chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: DTAP, FLU3, HPV4
Symptoms: Cold sweat, Diarrhoea, Dizziness, Fall, Headache
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 12-Nov-2012) concerns an 11-year-old male patient, who had no pertinent medical history or drug allergies. He was not taking any concomitant medication at the time of the event. On 09-Nov-2012 the patient received AFLURIA (batch number was not provided). On the same day he also received Tdp vaccine and his first dose of GARDASIL injection. The patient also had blood drawn for unspecified blood work when vaccines were administered. On 09-Nov-2012, after receiving vaccination, the patient felt dizzy and nauseated. He had an episode of 'explosive diarrhoea' and fainted on toilet. No injuries incurred. At that time, the patient had no wheezing, no injuries and no hypotension, but the patient was 'clammy and pale'. After leaving the office, the patient had another syncopal episode and diarrhoea in the parking lot. No injuries reported from the fall. The mother called the physician this weekend to report that the patient continued to have vomiting, diarrhoea and severe headache and that she was taking him to the ER (Emergency Room).
Age: 11.0
Sex: M
Vaccine: DTAP, FLU3, HPV4
Symptoms: Nausea, Pallor, Syncope, Vomiting
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 12-Nov-2012) concerns an 11-year-old male patient, who had no pertinent medical history or drug allergies. He was not taking any concomitant medication at the time of the event. On 09-Nov-2012 the patient received AFLURIA (batch number was not provided). On the same day he also received Tdp vaccine and his first dose of GARDASIL injection. The patient also had blood drawn for unspecified blood work when vaccines were administered. On 09-Nov-2012, after receiving vaccination, the patient felt dizzy and nauseated. He had an episode of 'explosive diarrhoea' and fainted on toilet. No injuries incurred. At that time, the patient had no wheezing, no injuries and no hypotension, but the patient was 'clammy and pale'. After leaving the office, the patient had another syncopal episode and diarrhoea in the parking lot. No injuries reported from the fall. The mother called the physician this weekend to report that the patient continued to have vomiting, diarrhoea and severe headache and that she was taking him to the ER (Emergency Room).
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Chest X-ray, Influenza A virus test positive, Respiratory tract congestion
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 13-Nov-2012) concerns a 92-year-old female patient, who had a medical history of hypertension, high cholesterol, PMR (polymyalgia rheumatica), multi-nodular goitre and TIA (transient ischaemic attack). She was allergic to PETHIDINE, tramadol and hydrocodone. Concomitant medications included nifedipine, hydrochlorothiazide, potassium chloride, meclizine, nystatin; triamcinolone combination, oxycodone; paracetamol combination, clopidogrel, pravastatin, hydrocortisone, metoprolol, diazepam, ranitidine and simvastatin. On 24-Oct-2012 the patient received AFLURIA (batch number: 07449221A) injection at a dose of 0.5 mL once intramuscularly. The patient became weak and congested 17 days after vaccination, and went to the ER (emergency room) on 09-Nov-2012. The patient was not admitted to hospital. She was tested positive for type A influenza. She also had a chest x-ray and blood tests. The patient was following up with her doctor and was currently at home. The doctor advised the patient and her daughter to have the patient come to the hospital if she becomes dehydrated or her respiratory symptoms worsen. Treatments included oseltamivir phosphate, guaifenesin and levosalbutamol. The event outcome was recovering.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Brachial plexus injury, Hypoaesthesia, Muscular weakness, Musculoskeletal pain, Nerve conduction studies abnormal
Clinical narrative: This literature report (initial receipt: 13-Nov-2012) concerns a 47-year-old male patient, who had no significant past medical history. On an unknown date the patient received a flu shot (manufacturer, brand name and batch number were not provided). On an unknown date, the patient experienced symptoms 12 days after receiving the flu shot. The patient presented to clinic 2 days after awakening with pain (left shoulder, posterior aspect of upper left arm, medial aspect of left forearm), numbness (over left 5th finger and posterior lateral aspect of left arm), and muscle weakness (left arm and left hand). He also described shooting pain down his left arm with any movement of the left shoulder most prominently with arm abduction. He reported similar symptoms of shooting pain with palpation of the anterior aspect of his left shoulder. The patient was without any known trauma or preexisting pathological conditions to his neck, shoulder, or arms. The only significant recent event was receiving a flu shot 12 days prior to the start of his symptoms. Physical examination revealed no cervical spinal tenderness. Motor testing revealed weakness in his left biceps, left deltoid, and with external shoulder rotation on the left. Adson's sign was positive on the left. Neural tension stretch testing was positive on the left when specifically stretching the median nerve. The patient was prescribed a prednisone taper and pain medication (ULTRACET). Subsequent MRI (magnetic resonance imaging) scan was significant for findings consistent with a brachial plexus injury (likely Parsonage-Turner Syndrome) considering the patient's symptoms, history, and physical examination findings.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Neuralgic amyotrophy, Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity, Radial pulse decreased
Clinical narrative: This literature report (initial receipt: 13-Nov-2012) concerns a 47-year-old male patient, who had no significant past medical history. On an unknown date the patient received a flu shot (manufacturer, brand name and batch number were not provided). On an unknown date, the patient experienced symptoms 12 days after receiving the flu shot. The patient presented to clinic 2 days after awakening with pain (left shoulder, posterior aspect of upper left arm, medial aspect of left forearm), numbness (over left 5th finger and posterior lateral aspect of left arm), and muscle weakness (left arm and left hand). He also described shooting pain down his left arm with any movement of the left shoulder most prominently with arm abduction. He reported similar symptoms of shooting pain with palpation of the anterior aspect of his left shoulder. The patient was without any known trauma or preexisting pathological conditions to his neck, shoulder, or arms. The only significant recent event was receiving a flu shot 12 days prior to the start of his symptoms. Physical examination revealed no cervical spinal tenderness. Motor testing revealed weakness in his left biceps, left deltoid, and with external shoulder rotation on the left. Adson's sign was positive on the left. Neural tension stretch testing was positive on the left when specifically stretching the median nerve. The patient was prescribed a prednisone taper and pain medication (ULTRACET). Subsequent MRI (magnetic resonance imaging) scan was significant for findings consistent with a brachial plexus injury (likely Parsonage-Turner Syndrome) considering the patient's symptoms, history, and physical examination findings.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Multiple sclerosis
Clinical narrative: Information has been received from a physician concerning a 15 year old male patient, who on an unknown date was placed on therapy with GARDASIL (dose, route and lot # not reported). It was reported that, on an unknown date, the patient developed symptoms of multiple sclerosis after receiving GARDASIL. At the time of the report, the patient's outcome was unknown. Relatedness for multiple sclerosis symptoms was unknown for GARDASIL. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pustule, Injection site swelling, Pain in extremity
Clinical narrative: Case number PHEH2012US023202 is an initial spontaneous report received from a nurse on 20 Nov 2012. This case refers to a 29-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 123324) on 10 Oct 2012. On the same day of vaccination she experienced pain in the arm and swollen area at the injection site that was full of pus. Saw her physician on 17 Oct 2012 due to these events. On 25 Oct 2012 she returned back to see her physician and all the symptoms had dissipated. The seriousness and causality was not reported.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: On Day 1, severe crippling pain in both hands and fingers, then Day 2 moved to 1 knee, Day 3 moved to both knees, however, hands were better.  Day 4 thru Day 7 severe pain has alternated between both hands and knees, sometimes right side sometimes left side, sometimes all 4 joints at the same time.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Pain, Pruritus, Scar
Clinical narrative: Swelling redness and itching happened immediately and lasted about 4 days.  Large bump under the skin which lasted for a couple of weeks, itching.  Now small bump/swelling under the skin with brown scar on outside.  Sometimes itches.  Sometimes hurts to touch.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Swelling redness and itching happened immediately and lasted about 4 days.  Large bump under the skin which lasted for a couple of weeks, itching.  Now small bump/swelling under the skin with brown scar on outside.  Sometimes itches.  Sometimes hurts to touch.
Age: 65.0
Sex: M
Vaccine: PER, PPV, TD
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and fever.
Age: 52.0
Sex: F
Vaccine: FLU3, HEPAB, IPV, JEV1, MMR, TDAP, TYP
Symptoms: Induration, Inflammation, Vulvovaginal pain
Clinical narrative: Vulva inflammation with severe, incredible pain.  Pt stated that her vulva became rock hard a couple days after the vaccination.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash developed in the middle of pts back. By days end the rash had spread across the back with some spots on shoulders and arms. No other symptoms.
Age: 27.0
Sex: F
Vaccine: FLU3, HEP, PPV
Symptoms: Cellulitis, Erythema, Mobility decreased, Pain, Skin warm
Clinical narrative: Red, hot to touch, swollen, range of motion limited by pain.
Age: 27.0
Sex: F
Vaccine: FLU3, HEP, PPV
Symptoms: Swelling
Clinical narrative: Red, hot to touch, swollen, range of motion limited by pain.
Age: 0.35
Sex: M
Vaccine: 6VAX-F, PNC13, RV1
Symptoms: Aphagia, Crying, Nasal congestion, Shock, Unresponsive to stimuli
Clinical narrative: Stuffed nose, baby was crying for 2 hours in a row, high pitched screaming, like absent and not responding to me. He was like in shock. Unable to eat due to stuffy nose. I have him Tylenol and finally he felt sleep for 8 hours (he usually sleeps only 5 hours in a row). This morning he woke up and acted normal, smiling, etc. He ate a bottle.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal sensation in eye, Asthenia, Conjunctivitis, Cough, Eye discharge
Clinical narrative: 1 hour aft started feeling weak--needle entry was sore--2 hrs aft felt feverish, throat tightened up, coughed a little and began wheezing a little--3 hrs aft eyes became red and warm and developed low grade fever (1.5 degree about normal temp)-4 hrs after had all symptoms of conjunctivitis and yellow phlegm came out of both eyes, right eye was a little worse--took Advil PM and slept--eyes were a little crusty next morning and still felt tired and weak--slept most of day and felt OK within 24 hours and eyes were almost clear...just a little bloodshot--1 week later (today) is the first time I haven't felt tired--
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid margin crusting, Fatigue, Injection site pain, Ocular hyperaemia, Pyrexia
Clinical narrative: 1 hour aft started feeling weak--needle entry was sore--2 hrs aft felt feverish, throat tightened up, coughed a little and began wheezing a little--3 hrs aft eyes became red and warm and developed low grade fever (1.5 degree about normal temp)-4 hrs after had all symptoms of conjunctivitis and yellow phlegm came out of both eyes, right eye was a little worse--took Advil PM and slept--eyes were a little crusty next morning and still felt tired and weak--slept most of day and felt OK within 24 hours and eyes were almost clear...just a little bloodshot--1 week later (today) is the first time I haven't felt tired--
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Wheezing
Clinical narrative: 1 hour aft started feeling weak--needle entry was sore--2 hrs aft felt feverish, throat tightened up, coughed a little and began wheezing a little--3 hrs aft eyes became red and warm and developed low grade fever (1.5 degree about normal temp)-4 hrs after had all symptoms of conjunctivitis and yellow phlegm came out of both eyes, right eye was a little worse--took Advil PM and slept--eyes were a little crusty next morning and still felt tired and weak--slept most of day and felt OK within 24 hours and eyes were almost clear...just a little bloodshot--1 week later (today) is the first time I haven't felt tired--
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint movement impairment, Mobility decreased, Musculoskeletal pain, Pain in extremity, Periarthritis
Clinical narrative: Pt states day after shot arm felt like someone punched it. By the 2nd day she couldn't move it. Decreased ROM of left shoulder with abduction to about 20 degees. Frozen shoulder, shoulder pain. Pain has stopped, but still can't move shoulder. She's the third person who's complained of a shore shoulder with a frozen shoulder due to the vaccine. The other two were vaccinated elsewhere.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Musculoskeletal stiffness, Pain
Clinical narrative: Left arm stiffness and pain with movement, a week after receiving Fluvax vaccine.  Afebrile, denies weakness, numbness, or coldness.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Swelling, long red rash, pain below injection site on right arm.
Age: 0.18
Sex: M
Vaccine: DTAP, IPV, PER, RVX
Symptoms: Bacterial test negative, Diarrhoea, Full blood count, Urine analysis
Clinical narrative: Diarrhea every 2-4 hours. Taken to doctor 3 times. Labs were negative for bacteria. Reason for diarrhea could not be explained.
Age: 1.11
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient had his 12 month check up 10/24/2012 and was given the Hepatitis A vaccination along with other vaccinations....Yesterday, the nurse gave him another dose of Hepatitis A and was suppose to give him the Flu Shot instead....The nurse called me at 5 pm last night and left a message on my cell phone to call her back the next day...Today, I called her and she said that she was very sorry to give him another dose and that he will be fine..Nothing will be wrong with him...She should of looked at his chart...They should be checking to make sure that this does not happen....She could of given him something else...I am looking out for the welfare of my child and other children who go to that clinic...This should of never of happened and it was only 4 weeks of the second dose....My husband and I are going to get his FLU shot at 3 PM today  11/27/2012 and hopefully talking to the DR...in what he has to say about this....
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Type 2 diabetes mellitus, VIIth nerve paralysis
Clinical narrative: On 10/8/12, patient's tongue started feeling strange like she had been to the dentist. A few days later she woke up with the left side of her face droopy.  This lasted for 2 1/2 weeks.  She saw a physician at the local emergency room and was referred to a neurologist.  She followed up with her PCP. She was diagnosed with Bell's Palsy.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Patient noted that he had itching at injection site. After looking at arm patient noted that area was red, warm to touch and hard. Patient stated itching seemed to be getting worse. Came to pharmacy on 11/27/2012 to seek treatment. At pharmacy, pharmacist inspected injection site. The area was warm to touch, noted induration and erythema about 4 inches in diameter. Pharmacy contacted manufactuer and physician. Physician told patient to put Benadryl cream on area and warm compress. Called patient around 3pm and patient said heat and warm compress seemed to be helping symptoms.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Received vaccine 11-7-12 in left upper deltoid. Came back 11-9-12 and stated upper right deltoied was red and very swolen. 11-7 & 8 she said "It hurt all the way down to my thumb."
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site oedema, Injection site warmth
Clinical narrative: Injection site (left thigh) edematous the size of an egg.  This area was warm to touch.  No redness at site.
Age: 1.3
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash to arms and legs.
Age: 14.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Gait disturbance, Joint swelling, Skin warm
Clinical narrative: Swelling in all joints elbows, ankles, feet swollen, hands have swollen burning on her buttocks. All joints very hot to touch. Can't walk without help.
Age: 14.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Joint swelling, Pain
Clinical narrative: Swelling in all joints elbows, ankles, feet swollen, hands have swollen burning on her buttocks. All joints very hot to touch. Can't walk without help.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Very high temperature 101.8 from time of vaccine until present.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Chills and fever presenting in the evening. Resolved by next morning, no treatment given.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister, Hypoaesthesia, Myalgia, Pain
Clinical narrative: Aching upper right side of back/r.arm,1 1/19 fluid-filled blisters right arm/shoulder, tingling, 11/20 stinging, 11/22 burning pain, numbness in r. hand thumb/11/22-11/25 swelling above right clavicle, sharp shooting pain started 11/25, fever 100.5 11/19, 99.9 11/20, extreme muscle soreness in right arm, burning and sharp pains, and muscle soreness still ongoing.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Pyrexia, Swelling
Clinical narrative: Aching upper right side of back/r.arm,1 1/19 fluid-filled blisters right arm/shoulder, tingling, 11/20 stinging, 11/22 burning pain, numbness in r. hand thumb/11/22-11/25 swelling above right clavicle, sharp shooting pain started 11/25, fever 100.5 11/19, 99.9 11/20, extreme muscle soreness in right arm, burning and sharp pains, and muscle soreness still ongoing.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Burning sensation, Joint injury, Musculoskeletal stiffness, Pain, Vaccination complication
Clinical narrative: Burning, stiff, sore, very painful to move in any direction. Steadily got worse into the day.  Have been in severe pain for 3 weeks.  Went to Orthopedic Doctor today.  Diagnosed with SIRVA.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: X-ray normal
Clinical narrative: Burning, stiff, sore, very painful to move in any direction. Steadily got worse into the day.  Have been in severe pain for 3 weeks.  Went to Orthopedic Doctor today.  Diagnosed with SIRVA.
Age: 36.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abortion spontaneous
Clinical narrative: Spontaneous miscarriage of pregnancy.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Oral pain, Pain in extremity
Clinical narrative: Left arm is painful, sore, unable to raise it, rash, sore mouth, and unable to turn wrist.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Chills, Computerised tomogram, Cystitis, Dyspnoea
Clinical narrative: Mild fever/chills;  Migraine developed overnight;  9/22/12 afternoon - severe migraine, fever, hypertension & low O2 stats; 09/23/12 continued migraine, trouble breathing, hypertension, muscle aches.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Hypertension, Migraine, Myalgia, Oxygen saturation decreased, Pyrexia
Clinical narrative: Mild fever/chills;  Migraine developed overnight;  9/22/12 afternoon - severe migraine, fever, hypertension & low O2 stats; 09/23/12 continued migraine, trouble breathing, hypertension, muscle aches.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Sinusitis
Clinical narrative: Mild fever/chills;  Migraine developed overnight;  9/22/12 afternoon - severe migraine, fever, hypertension & low O2 stats; 09/23/12 continued migraine, trouble breathing, hypertension, muscle aches.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: Strong tingling sensation along the left flank (vaccine given in left deltoid) that increased in intensity to the point of cannot touch it or use muscles underlying the skin. Skin appears normal.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Raised red fluid filled rash across rt chest/scapula.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dyspnoea, Erythema, Malaise, Pain
Clinical narrative: SEVERE PAIN, REDNESS AND WARMTH IN UPPER ARM, MALAISE, FEVER, SOME SOB AND CHILLS, SHE TOOK TYLENOL THAT NIGHT AND FELT SOMEWHAT BETTER ON 11/13, BUT STILL FELL GENERALIZED BODY ACHES.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: SEVERE PAIN, REDNESS AND WARMTH IN UPPER ARM, MALAISE, FEVER, SOME SOB AND CHILLS, SHE TOOK TYLENOL THAT NIGHT AND FELT SOMEWHAT BETTER ON 11/13, BUT STILL FELL GENERALIZED BODY ACHES.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Headache, Injection site reaction, Malaise
Clinical narrative: This was the third of Gardasil vaccine.  Feeling Faint and light-headed, headache - worse with movement and activity. Fever over 102, not brought down with Motrin, Tylenol given, temp down to 99.7. Severe muscle aches primarily in calves, chest and injection site.  Shortness of breath, somewhat resolved with bronchodilators.  Malaise, treated with hydration and rest.  Almost all symptoms resolved by the following day about 5pm.  However, activity and movement seem to provoke SOB and headache.  Missed a day of work.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: This was the third of Gardasil vaccine.  Feeling Faint and light-headed, headache - worse with movement and activity. Fever over 102, not brought down with Motrin, Tylenol given, temp down to 99.7. Severe muscle aches primarily in calves, chest and injection site.  Shortness of breath, somewhat resolved with bronchodilators.  Malaise, treated with hydration and rest.  Almost all symptoms resolved by the following day about 5pm.  However, activity and movement seem to provoke SOB and headache.  Missed a day of work.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Incorrect dose administered, Pain, Pain in extremity, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old female patient with allergy to penicillin. The patient was vaccinated with PNEUMOVAX 23 (lot number reported as H011780, expired date 16-FEB-2014) (0.5 ml, intramuscular) on 08-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 08-OCT-2012 the patient experienced severe swelling. Pharmacist followed up with patient today on 21-NOV-2012 and patient was still experiencing some pain and due to arm pain, patient missed some work. Patient told the pharmacist that she thought she received another dose of PNEUMOVAX 23 about two years ago in approximately November 2010. Treatment VOLTAREN and diclofenac were given for adverse event. The patient was still experiencing some pain and arm pain. The outcome of severe swelling was unknown. The reporter considered that the pain caused the disability as missed work. This is one of several reports received from the same source. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm red, swollen, tender, warm at injection site.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Gait disturbance, Pain, Swelling, Tenderness
Clinical narrative: Received FLUZONE in (L) lateral thigh 11/17/12. Initially (1hr later) had pain, trouble walking & swelling- resolved with ibuprofen. 36 hrs later seen at medical center for swelling, redness, tenderness. Rx - Cephalexin. Resolved without complications.
Age: 39.0
Sex: U
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: I got the flu shot on Oct 10, 2012. As of today 11/27/12, my right arm is still not able to move as normal like before. The arm will not able to lift very high or it will be painful when I try to lift high.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Injection site erythema, Pain in extremity
Clinical narrative: Pt had pneumonia (subq) & flu shot (IM) administered on right hand. 2-3 day experiencing pain radiating from top to elbow of arm. Area became red especially at site of adm (5 cent coin size) pt used TYLENOL for pain relief & pt had chills all through. Pt has had both shots previously with no ADR.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Rotator cuff syndrome
Clinical narrative: She claims arm has been sore since receiving shot. Diagnosis by Dr. left rotator cuff tendonitis on 11/26 for which he gave her a MEDROL Dose pak. Then use cortisone shot or physical therapy.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Vaccine administered on Sun 11/25/12. Patient contacted pharmacy at 8 am on 11/27/12 to say she had a red, round area around vaccination site about the size of a silver dollar.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Pain, Pruritus, Rash erythematous, Rash macular
Clinical narrative: Flu vaccine taken 10/26/12 at 1130 am & awoke w/ a red, raised macular rash 10/28/12 on chest. Rash spread up her neck to face & down both arms to fingers. Extremely itchy & painful. Treated w/ prednisone, topical cream, Hydroxyzine. Didn't feel good for 3 weeks, but fine now.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: In 24 hours after immunization, patient experienced unusual muscle pain. He complained that he could not raise his arm, the pain radiated from shoulder to the elbow & lasted 10 days.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Hypersensitivity
Clinical narrative: Allergic reaction resulted in E.R. visit. Drs office visit today (11-27-12) cellulitis.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Influenza, Influenza like illness, Oropharyngeal pain, Pain
Clinical narrative: (Within 24 hours) 1 day after Flu shot pt c/o flu like symptoms. Fever, aches, chills, sore throat - stated "full blown flu symptoms". Pt saw PCP & given a Z pack (Abx) - pt now recovering.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: (Within 24 hours) 1 day after Flu shot pt c/o flu like symptoms. Fever, aches, chills, sore throat - stated "full blown flu symptoms". Pt saw PCP & given a Z pack (Abx) - pt now recovering.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Cellulitis requiring IV antibiotics.
Age: 70.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Fatigue, Herpes zoster, Skin burning sensation
Clinical narrative: 10/26 Burning heat on neck, shingles came out. Called dermatologist right away and was diagnosed with shingles during the visit. Prescribed 7 day of VALTREX and 10 days of Gabapentin for pain. On 11/5 went to regular doctor when felt better to drive. Doctor confirmed the shingles. A month in and still feels tired, wiped out and exhausted. About 95% of rash is gone and also pinching.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Lymphadenopathy, Pyrexia
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a 60 year old female patient with no pertinent medical history and no drug reactions/allergies. On 17-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number was reported as H013940, expiration date was reported as 25-OCT-2013), subcutaneously. Lot number and expiry date was reported as H013940 and 25-OCT-2013 respectively. Concomitant medications included BENICAR, Hydrochlorothiazide, CLIMARA, LOVAZA, PREMARIN, PROTONIX, SYNTHROID and TOPROL XL TABLETS. On an unknown date in November 2012, the patient experienced swelling at the injection site, swollen glands under her arm and fever after receiving ZOSTAVAX. The patient sought an unspecified medical attention. No treatment was provided. No lab diagnostics studies were performed. The outcomes of all the events were reported as not resolved. No further information was provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Lymphadenopathy, Pyrexia
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a 60 year old female patient with no pertinent medical history and no drug reactions/allergies. On 17-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number was reported as H013940, expiration date was reported as 25-OCT-2013), subcutaneously. Lot number and expiry date was reported as H013940 and 25-OCT-2013 respectively. Concomitant medications included BENICAR, Hydrochlorothiazide, CLIMARA, LOVAZA, PREMARIN, PROTONIX, SYNTHROID and TOPROL XL TABLETS. On an unknown date in November 2012, the patient experienced swelling at the injection site, swollen glands under her arm and fever after receiving ZOSTAVAX. The patient sought an unspecified medical attention. No treatment was provided. No lab diagnostics studies were performed. The outcomes of all the events were reported as not resolved. No further information was provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 years old female patient. The patient was vaccinated with dose 1, .5 ml GARDASIL on 27-DEC-2010, with dose 2, .5 ml GARDASIL on 25-FEB-2011, with dose 3, .5 ml GARDASIL on 20-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient was vaccinated with first dose of GARDASIL 12/27/2010, second dose of GARDASIL on 02/25/2011 and the third dose of GARDASIL on 09/20/2012 with No adverse event. No treatment information was reported. The outcome of vaccinated with first dose of GARDASIL 12/27/2010, second dose of GARDASIL on 02/25/2011 and the third dose of GARDASIL on 09/20/2012 and no adverse event is unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Scattered vesicular lesions 30-40 over face and trunk.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Patient reports a mild zoster outbreak on her face about one week after receiving the vaccine. Patient states she has some shooting pain as a result.
Age: 0.54
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, PNC
Symptoms: No adverse event
Clinical narrative: No adverse events.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Face and mouth X-ray, Fall
Clinical narrative: Pt got dizzy and fell to the floor.
Age: 46.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Rash generalised
Clinical narrative: Spots all over body face.
Age: 1.69
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Pruritus, Skin warm
Clinical narrative: Pt reports an localized injection site reaction. Localized redness, warm to the touch and slightly itching.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a health care worker concerning a female patient (age unknown). It was reported that the patient received GARDASIL (route and lot # not reported) on 28-SEP-2008 and on 29-OCT-2012. No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse. She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included live, oral, ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patient s is not related to MMR II and live, oral ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide the details when she is able to retrieve the information. SR # provided. It is not known at this time if there have been any adverse effects. MMR vaccine Date given 11/01/2012. Medical record # 19771. Lot # 1571AA. Additional information has been requested.
Age: 1.34
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 months old female patient with vaccination. The patient's medical history included kingella infection. The patient was vaccinated with VARIVAX (merck) on 13-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 21-NOV-2012 the patient experienced injection site reaction, 9 days after onset of therapy, injection site swollen, warm swollen area at injection site and low grade fever. No treatment information was reported. The outcome of injection site reaction, injection site swollen, warm swollen area at injection site and low grade fever was reported as not recovered/not resolved. The relatedness for injection site reaction, injection site swollen, warm swollen area at injection site and low grade fever is unknown for VARIVAX (Merck). Drug Reactions/Allergies: Ceftriaxone. No further information is available. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 77 years old patient. The patient was vaccinated with, .65 ml ZOSTAVAX on 19-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 19-NOV-2012 the patient received a dose of ZOSTAVAX (lot # 1268AA) 11/19/2012 that expired on 11/05/2012. The patient experienced no adverse event. No treatment information was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a multiple patient (gender and age unknown). On an unknown date, the patients were vaccinated with varicella virus vaccine live (unspecified). No other co-suspects were reported. No concomitant medications were reported. It was reported that their county was experienced an outbreak of chickenpox. The nurse believed that there or may be more previously vaccinated patients who may have developed chickenpox. The reporter stated that this county had a very high rate of parents who opt-out of vaccines. At the time of the report, the outcome of chickenpox was unknown. The relatedness for chickenpox was unknown for varicella virus vaccine live (unspecified). Additional information has been requested. This is one of the several reports of the same source,
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse, She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with M-M-R II. Other suspect therapies included ROTATEQ, Oral. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50f for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50f for 48 hours were administered to patients is not related to M-M-R II and ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide the details when she is able to retrieve the information. SR # provided. It is not know at this time if there have been any adverse effects. Rotavirus vaccine Date given 11/02/2012. Lot # 0210AE. Additional information has been requested.
Age: 1.04
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse, She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with M-M-R II. Other suspect therapies included ROTATEQ, Oral. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50f for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50f for 48 hours were administered to patients is not related to M-M-R II and ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide the details when she is able to retrieve the information. SR # provided. It is not know at this time if there have been any adverse effects. Additional information received 13Nov2012: MMR vaccine Date given 11/02/2012. Lot # 1571AA. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse. She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50 F for 48 hours were administered to patients is not related to MMR II and ROTATEQ. At the time of the call, she does not known who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide the details when she is able to retrieve the information. SR # provided. It is not known at this time if there have been any adverse effects. Rotavirus vaccine Date given 03Nov2012. Medical records # 140652. Lot # 0057AE. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse. She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients is not related to MMR II nd ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide details when she is able to retrieve the information. SR # provided. It is not known at this time if there have been any adverse effects. Additional information 13Nov2012: MMR vaccine Date given 11/01/2012. Lot # 1571AA. Additional information has been requested.
Age: 1.04
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse. She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients is not related to MMR II nd ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide details when she is able to retrieve the information. SR # provided. It is not known at this time if there have been any adverse effects. Additional information 13Nov2012: MMR vaccine Date given 11/03/2012. Lot # 1571AA. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse. She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included live, oral ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients is not related to MMR II and live, oral ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide the details when she is able to retrieve the information. SR # provided. It is not known at this time if there have been any adverse effects. Medical Record # 147563, Rotavirus vaccine date given 11/01/2012. Lot # 0210AE. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse refers to a 75 years old female patient Type 2 diabetes mellitus. the patient was vaccinated with, .65 ZOSTAVAX on 24-OCT-2012 in left arm. No other co-suspects were reported. Concomitant medications included: aspirin. On 26-OCt-2012 the patient experienced red bump, 4 mm in diameter around injection site, 3 days after onset of therapy, arm slightly swollen and pain shooting down arm. No treatment information was reported. The outcome of red bump, 4 mm in diameter around injection site, arm slightly swollen and pain shooting down arm was reported as recovering/resolving. The relatedness for red bump, 4 mm in diameter around injection site, arm slightly swollen and pain shooting down arm is unknown for ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test, Blister, Erythema, Rash
Clinical narrative: This spontaneous report as received from a 65 years old female patient reporting on herself, who approximately in August 2012 (at least 2 or 3 months) was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. Concomitant medications included: LIPITOR. The patient reported that after receiving the vaccine, a few weeks later, "a month or so" (approximately in October 2012), she exhibited a rash from her chest to mid thighs "little red patches" and also had one blister on her chin. No itching just the rash. Blood work (dates unspecified) concluded the patient had herpes "titer 1 and 2". Unspecified treatment was given for an AE. The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: This spontaneous report was received from a 70 years old female consumer reporting on herself with allergy to penicillin, guanfacine, codeine, morphine, BENADRYL, naproxen, DARVOCET, ciprofloxacin, promethazine, hydrocodone, tramadol allergy and drug allergy. The patient's medical history included chickenpox and shingles (in the 1990's). The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on 01-JUL-2008. No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on 01-NOV-2012, the patient began experiencing nerve pain in an unspecified area of her body. On or around 14-NOV-2012, the patient developed a rash on an unspecified area of her body. She saw the physician on 20-NOV-2012, who diagnosed the rash as shingles. The physician prescribed the patient ZOVIRAX 400 mg 5 times daily to treat the shingles. No lab diagnostic tests were performed. At the time of the report the outcome of shingles was reported as not recovered. The relatedness for the event was not provided for ZOSTAVAX. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse. She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients is not related to MMR II and ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide details when she is able to retrieve the information. SR # provided. It is not known at this time if there have been any adverse effects. Rotavirus vaccine Lot # 0210AE, Date Given 10/31/2012. Additional information has been requested.