chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: ADEN_4_7, HEP, HEPA, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives on body.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, C-reactive protein, Cytomegalovirus test, Epstein-Barr virus test, Fatigue
Clinical narrative: This spontaneous report was received from a physician and refers to a 19 years old female patient with attention deficit/hyperactivity disorder, and without drug reactions or allergies. The physician reported that on 12-AUG-2014, the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscular, (anatomical location, lot number and expiration date were not provided), and then on 10-AUG-2015, the patient was vaccinated with the second dose of GARDASIL, lot # L007531, 0.5 ml, intramuscular, (anatomical location, and expiration date were not provided). Concomitant therapies included ADDERALL. The physician stated that the patient was seen in his office on 18-AUG-2015 due to a high fever, ranging from 104 degrees F to 106 degrees F. It was also reported that the patient was seen every day from 18-AUG-2015 through 21-AUG-2015, because she was very sick. Additionally, multiple laboratory tests were performed during those visits, which included on 18-AUG-2015, complete blood count (CBC), an Epstein Barr viral panel and C-reactive protein, and on 20-AUG-2015, a CBC,  cytomegalovirus antibody titer and a liver panel, the results were not provided. Subsequently, the patient was diagnosed with mononucleosis, and was prescribed ibuprofen as treatment for the fever. The outcome of mononucleosis was reported as not recovered. The relatedness between mononucleosis and therapy with GARDASIL was not reported. No product quality complaint was involved. The reporter considered mononucleosis to be serious due to disability, because the extreme fatigue was preventing the patient from attending college classes. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count, Infectious mononucleosis, Liver function test, Malaise, Pyrexia
Clinical narrative: This spontaneous report was received from a physician and refers to a 19 years old female patient with attention deficit/hyperactivity disorder, and without drug reactions or allergies. The physician reported that on 12-AUG-2014, the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscular, (anatomical location, lot number and expiration date were not provided), and then on 10-AUG-2015, the patient was vaccinated with the second dose of GARDASIL, lot # L007531, 0.5 ml, intramuscular, (anatomical location, and expiration date were not provided). Concomitant therapies included ADDERALL. The physician stated that the patient was seen in his office on 18-AUG-2015 due to a high fever, ranging from 104 degrees F to 106 degrees F. It was also reported that the patient was seen every day from 18-AUG-2015 through 21-AUG-2015, because she was very sick. Additionally, multiple laboratory tests were performed during those visits, which included on 18-AUG-2015, complete blood count (CBC), an Epstein Barr viral panel and C-reactive protein, and on 20-AUG-2015, a CBC,  cytomegalovirus antibody titer and a liver panel, the results were not provided. Subsequently, the patient was diagnosed with mononucleosis, and was prescribed ibuprofen as treatment for the fever. The outcome of mononucleosis was reported as not recovered. The relatedness between mononucleosis and therapy with GARDASIL was not reported. No product quality complaint was involved. The reporter considered mononucleosis to be serious due to disability, because the extreme fatigue was preventing the patient from attending college classes. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a Registered Nurse via a company representative, regarding a female patient of unknown age. Patient's medical history and concomitant conditions were not informed. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (dose, route, frequency and lot No. were not provided). Concomitant medications were not described. On an unspecified date, the patient experienced a seizure after her second dose of GARDASIL. The patient sought medical attention as she was in hospital. It was unknown whether the vaccine was GARDASIL or GARDASIL 9. At the time of this report, the outcome of seizure event was unknown. Upon internal review, the event seizure was considered as medically significant. No product quality issue was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a 3 unspecified patients of unknown demographics. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (lot # K026246; expiry: 28-JAN-2017) (dose #, route and frequency unspecified) (incorrect product storage). No concomitant medications were reported. No adverse effects reported. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. Sometime on an unknown dates, when unspecified staff at her office draw up GARDASIL 9 from single dose vials to be administered (unspecified patients, unspecified dates), there was more than 0.5mll in vial. The reporter also stated some staff administered just 0.5 ml to the unspecified patients and other staff administered the total contents in the GARDASIL 9 vial which at times was more than 0.5 ml. Product Quality Complaint (PQC) was filed. No adverse effects reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: 4cm by 3.5 cm area on (L) upper arm.(+) indurated erythema non tender, slightly warm to the touch-itching-not painful -occurred 24 hours after shot.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Syncope, Vision blurred, Vomiting
Clinical narrative: Fainted after HPV 9. Blurred vision resolved prior to leaving office. C/O headache and vomited x2. Yesterday all sx resolved.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pain in extremity, Tenderness
Clinical narrative: Patient c/o (L) arm soreness, tender to touch for 1mos - since injection. Not swelling, on exam -> Full ROM - pt has 1cm area of faint erythema and mild thickening, non tender. Tx = ibuprofen, stretching and ice.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: This is a spontaneous report from a contactable HCP (Nurse Practitioner or a Physician's Assistant) received via a sales representative. An adult female patient (in late 50's, early 60's) of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on unknown date in Aug2015 at 0.5 ml, single. The patient medical history and the patient's concomitant medications were not reported. The patient experienced redness, itching and swelling. For the events the patient received steroids. The outcome of the events was reported as unknown. The events were assessed as important medical events.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Aphasia, Confusional state, Disorientation, Pyrexia, Tremor
Clinical narrative: Patient started having fever at 8pm, he was shaking I took his temperature and it was 100.8. I gave him ADVIL, he went to sleep and woke up at 1 am shaking even more, with a temp. of 101.2. After 10 min he didn't respond to me, he couldn't talk, I took him to emergency, his fever reached 104 degrees, he was confused, he didn't know his name, where he was, he didn't know me. He recovered around 4.30am.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient started having fever at 8pm, he was shaking I took his temperature and it was 100.8. I gave him ADVIL, he went to sleep and woke up at 1 am shaking even more, with a temp. of 101.2. After 10 min he didn't respond to me, he couldn't talk, I took him to emergency, his fever reached 104 degrees, he was confused, he didn't know his name, where he was, he didn't know me. He recovered around 4.30am.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt came in with 3 x 4" red area at injection site. Area was warm to touch.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Diffuse redness surrounding injection site, no pain associated with redness. Redness began at least 24 hours after immunization.
Age: 17.0
Sex: F
Vaccine: HEP, IPV, MNQ
Symptoms: Pruritus, Rash
Clinical narrative: Rash on cheeks bilaterally - stated itching after shots given - rash appeared on Saturday. Has not changed since Saturday. No difficulty breathing.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site pain, Injection site reaction, Musculoskeletal pain, Pain in extremity
Clinical narrative: This is a prospective pregnancy case. This 31-year-old female subject was enrolled in an open label study. The subject received BOOSTRIX .5 ml on 6th August 2015. Concomitant products included Prenatal Vitamins. The subject's last menstrual period was on 24th December 2014 and estimated date of delivery was 25th September 2015. The subject received BOOSTRIX at week 32 of the pregnancy and during the third trimester of pregnancy. On 6th August 2015, less than a day after receiving BOOSTRIX, the subject developed injection site (Non-serious). Additional event(s) included shoulder pain on 6th August 2015 and vaccine exposure during pregnancy. The outcome of injection site pain was unchanged. The outcome(s) of the additional event(s) included shoulder pain (unchanged) and vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the injection site pain and shoulder pain to be related to BOOSTRIX. HCP initially called for information regarding side effects of BOOSTRIX, specifically arm pain. Additional details were provided as follows: On 6th August 2015, the patient received BOOSTRIX on left deltoid (batch number NL7K3, expiry date 15th September 2017). On 6th August 2015, less than a day after receiving BOOSTRIX, the patient experienced left arm and shoulder pain. The patient experienced increased pain over the weekend which intensified with range of motion. The patient visited to the clinic for the investigation of that discomfort. The injection site was not red and swollen and there were no other abnormalities. No further information was available regarding events.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pustular
Clinical narrative: Second pustule popped up directly below initial pustule. States his wife may have a pustule on her mouth.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Epistaxis, Headache, Pyrexia
Clinical narrative: Started out as a severe nose bleed, pounding headache, fever and then shortness of breath. Went to urgent care clinic & MD stated that he has seen 3 other pts w/rxn to flu shot this year.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site induration
Clinical narrative: 8x8 cm area of induration of injection site. Appeared 24 hours post vaccination. No eryteham. Non-tender.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Exposure during pregnancy, Fatigue, Headache
Clinical narrative: 6:30-9:30pm 8/25: Fatigue, Headache (moderate), Chills (severe),  nausea (mild). 9:30pm 8/25 - 3:00pm 8/26: fever(99.9-100.4 F) body aches (severe), headache (moderate). 3:00pm - 11pm 8/26 fever(99.1-99.9), dizziness. Took Tylenol as recommended on bottle (2 every 4 hrs), sipped fluids, rested - I am pregnant unable to take other meds or hot bath, etc.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: 6:30-9:30pm 8/25: Fatigue, Headache (moderate), Chills (severe),  nausea (mild). 9:30pm 8/25 - 3:00pm 8/26: fever(99.9-100.4 F) body aches (severe), headache (moderate). 3:00pm - 11pm 8/26 fever(99.1-99.9), dizziness. Took Tylenol as recommended on bottle (2 every 4 hrs), sipped fluids, rested - I am pregnant unable to take other meds or hot bath, etc.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
Clinical narrative: Redness, swelling, tenderness, cellulitis.  Treated with Clindamycin 75mg/5ml, take 15ml po tid x10 days.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chest pain, Dysstasia, Motor dysfunction
Clinical narrative: pt woke the morning of 08/25/15 with chest pain, as child woke he was unable to stand on his own. Mom took him to a local hospital who was unable to find a cause of his motor loss. He was then transferred to another Hospital where he was admitted. Hospital called our office today and notified us of this child's case and requested that we report to VAERS
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Campylobacter test positive, Diarrhoea, Diarrhoea haemorrhagic, Weight decreased
Clinical narrative: Developed mucousy, bloody diarrhea.  Note, with prior rotavirus vaccine given 6/3/2015, had similar sx starting several days after given vaccine, that lasted for 2 weeks, had weight loss, diagnosed with campylobacter but unknown source.
Age: 0.16
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Swollen tongue
Clinical narrative: Her tongue was swollen and she was sticking it out for about two days then she was able to keep it in her mouth.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: SWELLING IN ARM TO ELBOW / PATIENT PRESENTED AND WAS TREATED WITH COLD COMPACT AND BENADRYL.
Age: 0.18
Sex: M
Vaccine: IPV
Symptoms: Abdominal pain, Diet refusal, Discomfort, Erythema, Insomnia
Clinical narrative: Redness in face, colicky, would not eat, could not sleep for more than an hour. Back arching every time we picked him up.  eyes squinting, holding his head, generally uncomfortable in his body.  Could not comfort him.
Age: 0.18
Sex: M
Vaccine: IPV
Symptoms: Opisthotonus, Strabismus
Clinical narrative: Redness in face, colicky, would not eat, could not sleep for more than an hour. Back arching every time we picked him up.  eyes squinting, holding his head, generally uncomfortable in his body.  Could not comfort him.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood test abnormal, Dysstasia, Pain
Clinical narrative: A few months after the final shot in June I started becoming very weak. I could barely stand, was in constant pain, doctor thought it might be lupus since bloodwork was crazy.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Erythema, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Case number PHEH2015US016162 is an initial spontaneous report received from a consumer on 18 Aug 2015. This report refers to a 44 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in Sep 2014. It was reported that her injection site became red, swollen and angry in Sep 2014. She was prescribed an oral and topical antibiotic. The site got better and then worse. Her ankle became red and inflamed and a steroid cream was prescribed. It was reported that later three of her children were diagnosed with ring worm and the family was treated with an oral antifungal and steroid cream. The symptoms resolved two months after vaccination in Nov 2014. The seriousness of the event was not reported, but the events ankle inflammation and redness were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Papule, Pruritus, Urticaria
Clinical narrative: Bilateral upper extremity pruritus with papules urticaria.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Pyrexia
Clinical narrative: Pt got MMRV, mother reports was red and fever. The next day mother noticed hives in area, swollen and given BENADRYL. Mother call 2 day after pt was seen 2 day after, no hives upper arm was swollen and complained of itching. Tx BENADRYL prn
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Antinuclear antibody negative, Blood immunoglobulin A normal, Blood thyroid stimulating hormone normal, Borrelia test negative
Clinical narrative: About one month later; started with nausea/vomiting/abdominal pain/headaches. Multiple testing with no results but Dx of chronic migraines, hypermobility syndrome, malaise and fatigue.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Cytomegalovirus test negative, Epstein-Barr virus antibody positive, Fatigue, Full blood count normal, Headache
Clinical narrative: About one month later; started with nausea/vomiting/abdominal pain/headaches. Multiple testing with no results but Dx of chronic migraines, hypermobility syndrome, malaise and fatigue.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypermobility syndrome, Malaise, Migraine, Mononucleosis heterophile test negative, Nausea
Clinical narrative: About one month later; started with nausea/vomiting/abdominal pain/headaches. Multiple testing with no results but Dx of chronic migraines, hypermobility syndrome, malaise and fatigue.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Red blood cell sedimentation rate normal, Streptococcus test negative, Vomiting
Clinical narrative: About one month later; started with nausea/vomiting/abdominal pain/headaches. Multiple testing with no results but Dx of chronic migraines, hypermobility syndrome, malaise and fatigue.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles. Seen by M.D. on 8/26/15.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and fever.
Age: 0.33
Sex: F
Vaccine: IPV
Symptoms: Erythema, Respiratory arrest, Swelling
Clinical narrative: Patient had redness and swelling 2 hrs after vaccine then stopped breathing later. Also possible seizure that same day after vaccine.
Age: 6.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, itchiness, swelling, 3x3 raised redness to upper left arm. No fever, no acute distress. TX Diphenhydramine for swelling and itchiness.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Chills, Decreased appetite, Dyskinesia, Movement disorder, Pyrexia
Clinical narrative: Fever up to 102 within an hour after immunization jerking or constant movement of the body awake and asleep around midnight after shot not eating, chills 8-27-15.
Age: 22.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt came in today (8/27/15) around 11 AM with redness and swelling on (L) arm where varicella vaccine was given. Pt noted it swelled up day after inj. (8/26/15) and that it continued to swell even more. Walked pt in w/ FNP-C. Pt given Z-PAK 250 mg cap QD #6.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: Via interpreter services in Spanish: after returning home after visit for 6 mo well child appt pt turned white and unresponsive, called EMS and taken to hospital.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Hypotonia, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Leg (thigh) markedly swollen, tender, limping, no redness fever to 104 (did have fever prior to admin). Tx: MOTRIN. Sx developed within 24 hrs and much improved in 72 hrs.
Age: 26.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Red, painful, and hard site of vaccination right arm subcutaneous.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site induration, Injection site nodule
Clinical narrative: Has a hard knotted area to (R) deltoid. Noticed knot  arm.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: (L) arm and shoulder pain, decreased ROM (L) shoulder, fever started approx. 10-12 after vaccine administration.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash maculo-papular, Rash pruritic, Urticaria
Clinical narrative: Patient received MENVEO and HPV (GARDASIL) vaccines at well check up on 8/24/15 and developed itchy maculopapular facial rash with some wheals 24 hours later.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Staphylococcal infection
Clinical narrative: Patient called and states injection site has rash and swollen. Patient visited doctor and diagnosed staph infection.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-AUG-2015, the patient was vaccinated with expired dose of PROQUAD (Merck), lot # J014237, expiry date 07-MAY-2015, subcutaneously. It was unspecified by the reporting nurse if this was the first or second dose of PROQUAD (Merck) that the patient had been administered. No adverse effect reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) arm swollen and red at injection site. Treatment: Given MOTRIN and ice applied to site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen (L) upper arm. Area indurated and warm, tender.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 18-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose and frequency were not reported) lot # L008355, expiration date 11-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Muscle swelling
Clinical narrative: Swollen muscle and red hot inflammatory reaction over right upper arm. Hot to touch.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a 74 year old female patient, concerning herself. The patient had unspecified allergies. Concomitant medications included NASALCROM and pseudoephedrine sulfate. Drug allergies/reactions were reported as none. On 20-AUG-2015, the patient was vaccinated with ZOSTAVAX, subcutaneously, one time injection. On 21-AUG-2015, the patient experienced injection site rash after getting a vaccine shot of ZOSTAVAX and treated by taking unspecified antihistamines and TYLENOL. Lab diagnostic studies performed were reported as none. The patient was contacting the pharmacy where she received the injection and her healthcare professional on 26-AUG-2015 (Wednesday). The outcome of event was unknown. Causality assessment was not provided. Patient did not seek medical attention. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm erythema, swelling with mild induration and warmth. Initially had pain x1 day, pain now resolved. Full ROM arm continue ice, ibuprofen and try antihistamine.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On 13-JUL-2015, unknown doses of VAQTA were improperly exposed to 32F for 63 hours. Then, on unspecified dates since 13-JUL-2015, an unspecified number of patients may have received the improperly exposed VAQTA (lot# was reported as K026529, expiration date 02-JUN-2017, dose and route were unspecified). There were no known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 13-JUL-2015, unknown doses of RECOMBIVAX HB were improperly exposed to 32F for 63 hours. Then, on unspecified dates since 13-JUL-2015, an unspecified number of patients may have received the improperly exposed RECOMBIVAX HB (lot# K014548, expiration date 27-AUG-2016, dose and route were unspecified). There were no known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K020216, expiration date 17-SEP-2016) (lot # L006546, expiration date 10-NOV-2016), (route, dose and dose number were unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: The register nurse informed that on 17-AUG-2015, the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose and route were not reported), lot # L002424, expiration date 23-APR-2016, which was reconstituted with improperly stored sterile water diluent, lot# K018540, expiration date: 27-AUG-2017. Concomitant therapy was not reported. No adverse events were not reported. This is one of several reports received from the same reporter. Lot # K018540, has been verified to be a valid lot number for sterile water diluent. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On 13-JUL-2015, unknown doses of oral, ROTATEQ were improperly exposed to 32F for 63 hours. Then, on unspecified dates since 13-JUL-2015, an unspecified number of patients may have received the improperly exposed oral, ROTATEQ (lot# K010224, expiration date 13-MAY-2016, dose unspecified). There were no known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The registered nurse informed that on 17-AUG-2015, the patient was vaccinated with a incorrect storage dose of ZOSTAVAX (dosage, and route were not reported), lot # L002424, expiration date: 23-APR-2016, which was reconstituted with improperly stored sterile water diluent, Lot K018540, expiration date: 27-AUG-2017. Concomitant effects and adverse events were not reported. This is one of several reports received from the same reporter. Lot number K018540 has been verified to be a valid lot number for sterile water diluent. ADditional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with improperly stored doses GARDASIL (lot # K010215, expiration date 05-MAY-2017) (lot # K011325, expiration date 08-APR-2017) (route, dose and dose number were unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to 2 unspecified patients of unknown demographics. On an unknown date the patients were vaccinated with improperly stored VAQTA 25/0.5 ml (lot # K005323; expiry: 10-FEB-2017) (dose # and frequency unspecified) (incorrect product storage). No concomitant medications were reported. No adverse effects reported. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 21-AUG-2015, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (strength, dose and frequency were not reported) lot # K023623, expiration date 20-FEB-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to an unspecified patient of unknown demographics. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # J007943; expiry: 05-FEB-2016) (dose #, route and frequency unspecified) (incorrect product storage). No concomitant medications were reported. No adverse effects reported. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On 13-JUL-2015, unknown doses of GARDASIL were improperly exposed to 32F for 63 hours. Then, on unspecified dates since 13-JUL-2015, an unspecified number of patients may have received the improperly stored GARDASIL (lot# K009482, expiration date 06-MAR-2017, dose and route were unspecified). There were no known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from healthcare worker (medical assistant) referring to a male patient of unknown age. Patient's medical history and concurrent conditions were not reported. On 09-NOV-2012 the patient was vaccinated with the 1st dose of GARDASIL, intramuscular (lot #  not reported). Then on 14-APR-2015, the patient was vaccinated with the 2nd dose of GARDASIL, intramuscular, (lot # not reported). Finally on 18-AUG-2015, the patient was vaccinated with the 3rd dose of GARDASIL, intramuscular, (lot # K010215, expiry date 05-MAY-2017). Other co-suspect or concomitant medications were not reported. The healthcare worker reported that when the patient was receiving the 3rd dose of GARDASIL, the patient suddenly moved his arm, and a significant amount of the GARDASIL spilled onto the patient's arm. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Infectious mononucleosis
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. On an unknown date, the patient experienced mononucleosis after receiving GARDASIL. The outcome of mononucleosis was unknown. The relatedness between mononucleosis and therapy with GARDASIL was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a unspecified patients of unknown demography. On 11-AUG-2015, the patients was vaccinated with 4 doses of improperly stored PROQUAD (Merck) (dose, route and frequency were not reported) lot # K011311. No adverse experiences reported. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, HEPA, MMRV
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a 4-year-old female patient who received KINRIX (batch number 2AG24, expiry date 10th SEPTEMBER 2017). Concomitant products included PROQUAD and VAQTA. On 11 AUGUST 2015, the patient received the 1st dose of KINRIX (intramuscular) .5 ml. In August 2015, less than a month after receiving KINRIX, the patient experienced injection site redness. On an unknown date, the outcome of the injection site redness was not recovered/not resolved.  The reporter considered the injection site redness to be probably related to KINRIX. Additional details were provided as follows: On 11th AUGUST 2015, the patient received PROQUAD and VAQTA on the left thigh. The patient experienced redness on right leg (injection site). Only partial information was provided by the nurse.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning an unspecified number of patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with improperly stored dose of ROTATEQ, oral liquid, (dose and dose number were unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Emotional distress, Irritability
Clinical narrative: Patient started to exhibit signs of excessive crying and irritability 24 hours after the shot was administered. Patient continued to be excessively irritable and inconsolable for a few days following the start of symptoms.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # K026532, expiration date 07-AUG-2017) (Lot # L006546, expiration date 27-NOV-2017), (route, dose and dose number were unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of M-M-R II (lot # K0248285, expiration date 02-DEC-2016) (lot# K021152, expiration date 02-NOV-2016), (route, dose and dose number were unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her sister, a female patient of unknown age. No relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose, frequency and route not reported). On an unknown date the patient developed shingles after getting the ZOSTAVAX. The outcome of the event was unknown. Causality assessment was not reported. Additional information is not expected as no contact details is available.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 04-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with improperly stored unspecified doses of oral, ROTATEQ (dose, lot number not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to male patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 23-JUN-2015 the patient was vaccinated with improperly stored M-M-R II (unknown strength, route and dose) lot # K0071707 with an expiry date of 16-MAY-2016, stored at improperly temperature (51.6 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 03-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date; 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to male patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 23-JUN-2015 the patient was vaccinated with improperly stored M-M-R II (unknown strength, route and dose) lot # K007107 with an expiry date of 16-MAY-2016, stored at improper temperature (51.6 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant regarding an unspecified number of patients of uunknown age and gender. The patient's medical hisotry, drug reactions, allergie and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with a dose of an improperly stored oral, ROTATEQ, lot number K011663, expiration date 24-MAY-2016, lot number K016313, expiration date 31-MAY-2016 and lot number K023532, expiration date 21-JUN-2016, (dose, route and anatomical location were not reported). There was no concomitant medication reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Seizure
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-AUG-2015, the patient was vaccinated with a dose of GARDASIL (dose, route, lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. The physician stated that the person who administered the dose of GARDASIL to the patient "was not aware that the patient should be monitored for 15 minutes" and the patient stood up immediately after receiving the dose of GARDASIL and then lost consciousness immediately after standing. When the patient recovered consciousness, the patient was observed to experience an unspecified type of "seizure," and the patient was monitored for an unspecified period of time. The physician reported that the patient was ambulatory when left his office. The outcome of seizure was unknown. The causality was not reported. A product quality issue was not involved. Upon internal review seizure was considered as other important medical event. Additional information is not expected since no permission for further contact was given.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a patient of unknown age and gender. Patient's historical drug included vaccination with two doses of GARDASIL on 18-JUL-2013 and on 13-AUG-2014 respectively with no adverse effects reported (MARRS# 1508USA011661). The physician reported that on 18-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 and on 25-AUG-2015, a second dose of GARDASIL 9 was administered (doses, route, lot numbers and expiration dates were not provided). There was no concomitant medication described. No adverse effects were reported. This is one of two cases linked by the same patient. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 21-AUG-2015 the patient was vaccinated with an improperly stored dose of oral, ROTATEQ (lot# K024700, expiration date 30-JUL-2016) (strength, dose and route were not reported) (Incorrect product storage). No adverse effect reported. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient was vaccinated with his/her first dose, second dose and third dose of RECOMBIVAX HB (route, strength, lot# and dose were unknown) on 11-FEB-2011, 13-APR-2011 (inappropriate schedule of drug administration) and 23-JUL-2011 (inappropriate schedule of drug administration), respectively. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. The patient was vaccinated with the first dose of GARDASIL (lot#, dose and route not reported) "over a year ago". On 25-AUG-2015 the patient came in the office to receive the second dose of GARDASIL (lot#, dose and route not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with M-M-R II (dose, route not reported, lot# J016234 with expiration date 19-DEC-2015) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a female patient of approximately 1 year old. No information concurrent conditions and medical history was reported. On 16-JUN-2015 the patient was vaccinated with improperly stored MMR II (unknown strength, route and dose) lot # K007107 with an expiry date of 16-MAY-2016, stored at improper temperature (46.8 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Visual impairment
Clinical narrative: Patient developed shingles from the vaccine and said her vision was off. She received treatment from her doctor.