.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Pt developed urticaria the day after HPV vaccine was given to pt's left arm.
Age: 7.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Pruritus, Swelling
Clinical narrative: Swollen, itchy a few hours after administration. Hydrocortisone and cetirizine.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Pt reported swelling in arm extending down both towards the fingers and towards lymph nodes in chest. On ER visit BP was 82/47. Initial reported 8-5-14 was red until 9-8-14 to follow up on pt wellness.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Blindness unilateral, Depression, Headache, Multiple sclerosis
Clinical narrative: Headache. Loss of (L) eye sight. MS. Depression.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Blindness unilateral, Blood test, Computerised tomogram, Headache, Lumbar puncture
Clinical narrative: Headache. Loss of (L) eye sight. MS. Depression.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Multiple sclerosis, Nuclear magnetic resonance imaging, Vision blurred
Clinical narrative: Headache. Loss of (L) eye sight. MS. Depression.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Erythema, Joint range of motion decreased, Pain
Clinical narrative: 9/4/14 - Chills at night. 9/5/14 at 11:00 - pain, redness, and swelling, decreased ROM - tried ice, BENADRYL and ALLEVE - no relief. 9/6/14 at 11:00 - started BACTRIM DS  by doctor. Dx: Cellulitis. 9/8/14 - painlegs started feeling better, less swelling.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Swelling
Clinical narrative: 9/4/14 - Chills at night. 9/5/14 at 11:00 - pain, redness, and swelling, decreased ROM - tried ice, BENADRYL and ALLEVE - no relief. 9/6/14 at 11:00 - started BACTRIM DS  by doctor. Dx: Cellulitis. 9/8/14 - painlegs started feeling better, less swelling.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling of the deltoid area uniformly formed, no isolated mass. (Immunization given on 8/4/14, mom reported to us on 8/6/2014.)
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (lot #, expiration date and dose unspecified), oral. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: On 8/4/14 child woke up with hives all over his body. A few days ago had mild fever, no other symptoms other than rash, not ichy. No coughing, no rhin. no diarrhea. Good appetite. No new foods eaten, no meds currently.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Left arm, site reaction. Large erythematous, warm sharply demarcated area extending from upper arm to elbow. Patient was treated for cellulitis with antibiotics cephalexin 500 mg oral capsules, 1 capsule by mouth 4 times daily for 7 days. Follow up appointment scheduled for 9-8-14. Treatment to include cool compress, elevation and ibuprofen.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site rash
Clinical narrative: Mother states, she had a rash on (R) upper arm after vaccines were administered.
Age: 67.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash, warm, swelling around injection site left upper arm. Suggested to apply hydrocortisone 1% cream.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Ultrasound abdomen normal, Urinary system x-ray normal, Vomiting
Clinical narrative: Extreme, bilious emesis approx 4-5 hours after receiving ROTARIX. Evaluated in ER. No intussusception.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had a severe injection site reaction. The area was red and swollen.
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 and gender. The patient ws vaccinated with the first dose of GARDASIL intramuscularly (dose, lot number were not reported) in January 2013 (exact date unspecified). Subsequently the patient was vaccinated with the second dose of GARDASIL intramuscularly (dose, lot number were not reported) in March 2013 (exact date unspecified). It was reported that the patient would be vaccinated with the third dose of GARDASIL intramuscularly (dose, lot number were not reported) on 20-AUG-2014- at the time of the call. No adverse effect were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patient of unknown gender and age. It was reported that since 24-JUL-2014, impropery stored doses of (Oka/Merck) VARIVAX (dose, dose number, route, lot/batch number, expiration date were not reported) were administered to unknown number of patients in approximately 2014. No adverse effects were noted. No product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 27-AUG-2014 the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (route and dose not reported, lot # K002925, expiration date 26-FEB-2016). It was reported that the excursion for the (Oka/Merck) VARIVAX in question was found to be supported with in-house stability data. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 3 patients of unknown age and gender. On 28-AUG-2014 the patients were vaccinated with a dose of improperly stored VARIVAX (Merck) (route and dose not reported, lot # K002925, expiration date 26-FEB-2016). It was reported that the excursion for the VARIVAX (Merck) in question was found to be supported with in-house stability data. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Anal fissure, Arthralgia, Back pain, Diarrhoea, Headache
Clinical narrative: A mild fever, headache, nausea and diarrhea -> Few hours after shot. Severe joint pain -> (1) an inflammation of the right knee (2) pain of the lower back and the left hip (3) muscle weakness in the both legs (4) anal fissure as a result of diarrhea.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Inflammation, Laboratory test normal, Muscular weakness, Nausea, Pyrexia
Clinical narrative: A mild fever, headache, nausea and diarrhea -> Few hours after shot. Severe joint pain -> (1) an inflammation of the right knee (2) pain of the lower back and the left hip (3) muscle weakness in the both legs (4) anal fissure as a result of diarrhea.
Age: 0.9
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 9 month old patient. On an unknown date the patient was vaccinated with (Oka/Merck) PROQUAD. The pharmacist reported that the 9 month old patient was administered a dose of (Oka/Merck) PROQUAD which was before the 12 month old age recommendation. No adverse effects reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Pallor, Vomiting
Clinical narrative: This spontaneous report as received from a physician via field employee refers to a 11 year old male patient. No medical history or current condition was reported. ON 28-AUG-2014 the patient was vaccinated with GARDASIL lot # K009202, expiry 17-DEC-2016, dose 1. No concomitant medication was reported. On 28-AUG-2014, the patient experienced vomiting and light headedness and paleness after receiving the first dose of GARDASIL. The patient sought medical attention by office visit on 28-AUG-2014. There was no product quality complaint. The action taken,  causality and outcome is unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to  unspecified patients. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL (lot #, expiration date, dose and route unspecified). No adverse effects reported.  This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified patients. On an unknown date the patients were vaccinated with improperly stored doses of M-M-R II (lot #, expiration date, dose and route unspecified). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified patients. On an unknown date the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot #, expiration date, dose and route unspecified). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current conditions was reported. No pertinent medical history was reported. On 02-SEP-2014, the patient was vaccinated with (Oka/Merck) VARIVAX, .5 ml, subcutaneous. No concomitant medication was reported. On 02-SEP-2014, the patient received improperly stored VARIVAX, exposed to 23F for 3 hours. No adverse effects were reported. The outcome of patient received improperly stored VARIVAX was unknown. No further information was provided. No PQC was involved. This is one of the several reports. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current condition was reported. No pertinent medical history was reported. On 02-SEP-2014, the patient was vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous. No concomitant medication was reported. The outcome of patient received improperly stored VARIVAX was unknown. No further information was provided. No PQC was involved. This is one of the several reports. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current condition was reported. No pertinent medical history was reported. On 02-SEP-2014, the patient received improperly stored VARIVAX, exposed to 23F for 3 hours. No adverse effects were reported. The outcome of patient received improperly stored VARIVAX was unknown. No further information was provided. No PQC was involved. This is one of the several reports. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current condition was reported. No pertinent medical history was reported. On 03-SEP-2014, the patient was vaccinated with VARIVAX (Merck), .5 ml, subcutaneous. No concomitant medication was reported. On 03-SEP-2014, the patient received improperly stored VARIVAX, exposed to 23F for 3 hours. No adverse effects were reported. The outcome of patient received improperly stored VARIVAX was unknown. No further information was provided. No PQC was involved. This is one of the several reports. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current condition was reported. No pertinent medical history was reported. On 02-SEP-2014, the patient was vaccinated with (Oka/Merck) VARIVAX, .5 ml, subcutaneous. No concomitant medication was reported. On 02-SEP-2014, the patient received improperly stored VARIVAX, exposed to 23F for 3 hours. No adverse effects were reported. The outcome of patient received improperly stored VARIVAX was unknown. No further information was provided. No PQC was involved. This is one of the several reports. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient. On 28-JUL-2014 the patient was vaccinated with M-M-R II (lot # K000174, expiration date 11-JUN-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current condition was reported. No pertinent medical history was reported. On 03-SEP-2014, the patient was vaccinated with VARIVAX, .5 ml, subcutaneous. No concomitant medication was reported. On 03-SEP-2014, the patient received improperly stored VARIVAX, exposed to 23F for 3 hours. No adverse effects were reported. The outcome of patient received improperly stored VARIVAX was unknown. No further information was provided. No PQC was involved. This is one of several reports. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old male patient. On an unknown date the patient was vaccinated with (Oka/Merck) PROQUAD, 0.5 ml subcutaneous (dose number, anatomical location and expiration date were not reported) when the patient was supposed to receive (Oka/Merck) VARIVAX and M-M-R II separately. No adverse effects reported. Concomitant therapies were unspecified. Additional information is not expected because reporter refused additional information.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a patient of unknown age. On 20-AUG-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J009827, expiration date 10-AUG-2014, route not provided). No adverse effects reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Injury associated with device
Clinical narrative: This spontaneous prospective pregnancy report as received from 27 year old female medical assistant refers to herself. The medical assistant confirmed that she had chicken pox during her childhood and she discontinued use of HUMIRA pen for psoriasis "three weeks ago" (on 13-AUG-2014). On 03-SEP-2014 the medical assistant was inadvertently stuck in left fifth finger with VARIVAX (Merck) (lot#, dose, route not reported) needle prior to administration to patient. Concomitant medications included iron (unspecified), minerals (unspecified), vitamins (unspecified) (prenatal vitamins). Medical assistant was seven weeks pregnant at that time. She cleansed area and applied band aid. The physician at practice was made aware. The Last Menstrual Period (LMP) was estimated on 16-JUL-2014. The Estimated date of delivery (EDD) was estimated on 22-APR-2015. No treatment was given. The outcome of the pregnancy was unknown. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Dysphagia
Clinical narrative: This spontaneous report as received from a physician voice mail received via the SRP Voicemail on 22-AUG-2014 refers to a patient of unknown age and gender. In 2013 the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # not reported). On an unknown date, ever since receiving PNEUMOVAX 23 in 2013, the patient has been experiencing dysphagia. The outcome of dysphagia was not recovered. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PPV
Symptoms: Anaphylactic reaction, Dyspnoea, Erythema, Fear, Immediate post-injection reaction
Clinical narrative: 3 vaccines given (see below). Immediately after, pt experienced throat tightness, shortness of breath, reddening of face, fear. EPIPEN given (per order of MD) for anaphylactic reaction.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PPV
Symptoms: Throat tightness
Clinical narrative: 3 vaccines given (see below). Immediately after, pt experienced throat tightness, shortness of breath, reddening of face, fear. EPIPEN given (per order of MD) for anaphylactic reaction.
Sex: U
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, hot to touch, sore at the site of injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 years old female patient without drug reactions and allergies. On 31-AUG-2014 the patient was vaccinated with ZOSTAVAX lot # K003598, expiration date: 13-MAR-2015 (dose and route of administration were not reported). Concomitant therapies included SYNTHROID, Losartan potassium (manufacturer unknown), PREMARIN, PERCOCET, TOPAMAX, XANAX, trazodone hydrochloride, pravastatin sodium, NEXIUM, Vitamin D3, DILANTIN, hydrochlorothiazide (manufacturer unknown), PROAIR, FLUVIRIN and unspecified numbing mouthwash. In 2014 the patient experienced localized redness, itching and swelling after receiving ZOSTAVAX. The patient sought medical attention. She did not receive any treatment for the adverse events. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.