chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Feeling drunk, Headache, Immediate post-injection reaction, Metabolic function test normal, Pregnancy test urine negative
Clinical narrative: Within 4 hrs of receiving first HPV vaccine, she became confused, dazed, acting as if intoxicated. This behavior change lasted 48 hrs. She also had headache and dizziness develop immediately after the vaccine, which has persisted. Taken to local ER. No treatment given.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, MM, VARCEL
Symptoms: Rash
Clinical narrative: AFTER THE CHILD GOT VACCINES, SHE WAS LATER SEEN BY A DR, SINCE SHE HAD AN APPOINMENT FOR A WELL CHILD CHECK UP. THE DR NOTICED A RASH. AND PER MOTHER THE CHILD HAS HAD A REACTION TO EGGS BUT SHE DIDN'T REMEMBER. THEREFORE SHE DIDN'T LET US KNOW BEFORE THE CHILD WAS GIVE THE FLU SHOT.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: RIGHT DELTOID SWOLLEN AND MOVING TO LOWER ARM JUST ABOVE ELBOW. DR STARTED PATIENT ON KEFLEX WITH SOME IMPROVEMENT. SIZE 70MMX50MM CELLULITIS.
Age: 65.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Dysphonia, Lacrimation increased, Respiratory disorder, Throat tightness, Upper respiratory tract congestion
Clinical narrative: RESPIRATORY RESPONSE; THROAT CONGESTED, EYES RUNNY, RASPY VOICE REPORTED. PUT IN CONTACT WITH HER PRIVATE MD. NO TREATMENT GIVEN; WATCHFUL.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster
Clinical narrative: This spontaneous report was received from a 75 year old female patient with heart problem (unspecified), sulfa allergy, BACTRIM allergy and CIPRO allergy. On 08-FEB-2008, the patient was vaccinated with a dose of live ZOSTAVAX (lot number, expiry date, dose and route unspecified) in the arm. Concomitant medication included unspecified medication (reported as loads). On 25-DEC-2012, the patient broke out with the shingles on Christmas day even though she had received the vaccine 4 years ago. She sought the medical attention (she went to the doctor) and she was prescribed with some pills (unspecified) to help. On an unknown date in August 2012, blood test (unspecified) was performed to verify her whooping cough. The outcome of the event was unknown. The relatedness for the event was unknown for live ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous, Swollen tongue
Clinical narrative: This spontaneous report as received from the aunt of the consumer refers to a female patient of unknown age. On an unknown date the patient was vaccinated with dose 1 of a dose of M-M-R II(lot number and dose not reported). On an unknown date the patient experienced red, bumpy rash on her face and tongue became swollen after M-M-R II. The aunt also reported that the patient had a similar reaction to another unspecified vaccine. No treatment information was reported. The outcome of red, bumpy rash on her face and tongue became swollen is unknown. The relatedness for red, bumpy rash on her face and tongue became swollen is unknown for M-M-R II. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Joint swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with MMR II (lot # was unknown) a couple of years ago when she experienced joint swelling. It did not report whether the patient sought medical attention. The outcome of the adverse events was unknown. The relatedness for joint swelling and patient had a bad reaction was unknown for MMR II. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified amount of patients. She reported that live ZOSTAVAX that underwent an unsupported temperature excursion may have been administered to the patients on unspecified dates. No adverse effect reported. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: HEPAB
Symptoms: Diarrhoea
Clinical narrative: Diarrhea.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site paraesthesia, Joint range of motion decreased, Myalgia, Pain in extremity
Clinical narrative: Pt was complaining of symptoms for as long as a month after shot given. Patient called pharmacy with symptoms of tingling at site of shot , muscle pain & soreness in arm given. And feels like she lost some range to motion in her arm.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia, Neuralgia
Clinical narrative: Nerve with joint & muscle pain of left arm - currently using ibuprofen, ice, gentle positioning, & rest (all self-treatment currently). Reports pain began about 30 minutes post-injection. States will be seeking medical treatment.
Age: 40.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 40 years old pharmacist refers to himself. The pharmacist reported that he felt that he developed shingles from administering live ZOSTAVAX last summer (late summer 2012, date unspecified). The pharmacist did not report any needle stick or direct contact with the vaccine (pharmacist wore gloves), but had just completed a vaccination clinic in which he administered numerous doses of live ZOSTAVAX. The pharmacist stated that shingles was diagnosed and he took an unspecified antiviral within 72 hours of the start of the shingles. The pharmacist describes the shingles as a mild case and reported that he was recovered. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Eye discharge, Eye irritation, Eyelid oedema
Clinical narrative: I got shot (Flu shot) approx 2 pm - started sneezing at 6 pm by 7 pm coughing by 9 pm cold chills at 2 am could not open either eye - washed in warm water - could barely see - like looking thru plastic - 6 am same thing with eyes - for days my eyes were discharging & burning.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing, Visual impairment
Clinical narrative: I got shot (Flu shot) approx 2 pm - started sneezing at 6 pm by 7 pm coughing by 9 pm cold chills at 2 am could not open either eye - washed in warm water - could barely see - like looking thru plastic - 6 am same thing with eyes - for days my eyes were discharging & burning.
Age: 1.1
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash macular, Urticaria
Clinical narrative: Within 30 seconds-1 minute after completing shots, client developed 1-2 mm hives - few on top of each hand, few on left neck under jaw, and a few on upper left forehead. Also had generalized red blotchiness on face and all four limbs. All symptoms disappeared about 2 minutes after first appearance. Per mom, no further appearance since.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Increased upper airway secretion, Respiratory tract congestion
Clinical narrative: Pt. had phlegm/develop congestion, started losing voice. Reaction did not worsen. No trouble breathing.
Age: 1.3
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Computerised tomogram, Convulsion, Nuclear magnetic resonance imaging
Clinical narrative: Seizures.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oedema peripheral, Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: Big red rash and very itchy. The patient arm was sore and swollen.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Big red rash and very itchy. The patient arm was sore and swollen.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Disorientation, Gaze palsy, Hyperhidrosis, Muscle rigidity
Clinical narrative: Pt had stiffening of extremities, eyes rolling, disorientation, diaphoresis; resolved after 1-2 minutes.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Fall
Clinical narrative: Pt received GARDASIL, no c/o at time of vaccine. Pt found on floor moments later in lobby mom stated pt fell face first, pt brought to room, put on 2L O2, VSS, MD aware, 911 was called pt taken to ER.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash
Clinical narrative: Minor rash to cheeks and chin 24 hours following administration of FLUMIST.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received MENVEO, GARDASIL, and BOOSTRIX on 1/16/13. On 1/17/13, he developed increased redness, pain, and swelling of the right arm, where immunizations given. He was seen at our office 1/18/13 by NP and she suggested symptomatic care of cool compresses, IBU and TYLENOL. Recheck if symptoms persist or increase in severity.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Psychosomatic disease, Syncope
Clinical narrative: Psychosomatic response after flu vaccination -> syncope. Supportive care. EMT services called.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a 22 years old female patient, who approximately in 1997 (when she was 16 or 17 years old) was vaccinated with a dose of GARDASIL (dose, frequency, route and lot number were not reported. No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient "recently" had a pap smear that indicated an infection with type 16 of HPV. The physician believed it was a low grade lesion. No treatment information was reported. It was reported that it did not know if the patient received all GARDASIL doses at the correct intervals. The patient did not sought medical attention. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness of the adverse event for GARDASIL was unknown. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Electroencephalogram, Herpes zoster, Post herpetic neuralgia, Ultrasound scan
Clinical narrative: This spontaneous report was received from a 80 year old male consumer with high cholesterol, arthritis, high blood pressure and blocked coronary artery and no known drug reactions/allergies who three years ago, in approximately January 2010 was vaccinated with a dose of live ZOSTAVAX subcutaneous under the skin. No other co-suspects were reported. Concomitant medications included ZOCOR, COZAAR, baby aspirin and unspecified vitamins (OTC). The consumer reported that in December 2012, 3 years after receiving live ZOSTAVAX he was diagnosed with shingles that were affected his facial area severely. He also stated he believed she was now developing Post herpetic (PHN). On an unknown date, a barium ultrasound and an EEG were performed (results not provided). The patient was given FAMVIR 500 mg- 3 pills for 7 days as treatment for the events. The outcome  of shingles and PHN was unknown. The relatedness for shingles and PHN was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 59 years old female patient with atrial fibrillation and none drug reactions or allergies. The patient was vaccinated with a dose of live ZOSTAVAX, subcutaneous (route, lot number not reported) on 28-DEC-2012. No other co-suspects were reported. Concomitant medications included XARELTO and metoprolol. On 31-DEC-2012, the patient had a deep tissue massage on the entire body. On 01-JAN-2013, the patient developed a rash on the chest, neck, abdomen and wrists. The patient started acyclovir on 03-JAN-2013 as a treatment for adverse event. None laboratory tests were performed. The outcome of rash on the chest, neck, abdomen and wrists was reported as not recovered. The patient sought medical attention, came into the nurse practitioner's office. The relatedness for adverse event was not reported for live ZOSTAVAX. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Pain in extremity
Clinical narrative: Severe swelling & pain in both legs & feet. Treated with BACTRIM DS & LASIX. Taken off work 1 day. Onset of symptoms 24 hrs after receiving vaccine.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain
Clinical narrative: Pain radiating from shot location on upper arm to neck.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a male patient of unknown age. On 19-JUN-2012 the patient was vaccinated subcutaneously in the left upper arm with a single dose of live ZOSTAVAX (lot # 1716AA, exp. date:02-FEB-2013). On an unknown date of 2012, initially patient developed redness and swelling at the injection site which resolved without requiring medical treatment. The patient subsequently, on an unspecified date of 2012, developed "pain on the side of the left arm extending about 5 inches". The pain had been "persistent for the last few months". No lab diagnostic studies performed. No treatment was given. The patient came to the pharmacy to seek medical attention. The outcome of the pain on the side of the left arm was not recovered. The relatedness between the events and live ZOSTAVAX was unknown. Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: On 1/11/13 at 5-6AM fever 104, nausea, headache, & chilling. Temperature 101 later in day. Took ADVIL. Fever broke before 4:30pm.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 9 years old female patient with allergic rhinitis and asthma and no drug allergies. The patient was vaccinated with first dose of GARDASIL (lot# unspecified) intramuscularly on 25-JUL-2012. The patient was vaccinated with second dose of GARDASIL (lot number H010915, exp 13-FEB-2015) intramuscularly on 07-JAN-2013. No other co-suspects were reported. Concomitant medications included FLONASE, SINGULAIR, PROAIR and vitamins (unspecified). On some unspecified date after 07-JAN-2013, the patient experienced right knee and left elbow pain. The patient's mother had called the physician assistant for medical attention. No treatment information was given for the adverse event. No lab diagnostic studies performed. At the time of the report, the patient's outcome was unknown. The relatedness for right knee and left elbow pain was unknown for GARDASIL. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood creatinine normal, Chills, Mental status changes, Muscle spasms
Clinical narrative: Loss of bladder control in approx 20 min lasting approx. 12 hours. Chills, cramps in arms, hands, legs & feet 3-4 hrs. Weakness, mental status change - 30-60 sec following morning.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate increased, Urinary incontinence
Clinical narrative: Loss of bladder control in approx 20 min lasting approx. 12 hours. Chills, cramps in arms, hands, legs & feet 3-4 hrs. Weakness, mental status change - 30-60 sec following morning.
Age: 1.03
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Irritability, Rash
Clinical narrative: Pt given MMR on Wed. Friday pt cranky & fussy. Encouraged supportive care. Sat or Sunday pt developed rash starting on neck to chest. No SOB. Taken to ER & given steroid. Pt has severe milk allergy started coconut milk week prior to vaccines - (presumed cause) cleared after injection.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: I developed shingles. Within 48 hours, I had unexplained pain which worsened until the rash erupted 1 wk later. I was on Acyclovir 5x/day for 2 wks. It was very painful. Rash to my left back/side. I know I have been told & I have personally told patients, over & over, that the flu vaccine does not cause illness. But I always coincidentally have some symptom every single time I have a flu vaccine. I've had the typical flu like symptoms including chills, aches & cough with sore throats. I have lost my voice twice. I've had GI symptoms twice. And now this time I had an outbreak of shingles. I just wonder if it's possible that someone, like me, can just have very sensitive immune systems? Can you please research this possibility? I have never missed a flu vaccine in all these years. In fact, I used to work for flu vaccine clinics & would strongly encourage them. But I am concerned that my particular body system does not tolerate it. Which concerns me because I know as a nurse, it is strongly advised that I get vaccinated. But to get shingles for no apparent reason - I was not under stress & was feeling fine. I did have a cold 1 week prior, but it resolved before I had the vaccine. I am actually very sensitive to any medication I've ever taken, sensitive to the good effects as well as potential adverse effects. I do want to mention, I am so convinced of this coincidence, I am afraid to ever get a flu vaccine in the future. But I am afraid of the flu also. And concerned about what you must think. And concerned about what my employer's reaction will be if I choose not to get the vaccine ever again. Please advise me. Thank you for your time.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Severe joint pain/hips/knees/elbos/neck/jaw/lower back.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site cellulitis, Swelling
Clinical narrative: Mother reports that swelling and redness within the 24 hour period.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Balance disorder, Injection site pain
Clinical narrative: Soreness in Shot Site Lost Balance.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching/redness around site -> instructed pt to apply cool compresses and take BENADRYL called pt. 1-18-13 redness went down little still itching.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: REDNESS AT SITE BEGAN ON RIGHT UPPER ARM AND AREA CONTINUED TO INCREASE IN SIZE TO APPROXIMATELY SIZE OF EGG WITH A SMALL KNOT FELT UNDER SKIN IN SQ TISSUE.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Injection site pain
Clinical narrative: Pt received one dose of Flulaval which is indicated for adult use only.  Injection was given in right deltoid.  Her deltoid hurt quite abit the night of shot and the day after but normal on the second day.
Age: 1.45
Sex: F
Vaccine: HIBV, MMR
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Site of injection was very sore, red, warm to the touch and knot just below skin.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: 2-24-12 Patient received PEDIARIX immunization in right thigh. Had erythema size of a quarter at site - lasting 1 night. Mom noticed hard lump in right thigh at injection site 2 days after injection. 1-18-13 Still has hard lump in right thigh - slightly smaller. No other symptoms.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Erythema, Pyrexia, Vaccination site pain
Clinical narrative: Localized redness, fever/chills, localized pain around vaccination site (typical side effects listed on VIS that was reviewed with patient before receiving vaccine, and again when he presented with symptoms).  Symptoms resolving but not fully resolved as of 3:30 PM on 1/18/2013.
Age: 1.32
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Petechiae, Rash
Clinical narrative: Patient had red cheeks similar looking to "slapped cheek, (Hands, foot, mouth disease)?" Rash on all limbs. Small petechiae bumps.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Mobility decreased, Pain, Paraesthesia
Clinical narrative: Extreme pain (unable to lift arm up), felt like pins/needles with light touch, unable to get comfortable in bed (called for ok to take ibuprofen; pharmacist said ok); next day arm was red, inflamed (huge welt on upper area); told to take Benedryl.. didn't have so they said to take the Loradadine (Claritin OTC); second day following saw Doctor... he was concerned and wanted me to report reaction here.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Extreme pain (unable to lift arm up), felt like pins/needles with light touch, unable to get comfortable in bed (called for ok to take ibuprofen; pharmacist said ok); next day arm was red, inflamed (huge welt on upper area); told to take Benedryl.. didn't have so they said to take the Loradadine (Claritin OTC); second day following saw Doctor... he was concerned and wanted me to report reaction here.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site haematoma
Clinical narrative: Hematoma from elbow to shoulder on arm where Pneumovax was administered.
Age: 38.0
Sex: M
Vaccine: TD
Symptoms: Chest pain, Pain in extremity
Clinical narrative: Sore arm lasting for an extended period of time but pain migrated to chest area. Patient still experiencing pain.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: Redness swelling welts at injection site; fever.
Age: 10.0
Sex: F
Vaccine: FLUN3, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PT GOT SWELLING OF DELTOID AREA WHERE VACCINE WAS GIVEN. THE AREA IS RED, TENDER, HOT.  TREATED WITH BENADRYL.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administration error, Incorrect dose administered
Clinical narrative: I reimmunized this patient with Fluzone ID after discovering that a significant amount of the vaccine did not get injected.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: Headache, after around 4 hours begin to get worse so took 2 asprin-no help.  After another 2 hours became really bad and after two more hours took two more asprin-no help.  Went to bed a couple hours later it eventually went away.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Mobility decreased, Paraesthesia, Tremor
Clinical narrative: After finishing the administration, patient stated that he is having tingling in his left hand, I had him wait for 10 min. He said it is getting better. He left and I called him after over an hour he said the tingling is gone but his left hand is shaking and he can not bend his thumb.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Headache
Clinical narrative: Patient started to complain of a moderate headache approx 15 minutes following vaccination, took 650 mg of aspirin at 5 pm, did not have any other signs or symptoms, headache began to subside at about 6 pm.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flatulence
Clinical narrative: DIZZINESS, THROUGHOUT THAT DAY AND FOLLOWING DAYS, ALTHOUGH SEVERITY WAS LESS EACH DAY.  ALSO INCREASED GASTRIC GAS OUTPUT.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Dehydration, Dizziness, Fluid intake reduced, Nausea
Clinical narrative: Approx 10 min after administration of vaccine, PT reported feeling dizzy and nausea. PT stated last meal ~24 hrs ago, dehydrated with no fluid intake this date. PT's vital signs obtained and normal. PT provided meal and oral hydration. PT noted improvement but stated she was unable to continue working and needed to go home and rest; stating, "I'll be fine tomorrow. I just need some rest."
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: 1/17/13 patient states pneumococcal injection site tender, red, swollen. Reported to vaccine provider on 1/18/13.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site swelling, Oedema peripheral, Pyrexia
Clinical narrative: Pt reports that his arm began to swell around the site of the injection and then more into that same arm.  He reports that he developed a fever.  Pt reports that he later developed chills.  Pt does not have a thermometer and cannot tell us the degree of his reported fever.  He states that over the course of the day the swelling in his arm did go down.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster, Rash
Clinical narrative: Sudden rash on right arm and right side of back. Diagnosed on 12/18  as shingles.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Cold sweat, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swollen, sore at injection site. Body aches. Temperature = 100.7. Temp drops temporarily with Advil, peaks in evening. During day, body aches and cold sweats. Day 4 of symptoms. (This is day 4).
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Redness, swollen, sore at injection site. Body aches. Temperature = 100.7. Temp drops temporarily with Advil, peaks in evening. During day, body aches and cold sweats. Day 4 of symptoms. (This is day 4).
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Chest pain, Chills, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Started with low fever, 101 degrees, progressed to 103 on 01/18/2013, reached as high as 104.9. Used OTC children's Motrin, fever has not gone below 101. Complains of fever aches and chills and pain in chest, congestion and sore throat. Calls made to office to report effects to both children who received the vaccine, brother age 15 also has same reaction with slightly lower fever.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Respiratory tract congestion
Clinical narrative: Started with low fever, 101 degrees, progressed to 103 on 01/18/2013, reached as high as 104.9. Used OTC children's Motrin, fever has not gone below 101. Complains of fever aches and chills and pain in chest, congestion and sore throat. Calls made to office to report effects to both children who received the vaccine, brother age 15 also has same reaction with slightly lower fever.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Headache, Pyrexia, Rhinorrhoea
Clinical narrative: Fever 101; Headache; Stomach; Runny nose.
Age: 24.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified nurse practitioner concerning a patient of unknown gender and age who on an unknown date was vaccinated with the third dose of GARDASIL only 8 weeks after the second dose was given (route, lot number and expiration date were not provided). No adverse effects were reported. Additional information has been requested
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 50 year old female patient with no drug reactions/allergies who on 11-JAN-2013 was vaccinated with a 0.65 ml of live ZOSTAVAX subcutaneous (lot number H019997, expiration date 02-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that 2 or 3 days after vaccination, on approximately 13-JAN-2013, the patient developed a red raised and itchy area around injection site which was warm and uncomfortable. She stated that the rash was about 2.5 inches in diameter. The patient reported that there were no vesicle in the reddened area and declined VZVIP packet. The patient had not seen a physician concerning this injection site reaction. At the time of the report, the patient had not recovered from the event. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 50 year old female patient with no drug reactions/allergies who on 11-JAN-2013 was vaccinated with a 0.65 ml of live ZOSTAVAX subcutaneous (lot number H019997, expiration date 02-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that 2 or 3 days after vaccination, on approximately 13-JAN-2013, the patient developed a red raised and itchy area around injection site which was warm and uncomfortable. She stated that the rash was about 2.5 inches in diameter. The patient reported that there were no vesicle in the reddened area and declined VZVIP packet. The patient had not seen a physician concerning this injection site reaction. At the time of the report, the patient had not recovered from the event. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Local reaction to Tdap swelling right arm .
Age: 23.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Injection site atrophy, Injection site erythema, Muscle twitching
Clinical narrative: On 12/12/12, after vaccines administered, pt. reports she experienced '(L) arm muscle twitching' and the appearance of "a crater" in between both injections sites. This still persists. No pain, fever or chills. Pt. states area is "pink". No evaluation or tx at time of this report. Recommended pt. f/u with her doctor.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Cyanosis, Joint swelling, Oedema peripheral, Pallor, Rash
Clinical narrative: Pt had 12 mon vaccines 1/8/2013. Rash, started on abdomen 1/13 and pt was seen 1/14 in the office with red, maculopapular rash that was on trunk and face, no increased T no hives no itching. No other sx. F/U appt 1/18 pt now with red blanchable circular lesions on face, abd, back & legs. Bil hands purple and swollen, ankles swollen. Abd. soft & nondistended. No increased T . F/U will be as needed. Dx HSP.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Pt had 12 mon vaccines 1/8/2013. Rash, started on abdomen 1/13 and pt was seen 1/14 in the office with red, maculopapular rash that was on trunk and face, no increased T no hives no itching. No other sx. F/U appt 1/18 pt now with red blanchable circular lesions on face, abd, back & legs. Bil hands purple and swollen, ankles swollen. Abd. soft & nondistended. No increased T . F/U will be as needed. Dx HSP.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Hypopnoea, Nausea, Pharyngeal oedema, Respiratory rate increased, Sensation of foreign body
Clinical narrative: Approx. 4 hrs after receiving FLUZONE HD, pt. returned with throat swelling/lump in throat, nausea, rapid shallow breaths. Had her put head down between knees. Gave 50mg diphenhydramine IM. She vomited after about 10 mins & I sent her to emergency room.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Approx. 4 hrs after receiving FLUZONE HD, pt. returned with throat swelling/lump in throat, nausea, rapid shallow breaths. Had her put head down between knees. Gave 50mg diphenhydramine IM. She vomited after about 10 mins & I sent her to emergency room.
Age: 44.0
Sex: M
Vaccine: FLU3, HEPAB
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 24 hrs after receipt of vaccine arm became swollen & red & hot at site of intradermal flu injection.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Patient noticed a red rash on left arm around injection site; it is warm to the touch, itches, but not painful. She has been taking BENADRYL and CALADRYL lotion has been applied.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient noticed a red rash on left arm around injection site; it is warm to the touch, itches, but not painful. She has been taking BENADRYL and CALADRYL lotion has been applied.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 48 hrs after administration intradermal FLUZONE developed red, hot, swollen area at vaccine site.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial information has been received from a pharmacist concerning a patient with an unspecified age, gender, pertinent medical history or drug reactions / allergies. On 11-JAN-2013, the patient was vaccinated with an expired RECOMBIVAX HB (exp date October 2012)(dose, route were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. No treatment information was reported. Laboratory diagnostic studies were not reported. The patient's outcome was unknown. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pain, Lacrimation increased, Oedema mouth
Clinical narrative: Pt called approx 3 3/4 hours post AFLURIA flu immunization to report mouth was starting to swell, eyes hurt & watering; told him to please seek medical attention immediately. Pt said he would.
Age: 4.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dizziness, Dyspnoea, Rash
Clinical narrative: Pt came back 1/18/13 to report by 6 pm could not breathe / dizziness / rash on (R) arm & leg (not at injection site), pain in chest last night. Pt felt better today (3pm today).
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Flu shot given around 6 pm, patient sat & adjusting sweat shirt, for about 10 minutes, returned to the front of the store & passed out behind the front counter; ambulance called; pt left responding.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm, tired, exhausted (per patient).
Age: 1.51
Sex: M
Vaccine: FLU3
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: Date given 1/7/13 reaction on 1/8/13 extreme edema at inj. site with 102 degree fever. No treatment given Mom didn't notify our office until 1/18/13 & reaction imp. within 24 hours.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Diarrhoea, Headache, Malaise
Clinical narrative: Within 6 hours of vaccine administration, patient became very ill with decreased appetite, headache and diarrhea that lasted 3 days.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Malaise, Pyrexia
Clinical narrative: Pt has symptoms of a flu (flu like symptoms). She had fever & could not get out of bed for 1-2 days. After 2 days, patient started to feel better.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer reporting on herself a 69 years old female (also reported as male) patient with esophageal cancer and no drug reactions or allergies, who is 2007 was vaccinated subcutaneously with dose 1 live ZOSTAVAX (Dose and lot # not provided). No other co-suspects were reported. Concomitant medications included NEXIUM, herbs (unspecified) (Herbal) and CREON. Consumer stated he had vaccination with live ZOSTAVAX, then years later on 01-JAN-2013, got shingles. He had the outbreak as stated, on his right side from his scalp to his cheek. The patient sought medical attention and was treated with antivirals (unspecified) by 10 days and gabapentin, it has since cleared up with the antivirals prescribed. Labs diagnostics were not performed. The outcome of shingles on his right side from his scalp to his cheek was reported as recovering/resolving. The relatedness for shingles on his right side from his scalp to his cheek is unknown for live ZOSTAVAX. Additional information has been requested.
Age: 0.96
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Clumsiness, Dyskinesia, Feeling abnormal, Gait disturbance
Clinical narrative: Resolved suspected Guillain-Barre syndrome (mild). 12/07/2012 Mother is calling in. Pt got her 2nd dose of flu vaccine on Wednesday. Today she woke up "acting strangely". States she was a little fussy this AM but now is calm. She said she seems slow and uncoordinated and doesn't want to stand on legs. Asked mom if there is any local reaction (redness, swelling) or fever, which she denies. Mom wants to know if this is a reaction to the flu vaccine or something else. Please advise. Use TYLENOL or ADVIL for comfort, if not improving in the next 24-48 hours then needs OV. 12/07/2012 PC to mother; she states that patient is acting much more 'normal' after her lunch and nap; she will call if any further concerns. 11 mo healthy infant had received her 2nd flu shot 4 days ago. She has done well with all her vaccinations so far, the following morning, the mother found her acting a bit fussier, no fever, but seeming to not want to stand on her legs and was somewhat wobbling. She already has been crawling, pulling to stand and doing some assisted walking up to this point. She gave her TYLENOL and seemed a bit better that day. 3 days ago, she then refused to get up on her legs at all and drug them while crawling. She did not have fever. Her left thigh was the site of the shot and was not red or swollen. She was not having any obvious bowel or bladder changes (of course in diapers) and could still sit. Over the next 2 days she seemed to slowly improve and today is mostly back to her normal strength, will crawl, get up on her legs to pull to stand an do some assisted walking. Mom was wondering about her ears if they were infected causing her imbalance, or ringing in her ears. She is sleeping better at night as well. Concern after flu vaccination 10/6/12. For 2-3 days, grandparents and parents found her to be clumsier with her hands as well (this wasn't known per her visit in December), even not using her pincer grasp at the time. She also was not able to stand as well as she had been. She was pulling to stand and taking a few steps with assistance before the vaccination. This was her 2nd flu vaccination, she was back to normal strength when I saw her in the ov a few days later. She continues to progress normally with walking unassisted now.
Age: 0.96
Sex: F
Vaccine: FLU3
Symptoms: Irritability, Tinnitus
Clinical narrative: Resolved suspected Guillain-Barre syndrome (mild). 12/07/2012 Mother is calling in. Pt got her 2nd dose of flu vaccine on Wednesday. Today she woke up "acting strangely". States she was a little fussy this AM but now is calm. She said she seems slow and uncoordinated and doesn't want to stand on legs. Asked mom if there is any local reaction (redness, swelling) or fever, which she denies. Mom wants to know if this is a reaction to the flu vaccine or something else. Please advise. Use TYLENOL or ADVIL for comfort, if not improving in the next 24-48 hours then needs OV. 12/07/2012 PC to mother; she states that patient is acting much more 'normal' after her lunch and nap; she will call if any further concerns. 11 mo healthy infant had received her 2nd flu shot 4 days ago. She has done well with all her vaccinations so far, the following morning, the mother found her acting a bit fussier, no fever, but seeming to not want to stand on her legs and was somewhat wobbling. She already has been crawling, pulling to stand and doing some assisted walking up to this point. She gave her TYLENOL and seemed a bit better that day. 3 days ago, she then refused to get up on her legs at all and drug them while crawling. She did not have fever. Her left thigh was the site of the shot and was not red or swollen. She was not having any obvious bowel or bladder changes (of course in diapers) and could still sit. Over the next 2 days she seemed to slowly improve and today is mostly back to her normal strength, will crawl, get up on her legs to pull to stand an do some assisted walking. Mom was wondering about her ears if they were infected causing her imbalance, or ringing in her ears. She is sleeping better at night as well. Concern after flu vaccination 10/6/12. For 2-3 days, grandparents and parents found her to be clumsier with her hands as well (this wasn't known per her visit in December), even not using her pincer grasp at the time. She also was not able to stand as well as she had been. She was pulling to stand and taking a few steps with assistance before the vaccination. This was her 2nd flu vaccination, she was back to normal strength when I saw her in the ov a few days later. She continues to progress normally with walking unassisted now.
Age: 16.0
Sex: M
Vaccine: FLUX
Symptoms: Choking, Drooling, Electrocardiogram, Gaze palsy, Unresponsive to stimuli
Clinical narrative: Driving in car, patient's eyes rolled back and became unresponsive, then saliva came out of mouth and a choking sound. Total time lasted about 3-4 minutes.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: Fever - Motrin. Muscle aches and pain - Motrin, heating pad. Soreness at injection site.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: From 6:00 AM on 1/18/2013; vomiting, fever, headache, body aches, nausea, pain at injection site.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: From 6:00 AM on 1/18/2013; vomiting, fever, headache, body aches, nausea, pain at injection site.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Disturbance in attention, Feeling abnormal, Impaired work ability
Clinical narrative: I felt as though my mind/head was in a total fog, my ability to concentrate on my job and other tasks had declined. This seemed to last for almost a week. Ive been a vitmain and mineral supplement intake for close to 3 months.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Pain, Swelling
Clinical narrative: Redness, swelling to back and neck, and pain and numbness.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Bone pain, Pain in extremity
Clinical narrative: Sore arm, sore to the bone, from shoulder to elbow, worse when laying down.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, IPV, RVX
Symptoms: Diarrhoea, Faeces discoloured, Frequent bowel movements, Pyrexia
Clinical narrative: Increase in bowel movements from 2x a day to 9x.  Green watery, sometimes mucousy diarrhea and slight fever of 100 lasting 3 weeks so far.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Activated partial thromboplastin time, Axillary mass, Brain natriuretic peptide, Cardiac enzymes, Chest pain
Clinical narrative: Intense itching on the underside of the arm that the injection was given and a lump felt in the armpit.  By Tuesday there was pain in the chest and continued itching.  1/18/13 went to ER thinking she was having a heart attack.  Did CT Scan and it showed no heart involvement or blood clots. She was told to stop taking her Provera.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Differential white blood cell count, Electrocardiogram, Fibrin D dimer, Full blood count
Clinical narrative: Intense itching on the underside of the arm that the injection was given and a lump felt in the armpit.  By Tuesday there was pain in the chest and continued itching.  1/18/13 went to ER thinking she was having a heart attack.  Did CT Scan and it showed no heart involvement or blood clots. She was told to stop taking her Provera.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Metabolic function test, Prothrombin time, Pruritus, Smear test
Clinical narrative: Intense itching on the underside of the arm that the injection was given and a lump felt in the armpit.  By Tuesday there was pain in the chest and continued itching.  1/18/13 went to ER thinking she was having a heart attack.  Did CT Scan and it showed no heart involvement or blood clots. She was told to stop taking her Provera.
Age: 0.35
Sex: F
Vaccine: 6VAX-F, OPV, PPV, RVX
Symptoms: Diet refusal, Irritability, Pyrexia, Retching, Vomiting
Clinical narrative: Had been running a fever and been a bit fussy shortly after shots, but at 7:15 AM on the 19th she threw up all over until she was dry heaving she wouldn't eat either prior to that when I frayed to feed her at 6AM.  I called the clinic and the doctor saw her and told us to continue with the ibuprofen and only let her have small amounts of formula at a time.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Pain in shoulder especially during resting.  Pain is not getting better as of 1/19/2013.  Spoke to pharmacist at the facility. He said I don't want to scare you but this doesn't sound good.  I need to see my primary physician but I have to wait until Friday, 1/25.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hive like rash on face, neck shoulders and down back.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Diplopia, Headache, Pain in extremity
Clinical narrative: Severe chills, severe headache, severe leg pain, weakness, fever went from 99.0 to 105.5 with in 30 min, double vision.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Severe chills, severe headache, severe leg pain, weakness, fever went from 99.0 to 105.5 with in 30 min, double vision.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives. Starting on arm, spread to extremities, chest, neck, face within 24hrs.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pneumococcal vaccine administered on 02/13/2012. High fever-was 102 on 02/13/2012; maximum of 103.5 on 02/14/2012. Swollen, red and hot at injection site in arm.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Bed rest, Chills, Headache, Myalgia
Clinical narrative: Sudden profound chills, impressive headache and large muscles aches. 2 ASA taken and immediate bed rest. Symptoms subsided without complications within about 2 and 1/2 hrs. No further side affects.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Went to get out of bed, experienced vertigo for the 1st time in my life. Sat down, waited a minute, and was fine. Since then, I've experienced vertigo every morning and after sitting for a prolonged period.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Inflammation, Rash erythematous, Rash pruritic
Clinical narrative: Hundreds of red inflamed itchy bumps on my back and left torso front side.  No relief from hot itchy bumps.  Pharmacy recommended taking an antihistamine on 01/19/2013.  No relief as of yet.  I am very sensitive to chemicals and I now recall how I was sensitive to thimerosal that used to be in contact lense solution in the 1970s.  I could not use it.  I was not told by the pharmacy that the vaccine had mercury based thimerosal in it.  I was not given the option of waiting for the vaccine that they pharmacy now has in stock without thimerosal.  If I had know that the administered vaccine had mercury based thimerosal as a preservative I would not have taken the injection.  I would have waited for the non-thimerosal version.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting, fever (101).
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster, Herpes zoster ophthalmic
Clinical narrative: SHINGLES AFFECTING THE LEFT SIDE OF THE SCALP DOWN TO THE EYE.  TREATMENT CONSISTS OF 500MG OF FAMCYCLOVIR 3 TIMES DAILY FOR ONE WEEK, PLUS AN EYE OINTMENT OF GANCICLOVIR GEL 0.15% 5 TIMES DAILY.
Age: 1.6
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Consistent fever, lasting for 3 days.  Fever not helped by Motrin or acetaminophen.  Temperature ranged from 101.4 degrees F - 103.4 degrees F. On 1/19/2013 child woke with mild measle-like rash covering face, chest & stomach, and back.