chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: This spontaneous report as received from a physician and a certified medical assistant, via a company representative, refers to a male patient of unknown age. No information on medical history, concurrent conditions or concomitant drugs was provided. On an unknown date the patient was vaccinated with ZOSTAVAX; dose, route and site of administration, lot# and expiration date not provided. On an unknown date, two weeks after receiving ZOSTAVAX, the patient developed polymyalgia rheumatica. The patient sought medical attention, via visiting physician's office. The outcome of the polymyalgia rheumatica was unknown. Relatedness between vaccination with ZOSTAVAX and adverse event was not reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Lethargy, Sudden onset of sleep
Clinical narrative: This spontaneous report as received from a physician via company representative a 12 year old male patient. The patient's medical history was not reported. Approximately in April 2014 (Reported as in the past week) the patient was vaccinated with GARDASIL (Dose number 1). Concomitant medications were not reported. Approximately in April 2014 (reported as in the past week) the physician stated that after the patient received the GARDASIL he was tired and lethargic but coherent. When the patient "got to the car he fell asleep immediately. The physician brought the patient back into the office and had the patient stay there for an hour. The patient was given some sugar to alleviate any glycemic issues but it was not believed to be a problem with the patient's glycemic levels. No further information provided. The outcome was reported as recovered/resolved. The causality was not reported. Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare Worker (Medical Assistant) and refers to a 4 months old male patient. Pertinent medical history, concomitant medication, drug reactions and allergies were not provided. The reporter stated that the patent was vaccinate with an expired 2 ml dose of ROTATEQ oral (lot # H016251, expiration date 26-MAR-2014) today (on 06-MAY-2014). No adverse effects were reported at this time. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Rash began on right anterior lower trunk.  Started itchy and had become sharp, pin point pain.
Age: 38.0
Sex: F
Vaccine: DT
Symptoms: Erythema, Pain in extremity, Skin warm, Upper extremity mass
Clinical narrative: Painful, warm, redness, and lump at left arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: After vaccination was given the child was discharged home with no adverse reaction noted at this time.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Acoustic stimulation tests abnormal, Deafness, Insomnia, Nervousness, Tinnitus
Clinical narrative: Four hours after receiving the flu vaccine (injection) I had a severe reaction. My ears suddenly started ringing - then my entire body became shakey with an overwhelming feeling of nervousness and I vomited most of the night. My ears have been ringing ever since - and I have experienced some hearing loss. I visited my practitioner the next day to report the problem but she just dismissed it and said the flu vaccine could not have given me this reaction. I have been struggling ever since. I am unable to get a normal nights sleep, and if I do not get the ringing diagnosed properly and remedied I may lose my hearing. I have had ENT's examine my ears and they do not see any reason for the ringing based on a visual examination - though they tested my ears and did show evidence of some hearing loss. I am continuing to seek answers. I have an appointment with an allergist to determine if this may be an allergic reaction. I need a full list of ingredients in this vaccine to help me figure out why after 10 months my ears are still ringing.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor, Vaccination complication, Vomiting
Clinical narrative: Four hours after receiving the flu vaccine (injection) I had a severe reaction. My ears suddenly started ringing - then my entire body became shakey with an overwhelming feeling of nervousness and I vomited most of the night. My ears have been ringing ever since - and I have experienced some hearing loss. I visited my practitioner the next day to report the problem but she just dismissed it and said the flu vaccine could not have given me this reaction. I have been struggling ever since. I am unable to get a normal nights sleep, and if I do not get the ringing diagnosed properly and remedied I may lose my hearing. I have had ENT's examine my ears and they do not see any reason for the ringing based on a visual examination - though they tested my ears and did show evidence of some hearing loss. I am continuing to seek answers. I have an appointment with an allergist to determine if this may be an allergic reaction. I need a full list of ingredients in this vaccine to help me figure out why after 10 months my ears are still ringing.
Age: 0.17
Sex: M
Vaccine: DTPIHI, RV1
Symptoms: Haematochezia, Lethargy, Muscle spasms
Clinical narrative: Blood in stool, cramping, lethargy.
Age: 1.13
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Redness and swelling to injection site. Still has swelling to injeciton site x1month later with welt.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme treated with BENADRYL and steroids.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a 65 male consumer (reporting on himself). The patient did not have a pertinent medical history or drug reaction allergies. Around 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot #, and route not reported, 1 vaccine). Concomitant therapy was not reported). On 01-MAY-2014 shingles occurred on the right side of callers face and pain. The patient stated that he did not have the blisters, just the pain. He went to his doctor and the doctor said it was shingles even though there was not a rash. The patient was prescribed VALTREX with the stipulation to not take it until blisters occurred. Laboratory diagnostic studies were not performed. The outcome of shingles and pain was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a immunization official refers to an unknown number of patients of unknown age and gender. Medical history was not reported. On an unknown date the patient was vaccinated with VAQTA injection (lot # not provided) route, dosage and frequency were not reported. Concomitant therapy was not reported. The reporter informed that on an unknown date the patients may have received VAQTA that was improperly stored from 11-JUN-2013 to 22-APR-2014. No adverse effects were reported. This is one of several reports from the same reporter MARRS CASE #1405USA004444, #1405USA004445 and #1405USA004446. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistance refers to a 12 month old female patient. Medical history was not reported. On 29-APR-2014 the patient was vaccinated with M-M-R II, (lot # and expiration date not reported) 0.5 ml, subcutaneous in the left thigh. Other suspect therapies included PROQUAD (Merck) (lot #, expiration date, dose and route not reported). Concomitant therapy was not reported. The reporter stated that on 29-APR-2014, the patient was mistakenly vaccinated with M-M-R II and PROQUAD (Merck) at the same day. No adverse effects were reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Pain, Toothache
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unspecified date in 2014, "in the last couple of weeks", the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). The nurse reported that on an unspecified date in 2014 after vaccination, the patient developed swelling extending from the injection site down to her elbow. The patient then developed widespread aching, soreness and malaise. The patient stated that even her teeth hurt. The patient was evaluated at the local unspecified care facility and was prescribed an unspecified broad-spectrum antibiotic. At the time of the report, the patient was recovering. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The patient's relevant medical history and past drug history were unknown. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported). Other concomitant medications were not reported. The pharmacist reported a patient, while in the pharmacy, mentioned she had been administered a dose of ZOSTAVAX on an unspecified date and was subsequently diagnosed with shingles. The outcome of the event was not reported. Reporter's causality of therapy to adverse event was not provided. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear infection, Herpes zoster, Nuclear magnetic resonance imaging, Pain
Clinical narrative: This spontaneous report was received from a consumer (patient wife) refers to a 80 year old male patient. The patient pertinent medical history included mild congestive heart and diabetes. On an unknown date in 2010 (also reported as about four years ago) the patient was vaccinated with ZOSTAVAX (dose and frequency were not reported) subcutaneous. Concomitant medication included diabetes medications (manufacturing unknown). On 26-APR-2014, the patient experienced ear infection and pain. The patient sought medical attention and visited the physician office on an unspecified date. The patient was treated with ANTIPYRINE BENZOCAINE (unspecified dose/frequency and manufacturer), AMOXICILLIN (500 mg for ten days, unspecified manufacturer) and NEOMYCIN POLYMYXIN B SULFATES (unspecified dose/frequency and manufacturer), and HYDROCORTISONE (unspecified dose/frequency and manufacturer). On 30-APR-2014, the patient visited the physician office again and was diagnosed with shingles. On an unknown date, the patient had an MRI and result was unknown. On an unknown date, the patient discontinued all the treatment medications to treat the ear infection and pain and started using VALACYCLOVIR (1 g/ three times daily, unspecified manufacturer). The outcome of the event shingles was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: HIBV, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 18 month old patient with no medical history reported. On an unknown date the patient may have been administered a dose of GARDASIL (dose 0,5 ml, intramuscular), instead of the intended dose of PEDVAXHIB. Lot number of vaccine administered was not provided and identified by the physician as GARDASIL. Physician stated that this may have not occurred and may have been a documentation error. No adverse events were reported. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old female patient. The patient had no medical conditions, her concomitant medications, and past drug history were unknown. The medical assistant reported that the patient started ROTATEQ oral solution (dose unknown) on an unspecified date at two months of age (approximately in February 2014). On 30-APR-2014, the patient received her second dose of ROTATEQ oral solution (dose unknown) lot # H020560, expiration date: 18-APR-2014. No laboratory data was provided. As of 30-APR-2014, it was unknown if the patient continued to take ROTATEQ. The medical assistant reported that the patient was fine when she left their office and that they were going to contact the patient's mother and keep in tough with her to monitor the patient. 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 immunization official refers to an unknown number of patients of unknown age and gender. Medical history was not reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB injection (lot# not provided) route, dosage and frequency were not reported. Concomitant therapy was not reported. The reporter informed that on an unknown date the patients may have received RECOMBIVAX HB that was improperly stored from 11-JUN-2013 to 22-APR-2014. No adverse effects were reported. This is one of several reports received from the same reporter MARRS case #1405USA003763, #1405USA004445 and #1405USA004446. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. There was no pertinent medical history and current conditions, drug reactions/allergies reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB (1st dose 2.5/0.5 strength, route, lot# dose not reported). No concomitant medication reported. The pharmacist reported that a patient received a first dose of RECOMBIVAX HB on an unspecified date and never went back to the physician's office to receive the remaining doses. The pharmacist stated the patient would now like to receive the remaining doses of RECOMBIVAX HB. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site swelling, Rash pustular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with seasonal allergies. On 11-APR-2014 the patient was vaccinated with an unspecified dose number of ZOSTAVAX, 0.65 ml, once, (reported lot# 30OCT2014 and expiration date 30-OCT-2014) subcutaneously in the left arm. Concomitant therapies included LEVOCETIRIZINE, SINGULAIR, ALBUTEROL INHALER and azelastine hydrochloride, DYMISTA. On 11-APR-2014 the patient experienced red bump at the injection site and started forming pustules and blisters in her hairline which have increased over the last 2 days. It was reported that she had been putting generic MUPIROCIN ointment on the lesions after the blisters popped which seemed to drying them up. N diagnostic tests were reported. At the date of report on 13-APR-2014 it was unknown if she would receive another ZOSTAVAX the red bump at the injection site and pustules and blisters in her hairline continued but some of them were starting to dry up. The outcome of red bump at the injection site, pustules and blisters in her hairline were reported as not recovered/not resolved. The relatedness between all the events and ZOSTAVAX was not reported. Additional information has been received regarding lot # 30OCT2014 which is an invalid lot # for ZOSTAVAX. 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 Licensed Practical Nurse refers to a child patient of unknown gender and unknown age. Medical history, current conditions and drug reactions or allergies unspecified. On 28-APR-2014 the patient was vaccinated with VARIVAX (Merck) dose 2, 0.5 ml, subcutaneous (lot number and expiration date unspecified). Concomitant medications unspecified. On 28-APR-2014, patient received second dose of VARIVAX (Merck) that was improperly stored. No adverse effects reported. The nurse requesting stability for VARIVAX (Merck) (supported) in freezer at 6F for 66 hours due to unknown reason. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abnormal behaviour, Electroencephalogram, Full blood count, Loss of consciousness, Metabolic function test
Clinical narrative: Pt. received HPV last pt was talking, acting good stood up and walked behind mom and loss of conscious layed pt down on floor, took vital signs were in N/L range pt. didn't want nothing to eat or drink still not acting good, couldn't remember where she was called EMS to take to ER.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a immunization official refers to an unknown number of patients of unknown age and gender. Medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL injection (lot# not provided) route, dosage and frequency were not reported. Concomitant therapy was not reported. The reporter informed that on an unknown date the patients may have received GARDASIL that was improperly stored from 11-JUN-2013 to 22-APR-2014. No adverse effects were reported. This is one of several reports received from the same reporter MARRS case #1405USA003763, #1405USA004444 and #1405USA004445. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Nausea
Clinical narrative: 5 hours after SQ vaccine administered patient developed soreness, redness, raised, itchiness at injection site. No fever. (+) nausea. Ice applied to (R) arm, hydrocortisone and ADVIL PRN.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Fatigue
Clinical narrative: Lightheaded and fatigue.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt. was given vaccines at Kdg visit 2 days prior to reporting to clinic. Stated at that time s/s began 1 day ago. S/S inc. pain, swelling, redness to left thigh. Pain was improving as well as limp.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: At next day of vaccination patient noticed the vaccinated area red, swelled and hot. Went to her doctor and diagnosed cellulitis and prescribed to her CIPRO 750mg tabs.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Pain at injection site for 2 weeks without relief from OTC pain medication.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Pt started developing a red nodule at injection site the evening the ZOSTAVAX was administered. Continued getting redder and larger - was the size of a silver dollar when she came in 5-5-14 redness all up arm.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 9:35 patient came to health department with mom. She did consent to shots. Shots were given at then it was noted that injections were given on 5/1/14 at dr office. Their office put them in the computer at 10:35 after we gave our immunizations. No adverse signs/or symptoms noted.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Malaise, Pneumonia
Clinical narrative: Patient received PCV vaccine on 12/17/13 and 3/18/14. Patient had 2 inch wide red swollen spot at injection site after both. But, after 3/18/14 injection, swelling and "wheal" came back on 4/4/14, 4/10/14, and 4/18/14 (one month later). She also developed Pneumonia 4 days after vaccine, diagnosed 3/23/14 and was very sick for a month.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Epistaxis, Headache, Pain in extremity
Clinical narrative: Starting the night of and all days until today, has c/o leg pain, stomach pain, headache; and a nosebleed today only.
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Emotional distress, Irritability, Screaming
Clinical narrative: Became inconsolable about 4 hrs after shots - screamed for about 4 hours - no temp - mom gave TYLENOL every 4 hours for 24 hours. Still fussy next day.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient developed syncope episode immediately following administration of his immunization and while being prepared for blood drawing. Pt has a hx of syncope during blood drawings.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness, tenderness at injection site w/in 24 hrs. Referred to PCP - treated with Antibiotics x 10 days.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Classic shingles outbreak about 10 days after receiving shingles vaccine. Tx w/ acyclovir, pain med.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Rash, Rash erythematous
Clinical narrative: Small red bumps on her trunk and left arm. She also has poison ivy so received (prednisone) for treating that.
Age: 70.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccine administered on 5/9/14, over a period of 2 days patient developed redness and swelling in the left arm near the administration area (towards upper shoulder and elbow).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Body temperature increased, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 24 hours after vaccination some redness and swelling noticed. Seen 48 hours, later in office, swollen red, painful, warm to touch (L) deltoid. Temp if ofc. 100. 4" in diameter. Treated with KEFLEX 250 mg/5ml 10 ml po BID x 10 days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site warmth, Swelling
Clinical narrative: 24 hours after vaccination some redness and swelling noticed. Seen 48 hours, later in office, swollen red, painful, warm to touch (L) deltoid. Temp if ofc. 100. 4" in diameter. Treated with KEFLEX 250 mg/5ml 10 ml po BID x 10 days.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Chills, Tremor
Clinical narrative: 5 to 10 minutes after receiving GARDASIL, pt started to shake, entire body involved, as if severe shivering. Pt alert and responsive, but with uncontrolled shaking. Pt and mom then returned to office (did not stay for 15 minutes after vaccine as instructed). Placed in pt exam room, lying down, and covered with jackets. Vitals taken. T-98 degrees P-120 R-30 BP-118/82. Given fluids po and peanut butter crackers. Pt checked by MD and advised to go to the ER, if symptoms did not subside. Of special note, these same symptoms of severe body shaking has occurred after other medical procedures, per mom. On 5-2-14, checked with mom regarding recovery from symptoms. She stated that she did take patient to ER after leaving our office on 4-18-14. At the ER, pt was given a dose of ATIVAN, and then DEMEROL, before the symptoms of shaking were resolved. Patient has not had any symptoms of reoccurrence since. In speaking with mom, she told me that she did not feel this was a reaction to the vaccine, but perhaps an anxiety reaction to a medical procedure (i.e., the injection)
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling, Pruritus generalised, Radioallergosorbent test negative, Rash, Rash erythematous
Clinical narrative: 10-15 minutes after receipt of influenza vaccination to his right deltoid, he developed a "bright red rash to left arm" described as a flat pink rash to left hand, fingers, forearm, arm and swelling to left hand only. This rash did not itch and there was no other systemic or anaphylactic-like symptom. Pt had been on VICODIN and FLEXERIL for herniated discs. He denied any new food, clothing, soaps, detergents, shampoos, medications, etc. Oral BENADRYL provided partial resolution of rash. The rash spread to his left chest/back shoulder region later that evening. Left arm rash was resolved 24 hours later and the rest of the rash resolved within the next 48 hrs. There was no focal reaction at the vaccination site on his right arm. No brand name for the influenza vaccine given was recorded. A year later he received FLUZONE in his left deltoid. He reported approximately 10-15 minutes later he felt "his skin was on fire" and that his "body was burning and itching". He was unsure if his skin was red or not and there was no documentation in this event in his medical records. He again denied any new foods, exposure to chemicals, lotions, cleaning agents, clothing, fumes, medication, etc. He received two shots of BENADRYL 45 minutes apart, sleeping for 2 hours and awakening with resolution of symptoms. He has not had any reaction similar to this since and not with any other vaccinations.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Skin burning sensation, Skin test negative
Clinical narrative: 10-15 minutes after receipt of influenza vaccination to his right deltoid, he developed a "bright red rash to left arm" described as a flat pink rash to left hand, fingers, forearm, arm and swelling to left hand only. This rash did not itch and there was no other systemic or anaphylactic-like symptom. Pt had been on VICODIN and FLEXERIL for herniated discs. He denied any new food, clothing, soaps, detergents, shampoos, medications, etc. Oral BENADRYL provided partial resolution of rash. The rash spread to his left chest/back shoulder region later that evening. Left arm rash was resolved 24 hours later and the rest of the rash resolved within the next 48 hrs. There was no focal reaction at the vaccination site on his right arm. No brand name for the influenza vaccine given was recorded. A year later he received FLUZONE in his left deltoid. He reported approximately 10-15 minutes later he felt "his skin was on fire" and that his "body was burning and itching". He was unsure if his skin was red or not and there was no documentation in this event in his medical records. He again denied any new foods, exposure to chemicals, lotions, cleaning agents, clothing, fumes, medication, etc. He received two shots of BENADRYL 45 minutes apart, sleeping for 2 hours and awakening with resolution of symptoms. He has not had any reaction similar to this since and not with any other vaccinations.
Age: 42.0
Sex: M
Vaccine: RAB, YF
Symptoms: Eyelid oedema, Injection site erythema, Injection site swelling, Injection site urticaria, Miliaria
Clinical narrative: This 42 year old male was referred to VHC for clearance to continue with Rabies vaccination. He received first Rabies vaccine (Novartis lot #534011A) on 4/28/2014 along with YF booster (SP lot #UH669A). The next morning (24 hour later) he awoke with his face feeling puffy and swollen, L>R eyelid swelling and cheek swelling. He also had a prickly heat like rash described as multiple single red dots in band formation across his chest over breast region that extended from axilla to axilla (but did not include the axilla). His left deltoid had a red raised area over both the rabies and yellow fever site both about 3-5cm (per pt) he called a hive. He contacted medical personnel as he was on leave and was advised to take BENADRYL. He used BENADRYL for 2 days with resolution of swelling and rash on day 3. His site reaction persisted for total of 6 days with full resolution. He advised the site swelling was similar to reactions he had to bee stings in past. He denied any shortness of breath, chest pain, difficulty swallowing, lip/tongue swelling, eye/nasal drainage, visual disturbance, weakness, paresthesia or any new detergents, deodorants, food, travel, clothing, lotions, et al.
Age: 42.0
Sex: M
Vaccine: RAB, YF
Symptoms: Radioallergosorbent test, Rash, Rash erythematous, Skin test negative, Swelling face
Clinical narrative: This 42 year old male was referred to VHC for clearance to continue with Rabies vaccination. He received first Rabies vaccine (Novartis lot #534011A) on 4/28/2014 along with YF booster (SP lot #UH669A). The next morning (24 hour later) he awoke with his face feeling puffy and swollen, L>R eyelid swelling and cheek swelling. He also had a prickly heat like rash described as multiple single red dots in band formation across his chest over breast region that extended from axilla to axilla (but did not include the axilla). His left deltoid had a red raised area over both the rabies and yellow fever site both about 3-5cm (per pt) he called a hive. He contacted medical personnel as he was on leave and was advised to take BENADRYL. He used BENADRYL for 2 days with resolution of swelling and rash on day 3. His site reaction persisted for total of 6 days with full resolution. He advised the site swelling was similar to reactions he had to bee stings in past. He denied any shortness of breath, chest pain, difficulty swallowing, lip/tongue swelling, eye/nasal drainage, visual disturbance, weakness, paresthesia or any new detergents, deodorants, food, travel, clothing, lotions, et al.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Soreness on injection site for a few days, then pain down on arm, difficulty twisting or lifting of arm. After a few months, pain now moved to back of neck and shoulder area. Not seen by MD.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Body temperature increased, Nausea, Pain in extremity, Urticaria
Clinical narrative: Stomach ache, nausea, moderate arm pain, 102 degree F, urticaria on chest.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site reaction, Nasopharyngitis, Pain in extremity
Clinical narrative: 8-12 hrs after injection; became very cold, shivering x 8 hrs. Welt at site of injection commenced at 8-13 hrs. Several other raised, red areas also developed. Welts are sore. Improving now, but arm is still sore.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Urticaria
Clinical narrative: 8-12 hrs after injection; became very cold, shivering x 8 hrs. Welt at site of injection commenced at 8-13 hrs. Several other raised, red areas also developed. Welts are sore. Improving now, but arm is still sore.
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Cough, Culture positive, Influenza like illness, Influenza virus test, Laboratory test normal
Clinical narrative: Initial report was received from a scientific literature search on 06 May 2014. The case is not medically confirmed. The following is verbatim from the reporter: "Abstract Yellow fever (YF) is an important public health concern in areas where the disease is endemic. For more than 60 years a highly effective live attenuated vaccine has been available, its widespread use resulting in a dramatic decrease in the number of cases. On rare occasions, YF vaccine can cause mild to severe disease and rare adverse vaccine-associated events have been reported. Additionally, an average viremia of of 3-5 days after administration of the YF vaccine has been published. Here we present a case where YF vaccine was isolated in cell culture from a respiratory swab collected from a patient presenting with influenza-like illness. To the best of our knowledge, this is the first report finding replicating YF vaccine in the respiratory sample of a post inoculated individual." An unknown 19 year old female patient was vaccinated with Yellow Fever vaccine (manufacturer, batch, dose route and site of administration unknown) on an unreported date. The patient experienced influenza like illness including a fever of 103 F (39 C) for 3 days, nausea, vomiting, cough and myalgia 8 days later. The patient history did not note any recent travel, vaccination, animal contact or insect bites. Influenza like illness was the initial diagnosis and a respiratory swab was sent for influenza testing. YF vaccine was isolated in Caco-2 cells from a respiratory swab. The virus was further prepared, stained and imaged by EM before it was identified by sequence analysis of the NSS gene. Additional sequence analysis of the E and M gene verified highest identify to YF vaccine (strain 17D), reversions to wild-type YF virus (Asibi strain) were not present [15]. Patient outcome is recovered. Documents held by sender: None.
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Myalgia, Nausea, Polymerase chain reaction, Pyrexia, Vomiting
Clinical narrative: Initial report was received from a scientific literature search on 06 May 2014. The case is not medically confirmed. The following is verbatim from the reporter: "Abstract Yellow fever (YF) is an important public health concern in areas where the disease is endemic. For more than 60 years a highly effective live attenuated vaccine has been available, its widespread use resulting in a dramatic decrease in the number of cases. On rare occasions, YF vaccine can cause mild to severe disease and rare adverse vaccine-associated events have been reported. Additionally, an average viremia of of 3-5 days after administration of the YF vaccine has been published. Here we present a case where YF vaccine was isolated in cell culture from a respiratory swab collected from a patient presenting with influenza-like illness. To the best of our knowledge, this is the first report finding replicating YF vaccine in the respiratory sample of a post inoculated individual." An unknown 19 year old female patient was vaccinated with Yellow Fever vaccine (manufacturer, batch, dose route and site of administration unknown) on an unreported date. The patient experienced influenza like illness including a fever of 103 F (39 C) for 3 days, nausea, vomiting, cough and myalgia 8 days later. The patient history did not note any recent travel, vaccination, animal contact or insect bites. Influenza like illness was the initial diagnosis and a respiratory swab was sent for influenza testing. YF vaccine was isolated in Caco-2 cells from a respiratory swab. The virus was further prepared, stained and imaged by EM before it was identified by sequence analysis of the NSS gene. Additional sequence analysis of the E and M gene verified highest identify to YF vaccine (strain 17D), reversions to wild-type YF virus (Asibi strain) were not present [15]. Patient outcome is recovered. Documents held by sender: None.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Symptoms: Extreme pain at injection site, loss of strength in shoulder, loss of mobility of right arm. Time course: Patient had extreme pain for 48 hrs after injection. Pain and decreased mobility have continued to this date. Treatment: Gabapentin, NAPROXEN, VICODIN, massage (myofacial release), physical therapy.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound scan normal, X-ray normal
Clinical narrative: Symptoms: Extreme pain at injection site, loss of strength in shoulder, loss of mobility of right arm. Time course: Patient had extreme pain for 48 hrs after injection. Pain and decreased mobility have continued to this date. Treatment: Gabapentin, NAPROXEN, VICODIN, massage (myofacial release), physical therapy.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP, DTP, FLUX
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pain in left arm immediately which continued to increase each day  unable to lift arm at all needed to hold arm to under breast area could not sleep due to intense discomfort still need help getting dressed with certain items.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP, DTP, FLUX
Symptoms: Activities of daily living impaired, Discomfort, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Pain in left arm immediately which continued to increase each day  unable to lift arm at all needed to hold arm to under breast area could not sleep due to intense discomfort still need help getting dressed with certain items.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a claims administrator, concerning a 66-year-old female patient with no know allergies, with a history of receiving her last tetanus shot 4 years ago, received FLUZONE vaccinations 08-OCT-2012 and 07-OCT-2013, who on 18-MAR-2014 at "11:13 PM" (as reported) received her (Oka/Merck) ZOSTAVAX vaccination (Lot number J011213) subcutaneous in Left arm by the pharmacist. The pharmacist reported there were no prior doses of (Oka/Merck) ZOSTAVAX given. She had no illness at the time of vaccination. The adverse event was reported as "developed Herpes Zoster rash on forehead on 31-MAR-2014." The patient "stated she developed Shingles after receiving the injection." On an unspecified date, the patient required physician office visit for the adverse event. On 24-MAR-2014, the patient's physician prescribed ZOVIRAX (use substitute: acyclovir) for treatment of Herpes Zoster. On 24-MAR-2014, the pharmaacy record documented that a prescription was filled for acyclovir 800 mg tablet five times per day for 7 days. At the time of the report, it was not reported if the patient had recovered from the Shingles. It was reported that the patient "still has the rash." Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pain in extremity
Clinical narrative: Sore arm - starts at site of injection and goes down the arm taking prescribed ULTRAM.
Age: 34.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Sore arm - starts at site of injection and goes down the arm taking prescribed ULTRAM.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Febrile convulsion, Laboratory test, Pneumonia, Pyrexia, Urinary tract infection
Clinical narrative: Febrile seizure lasting 15 minutes with fever 102.7 about 18 hours after vaccine 1 previous febrile seizure.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure lasting 15 minutes with fever 102.7 about 18 hours after vaccine 1 previous febrile seizure.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus, Urticaria
Clinical narrative: Erythema and pruritis to left shoulder (injection site) and abdomen noted 6.5 hours post-vaccination.  Presented to clinic the following night with urticaria of the abdomen and BL arms.  Patient was given 50mg of Benadryl in clinic and Zyrtec 10mg to take BID x 5 days beginning 05/06/2014.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC10, RV1
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Patient started to develop stools with blood and mucus.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Mobility decreased, Muscle spasms, Pain
Clinical narrative: Extreme left at injection site; by 5:00 PM, could not lift my arm; getting out of my jeans/bra/jersey took me almost 30 min. due to inability to move L arm. Pain came and went but by 11PM. it seemed worse; woke up 3x w/Muscle cramps in my left leg; slept about 3hrs. +/-.
Age: 28.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Coordination abnormal, Disorientation, Fatigue, Heart rate increased
Clinical narrative: Rapid heart rate, extreme fatigue, muscle weakness, problems with coordination, disorientation, gastrointestinal upset lasting one week. I am still experiencing some fatigue and gastro issues.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness
Clinical narrative: Rapid heart rate, extreme fatigue, muscle weakness, problems with coordination, disorientation, gastrointestinal upset lasting one week. I am still experiencing some fatigue and gastro issues.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Leg amputation
Clinical narrative: Information has been received from a third party claims administrator concerning a female (unknown age). On 20-DEC-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml (lot # J006831 expiration 14-SEP-2014). It was reported that the patient sustained the shingles condition and as a result of this her right leg was amputated. At the time of this report the patient's outcome is unknown. Upon internal review right leg amputated was determined to be a significant medical event. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: The patient started experiencing hives on his arms and chest the night the vaccine was received. The patient was directed to go to the emergency room where he received Benadryl and Prednisone.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a immunization official refers to an unknown number of patients of unknown age and gender. Medical history was not reported. On an unknown date the patient was vaccinated with ROTATEQ oral (lot# not provided) route, dosage and frequency were not reported. Concomitant therapy was not reported. The reporter informed that on an unknown date the patients may have received ROTATEQ that was improperly stored from 11-JUN-2013 to 22-APR-2014. No adverse effects were reported. This is one of several reports received from the same reporter MARRS case # 1405USA003763, # 1405USA004444 and # 1405USA004446. Additional information has been requested.
Age: 1.31
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 multiple 1 to 4 year old patients. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. Multiple unidentified patients received VARIVAX (Merck) doses ( 0.5 ml, intramuscular) (unspecified in series) between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects reported. The lots affected include "private stock and VFC stock" with lots and expiration dates: private: Lot J006695 expiry 30-MAY-2015, Lot J005691 expiry 07-MAY-2015, Lot J012260 expiry 01-OCT-2015, VFC Lot J006358 expiry 23-MAY-2015 and lot J012210 expiry 28-SEP-2015. Follow up information was received. All telephone attempts to obtain follow-up information have been unsuccessful. The follow up was received from a medical assistant regarding 15 months old child of unknown gender. The child was vaccinated intramuscularly with a 0.5 ml dose of VARIVAX (Merck), lot # J006358 expiry date 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. This report is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no medical history, concurrent conditions reported. On 06-AUG-2010 the patient was vaccinated with GARDASIL first dose and on 30-DEC-2013 the patient was vaccinated with GARDASIL dose 2 reported as 120 y, strength, lot# route not reported) and no adverse symptoms reported. 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 medical assistant refers to a patient of unknown age and gender. On 08-MAY-2014, an unspecified patient was vaccinated with expired dose of ZOSTAVAX lot # J001010, expiry date 24-APR-2014, dose (unknown) and route of administration (unknown). No concomitants were reported. No adverse effect reported. No product quality complaint was involved. Outcome of events was unknown. No further information available. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This literature marketed report as received from a other health professional refers to a 3.9 year old patient. Effectiveness of varicella vaccine (manufacturer unknown) is assessed by reviewing the medical records of closely monitored HIV-infected children, including those receiving highly active antiretroviral therapy (HAART) between 1998 and 2007. The medical records of 164 perinatally HIV-infected children from between 1989 and 2007 were reviewed to determine whether and when they had received varicella vaccine (manufacturer unknown), developed varicella, and/or developed herpes zoster. All perinatally HIV-infected children were included except for those who developed varicella before 1 year of age, because varicella vaccine (manufacturer unknown) is not given before then. Immunized children received at least 1 dose of live attenuated varicella vaccine. The effectiveness of the vaccine was calculated as 1 minus the rate ratio. Incidence rates of varicella were calculated for 2 periods: the prevaccine era for HIV-infected children (1989-1998, when none of the children received varicella vaccine) and the vaccine era (1999-2007). Rate ratios for development of herpes zoster among children who had been immunized versus those who had varicella were calculated. It was reported that patient developed breakthrough varicella at 3.9 years after the last immunization. The outcome of the event reported was unknown. The author considered the event was related to varicella vaccine (manufacturer unknown). This case is linked to the case 1405USA005189 via Same Literature Link. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Dizziness, Presyncope
Clinical narrative: Pt received Anthrax and Typhoid vaccines in seated position. Following administration, patient talked to technician about signs and symptoms, vaccine schedules and his deployment checklist. Pt felt light headed and was heading towards the table when he had a vasovagal reaction. Pt was caught and placed on a table in the supine position with his legs rasied while he was evaluated by the nurse and technician. Blood pressure was taken and patient was monitored. Pt was then placed in the sitting position for the next 15 minutes while he was evaluated by the nurse and provider. Patient was later released without any physical treatments.