chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: 7-9-14 - Arm very painful after injection, 7/10/14 arm continued to be sore, 7-11-14 soreness increased, arm swollen at injection site. 7/12/14 soreness continued, arm red, swollen to about size of orange, hard knot at injection site, pt unable to lift arm above shoulder height.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Pain in extremity
Clinical narrative: 6-20-14 vaccination given - pt noticed Rt arm swollen at injection site 6/22/14, also pt did not feel well. 6/23/14 reported to pharmacy more swollen 3" diameter and arm hurting. Recommended BENADRYL orally and topically. Notify pharmacy and MD if not improved 24h. MD called.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a 4 year old patient of unknown gender. Pertinent medical history, drug reaction and allergies were not reported. On 17-JUL-2014 the patient was vaccinated with an expired dose of MMR II (lot # H012132, expiration date 25-JUN-2014, 0.5 ml, subcutaneously (dose number and strength were unspecified). No adverse effect was reported. No concomitant therapies were reported. No laboratory diagnostic studies were reported. The outcome of received an expired MMR II was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a female patient of unknown age with drug reactions and allergies to BENADRYL, Comprasene and Toprex reporting on herself. No pertinent medical history was reported. On 22-JUL-2013 the patient was vaccinated with PNEUMOVAX 23 (lot#, dose and route unspecified). Concomitant therapy included Hydrochlorazide. On an unknown date, the patient experienced that her whole arm was sore and painful with swelling and was useless for 3 days. No treatment was given for the events. At the time of the report the outcome of the whole arm was sore and painful with swelling was unknown and the outcome of whole arm was useless for 3 days was reported as recovered. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age (a child). On 18-JUL-2014 the patient was vaccinated with the first dose of ROTATEQ (dose and lot number were not reported) oral. The ROTATEQ was improperly stored. Concomitant medications were not reported. No adverse effects reported. Additional information is not expected, as the nurse stated she did not want to provide any other information.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 70 year old male patient. On 16-JUL-2014 (also reported as 17-JUL-2014 by the patient's wife) the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # K005261, expiration date 20-MAR-2015) subcutaneously. The pharmacist reported that on 18-JUL-2014, a hard lump and swelling at the ZOSTAVAX injection site, pain and swelling at the injection site and could see where the needle from the ZOSTAVAX injection went in. The patient did not seek medical attention. The patient was treated with TYLENOL. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 16-JUL-2014 the patient was vaccinated with an improperly stored (oka/MERCK) VARIVAX, subcutaneous, 0.5 ml, (lot number and expiration date not reported). No adverse effects reported. This is one of two reports from the same reporter (1407USA007856). Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a 41 year old female consumer refers to herself. On 03-JUN-2014 the patient was vaccinated with a dose of M-M-R II (lot # no reported), strength and dosage unknown, subcutaneous. The patient was also two months pregnant on reporting day (08-JUL-2014). The Estimated Due Date (EDD) was not reported and the last menstrual period was in approximately May 2014. She was not having any adverse reactions currently on that time. The pregnancy outcome was unknown. The outcome of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Rash maculovesicular, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patient was vaccinated with (oka/MERCK) VARIVAX lot # K001389 expiration date 29-JAN-2016, dose 0.5 ml, route subcutaneous. The reporter stated that on an unknown date after 2 to 3 days, the patient was vaccinated with (oka/MERCK) VARIVAX the patient developed significant erythema and induration, pain at the injection site and macular vesicular rash. The reporter also stated that the patient had a single chickenpox lesion. The patient was taken to an unspecified emergency room where he received unspecified antibiotics for possible cellulitis and BENADRYL. The physician mentioned that the patient was still experiencing some of the reported symptoms. The outcome of significant erythema and induration, for possible cellulitis, he has a single chickenpox lesion, macular vesicular rash and pain at the injection site was reported as not recovered/not resolved. No product quality complaint was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to 4 patients of unknown age. On an unknown date the 4 patients were vaccinated with a dose of (Oka/Merck) VARIVAX (lot #, dose, frequency were unspecified) which was improperly stored. No adverse symptoms reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with PNEUMOVAX23 were stored improperly and administe5red to an unspecified number of patients on unspecified dates. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected since we cannot contact physician.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL. Dose, route, lot number and expiration date were not reported. The nurse reported that doses of GARDASIL were stored, improperly and administered to an unspecified number of patients on unspecified dates.No adverse effects were reported. This is one report from the same source. Additional information is not expected since se cannot contact physician.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 19 year old female patient. Patient's medical history was not reported. On 24-JUN-2041, between 9:00 am and 3:00 pm, the patient was vaccinated with the second dose of GARDASIL, intramuscular, RD, (lot #J003727; Exp. Date: 07-NOV-2015) (strength and dose not reported). No co-suspect or concomitant therapies were reported. The vaccine storage refrigerator temperature dropped to 34 degrees for 16 minutes as per data logger. The patient did not have any illness at the time of vaccination. This is one of two reports for the same patient. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 19 year old female patient. Patient's medical history was not reported. On 24-JUN-2041, between 9:00 am and 3:00 pm, the patient was vaccinated with the second dose of GARDASIL, intramuscular, RD, (lot #J003727; Exp. Date: 07-NOV-2015) (strength and dose not reported). No co-suspect or concomitant therapies were reported. The vaccine storage refrigerator temperature dropped to 34 degrees for 16 minutes as per data logger. The patient did not have any illness at the time of vaccination. This is one of two reports for the same patient. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: This spontaneous report was received from a pharmacist referring to 66 year old male patient. Patient had a history of developing cold sores on an unspecified location. On 24-OCT-2007, the patient was vaccinated with ZOSTAVAX vial lot# 658602/1080U, expiry date 12-JAN-2009, 0.65 ml, subcutaneous. Concomitant therapies included LYRICA, amlodipine besylate, hydrochlorothiazide, TRIBENZOR, LOVAZA and meloxicam. After receiving the ZOSTAVAX, the patient did not develop cold sores for almost 7 years. On an unknown date in 2010, the patient had a bypass surgery. On an unknown date in 2014, the pharmacist reports that the cold sores are starting to develop in the patient again. No lab diagnostic test performed. The patient received treatment with acyclovir 800 mg for cold sores (treatment received also reported as 'no'). The patient did not sought medical attention. The outcome of bypass surgery and cold sores was unknown. The causality of the events was not reported. No PQC reported. Upon internal review bypass surgery was considered to be medically significant. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Oral herpes, Vascular graft
Clinical narrative: This spontaneous report was received from a pharmacist referring to 66 year old male patient. Patient had a history of developing cold sores on an unspecified location. On 24-OCT-2007, the patient was vaccinated with ZOSTAVAX vial lot# 658602/1080U, expiry date 12-JAN-2009, 0.65 ml, subcutaneous. Concomitant therapies included LYRICA, amlodipine besylate, hydrochlorothiazide, TRIBENZOR, LOVAZA and meloxicam. After receiving the ZOSTAVAX, the patient did not develop cold sores for almost 7 years. On an unknown date in 2010, the patient had a bypass surgery. On an unknown date in 2014, the pharmacist reports that the cold sores are starting to develop in the patient again. No lab diagnostic test performed. The patient received treatment with acyclovir 800 mg for cold sores (treatment received also reported as 'no'). The patient did not sought medical attention. The outcome of bypass surgery and cold sores was unknown. The causality of the events was not reported. No PQC reported. Upon internal review bypass surgery was considered to be medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Grand mal convulsion, Immediate post-injection reaction, Syncope, Urinary incontinence
Clinical narrative: Patient was anxious prior to vaccine and holding breath. After vaccine patient began rapid breathing. About 30-60 seconds after vaccine lost consciousness, (+) tonic clonic movement and loss of urine (30-60 secs). Regained consciousness and was transported to Emergency by Fire Department with stable vitals, on oxygen and fluids administered.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness, Respiratory rate increased, Tonic clonic movements, Urinary incontinence
Clinical narrative: Patient was anxious prior to vaccine and holding breath. After vaccine patient began rapid breathing. About 30-60 seconds after vaccine lost consciousness, (+) tonic clonic movement and loss of urine (30-60 secs). Regained consciousness and was transported to Emergency by Fire Department with stable vitals, on oxygen and fluids administered.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Depressed level of consciousness, Dizziness, Feeling hot, Somnolence
Clinical narrative: Within 2-3 minutes of vaccine administration c/o feeling hot/dizzy;  placed in supine position w/ legs elevated; pt c/o feeling sleepy became difficult to arouse, sternal rub caused her to opens eyes and answer questions w/ 1-2 word answers; VSS BP 120-144/80, HR 96 & regular; Resp 16 & non-labored; no hives; no rash; lungs clear;  Transported to ER via ambulance by 3:10 pm.  Per ER physician, ? syncope.  Symptoms resolved in ER and was discharged to home.
Age: 1.03
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema and edema to injection site (mild - mod). Pt prescribed BENADRYL 125/5.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Seizure like phenomena
Clinical narrative: Fever 102.4 - with seizure like activity lasting 20 minutes.
Age: 23.0
Sex: M
Vaccine: TYP, YF
Symptoms: Dysphagia, Hyperhidrosis, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat with difficulty swallowing, sweating, fever.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Nephrotic syndrome, Swelling, Weight increased
Clinical narrative: After my son had the (HPV) vaccine his body gradually gain weight and swollen.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain
Clinical narrative: Severe pain rt side of trunk Nov 2013. 4-6 nerve blocks. 2 epidural injection. LYRICA now Nortiptyline daily 50 mg.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Morning of 7/17 - itchy, swollen, hot, tender 3" by 4" in area of injection. Called MD 7/17 - diagnosed as cellulitis, rx written for Cefadroxil 500 mg bid x 10 days follow-up if need after 10 days or worse.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Hep A #2 was given 1 min pt.'s (R) arm about 10 minutes later pt. has swelling, burning, site redness.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Data exchange not properly working in EHR. Office procedure did not include immunization reconciliation causing extra dose to be given.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Data exchange not properly working in EHR. Office procedure did not include immunization reconciliation causing extra dose to be given.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Data exchange not properly working in EHR. Office procedure did not include immunization reconciliation causing extra dose to be given.
Age: 1.52
Sex: M
Vaccine: MMRV
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Fussy, fever, rash.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: No adverse reaction.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Data exchange not properly working in EHR. Office procedure did not include immunization reconciliation causing extra dose to be given.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Data exchange not properly working in E.A.R. office. Procedure did not include immunization reconcillation causing extra dose to be given.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Data exchange not properly working in office. Procedure did not include reconciliation of immunizations causing extra dose to be given.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Data exchange not properly working in EHR. Office procedure did not include reconciliation of immunizations causing extra dose to be given.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Data exchange not properly working in EHR. Office procedure did not include reconciliation of vaccines, causing extra dose to be given.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Data exchange not properly working in EHR. Office procedure did not include reconciliation of vaccines. Causing extra dose to be given.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Data exchange was not properly working in EHR office procedure did not include reconciliation of immunizations. Causing extra dose to be given.
Age: 24.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse refers to a 24 year old female patient. There was not medical history, patient's current condition included allergy to MOTRIN. On 10-JUL-2014 the patient was vaccinated with (Oka/Merck) VARIVAX injection, 0.5 ml, subcutaneous, lot number J006693, expiration date 30-MAY-2015. There was not concomitant therapy. The nurse informed that on 10-JUL-2014 the pregnant patient received a dose of (Oka/Merck) VARIVAX. She reported that she was unaware that the patient was pregnant at the time that the (Oka/Merck) VARIVAX was administered, also stated that the reason the patient received the (Oka/Merck) VARIVAX was because her titers showed that she was not immune on an unspecified date. The patient did not seek medical attention. There were not treatment given for the adverse event or laboratory studies performed. The patient became pregnant with LMP of 06-JUN-2014 and EDD of 13-MAR-2015. Initial exposure to (Oka/Merck) VARIVAX was at 5 week (s). The pregnancy outcome was pending. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse refers to a 24 year old female patient. There was not medical history, patient's current condition included allergy to MOTRIN. On 10-JUL-2014 the patient was vaccinated with (Oka/Merck) VARIVAX injection, 0.5 ml, subcutaneous, lot number J006693, expiration date 30-MAY-2015. There was not concomitant therapy. The nurse informed that on 10-JUL-2014 the pregnant patient received a dose of (Oka/Merck) VARIVAX. She reported that she was unaware that the patient was pregnant at the time that the (Oka/Merck) VARIVAX was administered, also stated that the reason the patient received the (Oka/Merck) VARIVAX was because her titers showed that she was not immune on an unspecified date. The patient did not seek medical attention. There were not treatment given for the adverse event or laboratory studies performed. The patient became pregnant with LMP of 06-JUN-2014 and EDD of 13-MAR-2015. Initial exposure to (Oka/Merck) VARIVAX was at 5 week (s). The pregnancy outcome was pending. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Data exchange was not properly working in EHR. Office procedure did not include reconciliation of immunizations. Causing extra dose to be given.
Age: 57.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Fatigue, Malaise
Clinical narrative: Notable fatigue & malaise, joint pain, particularly in both knees.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right leg is painful and swollen-3cm by 3cm--red/round warm area lateral side of thigh. Located in SQ of skin, no mass. Child says "ow" when touched on any area of RT as well as LT leg. Child is limping/favoring LT leg. Treatment; IBU, warm moist heat to area.  RTC PRN if symptoms worsen.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Dermatitis diaper, Diarrhoea, Feeding disorder, Irritability
Clinical narrative: Increase fussiness, decrease amount of oz with feeds and feeding changed. Having liquid stools with each feed. More stools than wet diaper. Developed severe diaper rash on day 5 which had 14 liquid stool.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Data exchange was not properly working in EHR. Office procedure did not include reconciliation of immunizations (only GRITS) causing an extra dose to be given.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Data exchange was not properly working in EHR. Office procedure did not include reconcilliation of immunizations (only GRITS) causing extra dose to be given.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Data exchange was not properly working in EHR office procedure did not include reconciliation of immunizations. (Only GRITS) causing extra dose to be given.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Data exchange was not properly working in EHR. Office process did not include reconciliation of immunizations. (Only GRITS) causing extra dose to be given.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Data exchange not properly working in EHR office procedure did not include immunization reconciliation - causing extra dose to be given.
Age: 1.66
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding an approximately 1 year old patient of unknown gender. The patient's demographics was not reported. There was no information on pertinent medical history and drug reaction or allergies. On 16-JUL-2014, the patient was vaccinated with two doses of GARDASIL (Product Lot# 673256/0629AE, Expiry date: 16-DEC-2014) dose 1, .5 ml (millilitre), intramuscularly in the arm. There was no information on concomitant medications. The patient received one dose of GARDASIL in each arm. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Injection site discolouration, Injection site vesicles, Pain in extremity
Clinical narrative: Pain in arm (L). Blister at injection site, purple area around site. On 7/4/14, burning sensation. 7/6/14 - came to pharmacy instructed to use cortisone cream, applied 2-3 x a day. Redness decreased, and injection site improved.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea/Vomiting and fever/chills and redness on the left arm 15cmx15cm.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Local swelling, Pruritus
Clinical narrative: Swelling and pruritus (L) arm after 2 shots 7/11/14. Resolved in 48 hrs.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative, No adverse event
Clinical narrative: This spontaneous reports as received from a nurse refers to an unspecified number of adult patients (no patient information was provided). On an unknown date the patients were vaccinated with the first dose of MMR II (dose, route and lot # not reported). The patients did not develop immunity after their first dose of MMR II. No adverse effects were reported. The outcome for patients and relatedness between MMR II and adverse event were not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a company representative via pharmacist refers to a 60 year old female patient. On 2014 the patient was vaccinated with ZOSTAVAX, 1 injection subcutaneous for prevention of shingles. On unknown date in June-2014 the patient called her physician reporting that she has experienced allergic reaction to ZOSTAVAX. The physician referred her to the emergency room and the physician found out later that the patient seemed to have allergic reaction to ZOSTAVAX. The patient needed sought of medical attention. No product quality complaint was reported. The patient was fine. The outcome of allergic reaction was reported as recovered/resolved on an unknown date. No additional AE information was provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On July 11, 2014 at 11:00am pt arrives at clinic with mother. C/O redness, swelling and warmth to touch on Rt. deltoid which started 10pm July 10th. Redness measured at 7cm x 12cm. Pt denies pain, nausea, vomiting, fever. Pt's mother instructed to go to the ER if sx worsen. Upon f/u call on July 14th at 9am, father of pt reported the swelling resolved with no further sx or concerns.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The patient had no pertinent medical history. On 09-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot# and frequency were unknown. On 09-JUL-2014, the patient developed a red, raised, itchy area on her arm near the injection site after receiving ZOSTAVAX. Patient sought medical attention via phone call to pharmacy. The outcome of the event was reported as not recovered/not resolved. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Received prescribed vaccine 7/16/14. Developed swollen, red arm in hours. No fev. Pain 5/10.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Dizziness, Dysphagia, Dysphonia, Nausea
Clinical narrative: 15 min. after shot, nausea, dizziness, 20 min. after, hoarseness, hard to swallow. Emergency room. Epi shot, several medicines. Released after 5 hrs. had hoarseness for next three days.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Large red area on right arm where vaccine was given. Patient also complains of pain from shoulder to elbow.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within 24 hrs left arm from 4" inches below shoulder to elbow became red, painful, hot and swollen. 48 hrs later symptoms have decreased but redness still present approximately 14 cm around injection site.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Pruritus
Clinical narrative: Itching and painful shingles. I had only 1 or 2 shingles per year prior to receiving the shingles vaccination. I now have 8 or 10 and more painful.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Erythema, Induration, Papule, Swelling, Tenderness
Clinical narrative: Local erythema, induration, tenderness. Swelling approximately equal to 10x15cm oval, 1 central 3mm papule. Noted 10 minutes after vaccine, seen in office 48 hours post vaccination.
Age: 1.03
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Measles post vaccine, Rash
Clinical narrative: Likely measles rash after vaccine. Rash started on face, then spread to back and stomach.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Up (L) arm swelling with redness and itching. 1 day after vaccine was given. BACTRIM DS x 10 days. MOTRIN x 5 days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Injection site warmth
Clinical narrative: Pt noticed red indurated area at site of ZOSTAVAX injection. Customer concerned about warmth and hardness of injection site. Went to PCP and placed on antibiotic for suspected infection. Developed in 24-48 hrs after injection. Pt reports no alcohol to site of injection. Give B-12 shots herself. I did use an alcohol wipe on her.
Age: 20.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: She was administered Tdap vaccine when she had Tdap vaccine 11-11-05. No adverse effects reported by patient.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: W/I 24 hr. develop large area of redness, swelling, tenderness and warmth.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: 5 inch (diameter) red area, swollen, hot to touch, hard. Pt was complaining of itchiness. Started within 24 hours after vaccine.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 15 year old female patient. The patient had no pertinent medical history and drug reactions/allergies. On 10-FEB-2000 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot#not reported), 0.5 ml, subcutaneous. No concomitant medications were reported. The physician assistant reported that the patient was diagnosed with shingles on 03-MAY-2011. The patient had sought medical attention via an office visit. Outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On 09-JUL-2014 (reported as today), the patient was vaccinated with an expired dose of ZOSTAVAX injection (lot # J003805, expiry date: 03-JUL-2014; dose, route of administration and indication unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. Since 17-JUN-2014, (in approximately 2014, exact date was not reported) unknown number of patients were inadvertently vaccinated with ROTATEQ oral (lot#, expiration date, dose not reported) that had been improperly stored (since unknown date). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. Since 17-JUN-2014, (in approximately 2014, exact date was not reported) unknown number of patients were inadvertently vaccinated with GARDASIL (lot#, expiration date, dose not reported) that had been improperly stored (since unknown date). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 28-MAY-2008 the patient was vaccinated with the first dose of VAQTA (dose, route, frequency, lot# and expiration date were unknown). On 21-NOV-2008 the patient was vaccine with the second dose of VAQTA (25U/0.5ml, dose, route, frequency, lot# and expiration date were unknown). No adverse symptoms reported. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a healthcare worker referring to approximately 5 year old patient (gender not reported). Pertinent medical history and concurrent condition were not reported. On 17-JUL-2014 the patient was vaccinated with expired dose of PROQUAD (lot # H020851, Expiry date: 26-MAY-2014) (dose not reported). No other concomitant therapies reported. The outcome of the event was unknown. The causality of the event was unspecified. No PQC reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX (dose, route of administration, lot # and expiration date were not provided). On an unknown date, the patient experienced vaccine reaction. The outcome of vaccine reaction was unknown. The reporter considered the event to be related to (Oka/Merck) VARIVAX. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness swelling warm to the touch on Friday afternoon. Seen at ER off base on Saturday was given antibiotics and told to f/u on base. Pt states after taking Bactrim and Cipro swelling redness went down. Pt states he feels alot better today but not 100%.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Feeling hot, Immediate post-injection reaction, Injection site pain, Insomnia
Clinical narrative: As soon as the needle entered my arm I felt a warm, burning, painful sensation that increased as the vaccine was injected. Within minutes it started to hurt at the site of the injection. The pain continued to increase as the hours passed. The pain was not typical post-vaccine pain of muscle soreness but rather a pain that felt/feels like it is under the muscle and slightly electric in nature yet sore as well. I have some weakness in my right arm and any movement of my arm significantly increases the pain. I have had great difficulty sleeping for the past four nights because of the pain in my arm. It is impossible to find a position when lying down that doesn't make my arm hurt. When I'm up for the day, my arm has continued to hurt consistently with an increase in pain when I move it. I do not have any other symptoms. Just the pain in my arm and some perceived weakness in my arm/shoulder. It is now July 22, 2014 and I am still having pain and have made an appointment with my doctor today.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Myalgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: As soon as the needle entered my arm I felt a warm, burning, painful sensation that increased as the vaccine was injected. Within minutes it started to hurt at the site of the injection. The pain continued to increase as the hours passed. The pain was not typical post-vaccine pain of muscle soreness but rather a pain that felt/feels like it is under the muscle and slightly electric in nature yet sore as well. I have some weakness in my right arm and any movement of my arm significantly increases the pain. I have had great difficulty sleeping for the past four nights because of the pain in my arm. It is impossible to find a position when lying down that doesn't make my arm hurt. When I'm up for the day, my arm has continued to hurt consistently with an increase in pain when I move it. I do not have any other symptoms. Just the pain in my arm and some perceived weakness in my arm/shoulder. It is now July 22, 2014 and I am still having pain and have made an appointment with my doctor today.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site rash
Clinical narrative: Local rash to sites.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, frequency, lot# and expiration date were unknown). On an unknown date (about six months to a years ago) the patient developed a red blister at the injection site. The outcome of developed a red blister at the injection site was reported as recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to over 40 unspecified patients of unknown age (no patient information provided). On an unknown date, the patient was vaccinated with, improperly stored outside temperature conditions listed in the product insert, ROTATEQ, (dosage regimen and indication were not provided). No adverse effects reported. The outcome of events 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: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to over 40 unspecified patients of unknown age (no patient information provided). On an unknown date, the patient was vaccinated with, improperly stored outside temperature conditions listed in the product insert, RECOMBIVAX HB injection, (dosage regimen and indication were not provided). No adverse effects reported. The outcome of the events 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: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Diarrhoea, Erythema, Malaise, Nausea
Clinical narrative: Generalized blisters with erythematous base, malaise, nausea/vomiting, diarrhea for 3 wks duration. Resolved with rash. Slight fever.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Generalized blisters with erythematous base, malaise, nausea/vomiting, diarrhea for 3 wks duration. Resolved with rash. Slight fever.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. Since 17-JUN-2014, (in approximately 2014, exact date was not reported) Unknown number of patients were inadvertently vaccinated with PROQUAD (lot#, expiration date, dose not reported) that had been improperly stored (since unknown date). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to over 40 unspecified patients of unknown age (no patient information provided). On an unknown date, the patient was vaccinated with, improperly stored outside temperature conditions listed in the product insert, GARDASIL (dosage regimen and indication were not provided). No adverse effects reported. The outcome of events 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: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to over 40 unspecified patients of unknown age (no patient information provided). On an unknown date, the patient was vaccinated with, improperly stored outside temperature conditions listed in the product insert, PNEUMOVAX 23 (dosage regimen and indication were not provided). No adverse effects reported. The outcome of events 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: MMRV
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a nurse (mid wife) refers to a three adult patients, over the age of 20 years, of an unknown gender. On an unkonwn dates, the three adult patients were inadvertently administered PROQUAD (Merck) 0.5ml, subcutaneous (lot # and expiration date were not provided). No adverse effects reported. Additional information is not expected because the reporter did not agree on further contract.
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dyspnoea, Heart rate increased, Heart rate irregular
Clinical narrative: Case number PHEH2014US014430 is an initial spontaneous report from a consumer received on 09 Jul 2014. This report refers to a female patient of an unknown age. She was vaccinated with FLUVIRIN (batch number: not reported) on unspecified date in Oct 2013. On the same day, within one hour after vaccination, she started getting shortness of breath that lasted about one hour. Then her blood pressure and pulse were elevated and indicated irregular heartbeat. About three hours after getting the flu shot this stopped. Seriousness and causality of the events were not reported.
Age: 1.1
Sex: U
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 13 month old patient of unknown gender. On unknown date in June 2014 (reported as within the last week or so) the patient was vaccinated with first dose of (Oka/Merck) VARIVAX 0.5 ml, subcutaneous (lot # J014228 and expiry date 08-NOV-2015). Concomitant therapies included PREVNAR 13 and dose of ACTHIB given on the same day in June 2014. On unknown date in June 2014 the patient experienced raised, large area, red, 1.5 inch by .75 inch wide. The outcome of the events was unknown. The relatedness between the events and (Oka/Merck) VARIVAX was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of GARDASIL, (dose number, lot/batch number, expiration date, route of administration not reported) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also M-M-R II, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS# 1405USA012894, 1406USA000956, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported. This is one of several reports from the same reporter. Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013 to March 2014. The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from Registered Nurse on 27-JUN-2014. The nurse stated that one dose of GARDASIL (Lot#J010395, expiration date 29-APR-2016, dose not reported) that was exposed to highest temperature of 9.5C for 6 hours from 28-AUG-2013 to June 2014 was administered to unspecified patient (unknown age and gender) on an unknown date. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of GARDASIL, (dose number, lot/batch number, expiration date, route of administration not reported) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also M-M-R II, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS # 1405USA012894, 1406USA000956, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported. This is one of several reports from the same source. Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013 to March 2014. The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from Registered Nurse on 27-JUN-2014.The nurse stated that one dose of GARDASIL (Lot #H021608, expiration date 13-AUG-2015, dose not reported) that was exposed to highest temperature of 9C for 6 hours from 28-AUG-2013 to June 2014 was administered to unspecified patient (unknown age and gender) on an unknown date. This is one of several reports from the same source. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Headache, Lethargy
Clinical narrative: S/s - headache, fever (101.0 at highest), lethargy shortness of breath, chest pain/heaviness lasting 2.5 days. No treatment given (advised to go to ER, but didn't comply).
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: S/s - headache, fever (101.0 at highest), lethargy shortness of breath, chest pain/heaviness lasting 2.5 days. No treatment given (advised to go to ER, but didn't comply).
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 21-JUL-2014 the patient was vaccinated subcutaneously with an expired dose of MMR II (0.5 ml, lot # H013042, expiration date 17-JUL-2014). No symptoms were reported. No PQC (product quality complaint) was involved. Additional information has been requested.