chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Rash
Clinical narrative: Mother states, "I had to take child to ER on 9/14/16, child had rash and itching on face and legs". Pt was prescribed BENADRYL 12.5 mg/5ml oral exlixir 25mg. Mother follow/up with Provider on 9/20/16.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Pain in extremity, Pyrexia, Tremor
Clinical narrative: On way home from flu clinic, patient experienced pain in left leg. After arriving home pt had episode of shaking, felt cold, perhaps fever. The next day she slept most of day. Did not seek medical tx or take temp. The following day she was back to normal.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Pain in extremity
Clinical narrative: Patient experienced sore arm for 1-2 days after vaccine-she accidentally received the high dose vaccine instead of the regular as indicated for her age.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Body temperature increased, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Warm, swollen, redness down to elbow, - moderate painful.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: White blood cell count normal
Clinical narrative: Warm, swollen, redness down to elbow, - moderate painful.
Age: 56.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site reaction
Clinical narrative: Intense injection site reaction.
Age: 78.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Full blood count normal, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Area red, slight edema below injection site on Lt arm from where Tdap vaccine was given - tender to touch.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 35 year old female patient who is not pregnant. The patient's pertinent history included diabetes mellitus and had a lot of allergies. On an unknown date the patient was vaccinated with PNEUMOVAX 23, single 0.5 ml dose, subcutaneously. On 26-SEP-2016, after receiving PNEUMOVAX 23 patient experienced a lot of swelling and pain around the injection site. The patient sought medical attention by visiting a pharmacy. On an unknown date in September 2016, the patient recovered/resolved from the events. The reporter did not provided the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 55 years old female patient with hypercholesterolaemia and osteoporosis. The patient had a medical history of "eye infection". The patient had none known allergies. Concomitant therapy included pravastatin. On 25-SEP-2016, the patient was vaccinated with ZOSTAVAX (strength, dose and frequency were unknown, lot # L046893, expiration date 23-FEB-2017) subcutaneously. Subsequently on an unknown date in September 2016, the patient received treatment with PROLIA for an unspecified diagnosis. No further information provided. The causal relationship between the adverse event and ZOSTAVAX was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Chlamydia test, Exposure during pregnancy, HIV test, Micturition urgency
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse referring to an 18 year old female patient. The patient did not have pertinent medical history, drug reactions or allergies. On 28-APR-2011, on 21-MAY-2015 and on 28-SEP-2016, the patient was vaccinated with the first, second and third dose of GARDASIL 9 respectively (lot number and expiration date were unknown, except for the third dose given on 28-SEP-2016, which had the lot number of M011840, expiration date 01-FEB-2018), intramuscular route. The patient did not have concomitant medication. The patient became pregnant with last menstrual period (LMP) of 10-SEP-2016 and estimate date of delivery (EDD) of 17-JUN-2017. The initial exposure to GARDASIL 9 was at 2 weeks. The nurse reported that in approximately September 2026 (reported as "about a week ago"), the patient made an appointment to go into the office because she was experiencing "vaginal itching, urinary frequency and urinary urgency". The patient went to her scheduled appointment on 28-SEP-2016, and while the patient was in the office the health care professional performed an urinalysis, "Testing for Sexually Transmitted Diseases (STD) blood work testing" for Gonorrhea, human immunodeficiency virus (HIV), syphilis, and chlamydia, and a pregnancy test. She also receive the third dose of GARDASIL 9 to complete the series. After the GARDASIL 9 was administered the nurse reported that she discovered that the pregnancy test was positive. Additionally, it was also reported that when the patient went to the office, the urinary frequency and urinary urgency were recovered on an unknown date in September 2016. However, the patient was still experiencing vaginal itching and it was unknown if the patient recovered from the vaginal itching. The patient received treatment for the adverse events with Clotrimazole 1% cream. The pregnancy outcome was outcome pending. The causality assessment between the events and therapy with GARDASIL 9 was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Pollakiuria, Pregnancy test positive, Treponema test, Urine analysis, Vulvovaginal pruritus
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse referring to an 18 year old female patient. The patient did not have pertinent medical history, drug reactions or allergies. On 28-APR-2011, on 21-MAY-2015 and on 28-SEP-2016, the patient was vaccinated with the first, second and third dose of GARDASIL 9 respectively (lot number and expiration date were unknown, except for the third dose given on 28-SEP-2016, which had the lot number of M011840, expiration date 01-FEB-2018), intramuscular route. The patient did not have concomitant medication. The patient became pregnant with last menstrual period (LMP) of 10-SEP-2016 and estimate date of delivery (EDD) of 17-JUN-2017. The initial exposure to GARDASIL 9 was at 2 weeks. The nurse reported that in approximately September 2026 (reported as "about a week ago"), the patient made an appointment to go into the office because she was experiencing "vaginal itching, urinary frequency and urinary urgency". The patient went to her scheduled appointment on 28-SEP-2016, and while the patient was in the office the health care professional performed an urinalysis, "Testing for Sexually Transmitted Diseases (STD) blood work testing" for Gonorrhea, human immunodeficiency virus (HIV), syphilis, and chlamydia, and a pregnancy test. She also receive the third dose of GARDASIL 9 to complete the series. After the GARDASIL 9 was administered the nurse reported that she discovered that the pregnancy test was positive. Additionally, it was also reported that when the patient went to the office, the urinary frequency and urinary urgency were recovered on an unknown date in September 2016. However, the patient was still experiencing vaginal itching and it was unknown if the patient recovered from the vaginal itching. The patient received treatment for the adverse events with Clotrimazole 1% cream. The pregnancy outcome was outcome pending. The causality assessment between the events and therapy with GARDASIL 9 was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of an unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 10-JUN-2016, the patient was vaccinated subcutaneously with an expired dose of M-M-R II (lot # M001200, expiration date: 28-AUG-2016, dose was not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. 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 nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not provided. On 02-DEC-2015, the patient was vaccinated with improperly stored dose of M-M-R-II therapy type unknown (dose, frequency, route of administration and indication were not reported, lot # L001336 with expiration date: 13-JAN-2017). Concomitant medications were not reported. No adverse events were reported. The administered dose was stored in 47 F for 8 hours.There was no previous temperature excursions. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a radiologic technologist refers to an unspecified number of patient's of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unspecified dates, the unspecified number of patient's were vaccinated with improperly stored doses of PEDVAXHIB (lot# M025193 and expiry date unknown) (dosage regimen was unknown). No adverse effect reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a radiologic technologist refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unspecified dates, the unspecified number of patients were vaccinated with improperly stored doses (incorrect product storage) of GARDASIL 9 (lot# L036301 and expiry date unknown) (dosage regimen was unknown). No adverse effect reported. No product quality complaint was filed. 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 was received from a medical assistant and refers to nine unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX lot # M009766 with an expiration date: 23-FEB-2018, subcutaneously (dose and frequency were not reported). Administered dose of VARIVAX experienced temperature excursion of 6.2 degree Fahrenheit for 14 hours 28 minutes, on 02-AUG-2016; 6.2 degree Fahrenheit for 13 hours and 45 minutes on 05-AUG-2016; 6.2 degree Fahrenheit for 14 hours and 10 minutes on 11-AUG-2016, 6.2 degree Fahrenheit for 13 hours and 59 minutes on 22-AUG-2016, 6.2 degree Fahrenheit for 61 hours and 50 minutes on 29-AUG-2016. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Radiologic Technologist refers to a unspecified number of patient's of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unspecified dates, the unspecified number of patient's were vaccinated with improperly stored doses of M-M-R II therapy type rHA (lot# M004305 and expiry date unknown) (dosage regimen was unknown). No adverse effect reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 10-JUN-2015, the patient received her first dose of GARDASIL 9 (lot# reported as K023432, expiry date 18-JUN-2016), her second dose of vaccine (lot# M003659, expiry date 20-SEP-2017) was administered later than recommended on 10-JUN-2016 and the third dose of GARDASIL 9 (lot# M011840, expiry date 01-FEB-2018) was administered earlier than recommended on 16-AUG-2016 (doses and routes of administrations were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding multiple unspecified patients. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored PROQUAD (dose and route were not reported) Lot# L040413 and expiry date: 13-APR-2016. No adverse effects were reported. No additional information was provided and there was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M007762 with expiration date 07-DEC-2018; lot # L051124 with expiration date 14-OCT-2018; dose and route were not reported). The vaccine was improperly stored at 32 Fahrenheit for 41 minutes. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # M013636, expiration date 15-FEB-2018, intramuscular). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unspecified dates, on schedules outside of the recommended schedule, the unspecified number of patients were vaccinated with an unspecified number of doses of GARDASIL 9 (lot, expiration date and dosing regimen were unknown). No adverse effects have been reported. No product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 28-SEP-2016, the patient was vaccinated with GARDASIL 9 (dose: 0.5 ml, lot and expiration date unspecified) (inappropriate schedule of drug administration). Reporting nurse mentioned that the patient received first and second dose of GARDASIL on 16-MAR-2016 and 23-MAY-2016, respectively. No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Hypoaesthesia, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 18 y/o male recruit with c/o posterior L arm redness and soreness X 3 days with suspected MOI of adverse reaction to SUB-Q immunizations which were given 4 days ago. Reports day following immunizations he woke up with pain in arm and this is when he first observed redness. Pain is currently 3/10 and is localized specifically to site of immunization. Was last seem by medical yesterday and given Rx BENADRYL and TYLENOL which have significantly improved s/sx and pain (5/10 yesterday). Reported numbness and tingling yesterday however these s/sx have improved. Denies fevers, chills, night sweats, NVD, constipation, dyspnea/SOB, cold s/sx, chest pain, dyspnea, or neck pain/stiffness. Member is otherwise asymptomatic and has no further medical complaints or concerns at this time. Exam Findings: Golf ball sized tender area of induration localized to L tricep with erythema directly over but no warmth to touch. Otherwise no significant findings on exam. Contact clinic and confirmed that pt was given SUBQ Varicella in L arm. Suspect adverse reaction to this immunization. Skin rash. Diphenhydramine 50 mg QID, Acetaminophen 1000 mg QID.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Pain in extremity, Paraesthesia, Rash
Clinical narrative: 18 y/o male recruit with c/o posterior L arm redness and soreness X 3 days with suspected MOI of adverse reaction to SUB-Q immunizations which were given 4 days ago. Reports day following immunizations he woke up with pain in arm and this is when he first observed redness. Pain is currently 3/10 and is localized specifically to site of immunization. Was last seem by medical yesterday and given Rx BENADRYL and TYLENOL which have significantly improved s/sx and pain (5/10 yesterday). Reported numbness and tingling yesterday however these s/sx have improved. Denies fevers, chills, night sweats, NVD, constipation, dyspnea/SOB, cold s/sx, chest pain, dyspnea, or neck pain/stiffness. Member is otherwise asymptomatic and has no further medical complaints or concerns at this time. Exam Findings: Golf ball sized tender area of induration localized to L tricep with erythema directly over but no warmth to touch. Otherwise no significant findings on exam. Contact clinic and confirmed that pt was given SUBQ Varicella in L arm. Suspect adverse reaction to this immunization. Skin rash. Diphenhydramine 50 mg QID, Acetaminophen 1000 mg QID.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not provided. On 11-NOV-2015 the patient was vaccinated with improperly stored dose of (wistar ra 27-3) M-M-R II therapy type unknown (dose, frequency, route of administration and indication were not reported, lot # L001336 with expiration date: 13-JAN-2017). Concomitant medications were not reported. No adverse events were reported. The administered dose was stored in 47 F for 8 hours. There was no previous temperature excursions. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information on patient's pertinent medical history or drug reaction/allergies was provided. On 30-SEP-2016, the patient was inadvertently vaccinated with a dose of expired PNEUMOVAX 23 lot # L007720 (expiry date 08-JUL-2016) intramuscularly (dose was not reported). Concomitant medications were not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M011117, expiration date 07-DEC-2017, dose and route were not provided), which were exposed to 50 Fahrenheit (F) for 40 minutes. Previous temperature excursion: 50.2 for 1 hour and 10 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Needle issue, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history nor concomitant therapy was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose, frequency and route were not reported). On an unknown date, the patient was vaccinated with less than a full dose of ZOSTAVAX because the needle leaked during administration. No adverse symptoms were reported. There was not reported if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L038534 with expiration date 19-AUG-2017; lot # L033694 with expiration date 06-JUN-2017; dose unknown; oral). The vaccine was improperly stored at 32 Fahrenheit for 41 minutes. No adverse effect was reported. This is one several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an adolescent patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-SEP-2016, the patient was vaccinated with an expired dose of (wistar ra 27-3) M-M-R II (lot # reported as L024104, expiration date 14-SEP-2016, dose not reported) subcutaneously in the right arm. No adverse effects were reported. Lot number L024104 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 21-SEP-2016, the patient was vaccinated with ZOSTAVAX (lot # L046900, expiration date 23-FEB-2017, intramuscular; dose was unknown). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with an improperly stored doses of GARDASIL 9 (lot# L040054 with expiration date 26-DEC-2017) (dosing regimen was unknown). No adverse effects have been reported. No product quality complaint was filed. 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 nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not provided. On 05-NOV-2015 the patient was vaccinated with improperly stored M-M-R II therapy type unknown (dose, frequency, route of administration and indication were not reported, lot # L001336 with expiration date: 13-JAN-2017). Concomitant medications were not reported. No adverse events were reported. The administered dose was stored in 47 F for 8 hours. There was no previous temperature excursions. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pustule, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 61 year old female patient. The patient's concurrent conditions included chronic obstructive pulmonary disease and her medical history included an allergic reaction to tetracyclines. On 30-SEP-2016, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, anatomical site of injection and frequency were not reported). Concomitant therapies included SYMBICORT and XANAX. On the same date in the evening, the patient experienced swelling, redness and blisters at the injection site, which had an inch in diameter and were filled with pus. On 03-OCT-2016, the patient sought medical attention at the reporter's office. The reporter stated that the patient had been taking TYLENOL and aspirin (manufacturer unknown) as treatment for the event (doses and frequencies were not reported), however, no laboratory diagnostic studies were performed. No product quality complain (PQC) was involved. At the reporting time, the outcome of the event was unknown. The reporter did not provide causality assessment between the event and the ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified child patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 05-OCT-2016, the patient was vaccinated with an expired dose of VARIVAX (lot # unknown with expiry date 23-SEP-2016) (dosing details and anatomical location not known). The reporter was not aware of an adverse experience. No Product Quality Complaint (PQC) was filed. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Rash
Clinical narrative: Pt had an immunization on 05 Aug and has had a slowly expanding red area around the site of injection. States it appears to improving. Rash. Diphenhydramine 25 mg QID.
Age: 1.4
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema urticarial in a 17-month-old female patient who received KINRIX (batch number 4F49N, expiry date 13th November 2017). On an unknown date, the patient received KINRIX .5 ml. On an unknown date, less than a month after receiving KINRIX, the patient experienced erythema urticarial and inappropriate age at vaccine administration. On an unknown date, the outcome of the erythema urticarial and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the erythema urticarial to be related to KINRIX. Additional details were provided as follows: This case was reported by a medical assistant (MA). The patient received KINRIX at 17 months age, which led to an inappropriate age at vaccination. The patient also developed a red welt on her leg.
Age: 0.5
Sex: F
Vaccine: MNQ, RV1
Symptoms: Irritability, Sleep disorder, Wrong drug administered
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sleep disturbance in a 6-month-old female patient who received MENVEO (batch number M16004, expiry date unknown). Concomitant products included ROTARIX, ranitidine hydrochloride and TYLENOL. On 26th September 2016, the patient received MENVEO. On 26th September 2016, less than a day after receiving MENVEO, the patient experienced sleep disturbance, irritability and wrong vaccine administered. On an unknown date, the outcome of the sleep disturbance, irritability and wrong vaccine administered were unknown. It was unknown if the reporter considered the sleep disturbance and irritability to be related to MENVEO. Additional details were provided as follows: Initially the case was reported by the patient's mother and later the pharmacist reported it. The patient was scheduled to receive Hib or Hepatitis B vaccine (unclear), but was administered MENVEO in error. This led to wrong vaccine administered. The injection site of MENVEO was right thigh. On the same day, the patient received ROTARIX vaccine orally. The patient was fussy and did not sleep well yesterday night. The dose given was reported to the mother as the standard dose. The healthcare professional stated the patient's primary healthcare provider might have reported the maladministration previously. The expiration date of the vaccine was unknown.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to her 4 month old son, who on 06-OCT-2016, was inadvertently administered a dose of GARDASIL (dose, route and lot# were not reported) instead of PEDVAXHIB. No adverse effect reported. No further information was provided. No product confusion occurred. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with M-M-R II (strength, dose, lot# and expiration date were not reported) intramuscularly (subcutaneous injection formulation administered by other route). No adverse symptoms were reported. No product quality complain was involved. Follow up information was received from the pharmacist on 05-OCT-2016, concerning a 18 years old female patient. On 11-AUG-2016, the patient was vaccinated with the first dose of M-M-R II (lot # L007216), by intramuscular route on the right arm. Additional information is not expected as all schedule follow up were received. Reporter information, patient information, product information, event information and narrative were updated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Patient's medical history and concurrent conditions were not provided. On an unknown date, the patients were orally vaccinated with improperly stored doses of ROTATEQ (dose, frequency and indication were not reported, lot unspecified). Concomitant medications were not reported. No adverse events were reported. It was not specified if the data digital logger was involved, (temperature excursion: 51.24F, time frame: 40 minutes). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Blood glucose normal, Chills, Cough, Fatigue, Hyperhidrosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor in a 81-year-old female patient who received BOOSTRIX. Previously administered products included Tetanus shot (received a couple years ago). Concomitant products included Influenza vaccine. On 27th September 2016, the patient received BOOSTRIX (intramuscular) .5 ml. On 27th September 2016, several hours after receiving BOOSTRIX, the patient experienced tremor and teeth chattering. On 28th September 2016, the patient experienced dry cough, general body pain, sweating and fatigue. On 29th September 2016, the patient experienced blood sugar increased. On 27th September 2016, the outcome of the tremor was recovered/resolved. On an unknown date, the outcome of the teeth chattering was recovered/resolved and the outcome of the dry cough, sweating and fatigue were not recovered/not resolved and the outcome of the general body pain and blood sugar increased were unknown. The reporter considered the tremor, teeth chattering, dry cough, general body pain, sweating and blood sugar increased to be related to BOOSTRIX. It was unknown if the reporter considered the fatigue to be related to BOOSTRIX. Additional details were provided as follows: the patient received BOOSTRIX at 17:30 pm on right arm. On 27th September 2016, the patient received influenza vaccine as concomitant medication on left arm, which was a non GlaxoSmithKline product. The caller reported that she received BOOSTRIX and a non GSK flu vaccine on Tuesday. By that evening she was shaking so bad her teeth were chattering. She had her daughter sleep over with her because she was afraid that she would need help. Her daughter said that the shaking stopped once she went to sleep. On 28th September 2016, in the morning, 1 day after receiving BOOSTRIX and flu vaccine, the patient was badly sweating so she had to change her clothing several times that day. She also had a dry cough and was so tired that she was unable get out of bed and her body was sore. On 29th September 2016 in the morning, the patient took her blood sugar and it was 171. She usually runs around 110-111. As per the recommended schedule by the PI tetanus shot can be received less than the 5 year interval. This case has been linked with case US2016GSK147230 as reported by same reporter.
Age: 81.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Mobility decreased, Pain, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor in a 81-year-old female patient who received BOOSTRIX. Previously administered products included Tetanus shot (received a couple years ago). Concomitant products included Influenza vaccine. On 27th September 2016, the patient received BOOSTRIX (intramuscular) .5 ml. On 27th September 2016, several hours after receiving BOOSTRIX, the patient experienced tremor and teeth chattering. On 28th September 2016, the patient experienced dry cough, general body pain, sweating and fatigue. On 29th September 2016, the patient experienced blood sugar increased. On 27th September 2016, the outcome of the tremor was recovered/resolved. On an unknown date, the outcome of the teeth chattering was recovered/resolved and the outcome of the dry cough, sweating and fatigue were not recovered/not resolved and the outcome of the general body pain and blood sugar increased were unknown. The reporter considered the tremor, teeth chattering, dry cough, general body pain, sweating and blood sugar increased to be related to BOOSTRIX. It was unknown if the reporter considered the fatigue to be related to BOOSTRIX. Additional details were provided as follows: the patient received BOOSTRIX at 17:30 pm on right arm. On 27th September 2016, the patient received influenza vaccine as concomitant medication on left arm, which was a non GlaxoSmithKline product. The caller reported that she received BOOSTRIX and a non GSK flu vaccine on Tuesday. By that evening she was shaking so bad her teeth were chattering. She had her daughter sleep over with her because she was afraid that she would need help. Her daughter said that the shaking stopped once she went to sleep. On 28th September 2016, in the morning, 1 day after receiving BOOSTRIX and flu vaccine, the patient was badly sweating so she had to change her clothing several times that day. She also had a dry cough and was so tired that she was unable get out of bed and her body was sore. On 29th September 2016 in the morning, the patient took her blood sugar and it was 171. She usually runs around 110-111. As per the recommended schedule by the PI tetanus shot can be received less than the 5 year interval. This case has been linked with case US2016GSK147230 as reported by same reporter.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Patient's medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II therapy type was unknown (dose, frequency, indication and route of administration were not reported, lot # L049455 with expiration date: 03-DEC-2017). Concomitant medications were not reported. No adverse events were reported. It was not specified if the data digital logger was involved, (temperature excursion: 51.24F, time frame: 40 minutes). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Patient's medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, frequency, indication and route of administration were not reported, lot # reported as M014926 with expiration date: 17-FEB-2019). Concomitant medications were not reported. No adverse events were reported. It was not specified if the data digital logger was involved, (temperature excursion: 51.24F, time frame: 40 minutes). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MENB, MNQ, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a physician via sale rep and described the occurrence of injection site redness in a adolescent patient who received MENVEO (batch number M16002, expiry date October 2017). Concomitant products included BEXSERO and ADACEL. On 28th September 2016, the patient received MENVEO (intramuscular). In September 2016, less than a week after receiving MENVEO, the patient experienced injection site redness, injected limb mobility decreased and injection site pain. In September 2016, the outcome of the injection site redness, injected limb mobility decreased and injection site pain were recovered/resolved. The reporter considered the injection site redness, injected limb mobility decreased and injection site pain to be probably related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. On 28th September 2016, the patient also received BEXSERO and ADACEL vaccines concomitantly along with MENVEO. MENVEO was the only vaccine given in the location of the injection site reactions. The other two vaccinations were given in another unknown location on her body. The patient experienced injection site redness, injection site soreness and was not able to lift her hand .
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 22-SEP-2016, the patient inadvertently received a dose of expired ZOSTAVAX lot # L011533, expiration date 03-07-2016. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: RT UE 3cm round area of redness and induration. Additional spread to almost circumferential just proximal to elbow Rt.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The report information has been received from a physician, via a company representative, concerning a multiple unspecified patients. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown date the patients were vaccinated with ZOSTAVAX (lot #, expiration dates, concentrations, dosages and therapy routes were not reported). Concomitant therapies were not informed. The physician reported that on unspecified dates, the patients experienced mild cases of shingles. The outcome of shingles was unknown at the time of the report. The causal relationship between ZOSTAVAX and shingles was not reported. No product quality complaint (PQC) was involved. Additional information is not expected as no consent for follow up was given.
Sex: U
Vaccine: RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 30-AUG-2016, the patient received a dose of improperly stored ROTATEQ (lot # M019691, expiry date: 02-NOV-2017). Excursion: 1.3C for 77 minutes cumulatively. Data logger was involved. No adverse effects reports. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 30-AUG-2016, the patient received a dose of improperly stored ROTATEQ (lot # M019691, expiry date: 02-NOV-2017). Excursion: 1.3C for 77 minutes cumulatively. Data logger was involved. No adverse effects reports. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 05-OCT-2016, the patient was vaccinated with an expired dose of VARIVAX, lot number K007786, expiration date 28-MAY-2016, (dose, route and anatomical location were not reported) (product use issue). There was no concomitant medication reported. The patient had not experienced any adverse effects. Additional information has been requested.
Sex: U
Vaccine: RAB
Symptoms: Adverse event
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of adverse event in a patient who received RABAVERT. On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, 7 days after receiving RABAVERT, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to RABAVERT. Additional details were provided as follows: The age at administration was not reported. The reporter stated a veterinary student that received pre-exposure vaccination with RABAVERT. The reporter indicated that she was told the student might have had a reaction to the RABAVERT although she was unsure because what the student was experiencing occurred over a week after the vaccination. The reporter was unable to provide any further details at the time of the call.
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash macular
Clinical narrative: This spontaneous report was received from a pharmacist regarding to a female patient on her 70's. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not provided. On 20-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 lot # M000592 and expiration date 12-OCT-2017. Dose and route were not provided. On 27-SEP-2016, the patient noticed red blotches on her arms and legs. The patient stated that the blotches were itchy at first but had stopped itching and were just blotches present on her arms and legs. It was not a product quality complaint involved. At the time of reporting the outcome of the events was unknown. The reporter's causality between the events and the suspect therapy was not reported. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Cough, Decreased appetite, Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: 9/19/16 Pt. presents after rash all over body which started 9/18/16. Rash is itchy, non painful, mild cough and subjective hx of fever as per mom. 9/20/16 MD reports to nurse to fill out VAERS. 1 yo presents with rash all over body which started yesterday. Appeared first in arms and then spread all over body. Rash is itchy, non painful. Child had a Fever 3 days prior (subjective) which subsided with TYLENOL (TYLENOL given twice on day of fever), assoc with cough (non productive) since 3 days as well. No sick contacts at home. Mild decrease in appetite, but good no. of wet diapers. No h/o playing outside or contact with foreign substance. No h/o allergic reactions to vaccines prior.
Age: 22.0
Sex: F
Vaccine: MENB, RAB
Symptoms: Headache, Lymphadenopathy, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of enlargement of lymph nodes in a 22-year-old female patient who received BEXSERO (batch number 596011A, expiry date 31st December 2018). Concomitant products included BEXSERO. On 13th September 2016, the patient received BEXSERO (intramuscular). In September 2016, less than a week after receiving BEXSERO, the patient experienced enlargement of lymph nodes, headache, fever and vomiting. On an unknown date, the outcome of the enlargement of lymph nodes, headache and fever were recovering/resolving and the outcome of the vomiting was unknown. The reporter considered the enlargement of lymph nodes, headache and fever to be probably related to BEXSERO. It was unknown if the reporter considered the vomiting to be related to BEXSERO. Additional details were received as follows: The reporter was told about a female veterinary student that received two doses of RABAVERT fro pre-exposure. On 6th September 2016, the patient received the first dose on her right deltoid. The patient received the second dose on her left deltoid. Within 48 hours of received the second dose, the patient experienced swollen lymph glands, fever, vomiting, and headache. The patient went to an urgent care facility for treatment. The reporter was unable to provide any further details at the time of the call. The call was transferred to Medical information.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Urticaria
Clinical narrative: Hive-like rash extended from deltoid to underarm approx. 3 cm x 17 cm. Pain radiated from (R) deltoid to (R) shoulder.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was intramuscularly vaccinated with improperly stored of PNEUMOVAX 23 (dose, frequency and indication were not reported, lot # M024673 with expiration date: 17-NOV-2017). No adverse effects reported. The administered dose was stored in 52 F for 4 hours. There was no previous temperature excursion. The data logger was involved. Additional information has been requested.