chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Injection site pruritus, Local reaction, Oedema peripheral, Skin warm
Clinical narrative: Mother of pt called today w/ c/o pt's local reaction on R arm -red, raised, swelling increased from yesterday, 8/25/13, reported diameter of local reaction > 2 in, warm to touch but pt denies pain, afebrile, range of motion within normal, skin intact, states no red streaks on R arm, and site itchy. Mother stated applied-home treatment - ice x 2 days but redness and swelling worse today; no oral OTC meds given. Mom will continue ice and apply hydrocortisone to site. Mother instructed to seek MD care if no relief w/ home treatment and symptoms worse. Mother agreed w/ plan.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Depressed level of consciousness, Dizziness, Fall
Clinical narrative: Weak and almost fainting. Patient fell to the ground, but never fully lost consciousness.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Autopsy, Cardiac arrest, Death, Gastrointestinal necrosis, Irritability
Clinical narrative: Excessive fussiness, vomiting, came to urgent care asystolic, time of death called after resuscitative efforts failed, small bowel necrosis determined at autopsy.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Resuscitation, Vomiting
Clinical narrative: Excessive fussiness, vomiting, came to urgent care asystolic, time of death called after resuscitative efforts failed, small bowel necrosis determined at autopsy.
Age: 11.0
Sex: F
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Full body hives same day vaccine given. 5 day steroid treatment.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Cellulitis, Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old female patient. On 26-JUN-2013 the patient was vaccinated with a dose of PROQUAD (Merck) (injection, lot# reported as H017885, expire date, dose and route were unspecified). Nurse reported the patient experienced local reactions, large, swollen, red area, about size of an egg on the thigh after receiving PROQUAD (Merck). Patient went to an unspecified Emergency Room for a swollen right leg on 28-JUN-2013. Patient was diagnosed with cellulitis. Patient was prescribed BACTRIM, but did not take BACTRIM, for unspecified reason. Cold compresses were applied and the cellulitis resolved(unspecified date in 2013). This is one of three reports that received from the same source. 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 nurse refers to an unknown number of patients. On an unknown date the patient was vaccinated with GARDASIL (lot# was not reported). The nurse reported that the patients might have received improperly stored GARDASIL. No adverse event reported. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a series of RECOMBIVAX HB (Lot number, expiry date, route and dose were not reported) as a child. On an unspecified date, the patient had the titers drawn that had resulted negative. The outcome of the reported event was unknown. This is one of the two reports received from the same reporter Link(MARRS#1308USA011228). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a consumer refers to a 19 year old female patient with drug reaction to sulfa drugs. No concomitant medications and pertinent medical history were reported. On 31-JUL-2013, the patient was vaccinated with VARIVAX (Merck) dose 1, .5 ml, subcutaneous (lot number and expiry date not provided). On 14-AUG-2013, 15 days after onset of therapy the patient developed a rash at the injection site of her arm since receiving her first VARIVAX injection. The reporter stated that the rash did not develop until about two weeks after receiving the injection. The patient did not receive any treatment. The outcome of developed a rash at the injection site of her arm since receiving her first VARIVAX was reported as not recovered/not resolved. The reporter did not assess the relationship between the event and VARIVAX (Merck). The patient did not seek medical attention. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a health care worker refers to about a dozen of unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with a series of hepatitis B vaccine (recombinant) (manufacturer unknown) (Lot number, expiry date, route and dose were not reported) as a children. On unspecified dates, the patients had the titers drawn that had resulted negative. The outcome of the reported event was unknown. This is one of the two reports received from the same reporter Link (MARRS#1308USA010407). 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 an unspecified number of patients of unknown age and gender. On an unknown date, the patients may have been vaccinated with a dose of ROTATEQ (Lot number, expiry date, route and dose were not reported) that was exposed to 53 Fahrenheit for 48 hours and then were exposed to 30 Fahrenheit for 72 hours. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV4, RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse. The nurse reported that ROTATEQ, GARDASIL, RECOMBIVAX HB and VAQTA were exposed to 20 hours outside of range with a minimum temperature of -1.5 centigrade(C). She also stated that they were exposed to temperatures of 9C for 3 hours and 1C for 3 hours and 10 minutes. The temperature excursion could not be supported. Nurse stated that she was unsure whether or not any of the unsupported doses were administered. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Varicella
Clinical narrative: This spontaneous report as received from a physician, via a company representative refers to a 62 year old female patient. On 03-APR-2013, the patient was vaccinated with a single dose of ZOSTAVAX, subcutaneous (lot number and expiry date not provided). On an unknown date in 2013, the patient experienced a rash and was diagnosed with chickenpox after receiving the ZOSTAVAX. The outcome of diagnosed the adverse event was reported as recovering/resolving. The patient sought medical attention by seeing a doctor. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 64 years old female. The patient had no pertinent medical history, no drug reactions/allergies. On 24-JUL-2013 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot# J001690, expiration date: 08-MAY-2014), subcutaneous at unspecified location. No concomitant therapies reported. On an unspecified date, the patient who was taking ZOSTAVAX developed redness at injection site that persists. Patient reported to pharmacist that there was no discomfort, and the area of redness had decreased in size. The patient had sought medical attention via pharmacy visit. No treatment was given for redness at injection site. None lab diagnostics studies was performed. At the time of report, the outcome of the redness at injection site was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist reported an unspecified number of patients received ZOSTAVAX (lot# unspecified), route unspecified "in the back of the arm". No adverse symptoms reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a 63 year old male patient. On 09-AUG-2013 the patient was inadvertently vaccinated with first dose of GARDASIL (120 Y, site, route, dose not reported). No adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered nurse concerning a female patient of unknown age. On an unknown date (reported as one  unspecified patient received the vaccine about a year ago and the other unspecified patient received the vaccine about a couple of years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date (reported as recently), the patient was diagnosed with shingles after receiving ZOSTAVAX. The patient sought an unspecified medical attention. An unspecified treatment was given to the patient. It was unspecified if any lab tests were performed. On an unknown date, the patient was recovered from shingles. The relatedness for shingles was unknown for ZOSTAVAX. This is one of the two reports from the same source. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a nurse for VARIVAX (Merck) a Pregnancy Registry product concerning a female patient of unknown age. On 10-JUL-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, expiry not reported) and the patient became pregnant since then. The LMP and EDD was not known. The pregnancy out come was outcome pending. The pregnancy was normal to date. The patient would call back with her obstetrician's information when it was available. Patient sought medical attention contacted the clinic. The patient would have an unspecified genetic testing early in the pregnancy. 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 patient of unknown age and gender. On 13-AUG-2013 the patient was vaccinated with a dose of GARDASIL, intramuscular injection, 0.5 ml (lot # H017698; exp.date 15-JUL-2015), that was improperly stored and exposed to 31F for 2 hours. No adverse effect was reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV2, MNQ
Symptoms: Aphasia, Fatigue, Feeling abnormal, Pain in extremity, Thinking abnormal
Clinical narrative: Day after receiving shots (HPV and Meningococcal) pt could not think straight. Could not finish sentences. Patient was very fatigued. Cound not remember what she was doing, went to bathroom to brush teeth and forgot what she was doing. Patient complained to Mom that she could not think straight. Patient acted loopy. C/O sore Rt. arm, no temp.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Aphasia, Cyanosis, Fall, Muscle rigidity, Pallor
Clinical narrative: Within 15 sec. of completion of vaccination administration pt. (sitting on father's lab for immun.) became rigid and fell back against Dad. Lasted not even 5 sec. Then arms, legs normal, but not talking, lips blue, skin pale, lasted another 5 sec. Then child would respond with nodding of head, took sips of water without problems - started talking within 5 sec. Cool moist cloth applied to neck and arms throughout incident. Pt. back to normal, laughing and talking - walked with Father out of office.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Bacterial test positive, Beta haemolytic streptococcal infection, Intensive care, Pain, Speech disorder
Clinical narrative: Called our on call MD on 8/24 reporting Uvula dropped and was having trouble talking and a lot of pain. Referred to ER. Admitted to hospital PICU. Discharged 08/26/13 on Augmentin. Cultured positive for group A strep during admission.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Streptococcus test positive
Clinical narrative: Called our on call MD on 8/24 reporting Uvula dropped and was having trouble talking and a lot of pain. Referred to ER. Admitted to hospital PICU. Discharged 08/26/13 on Augmentin. Cultured positive for group A strep during admission.
Age: 44.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Back pain, Chills, Dizziness, Injected limb mobility decreased, Injection site pain
Clinical narrative: 44yo patient presents to the emergency room the following day after receiving a pneumococcal vaccine. The patient reported fever (101), chills and tenderness with swelling at the injection site (right arm). Dizziness, wheezing and pain made it hard to sleep. The pain radiated from the site of the injection to the patient's back and shoulder Stiffness and pain in the neck was also reported. The upper arm showed mild confluent blanching erythematous maculopapular rash and reduced range of motion due to pain. Patient received diphenhydramine 50mg IV and morphine in the ER with improvement. On discharge patient received pain medication and diphenhydramine capsules and was instructed to apply warm compresses. No further event noted.
Age: 44.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site swelling, Insomnia, Musculoskeletal stiffness, Neck pain, Pallor
Clinical narrative: 44yo patient presents to the emergency room the following day after receiving a pneumococcal vaccine. The patient reported fever (101), chills and tenderness with swelling at the injection site (right arm). Dizziness, wheezing and pain made it hard to sleep. The pain radiated from the site of the injection to the patient's back and shoulder Stiffness and pain in the neck was also reported. The upper arm showed mild confluent blanching erythematous maculopapular rash and reduced range of motion due to pain. Patient received diphenhydramine 50mg IV and morphine in the ER with improvement. On discharge patient received pain medication and diphenhydramine capsules and was instructed to apply warm compresses. No further event noted.
Age: 44.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Pyrexia, Rash erythematous, Rash maculo-papular, Wheezing
Clinical narrative: 44yo patient presents to the emergency room the following day after receiving a pneumococcal vaccine. The patient reported fever (101), chills and tenderness with swelling at the injection site (right arm). Dizziness, wheezing and pain made it hard to sleep. The pain radiated from the site of the injection to the patient's back and shoulder Stiffness and pain in the neck was also reported. The upper arm showed mild confluent blanching erythematous maculopapular rash and reduced range of motion due to pain. Patient received diphenhydramine 50mg IV and morphine in the ER with improvement. On discharge patient received pain medication and diphenhydramine capsules and was instructed to apply warm compresses. No further event noted.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Erythema, Induration, Injection site cellulitis, Pyrexia, Tenderness
Clinical narrative: (L) Deltoid cellulitis secondary to imm administration (KINRIX). Cephalexin 250mg/5ml 6ml tid for 10d.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Hyperhidrosis, Nausea, Pain, Swelling
Clinical narrative: Initial swelling/redness and pain. Several hours later experienced nausea, sweating and vomiting.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Initial swelling/redness and pain. Several hours later experienced nausea, sweating and vomiting.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a pediatric patient of unknown age and gender. On 16-AUG-2013 the patient was administered an adult dose of VAQTA. The first dose of VAQTA was administered on a prior unspecified date. No adverse effect reported. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a office manager via company representative refers to a 18 month old patient. On an unknown date the patient was inadvertently administered a dose of ZOSTAVAX instead of VARIVAX (Merck). There was no adverse event reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Developed red, swollen upper arm at injection site on night of administration. She also c/o of a headache, moderate intensity, that lasted for approximately 5 days. Arm was still red and tender 1 week later. Discomfort remains, but lessened. A clinic nurse examined the site and encouraged her to use a wet compress and take a Tylenol 2 or 3 times daily. Tylenol alleviated the discomfort.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Developed red, swollen upper arm at injection site on night of administration. She also c/o of a headache, moderate intensity, that lasted for approximately 5 days. Arm was still red and tender 1 week later. Discomfort remains, but lessened. A clinic nurse examined the site and encouraged her to use a wet compress and take a Tylenol 2 or 3 times daily. Tylenol alleviated the discomfort.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Arthralgia, Joint swelling, Local swelling
Clinical narrative: Intermittent swelling and pain of ankles, knees, fingers and knuckles started approx 8/4/13. Previously rash. Rash and fever 6/26 (PROQUAD on 6/17/13) lasted 3 days.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: Intermittent swelling and pain of ankles, knees, fingers and knuckles started approx 8/4/13. Previously rash. Rash and fever 6/26 (PROQUAD on 6/17/13) lasted 3 days.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Mom reports redness and hardness at injection site (Right arm, SQ). Provider seen, suggested BENADRYL ointment and BENADRYL PO, per mother. 8/23/13.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site erythema, Injection site swelling
Clinical narrative: 9x6 cm red induration. Red and swollen upper (R) arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site was red, swollen, warm to touch, painful, itchy.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a physician concerning a 15 year old female patient. The patient's pertinent medical history, drug reactions/allergies were unknown. On an unknown dates, the patient received first, second, and third doses of RECOMBIVAX HB (also reported as manufacturer unknown) (dose, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. On an unknown date, it was reported that the patient had negative titers (titers lab test performed on an unspecified date). At the time of the report, the patient's outcome and relatedness between the event and suspect drug were not provided.  Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema
Clinical narrative: Local inflammatory lesion 7x8 cm with erythema and edema at site of immunization.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Swelling of arm redness on area. Doctor is treating with Ibuprofen and Cutivate topical cream 0.05%.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health worker, the reporter reported that RECOMBIVAX HB (lot#, dose, route, indication not reported) was exposed to 24.5 F for 8 hours and could not be supported, she didn't know whether any doses were administered to patients. SR# provided to follow up if any patients were administered unsupported doses. No adverse effects reported. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Activities of daily living impaired, Influenza like illness, Local swelling, Pain, Pain in extremity
Clinical narrative: Evening of vaccine admin. pt noted (R) arm swelling ache and flu like symptoms. Pt states was in bed x2 days with fever 102 body aches swollen (R) arm.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: Evening of vaccine admin. pt noted (R) arm swelling ache and flu like symptoms. Pt states was in bed x2 days with fever 102 body aches swollen (R) arm.
Age: 41.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 41 year old female patient. On 20-AUG-2013, the patient was vaccinated with a dose of RECOMBIVAX HB (Lot # reported as J001389, expiration date 07-NOV-2014). The medical assistant reported that on 20-AUG-2013, 45 min after vaccination, the patient experienced raised rash on her neck. The patient was treated with BENADRYL. There were no Lab/diagnosis or studies performed. The outcome of raised rash was reported as recovering/resolving. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 41 year old female patient. On 20-AUG-2013, the patient was vaccinated with a dose of RECOMBIVAX HB (Lot # reported as J001389, expiration date 07-NOV-2014). The medical assistant reported that on 20-AUG-2013, 45 min after vaccination, the patient experienced raised rash on her neck. The patient was treated with BENADRYL. There were no Lab/diagnosis or studies performed. The outcome of raised rash was reported as recovering/resolving. Additional information has been requested.
Age: 1.15
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Ear infection, Pyrexia, Rash
Clinical narrative: Parents report high fever and rash. Taken to ED, where patient was diagnosed with ear infection. Parents are sure this was a reaction to immunizations.
Age: 1.15
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash papular
Clinical narrative: Patient developed erythematous, papular, nonpruritic rash a few hours after receiving vaccinations. Father also reported fever to 101.2 F. Rash still present 8/13.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding to an unspecified number of patients of unknown age and gender with no pertinent medical history reported. The pharmacist reported that on unspecified dates the medical center he works for, may have possibly administered to an unspecified number of patients an improperly stored M-M-R II (lot number and expiration date not reported) (dose and route not specified). No other suspect therapies or concomitant medications were reported. The pharmacist stated he was not sure, he also stated that he did not know if the information he had was correct or not. No symptoms were reported. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: Information has been received from a physician via company representative concerning a female patient in her 20's who on an unknown date was vaccinated with a dose of GARDASIL (lot number, route were not reported). The physician reported that the patient fainted and vomited after receiving GARDASIL. At the time of the report, the patient outcome was not provided. Additional information has been requested. This report is linked to MARRS case 1308USA08732, same reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Pharmacist reported that on an unknown dates, multiple unspecified patients may have been administered ROTATEQ (dose, lot number and route were not reported), that went through an unsupported temperature excursion. Concomitant medications were not reported. No adverse effects reported. This case is linked to case 1308USA011686 and 1308USA010000 via same reporter link. 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 pharmacist refers to multiple unspecified patients of unknown age and gender. Pharmacist reported that on an unknown dates, multiple unspecified patients may have been administered PNEUMOVAX23 (dose, lot number and route were not reported), that went through an unsupported temperature excursion. Concomitant medications were not reported. No adverse effects reported. This case is linked to cases 1308USA011687 and 1308USA010000 via same reporter link. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Fevers x 60 hrs up to 102-103 degrees. Soreness until 8/18/13. Swollen to size of a baseball on 8/15/13.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Rash macular
Clinical narrative: Erythematous maculopapular lesions after 3rd injection. Tx: IV BENADRYL 50 mg, SOLUMEDROL 125 mg, ZANTAC 50mg.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Information has been received from a registered pharmacist, via a physician, concerning a female patient of unknown age. On 19-MAY-2013, 3 months ago, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and frequency were not reported) (Lot # and expiration date not reported). The patient sought medical attention by seeing the physician. At the time of the report, the patient's outcome of redness, pain and significant arm swelling "up to the shoulder" was unknown. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Mild body rash.
Age: 41.0
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 41 week old patient. On 20-AUG-2013, the patient was vaccinated with the third dose of ROTATEQ (route and lot # not reported). No adverse effect was reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Local swelling, Pain, Skin tightness
Clinical narrative: Swelling, redness, (R) arm. Tightness, pain. Spoke with neuromuscular Dr. and not related to his disease.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Large bruise at injection site started during the night with soreness then next morning had baseball sized bruise. Reduced in size over next few days.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Eosinophil count increased, Irritability, Pyrexia
Clinical narrative: Fever, fussiness night after given immunizations.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Discomfort, Erythema, Induration, Local swelling
Clinical narrative: Arm became red/firm/swollen - lg area of redness. Discomfort x 2-4 days. Mom treated with OTC pain reliever, rest and bathing.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Started with itching, redness, swelling and warmth in (L) arm where varicella vaccine given on 8/20/13. Redness, swelling and discomfort increased and pt was seen by Nurse Practitioner on 8/22/13. Pt was placed on cephalexin 250 mg 3 capsules in AM and 3 capsules in PM x 10 days.
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site swelling, Injection site warmth, Upper extremity mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 14-AUG-2013 (reported as last Wednesday), the patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported). Concomitant therapy was not reported. It was reported that after receiving ZOSTAVAX, in August 2013 the patient experienced a lump on her arm near injection site, swelling and hot (warmth) around injection site. The patient also stated that the area near injection site was hardened. The patient sought medical attention by speaking with the pharmacist, and no treatment was given for the adverse events. At the time of the report, the patient's outcome was not recovered. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Patient mother called stating child had welts at injection sites on both legs about 8 inches around. She could not bring child in to be seen. Stated no fever, and itchy at the site. Informed patient mom to use ice and BENADRYL. Patient's mother admitted to giving her an antihistamine already stated it is getting a little better. Patient was playing in background and sounded happy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Dark circles under eyes, Rash
Clinical narrative: 8/23/13 at 1655 - Mom called clinic reported child developed rash (spots) under eyes. Dark earlier, lighter now. No SOB, no itching, no fever.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Convulsion, Gaze palsy, Laboratory test
Clinical narrative: 8-21-13 4 A febrile seizures focal (L) eye deviation.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Acne, Injection site erythema, Local reaction
Clinical narrative: 2 1/2 cm redness at injection site. Right - circular local reaction with pimples within circle.
Age: 0.61
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever to 107F in ED hrs after vaccine admin.
Age: 27.0
Sex: U
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site warmth
Clinical narrative: Site of injection warm to touch, red. Feeling tired for 2 days.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, CSF culture negative, Culture urine negative, Epstein-Barr virus test negative, HIV test negative
Clinical narrative: Patient admitted to hospital on the same day of vaccinations for failure to thrive and later that day had fever and continued with fevers up to 104 for the next 2 weeks with leukocytosis - WBC 52,000.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hepatitis viral test negative, Herpes simplex serology negative, Leukocytosis, Polymerase chain reaction, Pyrexia
Clinical narrative: Patient admitted to hospital on the same day of vaccinations for failure to thrive and later that day had fever and continued with fevers up to 104 for the next 2 weeks with leukocytosis - WBC 52,000.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Staphylococcus test negative, White blood cell count increased
Clinical narrative: Patient admitted to hospital on the same day of vaccinations for failure to thrive and later that day had fever and continued with fevers up to 104 for the next 2 weeks with leukocytosis - WBC 52,000.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Convulsion, Head injury, Muscle rigidity
Clinical narrative: The patient was given the MENACTRA and HPV vaccines and asked to wait 15 min. afterwards. Approximately 5 min after receiving the vaccines the mother started yelling for help. The patient appeared to being having a seizure and was very stiff in the limbs. The patient was laid down and came around almost immediately. Pulse was 72, BP 100/70, P ox, 68. Given some candy and water and asked to lay down. An ice pack was applied to the head due to hitting it when seizing. About 20 min. later the patient walked out of the clinic on her own after being evaluated by a MD.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Right leg swelling and cellulitis from the knee down - days after injection of PEDIARIX given in right thigh. Treated with oral antibiotics.
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: Back pain, Herpes zoster, Musculoskeletal pain, Pain, Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 year old female patient with no pertinent medical history or drug reactions/allergies. On 08-JUL-2002 the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, expiration date not reported), 0.5 ml, subcutaneously. On 08-FEB-2013, the patient got shingles. The patient had pain on the inside of the left side and then a rash broke out in a linear fashion on the left side that did not cross midline. The location of the rash and the pain was the left lower back and buttock. The patient sought medical attention via office visit on 12-FEB-2013. The patient received 10 days of acyclovir and 5 days of prednisone (manufacturer unknown), ZOVIRAX cream. No lab diagnostics studies performed. The outcome of the events was recovered on an unspecified date. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Pain, Swelling, Vaccination complication
Clinical narrative: Reaction to TDAP - swelling, pain, redness, heat.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Pharmacist reported that on an unknown dates, multiple unspecified patients may have been administered M-M-R II (dose, lot number and route were not reported), that went through an unsupported temperature excursion. Concomitant medications were not reported. No adverse effects reported. This case is linked to cases 1308USA011686 and 1308USA011687 via same reporter link. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Arthralgia, Dizziness, Injection site erythema, Injection site induration
Clinical narrative: Redness at site, pain 5/10, red, raised indurated itchy 50 mm diameter. Systemic, feels "sick" joint aches, nausea, cramping yesterday in abdomen and lower back - now sore. Temp not taken. Dizzy.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Malaise, Muscle spasms
Clinical narrative: Redness at site, pain 5/10, red, raised indurated itchy 50 mm diameter. Systemic, feels "sick" joint aches, nausea, cramping yesterday in abdomen and lower back - now sore. Temp not taken. Dizzy.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain
Clinical narrative: Redness at site, pain 5/10, red, raised indurated itchy 50 mm diameter. Systemic, feels "sick" joint aches, nausea, cramping yesterday in abdomen and lower back - now sore. Temp not taken. Dizzy.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pain
Clinical narrative: SC injection of PNEUMOVAX 23 / 1 25mcg / 0.5 ml Merck NDC 00006-4943-00 11:15 am on 8/23 - got vaccine, came in on 8/24 with swelling and redness over arm spreading over whole area. Felt tired and sore.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site rash
Clinical narrative: Rash from injection site (thigh) to his foot.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: Information has been received from a physician via company concerning a 19 year old female patient who on an unknown date was vaccinated with a dose of GARDASIL (lot number, route were not reported). The physician reported that the patient fainted and vomited after receiving GARDASIL. At the time of the report, the patient outcome was not provided. Additional information has been requested. This report is linked to MARRS case 1308USA011581, same reporter.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Impaired driving ability
Clinical narrative: Pt said arm went numb. Today, (day 2) after administering vaccine she can move her arm but still can not drive with left arm.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash, Pruritus, Pyrexia
Clinical narrative: Large 10 cm circular rash at MMRV injection site in right thigh. Itchy, low grade fever to 100.5 F ax. Responded to oral steroids x 3 days.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Chest X-ray normal, Dyspnoea, Hypotonia, Screaming, Wheezing
Clinical narrative: Pt screamed for 2 hrs. Went limp and started gasping for air. Taken to ER. O2 administered. Wheezing, inc. work of breathing.
Age: 1.92
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left leg is red and swollen.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site nodule, Pain, Pyrexia
Clinical narrative: Fever, body aches, severe headaches, "knot" at injection site, upper arm red from shoulder to elbow. Redness subsided 5 days after injection. Treated with ibuprofen, diphenhydramine, hydroxyzine.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a patient of unknown age. On 20-MAY-2013, the M-M-R II vials in the physician's office were improperly stored at 48F for 16 hours. On 21-MAY-2013 one of these M-M-R II HSAS (lot# H010136, exp. 17-MAY-2014) was subcutaneously administered to the patient. No known adverse effects. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 17 year old female patient. In 2002 the patient was vaccinated with a dose of VARIVAX (Merck), dose, frequency and route were unknown. On an unspecified time, before 2012, the patient experienced shingles. It was unspecified if the patient sought medical attention. At time of report the outcome of shingles was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report as received from Licensed Practical Nurse refers to a 50 year old female patient with drug allergy to DULERA (MARRS# 1308USA010544). The patient's medical history included asthma. On 15-AUG-2013 the patient was vaccinated with the first dose of PNEUMOVAX23(lot # was reported as H022280, exp. date 16-JUL-2014), 0.5 ml, intramuscular in the left arm. Concomitant therapies included desonide, montelukast sodium(manufacturer unknown), PROAIR, omeprazole(manufacturer unknown) and ESTRACE. Patient visited the physician's office today, on 16-AUG-2013, presenting with pain and itching at injection site as well as "extreme" swelling and redness from the patient's shoulder down to her elbow. Patient was administered the PNEUMOVAX23 in the left arm however both the patient's right and left hand are swollen. Nurse stated that the "patient's arm was quite swollen." Physician prescribed an unspecified dose of BENADRYL and ice to the affected area. The patient was not recovered from the events. The therapy did not discontinue. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 year old female patient. On 19-AUG-2013 the patient was vaccinated with PROQUAD (lot # J002304, exp 22-AUG-2014). On 20-AUG-2013, the patient experienced local reactions, large, swollen, red area, about size of an egg on the thigh after receiving PROQUAD. Patient was seen in the office on 21-AUG-2013 and received BENADRYL 25 mg as treatment. The outcome of the adverse event was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed practical nurse refers to unspecified number of patients. On unknown dates, the patients might have received doses of PEDVAXHIB (Lot # not reported) and GARDASIL (Lot # not reported) that were exposed to an unsupported temperature excursion. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist who reported that improperly stored RECOMBIVAX HB 10 microgram (route and lot # were unknown) might have been administered to unspecified number of patients on unspecified dates. RECOMBIVAX HB doses were exposed to unsupported temperature excursions and some doses might have been administered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Vomiting
Clinical narrative: Vomiting for days.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Amyotrophic lateral sclerosis, Death, Gene mutation, Gene mutation identification test positive
Clinical narrative: This report is follow-up to VAERS 449334. Pt. had rapidly progressing ALS. She was positive for the FUS gene mutation. She died from ALS on 8/26/11.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MENHIB
Symptoms: Electrocardiogram, Electromyogram, Lumbar puncture, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: Tingling in hands and feet.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MENHIB
Symptoms: Paraesthesia, X-ray
Clinical narrative: Tingling in hands and feet.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Injection site nodule, Injection site pain, Muscle spasms, Musculoskeletal pain
Clinical narrative: My primary physician suggested I contact you. My arms seized up with absolutely no warning approximately 26 hours after I received an injection of Zostavax.  My arms were crossed with my hands on my chest like a dead person in a coffin.  My jaw seized up in another 6 hours.  The pain in my arms, from below the shoulder and above the elbows was excruciating...it never let up. Because of my jaw being seized shut I could not explain to the Hospitalist on call that this was not arthritis pain.  I have had arthritis for 53 years.  I KNOW what arthritis pain feel like. I still have a knot in my arm, although tiny now, in which I received the injection.  Even today, when I press on the tiny knot I faintly feel the same pain. Is it possible this was caused by an allergic reaction or an improperly administered injection. I am giving you the following so you will know this actually has happened. Clinic $726.92; Hospital $18,812.95; Hospitalist for clinic $367.00; ER visit 171.10 Hospital visit & Discharge. I need to see someone re my lower dentures for, due to the strong pressure in my jaws while they were seized up, my lower dentures now do not fit.  Cost for this is unknown at this time. Thank you for your attention to this problem. Should you have any questions and/or suggestions please feel free to contact me for I certainly NEVER want to go through this again.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain in extremity, Pain in jaw, Trismus
Clinical narrative: My primary physician suggested I contact you. My arms seized up with absolutely no warning approximately 26 hours after I received an injection of Zostavax.  My arms were crossed with my hands on my chest like a dead person in a coffin.  My jaw seized up in another 6 hours.  The pain in my arms, from below the shoulder and above the elbows was excruciating...it never let up. Because of my jaw being seized shut I could not explain to the Hospitalist on call that this was not arthritis pain.  I have had arthritis for 53 years.  I KNOW what arthritis pain feel like. I still have a knot in my arm, although tiny now, in which I received the injection.  Even today, when I press on the tiny knot I faintly feel the same pain. Is it possible this was caused by an allergic reaction or an improperly administered injection. I am giving you the following so you will know this actually has happened. Clinic $726.92; Hospital $18,812.95; Hospitalist for clinic $367.00; ER visit 171.10 Hospital visit & Discharge. I need to see someone re my lower dentures for, due to the strong pressure in my jaws while they were seized up, my lower dentures now do not fit.  Cost for this is unknown at this time. Thank you for your attention to this problem. Should you have any questions and/or suggestions please feel free to contact me for I certainly NEVER want to go through this again.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Laboratory test, Medical device complication, Muscle spasms, Nodule
Clinical narrative: My primary physician suggested I contact you. My arms seized up with absolutely no warning approximately 26 hours after I received an injection of Zostavax.  My arms were crossed with my hands on my chest like a dead person in a coffin.  My jaw seized up in another 6 hours.  The pain in my arms, from below the shoulder and above the elbows was excruciating...it never let up. Because of my jaw being seized shut I could not explain to the Hospitalist on call that this was not arthritis pain.  I have had arthritis for 53 years.  I KNOW what arthritis pain feel like. I still have a knot in my arm, although tiny now, in which I received the injection.  Even today, when I press on the tiny knot I faintly feel the same pain. Is it possible this was caused by an allergic reaction or an improperly administered injection. I am giving you the following so you will know this actually has happened. Clinic $726.92; Hospital $18,812.95; Hospitalist for clinic $367.00; ER visit 171.10 Hospital visit & Discharge. I need to see someone re my lower dentures for, due to the strong pressure in my jaws while they were seized up, my lower dentures now do not fit.  Cost for this is unknown at this time. Thank you for your attention to this problem. Should you have any questions and/or suggestions please feel free to contact me for I certainly NEVER want to go through this again.