chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Peripheral swelling, Piloerection, Pruritus, Pyrexia, Skin warm
Clinical narrative: Woke next day with swelling. Warm to touch and tender to touch.  Continued to swell down to elbow. Not above shoulder. On 6/20/17 started to resolve and get better. Fever of 101. Raised goose bumps in area and itchy.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Tenderness
Clinical narrative: Woke next day with swelling. Warm to touch and tender to touch.  Continued to swell down to elbow. Not above shoulder. On 6/20/17 started to resolve and get better. Fever of 101. Raised goose bumps in area and itchy.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In December 2015, the patient was vaccinated with a dose of VAQTA 5/1.0 U/ml (dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. Then, on 13-JUN-2017, the patient was vaccinated with other dose of VAQTA 5/1.0 U/ml (lot # N005605 with expiration date of 08-APR-2018; dose, route and anatomical location were not provided), also for prophylaxis, which was outside of the prescribing information. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Epilepsy, Loss of personal independence in daily activities, Seizure
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, any known allergies or reactions, medical history or concomitant medications. In approximately 2014, (reported as two or three years ago), the patient was vaccinated with GARDASIL, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The physician was informed by the patient's mother that the patient with no prior history of seizures "experienced seizures three weeks after receiving GARDASIL". Due to the events, the patient sought medical attention. Therefore, she "was seen by a neurologist" on unspecified date and was diagnosed as epileptic and needed help showering on an unspecified date (reported as "now"). The patient received unspecified treatment for the event. At the time of reporting, the patient had not recovered from epilepsy. The causal relationship between the event and therapy with GARDASIL or GARDASIL 9 was not reported. Upon internal review epilepsy was considered to be a medically significant and disabling event. Additional information is not expected because there was no consent to contact physician.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on medical history, past drugs and concurrent conditions were not provided. The medical assistant reported that on 16-JUN-2017, the patient was vaccinated with an expired dose of VAQTA (lot # M034893, expiry date: 26-MAY-2017) for prophylaxis. No adverse effects were provided and no further information was provided. Additional information has been requested.
Sex: U
Vaccine: FLUN3
Symptoms: Syncope
Clinical narrative: A report has been received from a literature source concerning a patient of unknown age and gender, enrolled in an unsponsored/ non-interventional/post-marketing study. The study was conducted in 6 large integrated health care organizations participating in the Vaccine Safety Datalink (VSD). Trivalent LAIV safety was assessed in children who received LAIV between 01-Sep-2003 and 31-Mar-2013. Based on prior reports and biologic plausibility, 18 medically attended health outcomes were examined, including allergic, autoimmune, neurologic, respiratory, and infectious conditions. Using self-controlled case series analyses, incident rate ratios (IRRs) were calculated for each outcome.  During 2003-2013, 396173 children received 590018 doses of LAIV. For 124529 (21. 1%) of LAIV doses, other vaccines were administered on the same day. Five outcomes (anaphylaxis, non-anaphylactic allergic reactions, Stevens-Johnson syndrome (SJS), syncope, and respiratory failure) met criteria for manual medical record review. For the remaining 13 outcomes, there was no significant increase in risk after LAIV. After manual medical record review, most cases were excluded because diagnoses were ruled out or clearly attributable to other causes. One case of medical record-confirmed anaphylaxis was observed following FLUMIST: Wheezing, facial swelling, and hives occurred 2 hours after LAIV vaccination, in someone known to be egg-allergic (observed rate 1. 7 cases per million LAIV doses). In individuals who received LAIV only, and no other same-day vaccines, two cases of medical record-confirmed syncope were observed (3.4 cases per million LAIV doses). This case belongs to one of two patients who experienced syncope after receiving LAIV. The outcome of syncope was unknown.   The company physician considered syncope as important medical event. The reporter considered syncope to be related to LAIV.  ; Sender's Comments: Syncope is not listed in the company core data sheet of FLUMIST. Due to limited information on details of syncope (type), exact onset date of event, start date of suspect drug along with its indication, underlying comorbidities, past medical history, concomitant medications, age and gender of the patient, lab details ( complete blood tests, blood glucose values), detailed clinical and diagnostic workup (imaging studies, cardiological and neurological workup), it is not possible to make a conclusive assessment of the causal relationship of syncope with FLUMIST.
Sex: U
Vaccine: MENB
Symptoms: Drug administered at inappropriate site, Local reaction
Clinical narrative: This is a spontaneous report from a contactable Nurse. This nurse reported similar events for 2 patients. This is 1st of 2 reports. An 11-12 year-old patient (child) patient of an unspecified ethnicity and gender received TRUMENBA via an unspecified route of administration at single dose into the thigh muscle on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient was administered TRUMENBA into the thigh muscle instead of the deltoid because the patient had less muscle mass, and experienced a larger local reactions compared to the older children given TRUMENBA in the deltoid with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017266663 same reporter, different patient, same drug/events.
Age: 0.5
Sex: M
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: GIVEN WRONG VACCINE.
Age: 27.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: CLIENT HAD EPISODE OF SYNCOPE 5 MINUTES AFTER RECEIVING SHOTS.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: PATIENT HAD A REACTION SITE REACTION, RED AND WARM. DOCTOR IS TREATING WITH ANTIBIOTIC FOR PREVENTATIVE MEASURE.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: PATIENTS AIRWAY WAS CLOSING COULDN'T BREATH, USED EPIPEN THAT SHE HAD AT HOME THEN WENT TO ER.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Pyrexia, Rash generalised
Clinical narrative: MOC reports that child had a fever up to 102 and a rash over her entire body.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Patient experienced swollen upper arm from shoulder to elbow as well as fever. Patient visited Dr's office and was given prescription for Keflex.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Patient had headache; very tender and painful at injection site; site around injection site was warm to the touch and red; pt said no issues on day of injection or day after, however she woke up with her arm hurting and with a headache.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Patient had headache; very tender and painful at injection site; site around injection site was warm to the touch and red; pt said no issues on day of injection or day after, however she woke up with her arm hurting and with a headache.
Age: 35.0
Sex: M
Vaccine: HEP, MNQ, PPV, TDAP
Symptoms: Chills, Erythema, Fatigue, Headache, Pain
Clinical narrative: 103 degree fever, aches, chills, red arm and hot to the touch, fatigue, headache.
Age: 35.0
Sex: M
Vaccine: HEP, MNQ, PPV, TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: 103 degree fever, aches, chills, red arm and hot to the touch, fatigue, headache.
Age: 15.0
Sex: M
Vaccine: IPV, MENB, MNQ, TDAP
Symptoms: Chills, Headache, Insomnia, Nausea, Vomiting
Clinical narrative: About 6:30 PM, headache began, a few hours later he became nauseated. Was sleepless and vomited about 12:00 midnight. He remained headachy and nauseated for several hours. Felt shivery. Awoke this AM (6/21/17) feeling somewhat better. Throughout the day he has continued to improve.
Age: 19.0
Sex: M
Vaccine: FLUX, HEP, HEPA, HPVX, IPV, MENB, TDAP
Symptoms: Rash
Clinical narrative: Many small fairly firm bumps near the injection site which persist to the present.
Age: 27.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Red, half dollar size, raised, non-itchy, non-painful but sore welt located on the back of the left arm.
Age: 11.0
Sex: F
Vaccine: HPV4, MENB, MNQ, TDAP
Symptoms: Fatigue, Headache, Paraesthesia, Paralysis, Tremor
Clinical narrative: Has had constant headaches, fatigue, tremors and tingling in legs and arms, temporary paralysis.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Barium enema, Intussusception
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of intussusception in a 7-week-old male patient who received ROTARIX (lyophilized formulation) (batch number YN47S, expiry date 9th November 2018). Concurrent medical conditions included umbilical hernia (finding at the baby visit on 26th May 2017). Concomitant products included PEDIARIX, Hib  vaccine and PCV-13 vaccine. On 26th May 2017, the patient received the 1st dose of ROTARIX lyophilized formulation (oral). On 5th June 2017, 10 days after receiving ROTARIX lyophilized formulation, the patient experienced intussusception (serious criteria hospitalization and GSK medically significant). The patient was treated with Barium Enema. In June 2017, the outcome of the intussusception was recovered/resolved. It was unknown if the reporter considered the intussusception to be related to ROTARIX lyophilized formulation. Additional details were reported as follows: The nurse stated that the patient received 1st doses of ROTARIX, PEDIARIX, Hib  vaccine  and  PCV-13 at a well baby 6 week old visit on 26th May 2017. The patient was hospitalized with intussusception on 5th June 2017. The nurse stated that there was no surgical intervention at the time of report. The patient received a barium enema which was successful in resolving the intussusception.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle twitching, Pain, Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in a 57-year-old male patient who received BOOSTRIX (batch number 3457Y, expiry date 20th May 2019). On 22nd May 2017, the patient received the 1st dose of BOOSTRIX (intramuscular) .5 ml. On 23rd May 2017, 1 days after receiving BOOSTRIX, the patient experienced pain and swelling. On 26th May 2017, the patient experienced muscle twitching. On 26th May 2017, the outcome of the pain and swelling were recovered/resolved. On an unknown date, the outcome of the muscle twitching was not recovered/not resolved. The reporter considered the pain and swelling to be almost certainly related to BOOSTRIX. It was unknown if the reporter considered the muscle twitching to be related to BOOSTRIX. Additional details were reported as follows: A patient developed bicep twitching 4 days after vaccination with BOOSTRIX. The symptoms were bothersome enough that the patient sought follow-up care from the physician who ordered the vaccine. The batch number of BOOSTRIX was corrected 345Y7 to 3457Y.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Chest X-ray normal, Chills, Electrocardiogram normal, Injection site erythema
Clinical narrative: PCV13 (pneumococcal conjugated) vaccine redness and pain to injection site, fever, chills. Pt went to ER 6/16/17 had chest x-ray (-), labs normal. F/U 6/17/17 pt given KEFLEX for cellulitis.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Laboratory test normal, Pyrexia
Clinical narrative: PCV13 (pneumococcal conjugated) vaccine redness and pain to injection site, fever, chills. Pt went to ER 6/16/17 had chest x-ray (-), labs normal. F/U 6/17/17 pt given KEFLEX for cellulitis.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Swelling face, Urticaria
Clinical narrative: Child left the office and within 30 mins developed hives and facial swelling. Took BENADRYL and went ER. No further action was needed.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Limb discomfort
Clinical narrative: Patient reported injection site pain followed by warm-hot skin. Redness at site and on arm for several days post vaccine. Arm was "heavy" unable to move it freely the night of vaccine. Back to normal 6-21-17 840AM.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: Patient reported injection site pain followed by warm-hot skin. Redness at site and on arm for several days post vaccine. Arm was "heavy" unable to move it freely the night of vaccine. Back to normal 6-21-17 840AM.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Pain
Clinical narrative: Shot administered on 6/14/16. Customer complained on 6/16/16 of a "2 inch welt and swelling and redness" at injection site. Local pain also reported.
Age: 0.67
Sex: F
Vaccine: PNC13
Symptoms: Crying, Eructation, Hypophagia, Irritability, Pyrexia
Clinical narrative: About 4 hours after PREVNAR 1, she got feverish, sleepy, fussy, ate less, for 1 1/2 days. Burping a lot 2nd day. While breast feeding, about 52 hr. after PREVNAR, had a 30 sec clonic AE's synchronous rhythmic SZ, then cried a minute, then slept all night. Normal today 6-15-17.
Age: 0.67
Sex: F
Vaccine: PNC13
Symptoms: Seizure, Somnolence
Clinical narrative: About 4 hours after PREVNAR 1, she got feverish, sleepy, fussy, ate less, for 1 1/2 days. Burping a lot 2nd day. While breast feeding, about 52 hr. after PREVNAR, had a 30 sec clonic AE's synchronous rhythmic SZ, then cried a minute, then slept all night. Normal today 6-15-17.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient received ZOSTAVAX immunization, she had a local reaction of enlarged redden area, feverish, hard raised at injection site.
Sex: U
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cold exposure injury, Generalised erythema, Pruritus, Urticaria
Clinical narrative: Body redness, hives and itchiness upon cold exposure (pool, ice, cold drinks) 1 week after shots (HPV/MENVEO/TDaP).
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain, Injection site swelling, Malaise, Pain
Clinical narrative: Hurting all over, general bad feeling, unable to function. Pain eased but general all over ill feeling last several day and kept me in the bed, swelling and pain at site of injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash pruritic, Rash vesicular
Clinical narrative: Developed an itching rash, soreness shoulder Rt. rash looked vesicular - like zoster.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Gingival disorder, Headache, Oral herpes
Clinical narrative: The morning after getting the shot in my right arm, my Rt temple was where my headache was focused. The skin at the temple and Rt eye area felt "weird" to the touch and my Rt eye ached. In my mouth on the upper right gum were little bumps and on the corner of my mouth (Rt side) were 3 cold sores. Headache gone by Monday. Rest gone in 6-7 days.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Swelling
Clinical narrative: 6.5" long - 5.5" wide. Red flat rash with swelling.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient c/o pruritus she has been experiencing since HPV shot that she received on Friday, 6/2/17. The skin irritation (pruritus and burning started Sunday, 6/4/17. Right after receiving the injection on Friday, patient reports just feeling normal soreness at injection site. However, on Sunday, 6/4/17 patient reports still feeling soreness at injection site, but with some burning and itchiness at injection site. She did not notice redness and raised, reddened skin in itchy areas until yesterday on 6/6/17. Reports still having burning and pruritis in left armpit, left upper forearm, and upper area on back side of left arm. Patient had no fever. Temperature of 98.4F; afebrile. Denies wheezing, SOB, and dyspnea. Denies recent changes in body lotions, soap, and clothing material.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Skin burning sensation, Skin irritation
Clinical narrative: Patient c/o pruritus she has been experiencing since HPV shot that she received on Friday, 6/2/17. The skin irritation (pruritus and burning started Sunday, 6/4/17. Right after receiving the injection on Friday, patient reports just feeling normal soreness at injection site. However, on Sunday, 6/4/17 patient reports still feeling soreness at injection site, but with some burning and itchiness at injection site. She did not notice redness and raised, reddened skin in itchy areas until yesterday on 6/6/17. Reports still having burning and pruritis in left armpit, left upper forearm, and upper area on back side of left arm. Patient had no fever. Temperature of 98.4F; afebrile. Denies wheezing, SOB, and dyspnea. Denies recent changes in body lotions, soap, and clothing material.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Fatigue, Headache, Injection site pain, Injection site reaction
Clinical narrative: Fever (102), mild nausea, headaches, myalgias, fatigue, pain/stiffness at injection site, swelling of arm -6/10/17 TYLENOL PRN, red, Hydroxyzine HCL 25 mg 1-2 every 6 hours PRN itching. Sx improving not gone.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Peripheral swelling, Pruritus
Clinical narrative: Fever (102), mild nausea, headaches, myalgias, fatigue, pain/stiffness at injection site, swelling of arm -6/10/17 TYLENOL PRN, red, Hydroxyzine HCL 25 mg 1-2 every 6 hours PRN itching. Sx improving not gone.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever (102), mild nausea, headaches, myalgias, fatigue, pain/stiffness at injection site, swelling of arm -6/10/17 TYLENOL PRN, red, Hydroxyzine HCL 25 mg 1-2 every 6 hours PRN itching. Sx improving not gone.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain, Rash macular, Skin warm, Swelling
Clinical narrative: Shot given in left arm on Thursday. By Friday very sore to move. On Saturday extremely sore and red blotches (hives?), raised, swollen and hot to touch. Symptoms lasted almost 1 week.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Mycobacterium tuberculosis complex test negative, Vaccination site cellulitis
Clinical narrative: Patient called Health nurse -6/13/17, to report she developed "non-specific cellulitis at TDaP vaccination site." The patient saw personal MD, and stated she was prescribed antibiotics. Full ROM, RUE, has continued working.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, Chest discomfort, Dysentery, Hypertension, Laboratory test
Clinical narrative: Tetanus shot administered 6-12-17, hospitalized 6-13-17 dysentery, vomiting, fever 103 degrees, tightness in chest and high BP 246/90 experienced w-loss of 6 lbs. in 2 days, then experienced pneumonia symptoms and given a penicillin shot 6-12-17 at urgent care->6-13-17 then went to hospital, diagnosed w-acute URI, discharged 6-13-17 at 22:18. Somewhat better w-low fever and pneumonia and pain in chest.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Pneumonia, Pyrexia, Upper respiratory tract infection, Vomiting, Weight decreased
Clinical narrative: Tetanus shot administered 6-12-17, hospitalized 6-13-17 dysentery, vomiting, fever 103 degrees, tightness in chest and high BP 246/90 experienced w-loss of 6 lbs. in 2 days, then experienced pneumonia symptoms and given a penicillin shot 6-12-17 at urgent care->6-13-17 then went to hospital, diagnosed w-acute URI, discharged 6-13-17 at 22:18. Somewhat better w-low fever and pneumonia and pain in chest.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site bruising, Peripheral swelling
Clinical narrative: Patient came by pharmacy to report she had bruising on both upper arms from getting VARIVAX (chicken pox) and MMR vaccines. Her arms were also swollen. Vaccines given in deltoid, but not SQ.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site bruising, Injection site urticaria
Clinical narrative: 24 hr. after administration, Mom reported a bruise at the site with an area of hives adjacent. Child went to baseball practice after injection and could have been injured at that time. Mom declined to bring the boy into the office.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: DTaP vaccine administered 6/8/17 in (R) thigh, 6/10/17 parent noticed red area around injection site. Eval 6/12/17, examined (R) lateral thigh 12x12cm red slightly warm area w/o significant edema. No fever. Mom advised to ice area, try OTC allergy med and f/u if no improvement.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Delirium, Paraesthesia, Pyrexia
Clinical narrative: Pt had a high fever 10-12 hrs later, delirious unaware of her surroundings and thought she had ticks all over her body.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Vomiting
Clinical narrative: Vomiting, right deltoid is red, swollen, hard and hot to the touch. Symptoms began about 4:30 am on 6/21/17.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site urticaria
Clinical narrative: Few hours after injection - developed 3 sm. raised hives at site - throughout next 24 hrs hives spread throughout stomach, trunk, upper thigh, buttocks - comes and goes- gave BENADRYL.
Age: 20.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Erythema, Eye pruritus, Eyelid oedema, Lip discolouration, Lip dry
Clinical narrative: Had lab work and immi's 6/7/17. Reports that on the am of 6-8-17, she had red rash (R) antecub with itching and redness and area spread upper and lower arm. No areas noted to injection sites of immi's. Lab work was drawn (r) antecub. C/O eyes red, puffy and itchy over wkend, but clear today. C/O lips rec, dry, puffy, painful and itchy. Starting 6/17/17. Nothing reported to rest of body or R/L injection sites. Cont to monitor. Taking PRN BENADRYL/lip balm.
Age: 20.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Lip pain, Lip pruritus, Lip swelling, Ocular hyperaemia, Pruritus
Clinical narrative: Had lab work and immi's 6/7/17. Reports that on the am of 6-8-17, she had red rash (R) antecub with itching and redness and area spread upper and lower arm. No areas noted to injection sites of immi's. Lab work was drawn (r) antecub. C/O eyes red, puffy and itchy over wkend, but clear today. C/O lips rec, dry, puffy, painful and itchy. Starting 6/17/17. Nothing reported to rest of body or R/L injection sites. Cont to monitor. Taking PRN BENADRYL/lip balm.
Age: 20.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Rash erythematous
Clinical narrative: Had lab work and immi's 6/7/17. Reports that on the am of 6-8-17, she had red rash (R) antecub with itching and redness and area spread upper and lower arm. No areas noted to injection sites of immi's. Lab work was drawn (r) antecub. C/O eyes red, puffy and itchy over wkend, but clear today. C/O lips rec, dry, puffy, painful and itchy. Starting 6/17/17. Nothing reported to rest of body or R/L injection sites. Cont to monitor. Taking PRN BENADRYL/lip balm.
Age: 70.0
Sex: U
Vaccine: PNC13
Symptoms: Mobility decreased, Nerve injury, Nuclear magnetic resonance imaging, Pain in extremity, Swelling
Clinical narrative: Severe pain in left arm. Swollen for months after the shot. Some nerve damage. Sometimes I can't move my left arm because of pain. Treatments: TORADOL, ADVIL, heat, a little exercise, etc.
Age: 70.0
Sex: U
Vaccine: PNC13
Symptoms: X-ray
Clinical narrative: Severe pain in left arm. Swollen for months after the shot. Some nerve damage. Sometimes I can't move my left arm because of pain. Treatments: TORADOL, ADVIL, heat, a little exercise, etc.
Sex: M
Vaccine: RV1
Symptoms: Accidental exposure to product, Laceration, No adverse event, Product quality issue
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injury in a male healthcare professional with ROTARIX (batch number A41CB558A, expiry date unknown). On an unknown date, the patient received ROTARIX. On an unknown date, immediately after receiving ROTARIX, the patient experienced injury, inadvertent exposure to vaccine and pharmaceutical product complaint. On an unknown date, the outcome of the injury, inadvertent exposure to vaccine and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injury to be related to ROTARIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The vial cap of ROTARIX popped off which then broke and lead to cutting self (injury) and was exposed to vaccine which led to inadvertent exposure to vaccine. This was happened twice. It was reported that, the pressure related issue occurred more than once as the altitude was 5000 feet (exploding issues). No side effects were reported. The expiry date of vaccine and the date of birth of the patient were not reported. This case was one of the 4 cases reported by the same reporter.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Injection site hypoaesthesia, Nausea, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 16-year-old female patient who received BEXSERO (batch number 159001A, expiry date March 2018). On 7th June 2017, the patient received the 1st dose of BEXSERO. On 7th June 2017, several hours after receiving BEXSERO, the patient experienced fever, general body pain, nausea, light headedness, headache and injection site numbness. On an unknown date, the outcome of the fever, general body pain, nausea, light headedness, headache and injection site numbness were unknown. It was unknown if the reporter considered the fever, general body pain, nausea, light headedness, headache and injection site numbness to be related to BEXSERO. Additional details were received as follows: In morning, the patient received a dose of BEXSERO. Soon after vaccination (less than a day after vaccination), the patient developed numbness at injection site. By 6 PM that evening, the patient developed a fever of 100 degrees F, nausea, lightheadedness, headache, and achiness all over. On the day of reporting the patient still had a low grade fever of 99.6 degree F. The reporting nurse practitioner stated that the patient had not yet taken any medications for reactions, at the time of reporting.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 16-year-old female patient who received BEXSERO (batch number 159001A, expiry date March 2018). On 7th June 2017, the patient received the 1st dose of BEXSERO. On 7th June 2017, several hours after receiving BEXSERO, the patient experienced fever, general body pain, nausea, light headedness, headache and injection site numbness. On an unknown date, the outcome of the fever, general body pain, nausea, light headedness, headache and injection site numbness were unknown. It was unknown if the reporter considered the fever, general body pain, nausea, light headedness, headache and injection site numbness to be related to BEXSERO. Additional details were received as follows: In morning, the patient received a dose of BEXSERO. Soon after vaccination (less than a day after vaccination), the patient developed numbness at injection site. By 6 PM that evening, the patient developed a fever of 100 degrees F, nausea, lightheadedness, headache, and achiness all over. On the day of reporting the patient still had a low grade fever of 99.6 degree F. The reporting nurse practitioner stated that the patient had not yet taken any medications for reactions, at the time of reporting.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Vaccine administered (Hep A) 6/7/2017 this was his second dose- the next morning he developed hives, increased today. Northing else now.
Age: 4.0
Sex: M
Vaccine: IPV, MMRV
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Abnormally swollen, red, irritation to left and right thighs for 1 week. Advised to use cold compress and continue to observe. Call office if it does not resolve.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Skin warm, Swelling
Clinical narrative: Pt received vaccine on 6/16/17; reported bump and slight redness Friday thru Mon. On Tues noted increased redness radiating up to shoulder and increased warmth. Denied pain/discomfort. Presented to clinic on Wed. Redness in upper left arm from mid upper arm to shoulder. Increased warmth. No pain. Just started antibiotic therapy.
Sex: U
Vaccine: MENB
Symptoms: Adverse event
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of adverse event in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. The reporter considered the adverse event to be possibly related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient had an emergency visit after vaccination. Clarification for the event experienced by the patient had been requested. It was unknown if the suspect vaccine was discontinued. It was unknown if the patient to be admitted to the hospital overnight or prolonged an existing hospitalization. No other seriousness criteria such as death, disabling, congenital anomaly, life-threatening and clinical intervention required was associated with the reported event.
Age: 22.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Erythema, Hyperaesthesia, Inflammation, Rash
Clinical narrative: Rash and redness w/inflammation on the back of left back of arm. Increase temp and sensitive to the touch. He received ibuprofen and Triamcinolone Cream.
Sex: U
Vaccine: RV1
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of adverse reaction in a infant patient who received ROTARIX oral suspension. On 26th May 2017, the patient received ROTARIX oral suspension (oral). On an unknown date, less than a month after receiving ROTARIX oral suspension, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to ROTARIX oral suspension. Additional details were received as follows: The age at vaccination was not reported. The patient experienced an unspecified adverse reaction after vaccination with a dose of ROTARIX. The reporter's call was disconnected and the reporter was unable to be contacted for full details as their office message indicated that it was closed for lunch with no opportunity to leave a voice mail message.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Bone marrow oedema, C-reactive protein normal, Full blood count normal, Injection site discomfort, Injection site pain
Clinical narrative: Continued left deltoid discomfort with sharp, pinching pain when arm is abducted. Pain has persisted with gradual but slow improvement over the last 5 weeks. Rest and ibuprofen taken but not helping much.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Muscle oedema, Nuclear magnetic resonance imaging abnormal, Pain, Red blood cell sedimentation rate normal
Clinical narrative: Continued left deltoid discomfort with sharp, pinching pain when arm is abducted. Pain has persisted with gradual but slow improvement over the last 5 weeks. Rest and ibuprofen taken but not helping much.
Age: 1.25
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Measles, Rash
Clinical narrative: Koplick's white spots oral. Patient evaluated 06/02/2017 by Dr. "Rash and other nonspecific skin eruption-cutaneous reaction to measles vaccines. "Plan, follow up as scheduled, may use BENADRYL or calamine as needed. Return it worsening or new symptoms.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Hives/rash on trunk.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Enema administration, Intussusception
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of intussusception in a 5-month-old female patient who received ROTARIX (lyophilized formulation) (batch number A41CB568A, expiry date 17th October 2017). Concomitant products included PEDIARIX, HIB-PRP-T vaccine and PREVNAR. On 31st May 2017, the patient received the 2nd dose of ROTARIX lyophilized formulation (oral). On 1st June 2017, 1 days after receiving ROTARIX lyophilized formulation, the patient experienced intussusception (serious criteria hospitalization, GSK medically significant and other). On an unknown date, the patient experienced blood in stool (serious criteria GSK medically significant) and crying. On 1st June 2017, the outcome of the intussusception was recovered/resolved. On an unknown date, the outcome of the blood in stool and crying were unknown. The reporter considered the intussusception to be probably related to ROTARIX lyophilized formulation. It was unknown if the reporter considered the blood in stool and crying to be related to ROTARIX lyophilized formulation. Additional details were provided as follows: The patient received PEDIARIX on left thigh, HIB-PRP-T vaccine on right thigh and PREVNAR on right thigh. On 31st May 2017 at 10:41, the patient received ROTARIX lyophilized formulation, on the same day the patient received HIB-PRP-T vaccine (batch number U1761AAA, expiry date 27th February 2011), PEDIARIX (batch number 9B4CD, expiry date 10th March 2019) and PREVNAR (batch number R48402, expiry date 30th April 2018). Less than a week after vaccination, the patient was crying continuously and had blood in stool. Later the patient was hospitalized for intussusception.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Haematochezia, Intussusception
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of intussusception in a 5-month-old female patient who received ROTARIX (lyophilized formulation) (batch number A41CB568A, expiry date 17th October 2017). Concomitant products included PEDIARIX, HIB-PRP-T vaccine and PREVNAR. On 31st May 2017, the patient received the 2nd dose of ROTARIX lyophilized formulation (oral). On 1st June 2017, 1 days after receiving ROTARIX lyophilized formulation, the patient experienced intussusception (serious criteria hospitalization, GSK medically significant and other). On an unknown date, the patient experienced blood in stool (serious criteria GSK medically significant) and crying. On 1st June 2017, the outcome of the intussusception was recovered/resolved. On an unknown date, the outcome of the blood in stool and crying were unknown. The reporter considered the intussusception to be probably related to ROTARIX lyophilized formulation. It was unknown if the reporter considered the blood in stool and crying to be related to ROTARIX lyophilized formulation. Additional details were provided as follows: The patient received PEDIARIX on left thigh, HIB-PRP-T vaccine on right thigh and PREVNAR on right thigh. On 31st May 2017 at 10:41, the patient received ROTARIX lyophilized formulation, on the same day the patient received HIB-PRP-T vaccine (batch number U1761AAA, expiry date 27th February 2011), PEDIARIX (batch number 9B4CD, expiry date 10th March 2019) and PREVNAR (batch number R48402, expiry date 30th April 2018). Less than a week after vaccination, the patient was crying continuously and had blood in stool. Later the patient was hospitalized for intussusception.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report has been received from a physician via rocky mountain poison & drug center referring to a 73 year old male patient with panhypopituitarism, cognitive difficulties and visual impairment. The patient's medical history included shingles. The patient concomitant therapies included levothyroxine sodium and hydrocortisone sodium succinate (HYDROCORTEF). It was reported that the patient also takes a "boat load" of medications but the physician did not have the details available. On 26-MAY-2017, the patient went to the pharmacy and because of the cognitive and visual impairment, the patient did not fill out the form for ZOSTAVAX correctly and the pharmacy gave him a dose of ZOSTAVAX (route of administration, lot #, expiration date, dosage number, strength, and anatomical location were unknown) for prophylaxis (also reported as: for an unknown indication); even though he had been on corticosteroids for a while. It was reported that the patient had not had any problems at the time. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report has been received from a physician via rocky mountain poison & drug center referring to a 73 year old male patient with panhypopituitarism, cognitive difficulties and visual impairment. The patient's medical history included shingles. The patient concomitant therapies included levothyroxine sodium and hydrocortisone sodium succinate (HYDROCORTEF). It was reported that the patient also takes a "boat load" of medications but the physician did not have the details available. On 26-MAY-2017, the patient went to the pharmacy and because of the cognitive and visual impairment, the patient did not fill out the form for ZOSTAVAX correctly and the pharmacy gave him a dose of ZOSTAVAX (route of administration, lot #, expiration date, dosage number, strength, and anatomical location were unknown) for prophylaxis (also reported as: for an unknown indication); even though he had been on corticosteroids for a while. It was reported that the patient had not had any problems at the time. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report has been received from a physician via rocky mountain poison & drug center referring to a 73 year old male patient with panhypopituitarism, cognitive difficulties and visual impairment. The patient's medical history included shingles. The patient concomitant therapies included levothyroxine sodium and hydrocortisone sodium succinate (HYDROCORTEF). It was reported that the patient also takes a "boat load" of medications but the physician did not have the details available. On 26-MAY-2017, the patient went to the pharmacy and because of the cognitive and visual impairment, the patient did not fill out the form for ZOSTAVAX correctly and the pharmacy gave him a dose of ZOSTAVAX (route of administration, lot #, expiration date, dosage number, strength, and anatomical location were unknown) for prophylaxis (also reported as: for an unknown indication); even though he had been on corticosteroids for a while. It was reported that the patient had not had any problems at the time. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Injection site warmth
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 64-year-old male patient. The patient had no pertinent medical history, drug reactions or allergies and did not use any concomitant medications. On 06-JUN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular injection into arm (side not specified), lot # M047519 with expiration date on 04-AUG-2018 (exact dose was not reported) as updated vaccine. On approximately 07-JUN-2017, the patient experienced soreness and redness at the injection site, which was so painful that it woke him up. On the same day (reported as "now"), the patient had welts and rash at the injection site, which also felt numb an tingly. The patient's wife sought a medical attention for him by calling the physician's office on 07-JUN-2017. The patient had put ice at the injection site for the treatment and would be coming into the physician's office on 07-JUN-2017, to rule out cellulitis. No laboratory diagnostics studies were performed. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Injection site rash
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 64-year-old male patient. The patient had no pertinent medical history, drug reactions or allergies and did not use any concomitant medications. On 06-JUN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular injection into arm (side not specified), lot # M047519 with expiration date on 04-AUG-2018 (exact dose was not reported) as updated vaccine. On approximately 07-JUN-2017, the patient experienced soreness and redness at the injection site, which was so painful that it woke him up. On the same day (reported as "now"), the patient had welts and rash at the injection site, which also felt numb an tingly. The patient's wife sought a medical attention for him by calling the physician's office on 07-JUN-2017. The patient had put ice at the injection site for the treatment and would be coming into the physician's office on 07-JUN-2017, to rule out cellulitis. No laboratory diagnostics studies were performed. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site urticaria, Poor quality sleep
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 64-year-old male patient. The patient had no pertinent medical history, drug reactions or allergies and did not use any concomitant medications. On 06-JUN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular injection into arm (side not specified), lot # M047519 with expiration date on 04-AUG-2018 (exact dose was not reported) as updated vaccine. On approximately 07-JUN-2017, the patient experienced soreness and redness at the injection site, which was so painful that it woke him up. On the same day (reported as "now"), the patient had welts and rash at the injection site, which also felt numb an tingly. The patient's wife sought a medical attention for him by calling the physician's office on 07-JUN-2017. The patient had put ice at the injection site for the treatment and would be coming into the physician's office on 07-JUN-2017, to rule out cellulitis. No laboratory diagnostics studies were performed. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 76-year-old male patient. The patient had no pertinent medical history, drug reactions or allergies and did not use any concomitant medications. On 26-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular injection, lot # M043424 with expiration date on 04-AUG-2018, (dose was not reported) for "vaccination update". On 27-MAY-2017, the patient experienced hard lump at injection site, which had no redness or drainage, which was very sore, but had improved from the previous day. The patient sought medical attention for the events and on 01-JUN-2017, he consulted with medical assistant. The patient was treated with warm compresses and unspecified local measures. There was no product quality complaint involved. The patient recovered from the events on an unspecified date in June 2017. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site induration, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 76-year-old male patient. The patient had no pertinent medical history, drug reactions or allergies and did not use any concomitant medications. On 26-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular injection, lot # M043424 with expiration date on 04-AUG-2018, (dose was not reported) for "vaccination update". On 27-MAY-2017, the patient experienced hard lump at injection site, which had no redness or drainage, which was very sore, but had improved from the previous day. The patient sought medical attention for the events and on 01-JUN-2017, he consulted with medical assistant. The patient was treated with warm compresses and unspecified local measures. There was no product quality complaint involved. The patient recovered from the events on an unspecified date in June 2017. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash, Rash erythematous
Clinical narrative: Low-grade fever, loss of appetite, irritability, vomiting. Two days later, raised red rash started on face and spread to trunk and back.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Vomiting
Clinical narrative: Low-grade fever, loss of appetite, irritability, vomiting. Two days later, raised red rash started on face and spread to trunk and back.
Age: 1.17
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: C-reactive protein increased, Red blood cell sedimentation rate increased, Weight bearing difficulty, White blood cell count increased
Clinical narrative: "Unwillingness to bear weight on lower left extremity".