chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Induration, Local swelling, Night sweats, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to a 4 year old female patient. It was reported that there was no pertinent medical history or drug allergies. On 19-JUN-2014 the patient was vaccinated with PROQUAD (Merck) (route, strength not reported). The reporter stated that she believes that this was patient's second dose of "MMR and varicella" and that was unsure if the patient received the PROQUAD (Merck) for the first dose, or whether they were received separately. The reporter stated that the patient's leg got swollen, and became hard and red on 19-JUN-2014 (reported as the first two days after injection). The reporter also mentioned that the patient got little bit of fever on an unknown date in 2014 and on 27-JUN-2014 the patient had small red bumps on her back, torso and face. The reporter also mentioned that bumps were not itchy, although there was one bump on her face which seemed to bother the patient. The reporter also mentioned that bumps were not itchy, although there was one bump on her face which seemed to bother the patient. The reporter reported that the patient wakes up at night around 11pm as bathed in sweat like her fever just broke. The reporter also stated that the patient was giving her baths and over the counter TYLENOL. The outcome of leg did swell and get hard and red was reported as recovered/resolved. The outcome of bathed in sweat and small red bumps on her back, torso and face, one bump on her face which seemed to bother her was reported as not recovered/not resolved. No product quality complaint was involved. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a consumer refers to a 4 year old female patient. It was reported that there was no pertinent medical history or drug allergies. On 19-JUN-2014 the patient was vaccinated with PROQUAD (Merck) (route, strength not reported). The reporter stated that she believes that this was patient's second dose of "MMR and varicella" and that was unsure if the patient received the PROQUAD (Merck) for the first dose, or whether they were received separately. The reporter stated that the patient's leg got swollen, and became hard and red on 19-JUN-2014 (reported as the first two days after injection). The reporter also mentioned that the patient got little bit of fever on an unknown date in 2014 and on 27-JUN-2014 the patient had small red bumps on her back, torso and face. The reporter also mentioned that bumps were not itchy, although there was one bump on her face which seemed to bother the patient. The reporter also mentioned that bumps were not itchy, although there was one bump on her face which seemed to bother the patient. The reporter reported that the patient wakes up at night around 11pm as bathed in sweat like her fever just broke. The reporter also stated that the patient was giving her baths and over the counter TYLENOL. The outcome of leg did swell and get hard and red was reported as recovered/resolved. The outcome of bathed in sweat and small red bumps on her back, torso and face, one bump on her face which seemed to bother her was reported as not recovered/not resolved. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (dose, frequency, strength and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that an unspecified number of patients (no patient information was known) were administered ROTATEQ, was improperly stored outside the temperature storage range listed in the product inserts, on an unknown date. No adverse effects reported. Additional information has been requested. These case is one (1) of four (4) reports from the same source.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, frequency, strength and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that an unspecified number of patients (no patient information was known) was administered GARDASIL which was improperly stored outside the temperature storage range listed in the product inserts, on an unknown date. No adverse effects reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Seen for 5 yr WCE on 7/10/14. Rec'd KD immunizations. S/S began eve. 7/11/14. Seen for s/s on 7/12/14. 5 inch x 4 inch area erythema, mod. edema, mild warmth and TTP to Lt arm at site. Tx with ibuprofen and ice packs.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 08-JUL-2014 the patient was vaccinated with an expired ZOSTAVAX, Expiration date: 21-JUN-2014 (dose, route and lot # were not reported). No adverse reactions reported. Additional information is not expected due to the pharmacist cannot be contacted again.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot # not reported). On an unknown date the patient developed a rash at the injection site after receiving ZOSTAVAX. Action taken with ZOSTAVAX was unknown. The outcome of rash at the injection site was unknown. The relatedness between the event and ZOSTAVAX was not specified. Additional information is not expected as the patient did not wish to provide any information and there was no mention of a physician in this case.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of VAQTA (dose, frequency, strength and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that an unspecified number of patients (no patient information was unknown) were administered VAQTA, which was improperly stored outside the temperature storage range listed in the product inserts, on an unknown date. No adverse effects reported. Additional information has been requested. These case is one (1) of four (4) reports from the same source.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of RECOMBIVAX HB (dose, frequency, strength and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that an unspecified number of patients (no patient information was known) was administered RECOMBIVAX HB, which was improperly stored outside the temperature storage range listed in the product inserts, on an unknown date. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified multiple patients. The medical history of unspecified number of patient was unknown. Approximately in June 2014 (last month), unspecified number of patients were vaccinated with PROQUAD (Merck) (dose unit, route, lot# and expiry date unknown) that were improperly stored. No concomitant medications were reported. No adverse effects were reported. The outcome of PROQUAD, was stored improperly and were administered to unspecified number of patients and no adverse effects reported was unknown. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a consumer reporting on himself: a 65 year old male patient. He had no pertinent medical history. No concurrent conditions were reported. The patient has had drug reaction/allergy to NIASPAN. On 23-JUN-2014 the patient was vaccinated with PNEUMOVAX 23 injection, dose 2, for prevention of pneumonia; lot#, expiration date not reported. Concomitant therapies included CRESTOR 20mg, Lisinopril (manufacturer unknown), COREG, PRILOSEC and ASPIRIN 81 mg. On 24-JUN-2014 the patient's arm (below the injection site) started to become red and swell. The next day, on 25-JUN-2014, the redness and swelling continued down the patient's arm and stopped right above the wrist. The patient saw his physician, on an unknown date, and was given unspecified steroid shot and an unspecified antibiotic shot. The patient was also prescribed cephalexin 500mg and prednisone 20mg. At the time of the report the patient was recovering after the physician started him on the treatment. It was also reported that the patient has had PNEUMOVAX 23 on an unspecified date (reported as "over 5 years ago") and did not have any adverse experience. Relatedness between use the PNEUMOVAX 23 and the adverse events was not reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy rash to the face. Took Claritin, Singulair, and topical hydrocortisone without change. Started on oral Prednisone today.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWELLING AT INJECTION SITE.TREATED FOR MILD CELLIUTIS WITH KEFLEX AND PREDNISONE(40 mg).
Age: 0.36
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Dysphagia, Gastric dilatation, Morphoea, Skin striae, Staring
Clinical narrative: Severe facial swelling Parent reports flattened facial features swelling of the both temporal lobes, swelling of the tongues white spots of stomach and swelling of stomach with stretch mark that remains from swelling. Parent reports infant has had trouble swallowing and staring off in distance since immunization.
Age: 0.36
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Severe facial swelling Parent reports flattened facial features swelling of the both temporal lobes, swelling of the tongues white spots of stomach and swelling of stomach with stretch mark that remains from swelling. Parent reports infant has had trouble swallowing and staring off in distance since immunization.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified multiple patients. The medical history of unspecified number of patient was unknown. Approximately in June 2014 (last month), unspecified number of patients were vaccinated with (Oka/Merck) VARIVAX (dose unit, route, lot# and expiry date unknown) that was improperly stored. No concomitant medications were reported. No adverse effects were reported. The outcome of (Oka/Merck) VARIVAX was stored improperly and were administered to unspecified number of patients and no adverse effects reported was unknown. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patient. On 05-AUG-2011 the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose and route unspecified). On 10-JUL-2014, the was vaccinated with the second dose of GARDASIL (lot #, expiration date, dose and route unspecified). No adverse effects reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. On 20-JUN-2014 the patient was inadvertently administered VARIVAX (0.5 ml, subcutaneous, lot# and expiry date were not reported) and PROQUAD (0.5 ml, subcutaneous, lot# and expiry date were not reported). No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot# and expiry date were not reported) for prevention of shingles. After the patient was injected she had a large local reaction approximately 15-20cm in diameter. It was reported that the patient has recovered (unknown date). The physician believed that the local reaction was nothing to much to be concerned with. The physician felt that was a normal event sometimes associated with the ZOSTAVAX. Additional information is not expected because there is no permission to contact a physician.
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a male patient in his 40's. On an unknown date the patient in his 40's was vaccinated with ZOSTAVAX (dose, units, dose number, anatomical location, route of administration, lot number were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients. The reporter stated that an unknown number of doses of (Oka/Merck) VARIVAX that have been exposed to 11 F for brief periods during defrost cycles had been administered. No adverse effect reported. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Erythema, Swelling face
Clinical narrative: Face became reddened. Swelling across eye brows, left eye and down to cheek. Dr notified. TYLENOL and BENADRYL were given. BENADRYL given by mom every 4 hours.
Age: 26.0
Sex: F
Vaccine: TD, TD
Symptoms: Paraesthesia
Clinical narrative: 07-09-14 1000 - 'Tingling opposite arm (like my arm fell asleep) went away same day. 7/10 and 7/11, opposite arm and upper back feel like I have a bad sunburn, but there is no rash or markings. (started 07/10/14 2:00 pm). 7-14-14 "Everything is back to normal. I'm just fine."
Age: 26.0
Sex: F
Vaccine: TD, TD
Symptoms: Paraesthesia, Sensory disturbance
Clinical narrative: 07-09-14 1000 - 'Tingling opposite arm (like my arm fell asleep) went away same day. 7/10 and 7/11, opposite arm and upper back feel like I have a bad sunburn, but there is no rash or markings. (started 07/10/14 2:00 pm). 7-14-14 "Everything is back to normal. I'm just fine."
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Hyperhidrosis, Migraine, Muscle spasms, Pyrexia
Clinical narrative: Severe muscle spasms all over, migraine type headache, profuse perspiration, fever, chills and uncontrollable shaking.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: Severe muscle spasms all over, migraine type headache, profuse perspiration, fever, chills and uncontrollable shaking.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Rash, fussiness and fever up to 104.1 Rectal. Treating with Tylenol for fever.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Local swelling, Musculoskeletal stiffness
Clinical narrative: I had what I thought were normal vaccine symptoms (soreness at injection site and some muscle stiffness on evening of 7/1/2014).  The next morning more soreness and redness at site.  This progressed thru the day.  On the evening of 7/2 I noticed more redness with a approx 1 inch line running around my arm with considerable pain into armpit.  By morning of 7/3 the red was all the way around my upper arm with increased tenderness and noticeable swelling.  I then made a appointment to be seen in clinic where exam was completed and course of prednisone was started.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: I had what I thought were normal vaccine symptoms (soreness at injection site and some muscle stiffness on evening of 7/1/2014).  The next morning more soreness and redness at site.  This progressed thru the day.  On the evening of 7/2 I noticed more redness with a approx 1 inch line running around my arm with considerable pain into armpit.  By morning of 7/3 the red was all the way around my upper arm with increased tenderness and noticeable swelling.  I then made a appointment to be seen in clinic where exam was completed and course of prednisone was started.
Age: 0.36
Sex: M
Vaccine: DTAP, HEP, MMRV, PER
Symptoms: Febrile convulsion, Grand mal convulsion, Myoclonic epilepsy
Clinical narrative: Seizures (Grand Mal, Myoclonic, Febrile )that continued for 3 years.  Still has febrile seizures.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Tinnitus
Clinical narrative: Noticable ringing in the ears, stronger in the right.
Age: 1.0
Sex: M
Vaccine: HEPAB
Symptoms: Product quality issue
Clinical narrative: Copied from e-mail received Parent: When I went to give the one, it had chunks of white floating in it, that did not dissolve with agitation.  The others had white sediment in them, as I agitated them, it swirled but was cloudy.
Age: 1.06
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Gait disturbance, Lethargy, Muscle twitching, Pyrexia
Clinical narrative: Fever 103, twitching Friday night with fever-possible seizure? lethargy, refusing to walk.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site discomfort, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: 11 x 16 cm erythematous blanchable rash noted on left thigh. Central head noted, no fluctuance/induration noted. No abscess or cellulitis, no pain to the touch; Warm to touch. Pt has had several dose of BENADRYL, placed ice on area, MOTRIN for discomfort.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Local swelling
Clinical narrative: Arm swelling
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy red rash 2 inches below injection site. Improved over 2 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Pt reported a hard lump measuring 8 cm in diameter that was red, painful and hot at site of vaccine about 2 days after receiving. Pt visited ER- told to put hot compresses on- has appt w/PCP tomorrow.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Immediate redness and swelling of all 4 sites - especially (R) lower anterior thigh site injection. Pt. has history of rashes due to allergies. BENADRYL 6.25mg given orally.
Age: 0.68
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Nodule, Oedema peripheral, Pyrexia
Clinical narrative: Fever of above 102 developed within 24 hrs baseball sized edema/erythema to thigh with knot.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Angioedema, Pain
Clinical narrative: Angioedema and pain
Sex: U
Vaccine: TYP
Symptoms: Typhoid fever
Clinical narrative: Abstract: Typhoid vaccination is recommended before travel to countries where typhoid fever is endemic, though little information is available on its effectiveness in travelers. We estimated typhoid vaccination effectiveness (VE) by comparing vaccination status in cases of typhoid fever and paratyphoid fever (Salmonella Paratyphi A infection, against which typhoid vaccine offers no protection) reported. We included travelers to a specific area and excluded persons <2 years old and cases in which vaccination status was not reported. From 2008 through 2011, 744 eligible cases (602 typhoid, 142 paratyphoid A) were reported to CDC. Typhoid vaccination was reported for 5% (29/602) of typhoid patients and for 20% (29/142) of paratyphoid A patients. Estimated VE was 80% (95% confidence interval, 66-89%). Because of missing data, we could not estimate VE for specific vaccines. We demonstrated moderate effectiveness of typhoid vaccination in travelers, supporting vaccination recommendations. Initial report retrieved from the scientific literature on 02 July 2014. Six patients, among vaccinated typhoid patients for whom the type of vaccine was reported, experienced typhoid after being vaccinated with a parenteral TYPHOID VACCINE (manufacturer unknown, lots and dates of administration not reported). Ages and genders were not reported. All patients had been vaccinated within five years of diagnosis, which occurred between 2008 and 2011. Additional information, including treatment, outcome, and disease course, were not reported. Documents held by sender: None.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Initial case received from a healthcare professional on 09 July 2014. It is part of a cluster of 2 patients who experienced similar events after administration of ADACEL. The other patient, who was unidentified, is captured in case number 2014SA073710. A 76-year-old female patient received an intramuscular injection of ADACEL (lot number U4875AA) on 02 June 2014 following a dog bite to the right arm and right breast on 01 June 2014. No other medical history was reported. On 04 June 2014, i.e. two days post-vaccination, the patient reported cellulitis. She was seen by her physician on 06 June 2014, and event was resolving. Per the reporter, no testing was done. Additional documents held by sender: None.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema multiforme, Pruritus, Rash, Urticaria
Clinical narrative: Skin rash, rash, erythema multiform and urticaria pruritus
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Alopecia
Clinical narrative: Alopecia began after HPV vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated inadvertently with 2 doses of (Oka/Merck) VARIVAX (lot#, doses not provided) during the same office visit. No adverse effects reported. Additional information is not expected, because the call was abruptly discontinued before any demographic information could be obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. It was reported that unknown number of doses of (Oka/Merck) VARIVAX were exposed to temperature of -14C for a few hours and then -10.2 C for less than 1 hour. It was reported that the doses might had been administered. No adverse effect was reported. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Erythema, Induration, Joint swelling, Joint warmth, Pyrexia
Clinical narrative: URI since 6/21, Fever 6/23, psosible coxsackie virus, used ibuprofen. Checkup 7/8, well child, recv'd MMR, no analgesics given. Rash started night of 7/11, by 7/12 hives and indurated lesions with surrounding erythema, hot and swollen joints: knee, ankle, thumbs, save BENADRYL and Prednisolone. Much better 3 hr later, continued course of prednisolone.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Upper respiratory tract infection, Urticaria
Clinical narrative: URI since 6/21, Fever 6/23, psosible coxsackie virus, used ibuprofen. Checkup 7/8, well child, recv'd MMR, no analgesics given. Rash started night of 7/11, by 7/12 hives and indurated lesions with surrounding erythema, hot and swollen joints: knee, ankle, thumbs, save BENADRYL and Prednisolone. Much better 3 hr later, continued course of prednisolone.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site inflammation, Injection site nodule, Injection site pain
Clinical narrative: Immediate swelling and pain at injection site, followed by constant pain, difficulty using his arm due to pain. Pt seen twice - OV 7/9/14, walk in 6/10, pt called office 6/17.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Immediate swelling and pain at injection site, followed by constant pain, difficulty using his arm due to pain. Pt seen twice - OV 7/9/14, walk in 6/10, pt called office 6/17.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unknown number of patients, unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of PROQUAD (dose, frequency, strength and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse reported that in her facility got a new thermometer system on 13-MAY-2014, and according to the thermometer, PROQUAD was exposed to temperatures above the recommended storage temperature on multiple occasions. At this time, it was not known whether or not the excursions were supported because data was insufficient to evaluate. The nurse stated that she was certain that doses of PROQUAD had been administered to patients since these excursions were recorded. No adverse effects have been experienced. Additional information has been requested. This case is one (1) or two (2) reports from the same source.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Disorientation, Dissociation, Electroencephalogram normal, Feeling abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Feelings of mental fogginess, disorientation, mental detachment, near syncope. Started 6 days after vaccine was given. Intermittent spells continue.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging normal, Presyncope
Clinical narrative: Feelings of mental fogginess, disorientation, mental detachment, near syncope. Started 6 days after vaccine was given. Intermittent spells continue.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Grimacing, Posture abnormal, Presyncope, Tonic clonic movements
Clinical narrative: Acute onset tonic clonic muscle contraction asso with grimacing and flexion of wrists, knees, hips. Vasovagal posturing. Reversal promptly with smelling salts.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient who administered a first 0.5ml dose of HPV VLP vaccine (yeast) (lot # 660391/0063X) intramuscularly to a patient on 25-OCT-2010, which had expired on 19-OCT-2010. No adverse effect reported. Follow up information has been received from the certified medical assistant who reported that the 14 year old female patient was vaccinated with the first 0.5 ml dose of HPV VLP (yeast) (lot # 660391/0063X) intramuscularly into right deltoid. The reporter also mentioned that the event did not require ER/doctor visit. Information has been received from a social media site regarding a female patient. The patient told her story regarding GARDASIL on a social media site. No further information is available.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient telephone 5 days after injection stating she has pain, and swelling at the site. Improved with ice. Follow up phone call on 6/28/14: Adverse effect resolved.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Injection site erythema, Local swelling, Oedema peripheral, Vaccination site nodule
Clinical narrative: Tetnis shot- swollen lump on arm, swollen and bruised under arm (week after) (R arm pit) 2 cm red nodule at vaccine site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Arthralgia
Clinical narrative: Pt's knee was hurting off and on beginning about 10 days after immunizations. Normal exam.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Day after vaccine patients arm where administered became swollen and painful to entire upper arm.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Local swelling
Clinical narrative: Local swelling an redness at site of vaccination. Treatment included ibuprofen and apply ice to site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unknown number of patients, unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose, frequency, strength and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse reported that in her facility got a new thermometer system on 13-MAY-2014, and according to the thermometer, (Oka/Merck) VARIVAX was exposed to temperatures above the recommended storage temperature on multiple occasions. At this time, it was not known whether or  not the excursions were supported because data was insufficient to evaluate. The nurse stated that she was certain that doses of (Oka/Merck) VARIVAX was administered to patients since there excursions were recorded. No adverse effects have been experienced. Additional information has been requested. These case is one (1) of two (2) reports from the same source.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site reaction
Clinical narrative: Reactive cellulitis (R) thigh and mild rxn (L) thigh. Azithro prophylactic ac tid-qid. Cool compresses x 48 hrs then low heat OK, ER if needed.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an administrator refers to a patients of unknown age and gender who on an unknown date, were vaccinated with PEDVAX HIB (does and route not provided). The reporter stated an unspecified number of patients may have received doses of PEDVAX HIB (does in series unspecified) that were exposed to 25F for up to 5 days (120 hours) (not supported). No adverse effects reported. Administrator stated she has no patient details at this time  . No further information provided. The outcome of incorrect product storage was unknown. This is one of several reports from same source. Additional information has been requested, since can contact the physician.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Mother reported to this provider that after patient received 2 month vaccines, patient developed fever within 24 hours. Max at 105 degrees -> ER for evaluation.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Arm became red, inflammed, painful, and itchy at injection site. Lesion was formed at the injecdtion site with white border.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Arm became red, inflammed, painful, and itchy at injection site. Lesion was formed at the injecdtion site with white border.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer reporting on himself who on 15-JUN-2011, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number was not reported). On 18-MAY-2014, the patient experienced was diagnosed with shingles, he went to the emergency room due to pain on the right side of his head. At the time of the report, the patient no longer had any symptoms of shingles. The relatedness for shingles and ZOSTAVAX was unknown. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to her daughter a currently 18 year old female patient. Pertinent medical history, drug reactions or allergies were not reported. On 02-APR-1997, the patient was vaccinated with (Oka/Merck) VARIVAX dose 1 (lot # was not reported) and on 08-AUG-2007, the patient was vaccinated with (Oka/Merck) VARIVAX dose 2 (lot # was not reported). Concomitant medication was not reported. On an unknown date, reported as "recently" the patient had titers drawn which showed less than 0.91 for varicella which was considered not immune. The outcome of had titers drawn which showed less than 0.91 for varicella which was considered not immune was unknown. Causality was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood pressure decreased, Fall, Head injury, Loss of consciousness, Pallor
Clinical narrative: After vaccines given, patient and mom standing at checkout desk, patient experienced LOC, fell back, landing on back, hit head on carpeted floor, no emesis, +? seizure activity lasting <5 seconds, LOC lasted <30 seconds, patient awoke on own, helped to upright position, sitting, still pale quiet, BP began to drop 82/60, patient allowed to rest supine on exam table, given water, apple juice, few bites chocolate pudding, color improved, more alert, home with mom and dad, instructions to call immediately if any concerns. Discussed sz/sx to watch/call for. Repeat BP 102/62, HR 70, cr immediate, neg Brudzinski's, EOMI; PERL, neuro exam intact, DTR's + 2/4. No swelling, abrasions, lacerations scalp; right elbow with superficial abrasion, no bleeding.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender who on 03-JUL-2014 was vaccinated with an expired dose of M-M-R II (lot #H010134, expiration date 17-MAY-2014), subcutaneous. No adverse effects reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial and follow up spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Since an unspecified date in February 2014 the unspecified number of patients might have been administered improperly stored doses of (Oka/Merck) VARIVAX (lot # unspecified) (dose, frequency, route and location unspecified). No adverse events were reported. Initial was made regarding improperly report vaccine where no AE was indicated. Follow up information had been received stating that (Oka/Merck) VARIVAX was administered.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a nurse concerning a 24 year old female patient. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, frequency, strength, lot number, expiration date and route were not reported).  Co-suspect and concomitant therapies were not reported. The nurse stated patient had serologic testing conducted for employment reasons at unspecified hospital where she works. Nurse stated patient's "equivocal for mumps came back 1.05" (negative titer results). Nurse states equivocal was conducted on 07-JUL-2014 and reported 09-JUL-2014. No adverse effects reported. Nurse stated pediatric records not available for review of M-M-R II vaccinations yet patient reported to nurse that she had received M-M-R II series as a child. At the time of the report the outcome was unknown.  Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain, Skin warm
Clinical narrative: Red, warm arm, painful. Went to MD, who diagnosed with cellulitis and prescribed KEFLEX 250
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, route and lot # were not reported). On an unknown date ZOSTAVAX was improperly stored and administered to unspecified number of patients. No adverse effects reported. Additional information is not expected due to the pharmacist cannot be contacted.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Axillary pain, Back pain, Balance disorder, C-reactive protein
Clinical narrative: This 39 year old female presents with: 1. hyperlipidemia. The onset of hyperlipidemia was 2014. Additional information: Patient here to discuss labs and treatment options for hyperlipidemia. 2. Reaction after Tdap. Patient reports having a reaction to her tetanus injection she received 1 week ago. She had a Tdap 1 week ago, within a day, she states, her left arm became very swollen, hard, painful, red. The following day, Friday, the pain and swelling into her left axillary and lymph node areas. She states her lymph were enlarged, quite painful and the next couple days the pain spread across her left chest wall to her sternum. She felt "out of it, lightheaded, problems with weakness/balance". Over the last 3 days the pain has progressed to her low back and now is "working up my spine". She states the pain has progressed up to the back of her neck and now causing more headaches and migraine-like headaches. She reports having a similar reaction 9 years ago and, at that time, they blamed it on a flu shot because she had received a flu immunization and Tdap at the same time. She states she had the exact same reaction with back pain, body aches, which eventually, over the following 2 years progressed to chronic fatigue, nausea, vomiting, bouts of diarrhea, chronic pain, which, she states was severe for about 2 years and then seemed to improve. She feels that what she is having now is the exact same reaction and she fears that it's going to progress into more pain and balance problems. She has not had any fevers, syncope, palpitations, chest pain. Her main concern is that she feels like she is drunk when she walks and she is imbalanced and feels "out of it". She's also concerned about chronic pain returning. She has tried TYLENOL and heat to her arm which seem to help.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Erythema, Feeling abnormal, Full blood count, Headache
Clinical narrative: This 39 year old female presents with: 1. hyperlipidemia. The onset of hyperlipidemia was 2014. Additional information: Patient here to discuss labs and treatment options for hyperlipidemia. 2. Reaction after Tdap. Patient reports having a reaction to her tetanus injection she received 1 week ago. She had a Tdap 1 week ago, within a day, she states, her left arm became very swollen, hard, painful, red. The following day, Friday, the pain and swelling into her left axillary and lymph node areas. She states her lymph were enlarged, quite painful and the next couple days the pain spread across her left chest wall to her sternum. She felt "out of it, lightheaded, problems with weakness/balance". Over the last 3 days the pain has progressed to her low back and now is "working up my spine". She states the pain has progressed up to the back of her neck and now causing more headaches and migraine-like headaches. She reports having a similar reaction 9 years ago and, at that time, they blamed it on a flu shot because she had received a flu immunization and Tdap at the same time. She states she had the exact same reaction with back pain, body aches, which eventually, over the following 2 years progressed to chronic fatigue, nausea, vomiting, bouts of diarrhea, chronic pain, which, she states was severe for about 2 years and then seemed to improve. She feels that what she is having now is the exact same reaction and she fears that it's going to progress into more pain and balance problems. She has not had any fevers, syncope, palpitations, chest pain. Her main concern is that she feels like she is drunk when she walks and she is imbalanced and feels "out of it". She's also concerned about chronic pain returning. She has tried TYLENOL and heat to her arm which seem to help.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperlipidaemia, Induration, Laboratory test, Local swelling, Lymphadenopathy
Clinical narrative: This 39 year old female presents with: 1. hyperlipidemia. The onset of hyperlipidemia was 2014. Additional information: Patient here to discuss labs and treatment options for hyperlipidemia. 2. Reaction after Tdap. Patient reports having a reaction to her tetanus injection she received 1 week ago. She had a Tdap 1 week ago, within a day, she states, her left arm became very swollen, hard, painful, red. The following day, Friday, the pain and swelling into her left axillary and lymph node areas. She states her lymph were enlarged, quite painful and the next couple days the pain spread across her left chest wall to her sternum. She felt "out of it, lightheaded, problems with weakness/balance". Over the last 3 days the pain has progressed to her low back and now is "working up my spine". She states the pain has progressed up to the back of her neck and now causing more headaches and migraine-like headaches. She reports having a similar reaction 9 years ago and, at that time, they blamed it on a flu shot because she had received a flu immunization and Tdap at the same time. She states she had the exact same reaction with back pain, body aches, which eventually, over the following 2 years progressed to chronic fatigue, nausea, vomiting, bouts of diarrhea, chronic pain, which, she states was severe for about 2 years and then seemed to improve. She feels that what she is having now is the exact same reaction and she fears that it's going to progress into more pain and balance problems. She has not had any fevers, syncope, palpitations, chest pain. Her main concern is that she feels like she is drunk when she walks and she is imbalanced and feels "out of it". She's also concerned about chronic pain returning. She has tried TYLENOL and heat to her arm which seem to help.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Migraine, Musculoskeletal chest pain, Neck pain, Oedema peripheral, Pain in extremity
Clinical narrative: This 39 year old female presents with: 1. hyperlipidemia. The onset of hyperlipidemia was 2014. Additional information: Patient here to discuss labs and treatment options for hyperlipidemia. 2. Reaction after Tdap. Patient reports having a reaction to her tetanus injection she received 1 week ago. She had a Tdap 1 week ago, within a day, she states, her left arm became very swollen, hard, painful, red. The following day, Friday, the pain and swelling into her left axillary and lymph node areas. She states her lymph were enlarged, quite painful and the next couple days the pain spread across her left chest wall to her sternum. She felt "out of it, lightheaded, problems with weakness/balance". Over the last 3 days the pain has progressed to her low back and now is "working up my spine". She states the pain has progressed up to the back of her neck and now causing more headaches and migraine-like headaches. She reports having a similar reaction 9 years ago and, at that time, they blamed it on a flu shot because she had received a flu immunization and Tdap at the same time. She states she had the exact same reaction with back pain, body aches, which eventually, over the following 2 years progressed to chronic fatigue, nausea, vomiting, bouts of diarrhea, chronic pain, which, she states was severe for about 2 years and then seemed to improve. She feels that what she is having now is the exact same reaction and she fears that it's going to progress into more pain and balance problems. She has not had any fevers, syncope, palpitations, chest pain. Her main concern is that she feels like she is drunk when she walks and she is imbalanced and feels "out of it". She's also concerned about chronic pain returning. She has tried TYLENOL and heat to her arm which seem to help.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Red blood cell sedimentation rate, Spinal pain
Clinical narrative: This 39 year old female presents with: 1. hyperlipidemia. The onset of hyperlipidemia was 2014. Additional information: Patient here to discuss labs and treatment options for hyperlipidemia. 2. Reaction after Tdap. Patient reports having a reaction to her tetanus injection she received 1 week ago. She had a Tdap 1 week ago, within a day, she states, her left arm became very swollen, hard, painful, red. The following day, Friday, the pain and swelling into her left axillary and lymph node areas. She states her lymph were enlarged, quite painful and the next couple days the pain spread across her left chest wall to her sternum. She felt "out of it, lightheaded, problems with weakness/balance". Over the last 3 days the pain has progressed to her low back and now is "working up my spine". She states the pain has progressed up to the back of her neck and now causing more headaches and migraine-like headaches. She reports having a similar reaction 9 years ago and, at that time, they blamed it on a flu shot because she had received a flu immunization and Tdap at the same time. She states she had the exact same reaction with back pain, body aches, which eventually, over the following 2 years progressed to chronic fatigue, nausea, vomiting, bouts of diarrhea, chronic pain, which, she states was severe for about 2 years and then seemed to improve. She feels that what she is having now is the exact same reaction and she fears that it's going to progress into more pain and balance problems. She has not had any fevers, syncope, palpitations, chest pain. Her main concern is that she feels like she is drunk when she walks and she is imbalanced and feels "out of it". She's also concerned about chronic pain returning. She has tried TYLENOL and heat to her arm which seem to help.
Age: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 63 year old male patient. Pertinent medical history, drug reactions or allergies were not reported. Additional information is not expected because reporter refused additional contact.