chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning ap patient of an unknown age and gender who on 10-APR-2015 was vaccinated with a dose of GARDASIL (lot # K006960) (dose and route not reported) that was 24 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a register nurse and refers to a 25 year old female patient with BACTRIM allergy. There was no patient's pertinent medical history. On 17-JUL-2051, the pregnant female patient was vaccinated with VARIVAX (Merck) (lot number: L000455, expiry date: 06-JAN-2017, dose: 0.5 ml, subcutaneous). There was no concomitant therapy. The last menstrual period (LMP) and estimated date of delivery (EDD) were not reported. The patient sought medical attention (office visit). There was no treatment given for adverse event and no lab diagnostic test performed. At the time of the report, the pregnancy outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to certain less than 50 year old patients of unknown gender. No information regarding the patients' pertinent medical history, concomitant medication, drug reactions or allergies was reported. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not provided). The reporter stated that there had been times that, on unknown dates, rheumatologists ordered ZOSTAVAX for certain patients who were less than 50 years of age. On unknown dates, rheumatologists ordered ZOSTAVAX for these certain patients before they began therapy with ENBREL or HUMIRA. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot was received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The certified medical assistant reported that on unspecified dates, unspecified number of patients received improperly stored doses of PROQUAD (Merck) (lot#, strength, dose #, dose and route of administration were not reported). There was not concomitant medication reported. No adverse effects were reported and there was not a product quality complaint involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: HPV4
Symptoms: Anogenital warts, Papilloma viral infection
Clinical narrative: This spontaneous report was received from a 25 year old patient (gender unspecified) via patient support program GARDASIL (access program). The patient's concurrent conditions and medical history were not reported. On an unknown date when the patient was 17 years old he/she was vaccinated with first dose of GARDASIL (lot # and dose were reported). The patient received all the three doses at right interval. Till he time of vaccination the patient have not had sex. On an unknown date (at the age of 25), the patient experienced condyloma. The gynecologist told the patient that she could not explain to herself, why it could happen that the patient got HPV. She also said that the GARDASIL injection was not just to prevent the girls from cervix cancer, but also from condyloma. The outcome of condyloma and papilloma viral infection was unknown. The reporter did not provide the relatedness of the events with GARDASIL. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 25-JUN-2015 the patient was vaccinated with ROTATEQ (dose was not reported, route of vaccination defaulted to oral, lot # K013661 with expiration date: 25-JUN-2016) which was improperly stored. No adverse symptoms reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients (eight) were vaccinated with GARDASIL injection (post temperature excursion) lot # K010574, expiration date: 08-APR-2017 (strength, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 81 year old female patient with diabetes mellitus, hyperlipidaemia, hypertension, osteopenia, gout, gastrooesophageal reflux disease (GERD) and an allergy to GLUCOPHAGE. On 15-JUL-2015, the patient visited physician's office with nasal congestion, runny nose, sore throat, both dry and productive cough lasting for 3 days and was diagnosed with upper respiratory infection (captured in MARRS#1507USA010143). On 15-JUL-2015, on the same visit, the patient was vaccinated with PNEUMOVAX 23 lot # K021030, intramuscular in the left arm. Concomitant therapies included COLCRYS, amlodipine besylate, fosinopril sodium, hydrochlorothiazide, meclizine hydrochloride and allopurinol. On 15-JUL-2015, several hours after vaccination, the patient reported that her entire left arm was sore and she could barely pick it up and she experienced headache. As treatment, patient was instructed to put ice on her deltoid region and perform active and passive range-of-motion exercises. The patient did not recover from adverse events at the time of this report. Causality assessment was not provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to an approximately 60 year old female patient. On 04-JUN-2015, the patient was vaccinated with ZOSTAVAX (#1000450) in the unspecified arm. On 10-JUN-2015, the patient developed a red itchy rash with a white ring around it at the site of injection. Around day 5, the injection site got swollen and formed a big round ball (a nodule). Then approximately days 8 through 10 after receiving the injection all of the symptoms subsided except that the patient still had a nodule at the site of injection. There were lab tests performed. The outcome of the event nodule at the site of injection was reported as not recovered and the other reported events were recovering at the time of this report. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding unspecified number of patient of unknown demographics. There was no information about concurrent condition and historical medication. Since 01-JUN-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was 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 health care worker refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On an unknown date the patient was vaccinated with improperly stored VARIVAX (Merck) (dose strength, route unspecified). No adverse effects reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to the case 1507USA009809 via same reporter link. 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 Registered Nurse regarding unspecified number of patient of unknown demographics. There was no information about concurrent condition and historical medication. Since 01-JUN-2015, the patient was vaccinated with improperly stored ZOSTAVAX (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site nodule
Clinical narrative: PER MOM STATES WOKE THAT AM WITH SMALL KNOT ON LLE THAT KEPT GETTING BIGGER BY THAT AFTERNOON.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING (patient described as softball size swelling at site of injection), REDNESS, HEAT, SEVERE IRITATION (patient reported could not have anything in contact with site), OCCASIONAL SHOOTING PAIN.  SWELLING, PAIN, HEAT AND SEVERE IRRITAION SUBSIDED BY 7-22-15 ALTHOUGH REDNESS AND SOME PAIN WITH PRESSURE REPORTED.
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 patient's medical history or concurrent conditions were not provided. On unknown dates between 01-JUN-2015 and 15-JUL-2015, the patients received improperly stored ROTATEQ (dose/doses in series were unspecified, lot # K015816, expiration date 29-MAY-2016) orally. Concomitant drug was not reported. No adverse effects were reported. It was unknown whether the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 24-APR-2015 was vaccinated with a dose of GARDASIL (lot # K006960) (dose and route not reported) that was 24 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to an 1 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was supposed to receive PREVNAR but was mistakenly vaccinated with a dose of PNEUMOVAX23 (dose, route, lot number and expiration date not reported), which was indicated for infants 2 years or older. Except for the adverse event of misuse, there were no additional adverse experiences. It was also stated that the therapy was not discontinued. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Approximately 5 minutes after vaccine given pt. became dizzy-c/o feeling faint-did lose consciousness briefly. Placed by staff in supine position w/ feet elevated-frequent VS.
Age: 69.0
Sex: M
Vaccine: HEP
Symptoms: Herpes zoster
Clinical narrative: On 06/20/2015 I was diagnosed with shingles (herpes zoster). I had been vaccinated with Zostavax in 2010.
Age: 2.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a consumer, who's a registered pharmacist refers to a 2 year old male patient. Patient's relevant medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date the patient was incorrectly vaccinated with GARDASIL strength, dose/frequency, lot # unspecified) (inappropriate schedule of drug administration). No concomitant medications were reported. Reporting consumer stated that they were going to be monitoring the patient's condition for adverse events. Additional information is not expected as the reporter did not wish further contact.
Age: 0.51
Sex: U
Vaccine: RV1
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information as received from a certified medical assistant (C.M.A.) refers to 6 months old infant of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2015, the patient was vaccinated with a dose of oral, ROTATEQ lot # K023159, expiration date 26-JUL-2016 which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 7-21-15 8:30 am at site of injection, back of (L) arm very red, raised reaction, warm to touch, cold pack given. 7-21-15: 2:30 pm initial red raised area was unchanged, but a light pink color was spreading out/across arm-beginning to itch bad. 7-22-15: 8:30 the bright red had not changed, but the pink color had spread down the back of her arm, almost to the elbow and moved up and around toward the top of her bicep. Dr. told her to continue to use hydrocortisone on the pink/red area.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Crying, Irritability
Clinical narrative: Irritability, persisting crying same day of vaccination (all day long).
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Rash generalised
Clinical narrative: Rash on body.
Age: 1.21
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Rash, Urticaria
Clinical narrative: Pt broke out in a small quarter size rash/hive near location where vaccine administered immediately after receiving vaccine. Varicella right thigh.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Pyrexia, Streptococcus test negative, Urine analysis normal
Clinical narrative: Patient started spiking high fever on the day vaccine was given and fever continued for 4 days. No cough no cold no vomit no diarrhea. Mom gave TYLENOL.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # L007228, expiration date- 03-SEP-2016, (dose strength and route was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unkonwn. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, PNC13
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: PATIENT REPORTS REDNESS, SWELLING, PAIN WITH MOVEMENT AND WARMTH TO TOUCH TO AREA OF ADMINISTRATION. PATIENT DENIES NUMBNESS OR TINGLING IN LIMBS. PATIENT ALSO STATES SHE FELT DIZZY 24 HOURS AFTER ADMINISTRATION WITH PROLONGED STANDING/WALKING.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Pt's mom calling in regards to a red hot spot 1/2 the size of a softball.  According to mom it is on the right deltoid and he was given a Kinrix on that arm.  He c.o. itching and warm to touch and some discomfort. Mother called this am and was advised to use a cool compress on site, give Benadryl for the itchiness and Tylenol for the fever.  Advised her I would call back in pm.  Also advised her to mark the redness with a pen and if it get beyond that marking she is call me so she can come in to have him examined.  Mother states that would work.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in arm, feels like it's asleep.
Age: 11.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Retinal depigmentation
Clinical narrative: Child was taken to eye specialist and was told a change was noticed to the retinal pigmentation of eye.
Age: 11.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Retinal pigmentation
Clinical narrative: Child was taken to eye specialist and was told a change was noticed to the retinal pigmentation of eye.
Age: 29.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Dizziness, Throat tightness
Clinical narrative: PT STATED SHE WAS FELT DIZZY 15 MINS AFTER VACCINES WERE GIVEN. LAY PT WITH WITH BOTH FEET ELEVATED, PT STILL COMPLAIN OF TIGHTNESS IN THE THROAT. 7/22/2015 @1114  Code Blue called overhead to Immunizations Clinic. @1115  LCDR, HMCS, NP, RN, LVN, and MA at the bedside w/ pt. VS noted. 29 y/o DEP female c/o "tightness in throat" s/p MMR vaccine L tricep SQ by MA. No c/o SOB. Per LCDR, lungs CTA all lobes. Heart RRR. No oropharyngeal edema noted. Up O2 NRB @15LPM, SaO2 100%. @1125  Pt updated to POC by NP. Pt v/u and agrees to POC. Per NP's v.o., pt given Benadryl 50mg, IM INJ, L deltoid, by this RN. MANF: WESTWARD. LOT: 015383. EXP: 01/2017. Pt tolerated well. BP 104/60. HR 65. Per NP exam, lungs CTA, all lobes. No congestion. O2 stable on room air trial, SaO2 100% on RA. NRB d/c'd at this time. @1134  Pt c/o returning s/s of throat tightening feeling. Pt updated to POC by NP. Pt v/u and agrees to POC. Per NP's v.o., pt given EpiPen 0.3mg IM INJ, R thigh, by this RN. MANF: MYLAN. LOT 4GM460. EXP: MAR2016. Pt tolerated well. Up O2 NRB @15LPM, SaO2 100%. @1136  BP 110/68, HR 72, 100% NRB @15LPM, @1140  Pt transported to Tx room via W/C. Pt placed on gurney, side rails up x2. Blankets provided. @1145  SaO2 100% on NRB @15LPM. HR 72. MA and HN at the bedside. @1200 - Per MA, NP at the bedside. O2 NRB d/c'd at this time. @1210 - Pt resting comfortably. No c/o SOB, or tightness in throat at this time. BP 106/62, HR 86, O2 99% on RA.  Will continue to monitor. @1219 - BP 106/70, HR 83, SaO2 100% RA. @1225 - Pt up OOB to BR via W/C. No c/o at this time. NP at the bedside. @1230 - BP 106/60, HR 94, SaO2 100% RA. @1245 - Per NP's v.o., discharge instructions reviewed w/ pt and pt friend. Strict 911/ED precautions reviewed. Advised to f/u w/ PCM as needed. Pt/pt friend v/u and agree to POC. Pt d/c'd to home w/ friend to drive pt home. Pt transported to POV via W/C. NP updated.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Activated partial thromboplastin time normal, Blood thromboplastin normal, Full blood count normal, Injection site haemorrhage, Injection site rash
Clinical narrative: SKIN: RASH: Location: upper legs and lower legs.  Description: multiple nonblanchable petechia 1-2mm in diam over 20 in number all over lower extrm, pt was sent to ER to r/o decreased platelett count on 6/27/15. Sencond visit on 6/29/15 noted the following patient is in for a follow-up on ER visit for reaction from vaccines. SYMPTOMS: Have improved. SYMPTOMS: The patient is still having the following symptoms: Skin: Petechia noted on legs, not "as red" but mother noted one faint one near right elbow. TREATMENT REGIMEN: has been completed.  (just observation) Patient has been seen at ER. ADDITIONAL COMPLAINTS (not related to followup): All other systems reviewed are negative.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Liver function test normal
Clinical narrative: SKIN: RASH: Location: upper legs and lower legs.  Description: multiple nonblanchable petechia 1-2mm in diam over 20 in number all over lower extrm, pt was sent to ER to r/o decreased platelett count on 6/27/15. Sencond visit on 6/29/15 noted the following patient is in for a follow-up on ER visit for reaction from vaccines. SYMPTOMS: Have improved. SYMPTOMS: The patient is still having the following symptoms: Skin: Petechia noted on legs, not "as red" but mother noted one faint one near right elbow. TREATMENT REGIMEN: has been completed.  (just observation) Patient has been seen at ER. ADDITIONAL COMPLAINTS (not related to followup): All other systems reviewed are negative.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Syncope
Clinical narrative: Pt stated she was feeling light headed and continued to sit after the vaccination. After approximately 5 minutes patient expressed she was ready to leave. After about 10 seconds of walking she had fainted.  A few secconds later she "woke up" and had a seat on a bench. Ambulance was called and shortly later cancelled due to patient requesting she did not want the ambulance. Patient sat on bench then lied down then sat back up over the course of 30 minutes without other loss on consciousness and was provided water and Orange Juice by management. Patient was alert and oriented when left but still wanted a wheel chair to avoid falling for now and did not want any medical treatment at this time. Vaccine provider called patient's primary doctor to notify them of this incident. Pt was alert and oriented upon leaving.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient report redness and an induration at the site of injection roughly 1-2" in diameter.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dysarthria
Clinical narrative: Slurred speech noted by patient, mom, teachers and peers.  Lasted until evening when went to sleep.  Awoke fine the next day.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Hives, itchy all over arms, neck, chest, legs, and back.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site extravasation, Injection site pruritus, Local reaction, Pain
Clinical narrative: Redness on L upper arm that started after getting Pneumonia vaccines on 07/16/15. Pt says it felt "like it didn't go in as deep as other vaccines". Now having redness and mild itching below the injection site. No f/c. Minimal pain. Local reaction to pneumococcal vaccine - appears to have extravasated fluid subcutaneous instead of the fluid going IM and now having localized reaction. Outlined area in permanent marker. Instructed pt to use triamcinolone cream that she already has to help calm down reaction. Rtc if red area is increasing in size or any f/c or worsening of symptoms.
Age: 22.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Area of redness, swelling and pain underneath her left upper arm. Mild itching.
Age: 41.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Dizziness, Hyperhidrosis, Pyrexia
Clinical narrative: Dizziness, sweats, fever (not sure how high - was at work) off and on for 4 1/2 hours.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Tenderness
Clinical narrative: Pt to immunization for smallpox vaccination follow up. Left upper arm (smallpox site) inflammed with axillary area sensitive to palpations. Redness (erythema) noted around lateral border of the pts upper left arm. Pt reports left shoulder pain also. Pt reports pain level is constant 5/10. Pt reports taking Tylenol for pain management on 22 July 2015 @2200.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Abasia, Gait disturbance, Injection site swelling, Poor quality sleep, Pyrexia
Clinical narrative: Patient had a very restless night. He awoke at 4am with fever (checked by ear thermometer) of 102. I gave Tylenol. Swollen leg, unable to walk on leg until Sunday. Finally stopped limping on Monday.
Age: 0.08
Sex: F
Vaccine: HIBV, PNC13, RV1
Symptoms: Crying, Pain, Pyrexia, Rash, Ultrasound scan
Clinical narrative: Severe pain, crying, vomiting, low grade fever, rash.
Age: 0.08
Sex: F
Vaccine: HIBV, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Severe pain, crying, vomiting, low grade fever, rash.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Hyperhidrosis, Irritability, Opisthotonus
Clinical narrative: Received 2 month vaccines on 7/20, 7/21 fussy, inconsolable crying, sweating. Fussy 7/22 Arching back temp today 100 (R). Seen in our office today. Possible immune reaction.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Pain in extremity, Skin warm
Clinical narrative: Arm is painful pain radiating to elbow and fingers. Noted redness, warm to touch. Pt was advised cold compresses. TYLENOL/ALEVE. KEFLEX ordered. Pt to return on 7/24/15.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Nasal congestion, Neck pain, Pharyngitis, Torticollis
Clinical narrative: Torticollis, acute pharyngitis, nasal congestion, neck pain. 12 days after vaccine was given.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding an unspecified patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in January 2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was 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 was received from a Registered Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent and historical medication. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (Merck) lot number K12918, expiration date- 28-FEB-2016 (dose strength and route was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was 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 was received from a Registered Nurse regarding 2 unspecified patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in February 2015, the patient was vaccinated with 2 doses of improperly stored VARIVAX (Merck) (dose strength, route and lot number was unkonwn). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was 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 was received from a Registered Nurse regarding an unspecified patient of unknown demographics. There was no information about concurrent condition and historical medication. on an unknown date in March 2015, the patient was vaccinated with improperly stored VARIVAX (Merck) (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.31
Sex: F
Vaccine: PNC13
Symptoms: Seizure
Clinical narrative: 07/22/2015 Moderate Other Patient has no known drug allergies. Patient was sent home. When arriving home she started to have a seizure. Patient was sent to emergency department.
Age: 1.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Pyrexia, Rash, Swelling
Clinical narrative: Patient had mild reaction 10 days after the varicella vaccine was given on left arm, mild fever and swelling, rash of hard bumps that lasted 1 week then it went away and it came back 2 weeks later stayed for 2 weeks and extended to torso, arms and legs per mom.
Age: 1.41
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever of 100.5 axillary on 1-22-15 only for the one date. Next day patient was fine.
Age: 1.03
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Mom noticed a red area on patient's arm the morning of 7/21/15. Patient was examined at our clinic on 7/22/15. His (R) deltoid was warm to the touch and a red area was on his (R) deltoid (about 4.5 cm in diameter). Mom to ice the area to reduce swelling and give patient ibuprofen as needed for discomfort.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash, Swelling
Clinical narrative: Rash, swelling between the eyes and arms.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Seizure
Clinical narrative: Pt. received HPV #1, MCV4 #1, and Tdap booster. Once pt. received HPV vaccine she started to feel faint, 30 seconds later pt. was observed having convulsions that lasted approximately 2-3 seconds. Then patient relaxed for 30-45 seconds and had one more episode of convulsions that lasted for 4-5 seconds, approximately. After last episode pt. felt slightly better and was helped up and taken to bed to lay down on her left side. 911 was called. Dr. evaluated pt before paramedics arrived. Pt. A and O x 3 and transported to emergency room for further evaluation.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The certified medical assistant reported that on unspecified dates, unspecified number of patients received improperly stored doses of VARIVAX (Merck) (lot#, strength, dose #, dose and route of administration were not reported). There was not concomitant medication reported. No adverse effects were reported and there was not a product quality complaint involved. This is one of two reprots received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 14-JUL-2015, the patient was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, once, subcutaneously (strength, anatomical location, lot number and expiration date were not reported), which was improperly storage. No adverse events were reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: Significant local reaction: pain, swelling, redness.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: Significant local reaction: pain, swelling, redness.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: Significant local reaction: pain, swelling, redness.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. The physician reported that on an unknown dates, the unspecified patients were vaccinated with doses of GARDASIL, (strength, dose, frequency, route, anatomical location, lot numbers and expiration dates were not reported), outside of the schedule recommended in the prescribing information of GARDASIL. No adverse events were reported. This is one of two reports received from the same reporter. Additional information is not expected, because the reporter did not consent for further follow up.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. The physician reported that on an unknown dates, the unspecified patients were vaccinated with doses of GARDASIL 9, (strength, dose, frequency, route, anatomical location, lot numbers and expiration dates were not reported), outside of the schedule recommended in the prescribing information of GARDASIL 9. No adverse events were reported. This is one of two reports received from the same reporter. Additional information is not expected, because the reporter did not consent for further follow up.
Age: 1.0
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a 1 year old patient of unknown gender. The patient's concurrent conditions and pertinent medical history were not reported. On 29-JUN-2015, the patient was vaccinated in error with a dose of GARDASI vial wet sd 120, intramuscular injection, (lot #, exp. date, strength and dose not provided). There was no known adverse effects. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a male patient of unknown age, reporting on himself. On an unkonwn date the patient was vaccinated with a dose of GARDASIL (dose, route and lot# not provided). The patient reported that he received the GARDASIL vaccine at age 34, which was other than indicated in the prescribing information (Inappropriate schedule of drug administration). No adverse effect was reported. Additional information is not expected as there is no contact details information.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Medical Assistant refers to a patient of unknown age and gender, who on 29-MAY-2015 was vaccinated with an improperly stored dose of GARDASIL (lot # K006960) (dose and route not reported). According to the reporter the vaccine dose administered underwent only one excursion of 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Medical Assistant refers to a patient of unknown age and gender, who on 27-MAY-2015 was vaccinated with an improperly stored dose of GARDASIL (lot # K006960) (dose and route not reported). According to the reporter the vaccine dose administered underwent only one excursion of 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 07-MAY-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent an unknown number of excursion hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Age: 50.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to  a50 year old male patient. Concurrent conditions, medical history and allergies were not reported. The pharmacist stated that on 13-JUN-2015 (reported as one month ago), the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, anatomical location, lot number and expiration date were not reported), which is an inappropriate schedule of vaccine administration, by an unspecified provider. Other suspect and concomitant therapies were not reported. The pharmacist indicated that the patient was presented in her pharmacy for the second dose of GARDASIL, however it was not administered by the pharmacist die to the age restriction concerns. No adverse events were reported regarding the first dose of GARDASIL. Additional information is not expected because the reporter did not consent for further follow up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, concerning a patient of unknown age and gender. Neither medical history nor concurrent conditions were reported. On 10-JUL-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose (lot # and expiration date unspecified). No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age. On 20-JUL-2015, the patient was inadvertently vaccinated with a dose of (Merck) PROQUAD (lot # L004005, expiration date 05-AUG-2016, 0.5 ml, subcutaneous) instead of the intended dose of (Merck) VARIVAX (wrong vaccine administered). No adverse experiences had been reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 12 month old patient of unknown gender. Concurrent condition and medical history were not reported. On 07-JUL-2015, the patient was inadvertently administered a dose of (Merck) VARIVAX, 0.5 ml subcutaneous (strength, dose #, anatomical location and lot # were not provided) and a dose of (Merck) PROQUAD 0.5 ml subcutaneous (strength, dose #, anatomical location and lot # were not provided) (overdose). There was not concomitant medication reported. No adverse events were reported. At the time of the report, the outcome of overdose was unknown. The relatedness of the adverse event and the vaccines (Merck) VARIVAX and (Merck) PROQUAD was not provided. 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 nurse refers to a patient of unknown age and gender. 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, anatomical location, lot number and expiration date were not reported), intramuscular, which was improperly storage. No adverse events were reported. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received from a nurse, refers to a 6 year old female patient. Concurrent conditions and medical history were not provided. The nurse stated that on 23-JAN-2009, the patient was vaccinated with the first dose of hepatitis b vaccine (manufacturer unknown) (dose, route, lot # and expiration date not provided) on 26-JUN-2009. There was no concomitant medication described. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site inflammation
Clinical narrative: Information has been received from a male physician of unknown age via field representative referring to himself. Information about medical history and concurrent condition was unspecified. On an unknown date, the patient was vaccinated with his first dose of PNEUMOVAX 23 (lot number, dose and route were unknown), and did not report any adverse effects from his first PNEUMOVAX 23 dose. On an unknown date (reported as "at least 5-10 years ago"), the patient was vaccinated with his second dose of PNEUMOVAX 23 (lot number, dose and route were unknown), and he experienced local inflammation around injection site with re-vaccination. The patient sought medical attention via physician visit, and recovered from the event on an unknown date. The causality between PNEUMOVAX 23 and the event was unspecified. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Paraesthesia, Radiculitis brachial
Clinical narrative: This medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a 42-year-old female patient. Her concomitant medications included fluoxetine, lamotrigine, bupropion and clonazepam. On 20-Aug-2014, the patient received intramuscular AFLURIA (batch number '257205') in the left arm. On 21-Aug-2014, the patient developed acute left shoulder pain, left arm tingling and brachial neuritis. Outcome was reported as not yet recovered. Reporter's comments: The health authority assessed the case as non-serious. The as-reported symptom was 'Injection site pain'.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Drug dependence, Dysphoria, Suicidal ideation
Clinical narrative: This medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a 28-year-old male patient. The patient had medical history of allergies to penicillin, peanuts, tree-pollen and mold. The patient received influenza (seasonal) vaccine (no brand name) in the past and experienced dysphoria and paresthesias (refer to case 2014046270). The patient had no illness at the time of vaccination. On 20-Aug-2014, the patient received intramuscular AFLURIA (batch number not reported) in the left arm. On 29-Aug-2014, the patient developed severe dysphoria, borderline suicidal ideation and a craving for euphorigenic drugs. Outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Hypotension, Loss of consciousness
Clinical narrative: This medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a 54 year old male patient. The patient received a tetanus shot for dog bites 12 days earlier and was coming off amoxicillin/clavulanic acid. His concomitant medications included ritonavir, tamsulosin, biotin, diltiazem hydrochloride, fish oil, abacavir sulphate, acyclovir, darunavir, selenium, raltegravir, acetylsalicylic acid, iopinavir/ritonavir and morphine sulphate. The patient had flu shot every year without any issue. On 08-Sep-2014, the patient received intramuscular AFLURIA (batch number '004766') on right arm, dose 1. On 08-Sep-2014, the patient started blacking out at the gym. The patient thought that perhaps his blood pressure was high but it was extremely low (70 over 45). The patient stayed with nurses who made him eat sugar and some food. Pressure came back up later in the day and was once again on the high side with medications which was the norm for the patient. Outcome was reported as recovered. Reporter's comments: The health authority assessed the events as non-serious. The patient was not certain if the flu shot had caused the black out or low blood pressure but the gym thought that the shot did factor into what happened. The patient reported it could perhaps be a combination of coming off AUGMENTIN for the dog bite, tetanus shot and then flu shot.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Dyspnoea, Pharyngeal oedema, Swelling face
Clinical narrative: This medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a 40-year-old male patient. On 06-Aug-2014, the patient received intramuscular AFLURIA (batch number '665221011702') in the left arm, dose 1. On 08-Aug-2014, the patient developed swelling of face and throat, had difficulty breathing, dizziness and weakness. Outcome was reported as 'missing'. Reporter's comments: The health authority assessed the case as non-serious.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Face injury, Fall, Heart rate decreased, Loss of consciousness, Seizure
Clinical narrative: This medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a 24 year old female patient. On 12-Sep-2014, the patient received intramuscular AFLURIA (batch number T57305) in left arm. On 12-Sep-2014, the patient passed out while sitting on the chair and fell on her face. She was convulsing (head and upper part of the body) which ceased after approximately 10 seconds. At that time, the patient became conscious. An ambulance arrived to assess the patient. She was transported to the hospital for an extremely low heart rate. Outcome was unknown. Reporter's comments: The health authority assessed the case as serious (hospitalisation). The health authority reported the symptom of 'face injury'.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eye movement disorder, Vomiting
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 45 year old female patient who had no current illness at the time of vaccination. On the 21-Aug-2014, the patient received AFLURIA (batch number T57606) in the right arm. On the 21-Aug-2014, the patient developed dizziness, vomiting and involuntary rapid movement side to side in both eyes. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Lung disorder
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 49 year old male patient. On an unspecified date, the patient received AFLURIA (batch number 06949221A) via the intramuscular route. On an unspecified date, the patient developed a lung problem. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.