chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (strength, dose, route, lot # were not reported). No Product Quality Complaint (PQC) was involved. This is one of the two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Concurrent or medical history were not reported. On 06-JAN-2015, the patient was vaccinated with ZOSTAVAX (dose, strength, route and lot number were not reported). Secondary suspects and concomitant therapies were not reported. Pharmacist reported that since the receipt of the vaccine, the patient had and at the time of report, complains of pain around the injection site, particularly when waking up in the morning. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients was vaccinated with improperly stored doses of PROQUAD (Merck) (strength, dose, route, lot # were not reported). No Product Quality Complaint (PQC) was involved. This is one of the two reports from the same source. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old male patient with no pertinent medical history nor drug reaction/allergies. On an unknown date in February 2015, reported as last week, the patient was vaccinated with ZOSTAVAX, subcutaneous. Dose, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. On an unknown date in February 2015, after vaccination with ZOSTAVAX the patient experienced chicken pox like rash all over his body. The pharmacist reported that the patient was seeing his primary care physician at the time of this report. The outcome of rash vesicular was reported as not recovered. No treatment was given for adverse events. No lab diagnostics studies were performed. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient of unknown gender. Nurse reported that on 13-FEB-2015, the patient was vaccinated with PROQUAD (Merck) (Lot number, dose and route not reported) and VARIVAX (Merck) (Lot number, dose and route not reported. No adverse effects were noted. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 49-year-old male patient who received ENGERIX B adult (batch number EA3Z2, expiry date 19th February 2017). Previously administered products included ENGERIX B (Dose 1). On 8th January 2015, the patient received the 2nd dose of ENGERIX B adult. On an unknown date, the dose was an unknown dose. On 8th January 2015, an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional information: HCP stated that this patient received the 1st dose of ENGERIX-B on 8/28/14. He presented to the pharmacy today (1/8/15) and received the 2nd dose of ENGERIX-B. Therefore, the product is not being given according to the recommended schedules in the product label.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) (route, dose, lot number and expiration date were not provided). Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 06-FEB-2015 the patient was vaccinated with a dose of MMR II 0.5 ml, subcutaneous, (lot # not reported) that had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from two registered nurses reporting together refers to an unspecified number of patients of unknown gender and age. The patients medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of PROQUAD (Merck), 0.5 ml dose, subcutaneous (dose number, lot/batch and expiration date were not reported) that underwent temperature excursions. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 16-FEB-2015 the patient was vaccinated with a dose of PROQUAD (Merck) (dose/frequency: 0.5 ml) subcutaneously that underwent temperature excursion. No adverse effect was reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-mont-old male patient who received KINRIX (batch number 54L2R, expiry date 23rd September 2016). On an unknown date, the patient received the 4th dose of KINRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: KINRIX was administered to 16month old child instead of just a DTaP vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 15-FEB-2015, unspecified number of patients were vaccinated with improperly stored doses of ZOSTAVAX, lot number reported as K021953, expiration date 10-FEB-2916. Dose and route were not reported. No co-suspect and concomitant therapies were reported. No adverse events reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 06-FEB-2015 the patient was vaccinated with a dose of GARDASIL 0.5 ml, intramuscular (lot # not reported) that had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (reported also as: healthcare worker) refers to 2 patients of unknown age and gender. Information regarding drug reactions or allergies and medical history was not reported. On an unknown date these two patients were inadvertently administered VAQTA (dose: 0.5 ml, intramuscular, lot#, expiration date were not reported) that had been improperly stored. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Limb discomfort
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient had none drug reactions/allergies. The patient's medical history included surgery for mitral valve repair. Concomitant therapies included CRESTOR and aspirin. The reporter stated that she received a dose of ZOSTAVAX (lot # J011882, exp. date: 04-JAN-2015, strength, dose not reported) to prevent shingles, on an unspecified date in an unspecified arm, that "may had been" administered via the intramuscular route instead of via the subcutaneous route. The reporter stated "a couple days after she got the shot her arm became sore at the injection site which developed into her entire arm feeling heavy like someone had punched me". There was no treatment of the events. No lab diagnostics performed. The reporter did not seek medical attention. The reporter stated "the soreness lasted about 3 weeks then just went away". The relatedness between events and ZOSTAVAX was not proved. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 2 year old patient. Medical history and drug reactions or allergies were not reported. On 04-FEB-2015 the patient was vaccinated an expired dose of PNEUMOVAX 23 (lot # J013345 expiration date 11-JAN-2015). Concomitant therapy was not reported. No adverse experience reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test, Culture wound, Haemorrhage, Molluscum contagiosum, Rash
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) refers to a 14 year old male patient. The patient's concurrent conditions included eczema and asthma. The patient did not have any drug allergies. On 22-OCT-2014, the patient was vaccinated with GARDASIL dose 1, intramuscular. (lot number was not reported). There was no concomitant medications reported. On an unknown date in November 2014 the patient was diagnosed with molloscom. The reporter stated that her son developed rash in November 2014. The patient had sought medical attention by consulting a dermatologist and a pediatric eczema specialist. The patient was treated with prednisone for the event. A wound culture, blood and skin testing were done on unspecified dates and the results were not provided. The patient received the second dose of vaccination on 22-DEC-2014. The rash got really bad by itching and bleeding and it had spread to the child's torso and extremities on 30-DEC-2014. There was no product  quality complaint involved. The outcome of molloscom was reported as recovering at the time of the report. The causality of the event was not reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Rash pruritic, Skin test
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) refers to a 14 year old male patient. The patient's concurrent conditions included eczema and asthma. The patient did not have any drug allergies. On 22-OCT-2014, the patient was vaccinated with GARDASIL dose 1, intramuscular. (lot number was not reported). There was no concomitant medications reported. On an unknown date in November 2014 the patient was diagnosed with molloscom. The reporter stated that her son developed rash in November 2014. The patient had sought medical attention by consulting a dermatologist and a pediatric eczema specialist. The patient was treated with prednisone for the event. A wound culture, blood and skin testing were done on unspecified dates and the results were not provided. The patient received the second dose of vaccination on 22-DEC-2014. The rash got really bad by itching and bleeding and it had spread to the child's torso and extremities on 30-DEC-2014. There was no product  quality complaint involved. The outcome of molloscom was reported as recovering at the time of the report. The causality of the event was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR
Symptoms: Cough, Haematocrit normal, Haemoglobin normal, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 54 week old female patient. Patient's concurrent conditions included Down's syndrome. On 06-JAN-2015, the patient was vaccinated with M-M-R II (0.5 ml) (lot number: K008202 with expiry date of 05-JUN-2016), subcutaneously. Concomitant medications were not reported. On 20-JAN-2015, the patient was diagnosed with measles. No treatment was given for the adverse event. The patient sought medical attention by visiting physician. The outcome of the events was unknown. The causality of the events with M-M-R II was not reported. Product quality issue was not involved. This case is linked to #1502USA007977 via same reporter link. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR
Symptoms: Rhinorrhoea, White blood cell count increased
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 54 week old female patient. Patient's concurrent conditions included Down's syndrome. On 06-JAN-2015, the patient was vaccinated with M-M-R II (0.5 ml) (lot number: K008202 with expiry date of 05-JUN-2016), subcutaneously. Concomitant medications were not reported. On 20-JAN-2015, the patient was diagnosed with measles. No treatment was given for the adverse event. The patient sought medical attention by visiting physician. The outcome of the events was unknown. The causality of the events with M-M-R II was not reported. Product quality issue was not involved. This case is linked to #1502USA007977 via same reporter link. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR
Symptoms: Measles post vaccine
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 54 week old female patient. Patient's concurrent conditions included Down's syndrome. On 06-JAN-2015, the patient was vaccinated with M-M-R II (0.5 ml) (lot number: K008202 with expiry date of 05-JUN-2016), subcutaneously. Concomitant medications were not reported. On 20-JAN-2015, the patient was diagnosed with measles. No treatment was given for the adverse event. The patient sought medical attention by visiting physician. The outcome of the events was unknown. The causality of the events with M-M-R II was not reported. Product quality issue was not involved. This case is linked to #1502USA007977 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a pediatric patient who was under 18 years of age. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (albumin status, lot#, dose, route and site of administration were not reported) according to the prescribing information. Concomitant medications were not reported. On an unknown date, the patient experienced really bad rash on the cheek. The outcome of event was unknown. The relatedness between the event and M-M-R II was not reported. Additional information is not expected, there was no consent to contact the physician.
Sex: U
Vaccine: MMR
Symptoms: Pyrexia, Regressive behaviour
Clinical narrative: This spontaneous report was received from a consumer concerning some patients (demographics unknown). On an unknown date the patients were vaccinated with a dose of M-M-R II (dose, route and lot# not provided). On an unknown date, the patients experienced regressive behavior reported as "regression" and fever. At the time of the report, the outcome of the patients was unknown. Additional information is not expected because the reporter declined to provide further information.
Age: 15.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Pharyngeal oedema, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This pt is from another country and no shot record is available. On 2/18/15 mother reported that the day after the child received vaccines on 9/24/14 she broke out in a "red raised itchy rash head to toe and had swelling in her throat". She denied fever or other symptoms. The rash lasted one week. They did not seek medical attention.
Sex: U
Vaccine: DTAPHEPBIP, HEP, HEPA
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received HAVRIX. Co-suspect products included PEDIARIX and ENGERIX. On an unknown date, the patient received HAVRIX at an unknown dose, PEDIARIX at an unknown dose and ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX, PEDIARIX and ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Up to 45 patients may have been vaccinated with vaccine stored outside data limits.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 13-FEB-2015, unspecified number of patients were vaccinated with improperly stored ZOSTAVAX. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. No adverse events reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction. Pt was administered a Zoster vaccine instead of a PROQUAD.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 14-FEB-2015, unspecified number of patients were vaccinated with improperly stored doses of ZOSTAVAX lot number reported as K021953, expiration date 10-FEB-2016. Dose and route were not reported. No co-suspect and concomitant therapies were reported. No adverse events reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Abasia, Inability to crawl
Clinical narrative: Wouldn't walk/crawl that occured approx. 5 hours after immun.
Age: 1.33
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received 1 yr vaccines on 01-15-15. On back of (R) arm there is noted redness and a "bump". This RN did not see child, mom sent me pictures. Advised to go to primary dr to get it looked at. Went to dr. Thought maybe reaction to filler. Gave low dose BENADRYL every morning for a week as reported by mom.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. In approximately 2012 (reported that at the time of the report "it had been two and a half years since the first vaccination"), the patient was vaccinated intramuscularly with the first dose of GARDASIL (0.5ml, lot# and expiration date were not reported). On 17-FEB-2015 (reported as "today") the patient was in the office for the second dose of GARDASIL (0.5ml, intramuscular, lot# and expiration date were not reported). Information about concomitant medication was not reported. No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Injection site erythema, Injection site joint pain, Injection site swelling
Clinical narrative: Day 2-swelling at injection site, and redness. Day 3-+ shoulder joint pain (left). Day 4-+ shoulder joint pain (right). Day 5-+ wrist and thumb joint pain (left). Day 7-+shingles on lower back, severe itching.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Day 2-swelling at injection site, and redness. Day 3-+ shoulder joint pain (left). Day 4-+ shoulder joint pain (right). Day 5-+ wrist and thumb joint pain (left). Day 7-+shingles on lower back, severe itching.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 29-AUG-2014, the patient was vaccinated with the first dose of VAQTA, intramuscularly (lot number and dose not reported) and RECOMBIVAX HB (lot number, dose and route not reported). In approximately September 2014, the patient received the second dose of RECOMBIVAX HB on schedule. On 06-FEB-2015, to complete the series, the patient was inadvertently administered the second dose of VAQTA intramuscularly (lot number and dose not reported) and the third dose of RECOMBIVAX HB (lot number, dose and route not reported) which she stated was to soon for both products. No adverse effects were reported. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Hypersomnia, Injection site swelling
Clinical narrative: This spontaneous report as received from a 82 year old female consumer refers to herself. Patient medical history and current condition was not reported. On 16-FEB-2015 the patient was vaccinated with the second dose of PNEUMOVAX 23 (Lot number and expiry date not provided). Other co-suspects and concomitant medication was not reported. On an unknown date the patient experienced injection site swelling, weakness, tiredness and also reported that she had been sleeping a lot after receiving PNEUMOVAX 23. The patient reported that, she did not have any adverse effects after receiving the first dose of PNEUMOVAX 23. Product quality complaint was not reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (route, dose, lot number and expiration date were not provided). Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: HEPA, IPV, TYP
Symptoms: Rash
Clinical narrative: 9-3-14 pt call to report body rash (chest, abdomen, lower neck, groin) started after taking last VIVOTIF (oral typhoid) pill aprox 8-12-14. Traveled to another country on 8/18/14. Saw pharmacist who gave her creams to apply. Creams were not helpful. No itching. Denied respiratory issues. Rash is fading on 9/3/14 day of this call. Advised to see PCP or same day sick clinic for evaluation of rash.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Pallor, Tinnitus
Clinical narrative: Patient became dizzy, pale, and complained of ringing in both ears about 10 min after receiving vaccines. Symptoms subsided about 10 min after onset. Patient was observed for 20 minute.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Below injection site patient developed pain, erythema, swelling, itching, area confluent.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Loss of consciousness
Clinical narrative: Within 30 seconds of receiving ENGERIX B 20mcg/mL patient passed out for about 5-10 seconds. He regained consciousness, VSS. 911 called. Pt observed. Pt has h/o needle phobia.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis, Lymphadenopathy
Clinical narrative: (L) upper thigh cellulitis. (L) inguinal lymphadenopathy, Warm soaks. Tx cephalexin 250mg/5 ml x 10 days.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. Pertinent medical history was unknown. On 31-MAY-2013 the patient was vaccinated with initial dose of VAQTA (intramuscular dose, anatomical location and lot number was unknown) and the reporting physician was intended to administer the second dose of VAQTA on 16-FEB-2015, which was greater than 18 months after the initial dose (inappropriate schedule of drug administration). Concomitant medications were unspecified by reporter. The reporter also reported that she intended to use two pediatric 0.5 ml doses to equal one adult 1.0 ml dose. The patient was in the office on unspecified date but the healthcare worker did not administer any doses to the patient. No adverse effect reported. The outcome of the event was unknown. No additional information reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient developed a rash on his back after receiving a ZOSTAVAX shot on 02-10-15. Patient called seeking relief for itching from rash on 2-17-15 and picked up the recommended Aveeno Bath, lotion and BENADRYL. Patent was also advised to seek medical care. Follow up call was given that night 02-18-15. Pt said he will seek medical care if no improvement when he can at end of the week.
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Eyelid rash, Urticaria
Clinical narrative: Rash and hives to (R) eye, face and back and upper torso. Treated with MEDROL dose pack, BENADRYL and ZYRTEC. Denies respiratory issues.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: See attached
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Patient called the next day complaining from a sore arm, she said she had a large whelp on her arm, she said if she doesn't get better she is going to see the dr., she goes to the urgent care a couple of days later.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Heart rate decreased, Hypotension
Clinical narrative: Patient became light headed and developed a headache. Was observed for about 2 hours, given fluid, juice, crackers, and banana. Then went home. She had low blood pressure and heart rate.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and  gender. On 06-FEB-2015 the patient was vaccinated with a dose of M-M-R II 0.5 ml, subcutaneous, (lot # not reported) that had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from two registered nurses reporting together refers to an unspecified number of patients of unknown gender and age. The patients medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of VARIVAX 0.5 ml, subcutaneous (dose number, lot/batch number and expiration date were not reported) that underwent temperature excursions. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Left upper arm- mild redness, tenderness at injection site. Pt noticed area 1 day ago.
Age: 13.0
Sex: M
Vaccine: HEPA, MMR, MNQ, TDAP
Symptoms: Blood immunoglobulin M, Decreased appetite, Headache, Measles, Photophobia
Clinical narrative: Rash over face and arms intiailly reported-progressed to include Koplik spots, light sensitivity, no fever 2/4/14-headache, loss of appetite.
Age: 13.0
Sex: M
Vaccine: HEPA, MMR, MNQ, TDAP
Symptoms: Polymerase chain reaction, Rash
Clinical narrative: Rash over face and arms intiailly reported-progressed to include Koplik spots, light sensitivity, no fever 2/4/14-headache, loss of appetite.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: Pt did not sustain any injury or trauma.
Age: 35.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Asthma, Condition aggravated, Local swelling
Clinical narrative: Localized swelling. Increased asthma symptoms.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Mild varicella from Grandmother's shingles. Had 2 doses of VARIVAX.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Injection site induration
Clinical narrative: 9cm indurated area at injection site that patient first noticed on 2-14-15. Also reports diarrhea. Seen in office on 2-17-15. Treated with topical steroid cream and oral antihistamines.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to a female patient (11-12 years old). In 2014 the patient was vaccinated with GARDASIL (dose, strength, site and route of administration not reported). After receiving the GARDASIL the patient fainted and fell forward after the observation period. It was not confirmed during if the patient was given any medical treatment for this adverse event. The outcome of the events was not provided. The relatedness between events and GARDASIL was not reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Measles post vaccine, Rash generalised
Clinical narrative: This spontaneous report as received from a pharmacist refers to a adult male patient of unknown age. Patients concurrent conditions and relevant medical history was not reported. On an unknown date 15-20 years ago, the patient was vaccinated with M-M-R II (dose, frequency, route and lot number unspecified). Concomitant medications were not reported. On an unknown date the patient went to the hospital and the staff at the hospital believed that the patient had broken out in measles because the patient has spots all over the body. No treatment was given for the adverse event. The patient was not admitted to the hospital. The outcome of the event was unknown. The causality of the event with MMR was not reported. Product quality issue was not reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Silver dollar sized raised area on (L) arm posterior to deltoid. Described as low class reaction per APN. Treating with hydrocortisone cream and ATARAX for itch.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: After immunization was given child fainted. She regained consciousness immediately.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Pt broke out on stomach and back with hives on 1-3-15. 1-4-15, broke out with hives on entire body. Mom gave BENADRYL and on 1-7-15 was still broke out with hives.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site papule, Tenderness
Clinical narrative: Approximately 3 cm erythema papular eruption at site, with localized tenderness. Observation only.
Age: 44.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Approx 8 cm erythema, swelling, warmth started within 2 hours. Resolving after 2 weeks. Rx with OTC antihistamine.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pain, redness, swelling (R) arm. Patient taking ALLEGRA, IBU, and using ice packs.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site swelling, Myalgia
Clinical narrative: Redness, muscle pain, swelling bilateral thighs - more swelling in (L).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Gingival blister, Pruritus generalised
Clinical narrative: Evening of shot, itching all over starting lower leg and moving up the body-had to take dentures out-blisters on gums.
Age: 18.0
Sex: M
Vaccine: HPV4, HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient did not experience any adverse reactions and did not require any treatment relating to the event. The time elapsed between the first and second dose is 8 weeks and 5 days, however the time interval between the second and third injections is 9 weeks and 6 days and the interval between the first and third injections is 18 weeks and 4 days; this timeframe is less that the minimum required for this series of injections. The patient has not experienced any adverse effects related to the early administration of the third and final of the GARDASIL vaccine. There has been clear re-education with clinical staff as to the required immunization schedule and the importance of strictly adhering to it, as well as following the correct administration protocol. The CDC was contacted to confirm the patient's need for an additional GARDASIL immunization as the third injection was prior to the minimum interval. The patient patent was contacted, made aware of the situation, and informed that he would need an appointment so that the vaccine could be administered. He indicated he would discuss it with his mother and he would call back to schedule that appointment. If you have any questions regarding this situation please contact our office.
Age: 18.0
Sex: M
Vaccine: HPV4, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Patient did not experience any adverse reactions and did not require any treatment relating to the event. The time elapsed between the first and second dose is 8 weeks and 5 days, however the time interval between the second and third injections is 9 weeks and 6 days and the interval between the first and third injections is 18 weeks and 4 days; this timeframe is less that the minimum required for this series of injections. The patient has not experienced any adverse effects related to the early administration of the third and final of the GARDASIL vaccine. There has been clear re-education with clinical staff as to the required immunization schedule and the importance of strictly adhering to it, as well as following the correct administration protocol. The CDC was contacted to confirm the patient's need for an additional GARDASIL immunization as the third injection was prior to the minimum interval. The patient patent was contacted, made aware of the situation, and informed that he would need an appointment so that the vaccine could be administered. He indicated he would discuss it with his mother and he would call back to schedule that appointment. If you have any questions regarding this situation please contact our office.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: GARDASIL 0.5 ml lot K008213 was administered on 02/04/15 to left deltoid. Mom called 02/09/15 to report his left arm became red, swollen and warm to touch at site of injection and spread quickly down his arm. She gave him BENADRYL on 2/4/15 and he was better. He's had BENADRYL over weekend.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness, swelling on bicep area of arm.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Diarrhoea, Influenza like illness, Myalgia, Vomiting
Clinical narrative: Woke up Monday AM with serious muscle and joint pain. By brkfst threw up then again around 1:00 PM. Diarrhea thru out day and flu like symptoms. Fine next day.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Pruritus, Swelling
Clinical narrative: Erythema Multiform and swelling, pruiritus
Age: 1.26
Sex: F
Vaccine: MMRV
Symptoms: Crying, Diarrhoea, Eating disorder, Irritability, Listless
Clinical narrative: Normal vaccine administration, that afternoon patient became very fussy and irritable. Irritability and frequent crying every day since vaccine. Not eating well, listless. Fever up to 101.6. Some loose stools. Measles-like rash on trunk, neck, and face. Will continue acetaminophen or ibuprofen and watch.
Age: 1.26
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Normal vaccine administration, that afternoon patient became very fussy and irritable. Irritability and frequent crying every day since vaccine. Not eating well, listless. Fever up to 101.6. Some loose stools. Measles-like rash on trunk, neck, and face. Will continue acetaminophen or ibuprofen and watch.
Age: 23.0
Sex: F
Vaccine: FLUX, HEPAB, YF
Symptoms: Anaphylactic reaction
Clinical narrative: Initial report received from a literature on 07 February 2015 and follow-up information received on 10 February 2015. This case is linked to case numbers 2015SA017232 and 2015SA017289 (same literature). Abstract: Background: Trivalent live attenuated influenza vaccine (LAIV3) was licensed and recommended for use in 2003 in children and adults 2-49 years of age. Post-licensure safety data have been limited, particularly in adults. Methods: We searched Vaccine Adverse Event Reporting System (VAERS) for reports after LAIV3 from July 1, 2005-June 30, 2013 (eight influenza seasons) in adults aged 18 years old. We conducted descriptive analyses and clinically reviewed serious reports (i.e., death, life-threatening illness, hospitalization, prolonged hospitalization, or permanent disability) and reports of selected conditions of interest. We used empirical Bayesian data mining to identify adverse events (AEs) that were reported more frequently than expected. We calculated crude AE reporting rates to VAERS by influenza season. Results: During the study period, VAERS received 1207 LAIV3 reports in adults aged 18-49 years old; 107 (8.9%) were serious, including four death reports. The most commonly reported events were expired drug administered (n = 207, 17%), headache (n = 192, 16%), and fever (n = 133, 11%). The most common diagnostic categories for non-fatal serious reports were neurological (n = 40, 39%), cardiovascular (n = 14, 14%), and other non-infectious conditions (n = 20, 19%). We noted a higher proportion of Guillain-Barre syndrome (GBS) and cardiovascular reports in a specific population compared to the general population. Data mining detected disproportional reporting of ataxia (n = 15); clinical review revealed that ataxia was a component of diverse clinical entities including GBS. Conclusions: Review of VAERS reports are reassuring, the only unexpected safety concern for LAIV3 identified was a higher than expected number of GBS reports in a specific population, which is being investigated. Reports of administration of expired LAIV3 represent administration errors and indicate the need for education, training and screening regarding the approved indications. The aforementioned information retrieved from full text article. A 23-year-old female presented anaphylaxis within 20 minutes after receiving LAIV3, Yellow Fever, and Hepatitis AB. The diagnosis was verified through medical record review. The case was determined to be Brighton Level 1 anaphylaxis. On an unspecified date, the patient had recovered. List of documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: FLUX, HPVX, MEN
Symptoms: Death, Laboratory test, Microscopy, Toxicologic test
Clinical narrative: Initial report received from a literature on 07 February 2015 and follow-up information received on 10 February 2015. This case is linked to case numbers 2015SA017276 and 2015SA017289 (same literature). Abstract: Background: Trivalent live attenuated influenza vaccine (LAIV3) was licensed and recommended for use in 2003 in children and adults 2-49 years of age. Post-licensure safety data have been limited, particularly in adults. Methods: We searched Vaccine Adverse Event Reporting System (VAERS) for reports after LAIV3 from July 1, 2005-June 30, 2013 (eight influenza seasons) in adults aged 18 years old. We conducted descriptive analyses and clinically reviewed serious reports (i.e., death, life-threatening illness, hospitalization, prolonged hospitalization, or permanent disability) and reports of selected conditions of interest. We used empirical Bayesian data mining to identify adverse events (AEs) that were reported more frequently than expected. We calculated crude AE reporting rates to VAERS by influenza season. Results: During the study period, VAERS received 1207 LAIV3 reports in adults aged 18-49 years old; 107 (8.9%) were serious, including four death reports. The most commonly reported events were expired drug administered (n = 207, 17%), headache (n = 192, 16%), and fever (n = 133, 11%). The most common diagnostic categories for non-fatal serious reports were neurological (n = 40, 39%), cardiovascular (n = 14, 14%), and other non-infectious conditions (n = 20, 19%). We noted a higher proportion of Guillain-Barre syndrome (GBS) and cardiovascular reports in a specific population compared to the general population. Data mining detected disproportional reporting of ataxia (n = 15); clinical review revealed that ataxia was a component of diverse clinical entities including GBS. Conclusions: Review of VAERS reports are reassuring, the only unexpected safety concern for LAIV3 identified was a higher than expected number of GBS reports in a specific population, which is being investigated. Reports of administration of expired LAIV3 represent administration errors and indicate the need for education, training and screening regarding the approved indications. The aforementioned information retrieved from full text article. A 19-year-old female died 10 days after receiving LAIV3, quadrivalent human papillomavirus, and meningococcal conjugate vaccines. Despite an extensive post-mortem examination including microscopic, neuropathological, toxicological, and chemical evaluation, the cause of death could not be ascertained. List of documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: FLUX, IPV, TYP, YF
Symptoms: Anaphylactic reaction
Clinical narrative: Initial report received from a literature on 07 February 2015 and follow-up information received on 10 February 2015. This case is linked to case numbers 2015SA017232, 2015SA017271 and 2015SA017276 (same literature). Abstract: Background: Trivalent live attenuated influenza vaccine (LAIV3) was licensed and recommended for use in 2003 in children and adults 2-49 years of age. Post-licensure safety data have been limited, particularly in adults. Methods: We searched Vaccine Adverse Event Reporting System (VAERS) for reports after LAIV3 from July 1, 2005-June 30, 2013 (eight influenza seasons) in adults aged 18 years old. We conducted descriptive analyses and clinically reviewed serious reports (i.e., death, life-threatening illness, hospitalization, prolonged hospitalization, or permanent disability) and reports of selected conditions of interest. We used empirical Bayesian data mining to identify adverse events (AEs) that were reported more frequently than expected. We calculated crude AE reporting rates to VAERS by influenza season. Results: During the study period, VAERS received 1207 LAIV3 reports in adults aged 18-49 years old; 107 (8.9%) were serious, including four death reports. The most commonly reported events were expired drug administered (n = 207, 17%), headache (n = 192, 16%), and fever (n = 133, 11%). The most common diagnostic categories for non-fatal serious reports were neurological (n = 40, 39%), cardiovascular (n = 14, 14%), and other non-infectious conditions (n = 20, 19%). We noted a higher proportion of Guillain-Barre syndrome (GBS) and cardiovascular reports in a specific population compared to the general population. Data mining detected disproportional reporting of ataxia (n = 15); clinical review revealed that ataxia was a component of diverse clinical entities including GBS. Conclusions: Review of VAERS reports are reassuring, the only unexpected safety concern for LAIV3 identified was a higher than expected number of GBS reports in a specific population, which is being investigated. Reports of administration of expired LAIV3 represent administration errors and indicate the need for education, training and screening regarding the approved indications. The aforementioned information retrieved from full text article. A 18-year-old male presented anaphylaxis within minutes after receiving LAIV3, yellow fever vaccine, poliomyelitis vaccine (inactivated), and typhoid vaccines. The diagnosis was verified through medical record review. The case was determined to be Brighton Level 1 anaphylaxis. On an unspecified date, the patient had recovered. List of documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported erythema, injection site soreness, inflammation, itching and swelling in her right deltoid.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature, Erythema, Headache, Injection site mass, Pruritus
Clinical narrative: Redness, swelling, itching, temp, headache; more severe than led to believe by brochure. Redness covered from above shoulder to 3/4s of way to elbow and full side-to-side involvement.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling, Vaccination site swelling
Clinical narrative: Redness, swelling, itching, temp, headache; more severe than led to believe by brochure. Redness covered from above shoulder to 3/4s of way to elbow and full side-to-side involvement.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reddened, swollen, warm to touch, tender to touch, bruising. Advised to keep area covered, take Tylenol as needed for discomfort, follow up with PCP.
Age: 44.0
Sex: M
Vaccine: FLUC3, PPV
Symptoms: Injection site bruising, Injection site reaction, Injection site swelling, Skin discolouration
Clinical narrative: Left shoulder/arm swelling, mottled, bruising, neurovascular intact.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enema administration, Intussusception, Ultrasound abdomen
Clinical narrative: 2/10/2015 Intussusception. Air contrast enema x3 required for tx.
Age: 0.15
Sex: M
Vaccine: PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Vaccine was not administered as prescribed as Facility ran out. Resulting in a delay in care.