chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Mobility decreased, Musculoskeletal stiffness, Neck pain, Paraesthesia
Clinical narrative: Swelling & stiffness in arm @ injection site. 01/08/2013 numbness in feet. 01/15/2013 numbness/tingling in feet, hands. 01/21/2013 burning sensation through shoulders, neck pain. 01/24/2013 symptoms continue, losing mobility in hands. 01/26/2013 symptoms continue, barely able to walk. 01/28/2013 Dr appt, muscle relaxers prescribed 01/29/2013 fall, unable to walk. 01/30/2013 Dr appt, carried to car, ER, hospitalization. Diagnosis- GBS Guillain-Barré syndrome. In the days/weeks following hospitalization: spinal tap, paralysis, plasma TPE, tracheotomy, ICU, code blue-resuscitation. 02/26/2013 transferred to another hospital, start of rehabilitation. Several weeks later massive blood clot in left leg. Made choice to leave hospital on 03/30/2013, due to no health insurance and the financial burden this was putting on my family.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Paralysis, Resuscitation, Thrombosis, Tracheostomy
Clinical narrative: Swelling & stiffness in arm @ injection site. 01/08/2013 numbness in feet. 01/15/2013 numbness/tingling in feet, hands. 01/21/2013 burning sensation through shoulders, neck pain. 01/24/2013 symptoms continue, losing mobility in hands. 01/26/2013 symptoms continue, barely able to walk. 01/28/2013 Dr appt, muscle relaxers prescribed 01/29/2013 fall, unable to walk. 01/30/2013 Dr appt, carried to car, ER, hospitalization. Diagnosis- GBS Guillain-Barré syndrome. In the days/weeks following hospitalization: spinal tap, paralysis, plasma TPE, tracheotomy, ICU, code blue-resuscitation. 02/26/2013 transferred to another hospital, start of rehabilitation. Several weeks later massive blood clot in left leg. Made choice to leave hospital on 03/30/2013, due to no health insurance and the financial burden this was putting on my family.
Age: 2.0
Sex: M
Vaccine: DTP, OPV
Symptoms: Cyanosis, Laboratory test, Loss of consciousness, Muscle rigidity, Tremor
Clinical narrative: Patient was given a DTP and Oral Polio when given the DPT shot in thigh, it cause him to draw up in a fist, lip's turn dark blueish purple. The face turn blue and passed out for over 30 min's or more. Was given an ammonia capsule and didn't respond just would shake so the call the ambulance to come get him.
Age: 2.0
Sex: M
Vaccine: DTP, OPV
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient was given a DTP and Oral Polio when given the DPT shot in thigh, it cause him to draw up in a fist, lip's turn dark blueish purple. The face turn blue and passed out for over 30 min's or more. Was given an ammonia capsule and didn't respond just would shake so the call the ambulance to come get him.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunoglobulin therapy, Platelet count decreased, Platelet transfusion, Rash
Clinical narrative: 5 days after shot, legs broke out in rash, went to doctor who drew blood and discovered blood platelets had decreased to 3 and went to hospital - stayed 3 days - received steroids, gamma globulins and platelets.
Age: 0.37
Sex: F
Vaccine: DTAPIPV, HIBV, PNC, RV5
Symptoms: No adverse event, Off label use
Clinical narrative: No adverse events resulting KINRIX given as off label (age) with no reactions.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Next day - fever, rash, lymphadenopathy.
Sex: U
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 33.0
Sex: F
Vaccine: YF
Symptoms: Pain, Pyrexia
Clinical narrative: Pt received yellow fever vaccine. She became having a reaction that night. Fever 102.7. Body aches, she thought throat was swelling used inhaler. Went to her physician 7-8-13.
Sex: F
Vaccine: HPV4
Symptoms: Meningitis
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with the second dose of GARDASIL (route, dose and lot # were unknown). On an unknown date the patient experienced meningitis. The patient saw a doctor. The outcome of meningitis was reported as recovering/resolving. Upon internal review, meningitis was considered to be a medically significant event. Additional information is not expected.
Age: 0.18
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events resulting. KINRIX given as off label with no reactions (age).
Age: 0.19
Sex: F
Vaccine: DTAPIPV, HIBV, PNC, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events resulting KINRIX given as off label (age) with no reactions.
Age: 0.34
Sex: M
Vaccine: DTAPIPV, HIBV, PNC, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events resulting. KINRIX given as off label (age) with no reactions.
Age: 0.2
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, PNC, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events resulting KINRIX given as off label (age) with no reactions.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injection site erythema, Injection site pain
Clinical narrative: Soreness in armpit area, redness at site of injection. Also soreness and pain in the shoulder area on arm of injection. Symptoms appeared on the morning after getting the vaccine. Symptoms are still present 3 days later taking TYLENOL to relieve pain.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Patient called and spoke to reporter and stated a painful rash has developed on her back she suspects shingles. Reporter instructed her to contact her physician. It was later discovered she was 49 years old.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: 11/1/12 Given wrong strength of Hep B vaccine adolescent instead of adult dose strength. Opted not to take adult Hep B series.
Age: 1.13
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash generalised, Varicella post vaccine
Clinical narrative: Mild case of chicken pox after getting the varicella vaccination which lasted 2 weeks. Patient has bumps on the head, face, arms, legs and belly.  Also mild rash outbreak for 1-2 days from MMR vaccination.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, soreness at site of injection.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Incorrect route of drug administration, Wrong drug administered
Clinical narrative: THIS MORNING TD VACCINE GIVEN SUBCUTANEOUSLY IN ERROR INSTEAD OF TB TEST.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Hypoacusis, Vision blurred
Clinical narrative: Client state feeling dizzy, blurry vision, and difficulty hearing. Ice pack applied over client left arm. Client were ask to take deep breath, and drink some sip of water.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: Pt was brought to the ER by mother after pt had hours of vomiting and diarrhea. Pt was admitted for dehydration.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Rash, Skin warm
Clinical narrative: Oval area under skin noted (approx 3 inches by 2 inches)-very hard and hot with a rash-like appearance. Took 3 days to come on. Self treated with hydrocortisone cream and OTC antihistamine.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Pt began to feel dizzy and nauseous.  Appeared diaphoretic.  BP was 111/75 pulse was 54.
Age: 37.0
Sex: M
Vaccine: FLU3, HEP, HEPA, MMR, TDAP, VARCEL
Symptoms: Discomfort, Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Approximately 3 weeks after receiving an MMR vaccination in his left arm, the client reported discomfort which progressed to pain, redness and swelling. "Hot". Lasted approximately 3 days and then went away. Spoke to a clinic but was not seen or evaluated.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Inflammation, Insomnia, Mobility decreased, Neck surgery
Clinical narrative: Could not lift arm about 2-3 hours after shot was administered--have had chronic pain ever since, could not sleep for about a month and used heat wraps on upper arm. Reported my event to pharmacy three times. Pharmacist suggested that I see my family physician which I did. She ordered an MRI and referred me to an orthopedic surgeon. He said my shoulder/arm condition was not related at all to my degenerative disc problem and gave me a steroid shot to relieve the pain. The MRI showed fluid on my arm and the diagnosis was inflammation. I have since had open neck surgery to replace discs, and the surgeon at hospital also said my left shoulder and arm problem was not related to the disc problem and suggested I see a neurologist. I will see my family physician tomorrow who will refer me to a neurologist. Please note that the flu shot was injected on my shoulder rather than my upper arm which my doctor was concerned about. It has been six months since I received the high dose flu shot, and I need some answers as to why I am still having significant pain and lack of mobility, and am concerned about this condition being permanent.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Could not lift arm about 2-3 hours after shot was administered--have had chronic pain ever since, could not sleep for about a month and used heat wraps on upper arm. Reported my event to pharmacy three times. Pharmacist suggested that I see my family physician which I did. She ordered an MRI and referred me to an orthopedic surgeon. He said my shoulder/arm condition was not related at all to my degenerative disc problem and gave me a steroid shot to relieve the pain. The MRI showed fluid on my arm and the diagnosis was inflammation. I have since had open neck surgery to replace discs, and the surgeon at hospital also said my left shoulder and arm problem was not related to the disc problem and suggested I see a neurologist. I will see my family physician tomorrow who will refer me to a neurologist. Please note that the flu shot was injected on my shoulder rather than my upper arm which my doctor was concerned about. It has been six months since I received the high dose flu shot, and I need some answers as to why I am still having significant pain and lack of mobility, and am concerned about this condition being permanent.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: 11/1/12 Wrong strength of Hep B vaccine given to patient. Adolescent dose instead of adult strength. Pt. has now completed adult Hep B series as of 6/26/13.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: 11/1/12 Wrong strength of Hep B vaccine given to patient. Adolescent dose instead of adult strength. Pt. has now completed Adult Hep B series as of 6/26/13.
Age: 61.0
Sex: M
Vaccine: YF
Symptoms: Arthralgia, Chills, Cough, Dizziness, Headache
Clinical narrative: High fevers, chills, myalgias, arthralgias, slight cough, headache, dizziness, loss of consciousness.
Age: 61.0
Sex: M
Vaccine: YF
Symptoms: Loss of consciousness, Myalgia, Pyrexia
Clinical narrative: High fevers, chills, myalgias, arthralgias, slight cough, headache, dizziness, loss of consciousness.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV4, MEN
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Confusional state, Dizziness
Clinical narrative: Dizziness, blacked out, confusion, throat tightening, wheezing, heart racing, pain.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV4, MEN
Symptoms: Electrocardiogram, Loss of consciousness, Pain, Palpitations, Throat tightness
Clinical narrative: Dizziness, blacked out, confusion, throat tightening, wheezing, heart racing, pain.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV4, MEN
Symptoms: Wheezing
Clinical narrative: Dizziness, blacked out, confusion, throat tightening, wheezing, heart racing, pain.
Sex: U
Vaccine: PPV
Symptoms: Drug ineffective, Mechanical ventilation, Pneumococcal infection
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23. The dose number, dose, lot number and expiry date were not reported. On an unknown date the patient experienced pneumococcal disease (hospitalization and life threatening). The patient was hospitalized for an unknown amount of time and hooked up to a ventilator. The reporter considered the event to be life threatening. The reporter stated that PNEUMOVAX23 is not working, the drug is like a placebo. The outcome of pneumococcal disease is unknown. This case was linked to case 1307USA002815, based on the same reporter. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Erythematous macular eruption on his trunk, back, flanks, upper arms and legs 5 days after vaccine administration.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt received ZOSTAVAX on 7/5/13 and experienced severe swelling at site (approximately 10 inches in diameter) and redness, itching.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Site redness, edema, pain. All symptom resolved 4-5 days.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: Patient has continued pain in left arm from flu shot. He sleeps on left side and it is so painful that he has trouble sleeping. It hurts him to even lift his arm. Began when shot was administered almost 5 months ago.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: 11/1/12 Wrong strength of Hep B vaccine given to patient. Adolescent dose instead of Adult strength. Pt. completed 2 dose of adult Hep B. Retired from company. Letter sent to encourage him to complete 3 dose on his own. 6/26/13.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: 11/1/12 Wrong strength of Hep B vaccine given to patient. Adolescent dose instead of Adult strength. Pt. has now completed Adult Hep B series as of 6/26/13.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: 11/1/12 Wrong strength of Hep B vaccine given to patient. Adolescent dose instead of Adult strength. Pt. has now completed Adult Hep B series as of 6/26/13.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pruritus, Injection site rash, Pain
Clinical narrative: Client called client reporting rash on arm where vaccine was given. States rash first appeared today and has been having soreness and redness since vaccination date on 06/18/13. Denies fever, complains of itching at rash site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Rash vesicular
Clinical narrative: Rash contained on right side (buttock, hip and top of leg (R) side), varicella-like rash, lots of itching and redness, treating with BENADRYL PO and topical.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Injection site scar, Local swelling, Pain in extremity
Clinical narrative: Upper arm, swelled, red, hot to touch, bruising, painful, skin now peeling. (When to doctor after reaction) scar at injection site now.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation, Skin warm
Clinical narrative: Upper arm, swelled, red, hot to touch, bruising, painful, skin now peeling. (When to doctor after reaction) scar at injection site now.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: 11/1/12 Wrong strength of Hep B vaccine given to patient. Adolescent dose instead of Adult strength. Pt. has now completed Adult Hep B series as of 6/26/13.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: 11/1/12 Wrong strength of Hep B vaccine given to patient. Adolescent dose instead of adult strength.
Age: 1.06
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Urticaria
Clinical narrative: Diffuse hives on trunk/arms - legs.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod sting, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately 60 year old female patient with no pertinent medical history and no drug reactions or allergies. On 29-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as H019996, and 14-FEB-2014 respectively) subcutaneously in the arm. Concomitant therapy included estradiol. On 29-JUN-2013 (reported as later that same day), the patient got stung by a bee in the same arm, close to the ZOSTAVAX site. The reaction to the bee sting site was encompassed the site of the ZOSTAVAX. The area was very red, painful, a deep burning and itching pain. It was like a big welt and was hard. The patient sought medical attention (called pharmacy). The patient was treated with BENADRYL and topical hydrocortisone. No lab tests were performed. The patient was recovering from all the events. The relatedness for the events was unknown for ZOSTAVAX. There was no product quality complaint. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately 60 year old female patient with no pertinent medical history and no drug reactions or allergies. On 29-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as H019996, and 14-FEB-2014 respectively) subcutaneously in the arm. Concomitant therapy included estradiol. On 29-JUN-2013 (reported as later that same day), the patient got stung by a bee in the same arm, close to the ZOSTAVAX site. The reaction to the bee sting site was encompassed the site of the ZOSTAVAX. The area was very red, painful, a deep burning and itching pain. It was like a big welt and was hard. The patient sought medical attention (called pharmacy). The patient was treated with BENADRYL and topical hydrocortisone. No lab tests were performed. The patient was recovering from all the events. The relatedness for the events was unknown for ZOSTAVAX. There was no product quality complaint. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 18 year old female patient. No medical history was reported. Patient had no drug allergies or reactions. The nurse reported that the patient developed abnormal menstrual bleeding after receiving her first 2 doses of GARDASIL. The nurse mentioned the bleeding started on unspecified dates right after the patient received GARDASIL on both occasions. No concomitant medications were reported. On 25-MAR-2013, the patient was vaccinated with a dose 1 of GARDASIL (lot # H016238, expiry: 11-APR-2013) and experienced abnormal menstrual bleeding approximately on an unknown date in March 2013, that lasted for one month (approximately till an unknown date in April 2013). On 01-MAY-2013, the patient was vaccinated with dose 2 of GARDASIL (lot # H017698, expiry: 02-APR-2015). On an unknown date approximately in May 2013, the patient experienced abnormal menstrual bleeding which had not yet stopped bleeding. The patient sought medical attention. The patient was seen in the office today and was prescribed an unspecified oral contraceptive. No laboratory diagnostics studies were performed. Additional information has been requested.
Age: 59.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (quality assurance coordinator) regarding a 59 year old patient(gender unknown). The healthcare worker reported that her facility had administered 9 doses of RECOMBIVAX HB, lot # J001183. On 24-MAY-2013, one of the patient's was vaccinated with dose 1 of RECOMBIVAX HB (lot # J001183, expiry: 08-SEP-2014). At the time of this report(01-JUL-2013), the patient had not yet received dose 2 of RECOMBIVAX HB. No adverse effects reported. This is 1 of 6 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients. On unknown dates, the patients were vaccinated with GARDASIL exposed to 25F for over 3 months, which was an excursion that was unsupported by in-house stability date. The reporter was unable to provide administration dates, however provided the lot #/expired date as follows: lot # H021608/expire date 13-APR-2015, lot # H01523B/expire date 11-APR-2015, lot # H20002/expire date 08-AUG-2015). No adverse symptoms provided at the time of report. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patient of unknown age. On an unknown date the patient was vaccinated with 1.0 ml dose of PNEUMOVAX23 (lot# not reported). No adverse event was reported. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (quality assurance coordinator) regarding a 38 year old female patient. The healthcare worker reported that her facility had administered 9 doses of RECOMBIVAX HB, lot # J001183. On 15-MAY-2013, the one of the patient's was vaccinated with dose 1 of RECOMBIVAX HB (lot # J001183, expiry: 08-SEP-2014). On 14-JUN-2013, the patient received her second dose of RECOMBIVAX HB (lot # J001183, expiry: 08-SEP-2014) one day early. No adverse effects reported. This is 1 of 6 reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (quality assurance coordinator) regarding a 34 year old patient(gender unknown). The healthcare worker reported that her facility had administered 9 doses of RECOMBIVAX HB, lot # J001183. On 07-MAY-2013, the one of the patient's was vaccinated with dose 1 of RECOMBIVAX HB (lot # J001183, expiry: 08-SEP-2014). At the time of this report(01-JUL-2013), the patient had not yet received dose 2 of RECOMBIVAX HB. No adverse effects reported. This is 1 of 6 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a vaccine specialist from health department (Healthcare worker) who was informed by the mother of a first unspecified child(age unknown). It was reported that a second unspecified child (age unknown) developed "a rash with a few bumps" (onset date unknown), after the second child had received VARIVAX (Merck) (date, dose, route and lot# not provided). No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient had sought medical attention. The mother of the first child was concerned about transmission of the varicella virus to her unvaccinated child. Action taken was not provided. The outcome was unknown. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (quality assurance coordinator) regarding a 61 year old patient(gender unknown). The healthcare worker reported that her facility had administered 9 doses of RECOMBIVAX HB, lot # J001183. On 21-MAY-2013, one of the patient's was vaccinated with dose 1 of RECOMBIVAX HB (lot # J001183, expiry: 08-SEP-2014). At the time of this report(01-JUL-2013), the patient had not yet received dose 2 of RECOMBIVAX HB. No adverse effects reported. This is 1 of 6 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The nurse reported that (Merck) VARIVAX (lot#, expiry not reported) was exposed to a temperature of 7 degree Fahrenheit (F) for 18.5 hours. The nurse also reported that she thinks that the same (Merck) VARIVAX had three previous excursions prior in which the vaccine was exposed to 6 F for 96 hours, 6 F for 72 hours, and 6F for 12 hours. The nurse reported that she was unsure if the vaccine overall average temperature remained between -58F and 5F. She stated that the (Merck) VARIVAX may have been administered. No adverse effect reported. Additional information has been requested.
Age: 42.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (quality assurance coordinator) regarding a 42 year old patient(gender unknown). The healthcare worker reported that her facility had administered 9 doses of RECOMBIVAX HB, lot # J001183. On 07-MAY-2013, the one of the patient's was vaccinated with dose 1 of RECOMBIVAX HB (lot # J001183, expiry: 08-SEP-2014). At the time of this report(01-JUL-2013), the patient had not yet received dose 2 of RECOMBIVAX HB. No adverse effects reported. This is 1 of 6 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Drug ineffective, Pneumococcal infection
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an unknown number of patients, referred to as multiple. Demographic information was not reported. On an unknown date the patients were vaccinated with PNEUMOVAX23. The dose number, dose, lot number and expiry date were not reported. On an unknown date the patients experienced pneumococcal disease. Treatment information and the outcome of pneumococcal disease was not reported. The reporter stated that PNEUMOVAX23 was not working in the patient population, the drug was like a placebo. He furthermore stated that he was going to prescribe PREVNAR for his patients, rather than PNEUMOVAX23. This case is linked to case 1307USA002300, based on same reporter. 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, unknown gender. On 02-JUL-2013 the patient was vaccinated subcutaneously with an expired ZOSTAVAX (lot # 672676/0069AE, expiry date 04-APR-2013). No adverse effects reported. The outcome of the event was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
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. On 24-JUN-2013 the patient was vaccinated with PNEUMOVAX23 (lot# 672057/1417AA, expiration date 22-JUN-2013) (strength and total daily dose not reported). It was reported that the patient received an expired dose of PNEUMOVAX23. No adverse effect was reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age. On 24-JUN-2013 the patient was vaccinated with the second dose of GARDASIL (lot #0552AA, expiry date on 23-JUN-2013, route and dose were unknown) had expired. The first dose of GARDASIL (lot # 0552AA, expiry date on 23-JUN-2013) was administered on 23-MAY-2013. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning an unspecified number of patients of unknown age and gender. On an unknown date, unspecified number of patients were vaccinated with 0.5 milliliter (ml) of PNEUMOVAX23 (lot number, expiry date and route unspecified). No concomitant medications were reported. On an unknown date, patients developed pneumococcal disease, specified that they continue to see pneumococcal disease in their HIV population. The outcome of the event was unknown. The relatedness for the event was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 33.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (quality assurance coordinator) regarding a 33 year old patient(gender unknown). The healthcare worker reported that her facility had administered 9 doses of RECOMBIVAX HB, lot # J001183. On 06-MAY-2013, the one of the patient's was vaccinated with dose 1 of RECOMBIVAX HB (lot # J001183, expiry: 08-SEP-2014). At the time of this report(01-JUL-2013), the patient had not yet received dose 2 of RECOMBIVAX HB. No adverse effects reported. This is 1 of 6 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients. On unknown dates, the patients were vaccinated with LIQUID PEDVAXHIB exposed to 25F for over 3 months, which was an excursion that was unsupported by in-house stability date. The reporter was unable to provide administration dates, however provided the lot#/expired date as follows: lot # H017030/expire date 17-JAN-2015, lot # J000360/expire date 25-OCT-2015). No adverse symptoms provided at the time of report. This is one of several reports received from the some source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a 5 year old patient of unknown gender. On 14-DEC-2007, the patient was vaccinated with dose 1 of RECOMBIVAX HB (2.5/0.5, units unspecified) (lot number, expiry date, dose and route unspecified). On 31-JUL-2008, the patient was vaccinated with dose 2 of RECOMBIVAX HB (2.5/0.5, units unspecified) (lot number, expiry date, dose and route unspecified). On 12-SEP-2008, the patient was vaccinated with dose 3 of RECOMBIVAX HB (2.5/0.5, units unspecified) (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Somnolence, Vomiting
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 13 year old male patient with no medical history and no drug reactions. On 26-JUN-2013, the patient was vaccinated with the first dose of GARDASIL, lot # J003727 (expire date: 07-NOV-2015), dose and route unspecified. Patient had no concomitant medication. On 26-JUN-2013, the patient experienced weakness, drowsiness and vomiting after receiving the first dose of GARDASIL. No lab test was performed and no treatment was given for AEs. The patient called to office for medical attention. The outcome of the patient was reported as not recovered/not resolved at the time of report. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to her husband of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, expiry date, dose, frequency, route and site unspecified). On an unknown date two weeks after having received the vaccine, the patient was diagnosed with shingles. The outcome of shingles was unknown. The reporter believed that the shingles was caused directly by the vaccine. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately 62 year old female patient with no drug reactions or allergies. Medical history of the patient included an unspecified cancer. On 25-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as 5001690 and 08-MAY-2014 respectively, dose and route unspecified). No concomitant medications were reported. On 25-JUN-2013, the patient developed swelling around the injection site and a rash that extended from the elbow of the patient to her arm pit that was approximately 5 inch long after receiving ZOSTAVAX. The patient sought medical attention (contacted pharmacist). She was treated with an ice and hydrocortisone cream. No lab tests were performed. The patient was recovering from the events. The relatedness for the events was unknown for ZOSTAVAX. Pharmacist reported Varicella Zoster Virus Identification Program (VZVIP) packet. VZVIP packet was faxed. Additional information is not expected.
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 approximately 5 patients. The patients were vaccinated with the first dose of GARDASIL (route, dose and lot # were unknown) on unspecified dates "years ago" and inquired when to receive the second dose. No adverse symptoms reported. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old male patient. On 28-FEB-2013 the patient was vaccinated with the first dose of GARDASIL 0.5 ml (lot # was unknown) intramuscularly, the second dose on 29-APR-2013 and the third dose on 01-JUL-2013. No adverse effects reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site nodule, Injection site pain, Injection site warmth, Somnolence
Clinical narrative: This spontaneous report as received from a physician refers to an 11 year old male patient with no pertinent medical history. On an unknown date in 2006 the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route, lot number and expiration date not reported). On 25-JUN-2013 the patient was vaccinated with the second dose of VARIVAX (Merck) (0.5 ml, lot # H011553, expiration date 11-JUN-2014) subcutaneous for school vaccine requirement. There was no concomitant medication reported. On 25-JUN-2013 the patient developed a "6cm by 6cm" nodule at the injection site that was very warm and "painful". The physician reported that the patient's mother called the physician's office on 26-JUN-2013 to inform the physician what the patient developed after receiving the VARIVAX (Merck). The patient was seen by the physician in her office on 27-JUN-2013 in which she instructed the patient to apply warm compresses to the nodule as well as to take BENADRYL every 8 hours for two days. The physician also reported that she informed the patient to stop taking the BENADRYL at an unspecified time (approximately June 2013) because the BENADRYL made him very drowsy. The physician reported that the patient was recovering and that the pain stopped at the patient's injection site on approximately June 2013 as well as the nodule began shrinking on approximately June 2013. No lab diagnostics studies were performed. The outcomes of warm and painful were reported as recovering. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Echocardiogram, Electrocardiogram, Pericarditis, Troponin I
Clinical narrative: This study case was received from the investigator in the trial on 26 June 2013. A 29 year-old male subject with no significant past medical history had received the following vaccines on 02 March 2011: an injection of ACAM2000 (lot number, route and site administration not reported), anthrax (manufacturer unknown, lot number, route and site of administration not reported) and TYPHIM Vi, Sanofi Pasteur (lot number, route and site of administration not reported). The subject experienced pericarditis acute, unspecified, at 22 days post-vaccination on 24 March 2011. The Troponin I result, ECG and Echocardiogram were not available. Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Biopsy skin abnormal, Extranodal marginal zone B-cell lymphoma (MALT type), Injection site erythema, Injection site nodule, Positron emission tomogram abnormal
Clinical narrative: Initially developed a red bump at injection site. The place never went away. Biopsy results showed B-cell Lymphoma. Later the lesion was totally excised.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Tumour excision
Clinical narrative: Initially developed a red bump at injection site. The place never went away. Biopsy results showed B-cell Lymphoma. Later the lesion was totally excised.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Biopsy skin abnormal, Extranodal marginal zone B-cell lymphoma (MALT type), Injection site erythema, Injection site mass, Positron emission tomogram abnormal
Clinical narrative: Initially developed a red bump at injection site. The place never went away. Biopsy results showed B-cell Lymphoma. Later the lesion was totally excised.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: B-cell lymphoma, Biopsy, Biopsy lymph gland abnormal, Flow cytometry, Injection site erythema
Clinical narrative: Initially developed a red bump at injection site. The place never went away. Biopsy results showed B-cell Lymphoma. Later the lesion was totally excised.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injection site swelling, Lesion excision, Positron emission tomogram
Clinical narrative: Initially developed a red bump at injection site. The place never went away. Biopsy results showed B-cell Lymphoma. Later the lesion was totally excised.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Patient received vaccine 6/7/13. She reported constant deep pain that runs down the length of her arms almost as bad as a badly restrained ligament.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Local swelling, Pain in extremity
Clinical narrative: Patient received vaccine 6/7/13. She reported constant deep pain that runs down the length of her arms almost as bad as a badly restrained ligament.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Pyrexia, Skin warm
Clinical narrative: Back of arm has egg size knot that is red and warm to touch. (Still present) fever of 99.9 for 2 days broke with TYLENOL.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Expired drug administered
Clinical narrative: Expired vaccine administered to patient.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Incorrect dose administered, Injection site erythema
Clinical narrative: Patient was given an accidental extra dose of VARIVAX on 6/27/13. It was discovered that she was given a PROQUAD and separate VZV when vaccine counts did not add up. Grandmother and CDC were called and she was advised to watch for increased reaction. She was seen on 6/28/13 for redness at injection site 2cm diameter. She was told to start KEFLEX (250/5) 4.5 ml PO TID x 10 days if persists after cool compress. She was to follow up 7/2/13 but canceled stating pt was better.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TD
Symptoms: Chest pain, Condition aggravated, Echocardiogram, Electrocardiogram, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 26 June 2013. A 28 year-old male subject whose past medical history included chest pain, shortness of breath and eczema was found to have other chest pain on the same day after the subject had received the following vaccines on 26 January 2011: an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Td, Adult absorbed vaccine (manufacturer, lot number, route and site of administration not reported). The Troponin I result, ECG and Echocardiogram were not available. Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Irritability, Occult blood positive, Pyrexia, Ultrasound abdomen normal
Clinical narrative: Within 12 hours of receiving vaccines (DTaP, IPV, PCV-13, ROTATEQ) pt developed fever to 102 and extreme irritability. Admitted to hospital for 4 days - explosive diarrhea and vomiting. Stools guaiac positive (for blood), concern for intussusception w/ ROTATEQ.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Within 12 hours of receiving vaccines (DTaP, IPV, PCV-13, ROTATEQ) pt developed fever to 102 and extreme irritability. Admitted to hospital for 4 days - explosive diarrhea and vomiting. Stools guaiac positive (for blood), concern for intussusception w/ ROTATEQ.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal pain
Clinical narrative: On 6/24/13 pt given Td injection (L) deltoid-next day noticed swelling at site along w/neck pain-onto back/shoulder. Pt seen here on 7/3/13 and still has warm to touch, tender swollen area at injection site.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Neck pain
Clinical narrative: On 6/24/13 pt given Td injection (L) deltoid-next day noticed swelling at site along w/neck pain-onto back/shoulder. Pt seen here on 7/3/13 and still has warm to touch, tender swollen area at injection site.
Age: 0.65
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Rash
Clinical narrative: Rash, possible contact dermatitis.
Age: 1.13
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC, VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction, Varicella virus test positive
Clinical narrative: Herpes zoster in very young 1 dose varicella vaccine recipient.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Immediate post-injection reaction, Unresponsive to stimuli
Clinical narrative: Administered 3 vaccines. After last injection which was HPV patient stated he was light headed. He immediately became unresponsive for 5-10 seconds. Patient was laid down on exam table during this time. After becoming responsive again the patient was given juice and crackers. These were tolerated. Physician and attending were notified. Patient was monitored in clinic.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Convulsion, Tremor
Clinical narrative: Pt had shaking of arms and head x 2 seconds. Pt has no recollection of the incident.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Polymerase chain reaction, Varicella virus test positive
Clinical narrative: Herpes zoster >42 days after receiving herpes zoster vaccine.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: ARM & SHOULDER PAIN, INABILITY TO USE MY ARM, MOBILITY RESTRICTED, PAIN INCREASED DAILY, SHARP BURNING STABBING PAIN IN MY SHOULDER, TRAVELING UP TO MY NECK DOWN TO MY HAND IN THE LEFT ARM WHERE THE INJECTION WAS GIVEN. I HAD CALLED MY DOCTOR AND REPORTED MY SYMPTOMS AND REQUESTED TO BE REFERRED TO PT FOR RELIEF OF THE PAIN.  SHE SUGGESTED I COME INTO THE OFFICE FOR HER TO EVALUATE.  I WAS UNABLE TO MAKE THE APPT. DUE TO A DEADLINE AT WORK, AND CONTINUED KEEPING IN TOUCH WITH HER DAILY TO REPORT MY SYMPTOMS.  I HAD FAMILY EMERGENCY AND HAD TO LEAVE TOWN ON JUNE 29TH AND WILL BE RETURNING JULY 13.  AT THAT TIME I WILL BE ABLE TO CONTINUE WITH TREATMENT & FURTHER TESTING.
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Bone pain, Insomnia, Middle insomnia, Vaccination site induration, Vaccination site nodule
Clinical narrative: First symptom, my bones in my lower arm felt like they were aching (vaccine site was upper arm).  Vaccine site swelled.  Swelling has gone down, but hard knot is still present and still have occassional "achy bone" feeling in the same arm (lower) 15 days after the vaccine was administered. May also be related - trouble sleeping, waking in the middle of the night (not normal).
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Vaccination site swelling
Clinical narrative: First symptom, my bones in my lower arm felt like they were aching (vaccine site was upper arm).  Vaccine site swelled.  Swelling has gone down, but hard knot is still present and still have occassional "achy bone" feeling in the same arm (lower) 15 days after the vaccine was administered. May also be related - trouble sleeping, waking in the middle of the night (not normal).
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: Headache, dizziness.
Age: 48.0
Sex: M
Vaccine: YF
Symptoms: Asthenia, Headache, Influenza like illness, Malaise, Pain
Clinical narrative: After the shot a few hours later I started feeling sick, later I developed aches and pain in my body, flu like symptoms, burns on my skin all over my body and head aches. Feeling weak.
Age: 48.0
Sex: M
Vaccine: YF
Symptoms: Skin burning sensation
Clinical narrative: After the shot a few hours later I started feeling sick, later I developed aches and pain in my body, flu like symptoms, burns on my skin all over my body and head aches. Feeling weak.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper arm reddened and swollen the next morning when this client woke up for the day.  Mom monitored arm throughout the day.  Mom monitored arm over the next couple days before she called me and reported the reaction.  Advised mom to take her to her provider.  Mom called me on 5/20/2013 and stated patient was seen by the doctor on 5/17/2013.  Doctor had no concerns other than it was a normal reaction to vaccinations per moms phone statement.
Age: 39.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Blood glucose, Electrocardiogram, Loss of consciousness, Syncope
Clinical narrative: Pt fainted post vaccine, had LOC for approx. 3 to 5 secs...
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Total upper arm redness, edema, warmth, soreness. IV Benadryl ordered for pt but has not yet been given at this time to evaluate response/recovery.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Patient developed a rash on both feet within 10 minutes of vaccine administration. Rash resolved 10 minutes later.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient received pneumococcal vaccine, spiked a temperature of 101.4 with swelling and pain at injection site.