chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse via a company representative refers to a 15 year old male patient. The patient's current conditions or medical history were not reported. On an unspecified date in July 2014, reported as this week, the patient was administered the first dose of GARDASIL intramuscular injection, 1 single shot, (lot number K006447 expiration date 19-JUN-2016). The patient fainted after receiving the first dose of GARDASIL. The patient sought for medical attention and did not received treatment. Outcome of fainted was unknown at the time of the report. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to 21 year old female patient who, on 27-MAY-2014, was vaccinated with a dose of GARDASIL (lot # J006850; expiration date 31-MAR-2016) in right "UT" (dose and route not provided). The GARDASIL that was administered to this patient had been stored below 36 degrees F, outside of the temperature ranges indicated in the prescribing information, on 10-APR-2011, 11-APR-2014, 22-APR-2014, 23-APR-2014, 24-APR-2014 and on 08-MAY-2014. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Abasia, Growing pains, Hypoaesthesia, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old male patient. On 14-JUL-2014, the patient was vaccinated with a dose of GARDASIL (Lot # J009788, expiration date 17-MAR-2016) (route not reported). The physician reported that on 18-JUL-2014 at 16:00, the patient's father called in behalf the son who was complaining on not having feelings in his legs. On 21-JUL-2014, the father called to state that the patient still was experiencing soreness in his leg and could not walk. The patient's father stated that he gave the patient MOTRIN and this relieved the symptoms but once the medication duration was completed the symptoms returned. On 24-JUL-2014, the father called back again to state that the soreness remained in the patient's legs. The physician recommended to the father to take the patient to the hospital. The outcome of could not walk and not having any feelings in his legs was unknown. The outcome of soreness in his legs was reported as not recovered. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 38 year old female patient with hypertension, depression, polycystic ovary disease and impaired glucose tolerance. After entering nursing school patient required M-M-R II series. On 21-APR-2013 the patient was vaccinated with the first dose of M-M-R II injection (dose and route not reported) lot # 0412AE, expired date 27-FEB-2014. On 21-APR-2013 the patient was vaccinated with the second dose of M-M-R II injection (dose, route and therapy type unknown, lot # 0412AE, expired date 27-FEB-2014). On 03-JUL-2014, titers were drawn. The patient was not reactive for measles and mumps. The patient did not seek medical attention and no treatment was given for the event. No adverse effects were noted. Outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an healthcare worker refers to some patients. On an unknown date the patients were vaccinated with PROQUAD (Merck) (lot#, strength, dose, route unknown). On 14-MAR-2014 the reporter reported a temperature excursion. Since the excursion that was reported, some of these doses of VARIVAX (Merck) (captured in MARRS 1407USA010231), PROQUAD (Merck) and ZOSTAVAX (captured in MARRS 1407USA010909) had been administered to patients. The healthcare worker did not report an adverse experience. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to three patients of unknown gender aged between 12-15 months old who on an unspecified date were inadvertently administered both PROQUAD (dose not provided), subcutaneous and VARIVAX (dose and route not provided) at the same office visit. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient demographics were not reported. There was no information reported on patient's medical history and concomitant medications. On 28-JUL-2014, the patient was vaccinated with PNEUMOVAX 23 Product lot# H021941, dose .5ml (millilitre), intramuscularly that expired on 11-JUL-2014. No adverse effects were reported. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, indication, route not reported) which was improperly stored, although supported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to 4 patients of unknown age and gender. On an unknown date (reported as during the month of June and July) the patients were vaccinated with an improperly stored PEDVAXHIB (dose, route and lot number were not reported). Concomitant medications were not reported. No adverse effects reported. This case is linked to case 1407USA013104 via same reporter link. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old female patient. Who unknown dates in 2012 (reported as two years ago) was vaccinated with dose 1 and 2 of GARDASIL (lot number, expiration date and route were not provided) and on 29-JUL-2014 the patient received the third dose of GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to 4 patients of unknown age and gender. On an unknown date (reported as during the month of June and July) the patients were vaccinated with improperly stored GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. No adverse effects reported. This case is linked to case 1407USA013966 via same reporter link. Additional information is not expected.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old male patient. The patient had no drug reactions/allergies. On 16-JUL-2014 the patient was vaccinated with ZOSTAVAX, (dose, frequency and route were not reported), lot#J011548, expired date: 19-DEC-2014. Concomitant therapies included OXYCONTIN, testosterone, alprazolam, duloxetine hydrochloride, tizanidine hydrochloride, ADVAIR, trazadone hydrochloride, SPIRIVA and atorvastatin. The patient called the pharmacy "this morning" (17-JUL-2014) to report that he has a "baseball sized red area" around the ZOSTAVAX injection site along with some swelling. No rash reported. The patient sought medical attention by pharmacy call. No treatment was given for AE. No lab diagnostics were performed. The outcome of adverse events was reported as not recovered. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site joint pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old male patient. The patient had no drug reactions/allergies. On 16-JUL-2014 the patient was vaccinated with ZOSTAVAX, (dose, frequency and route were not reported), lot#J011548, expired date: 19-DEC-2014. Concomitant therapies included OXYCONTIN, testosterone, alprazolam, duloxetine hydrochloride, tizanidine hydrochloride, ADVAIR, trazadone hydrochloride, SPIRIVA and atorvastatin. The patient called the pharmacy "this morning" (17-JUL-2014) to report that he has a "baseball sized red area" around the ZOSTAVAX injection site along with some swelling. No rash reported. The patient sought medical attention by pharmacy call. No treatment was given for AE. No lab diagnostics were performed. The outcome of adverse events was reported as not recovered. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old male patient. The patient had no drug reactions/allergies. On 16-JUL-2014 the patient was vaccinated with ZOSTAVAX, (dose, frequency and route were not reported), lot#J011548, expired date: 19-DEC-2014. Concomitant therapies included OXYCONTIN, testosterone, alprazolam, duloxetine hydrochloride, tizanidine hydrochloride, ADVAIR, trazadone hydrochloride, SPIRIVA and atorvastatin. The patient called the pharmacy "this morning" (17-JUL-2014) to report that he has a "baseball sized red area" around the ZOSTAVAX injection site along with some swelling. No rash reported. The patient sought medical attention by pharmacy call. No treatment was given for AE. No lab diagnostics were performed. The outcome of adverse events was reported as not recovered. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: PNC13, RV5, MER, RV5
Symptoms: Abdominal pain, Diarrhoea, Diet refusal, Enema administration, Faeces discoloured
Clinical narrative: Diagnosed with intussusception.
Age: 0.52
Sex: M
Vaccine: PNC13, RV5, MER, RV5
Symptoms: Intussusception, Screaming, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Diagnosed with intussusception.
Age: 0.52
Sex: M
Vaccine: PNC13, RV5, MER, RV5
Symptoms: Intussusception
Clinical narrative: Diagnosed with intussusception.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Erythema, Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: Patient developed soreness/pain of left arm immediately after injection of first HPV was given. The pain persisted and worsened over several days and then a rash developed in the antecubital fossa on 7/27/14. He was seen by my partner on 7/28/14 and diagnosed with a local vaccine reaction. He was given hydroxyzine to use as needed. He then developed a fever of 102 on 7/29/14 and the rash worsened- it spread up and down the anterior arm and the pain worsened. He then went to a local ER and CBC was done which showed leukopenia -- WBC 2.8k. He was sent home and rash continued to worsened- became vesicular and thus patient was seen in my office again on 7/30/14 by myself. He had a classic shingles rash and is currently feeling better. CBC at that time had a WBC of 2.9k. His re-eval is in 2 weeks.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Rash generalised
Clinical narrative: Patient developed soreness/pain of left arm immediately after injection of first HPV was given. The pain persisted and worsened over several days and then a rash developed in the antecubital fossa on 7/27/14. He was seen by my partner on 7/28/14 and diagnosed with a local vaccine reaction. He was given hydroxyzine to use as needed. He then developed a fever of 102 on 7/29/14 and the rash worsened- it spread up and down the anterior arm and the pain worsened. He then went to a local ER and CBC was done which showed leukopenia -- WBC 2.8k. He was sent home and rash continued to worsened- became vesicular and thus patient was seen in my office again on 7/30/14 by myself. He had a classic shingles rash and is currently feeling better. CBC at that time had a WBC of 2.9k. His re-eval is in 2 weeks.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Herpes zoster, Immediate post-injection reaction, Leukopenia, Local reaction, Pain in extremity
Clinical narrative: Patient developed soreness/pain of left arm immediately after injection of first HPV was given. The pain persisted and worsened over several days and then a rash developed in the antecubital fossa on 7/27/14. He was seen by my partner on 7/28/14 and diagnosed with a local vaccine reaction. He was given hydroxyzine to use as needed. He then developed a fever of 102 on 7/29/14 and the rash worsened- it spread up and down the anterior arm and the pain worsened. He then went to a local ER and CBC was done which showed leukopenia -- WBC 2.8k. He was sent home and rash continued to worsened- became vesicular and thus patient was seen in my office again on 7/30/14 by myself. He had a classic shingles rash and is currently feeling better. CBC at that time had a WBC of 2.9k. His re-eval is in 2 weeks.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Rash, Rash vesicular, Vaccination complication, White blood cell count decreased
Clinical narrative: Patient developed soreness/pain of left arm immediately after injection of first HPV was given. The pain persisted and worsened over several days and then a rash developed in the antecubital fossa on 7/27/14. He was seen by my partner on 7/28/14 and diagnosed with a local vaccine reaction. He was given hydroxyzine to use as needed. He then developed a fever of 102 on 7/29/14 and the rash worsened- it spread up and down the anterior arm and the pain worsened. He then went to a local ER and CBC was done which showed leukopenia -- WBC 2.8k. He was sent home and rash continued to worsened- became vesicular and thus patient was seen in my office again on 7/30/14 by myself. He had a classic shingles rash and is currently feeling better. CBC at that time had a WBC of 2.9k. His re-eval is in 2 weeks.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-JUL-2014, the patient received improperly stored ROTATEQ oral (dose, lot # and expiration date were not provided). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Local swelling, Swelling face, Urticaria
Clinical narrative: Full body case of hives, as well as swollen hands, feet, and face. Taking Benadryl, applied cortisone cream, started Prednisone prescription.
Age: 1.14
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Mother states in morning she noticed child had a "chicken pox" looking rash on both legs, arms and his chin. No fever or itching.
Age: 1.03
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Pain
Clinical narrative: NODE ON LEFT SIDE SOME REDNESS AROUND THE IT. PLACE LOCATED WHERE DTAP WAS ADMINISTERED. PARENT REPORTS PAIN FOR PATIENT WHEN WALKING.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from the consumer who was the father of a 13 year old female patient. The medical history and concurrent conditions was not reported. On 23-JUL-2014 the patient was vaccinated with GARDASIL dose 3 (dosing regimen and frequency unknown), injection (lot no not provided). Other suspect therapy included hepatitis A virus vaccine (manufacturer unknown) first dose was given on same day (dosing regimen and frequency unknown). There was no concomitant medications reported. On 23-JUL-2014 the patient experienced passed out (medically significant) two to three minutes after receiving the vaccine and recovered immediately after the reaction. The event occurred in the physician's office. No treatment was given for the event. No lab diagnostics studies were performed. Laboratory test done was none. No product quality complaint was involved. The causality of the event to the suspect therapies was unknown. Upon internal review the event was considered as medically significant. This case is related to case number 1407USA013430 (same reporter link). Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion
Clinical narrative: Patient received vaccines in clinic, later that day reported to ED with seizure activity.
Age: 1.53
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 months old patient. Patient was vaccinated with VAQTA vial 25/0.5 on 12-MAR-2010 and 07-SEP-2010. The two dates were 25 weeks apart but less than 6 months by calendar days. Inappropriate schedule of vaccine administration was reported. A school board was questioning the timing of the two doses and whether or not the doses were administered too close together. No adverse effect was observed or reported. No product quality complaint was reported. The outcome of events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event, Product expiration date issue
Clinical narrative: This spontaneous report as received from a healthcare worker refers to four patients of unknown age and gender. On an unknown date in June 2014, the patients were vaccinated with 4 doses of M-M-R II (HSA) lot # H009781, expiry date: 15-MAY-2014, 0.5 ml (route, dose number not reported). The healthcare worker reported product confusion of the M-M-R II (HSA). The healthcare worker reported the case of M-M-R II (HSA) read an expiry date of 15-MAY-2014 on the both the carton and vials, and this vaccine had been received to the physician's office in June 2014. Merck Order Management was contacted to verify the expiry date. When provided with the lot number of H009781, the reporter indicated that the Merck Order Management Center reported that lot should not expire until 15-JUL-2014. The healthcare worker reported four doses from this complaint carton had been used in June 2014 (dates unspecified) on four anonymous patients. No adverse reactions were reported. The outcome of event was not reported. Product Quality Complaint (PQC) was filed for product confusion. The lot verification result revealed that lot# H009781 was valid for M-M-R II with expired date as 15-MAY-2014 and Albumin status was HSA. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle atrophy, Myalgia, Swelling
Clinical narrative: Muscle loss, swelling and pain deltoid.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old female patient with anxiety, and no known allergies. The patient's medical history included biliary atresia at birth and kasai procedure. On 12-MAY-2014 the patient was vaccinated with the third dose of GARDASIL (lot # H020901, expiration date 05-JUL-2015) (dose and route were not reported). There were no concomitant medications. One week post vaccination, 09-MAY-2014, mother of client called the doctor office stating her daughter was complaining of intermittent abdominal pain, lightheadedness, and dizziness. Physician stated he asked the mother and child to come in for an office visit, but they had not. Patient's mother told the physician that she wanted the Lot number checked for GARDASIL. Physician stated that the patient did not experience any adverse effects after the first of second dose of GARDASIL. The outcome of intermittent abdominal pain and dizziness/lightheadedness was reported as not recovered/not resolved. No treatment was given for the adverse events. No lab diagnostic studies were performed. The relationship between GARDASIL and the events was not reported. Patient's mother called to the doctor office. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist.  The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date: 02-OCT-2016 and lot #J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.   Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 9 weeks old infant patient of unknown gender. On 23-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter.  Additional information is not expected.
Age: 17.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 year old patient (gender unknown). Pertinent medical history, drug reactions or allergies were not reported.   On 16-DEC-2013, the patient was vaccinated with a dose of ZOSTAVAX, 0.65ml, subcutaneous (lot # was not provided) instead of (Oka/Merck) VARIVAX.  The nurse stated that the patient also received a dose of (Oka/Merck) VARIVAX on an unknown date after receiving ZOSTAVAX. No adverse effect reported.   Additional information is not expected because the reporter refused further follow up.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, VARCEL
Symptoms: Erythema, Papule, Pruritus, Rash, Varicella post vaccine
Clinical narrative: Taken to hospital and reported that patient had been breaking out for the past 2 hours beginning location: back, arms, legs. Itching was noted. No treatment at hospital other than Benadryl as needed. At physician's office on 7/29/14, presented with scattered erythematous, pruritic papules scattered on back, buttocks, arms and legs. Diagnosed with varicella and told to monitor and return for any new or worsening symptoms or failure to improve. No medications given at this time.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, VARCEL
Symptoms: Erythema, Papule, Scab, Urticaria, Urticaria papular
Clinical narrative: Taken to hospital and reported that patient had been breaking out for the past 2 hours beginning location: back, arms, legs. Itching was noted. No treatment at hospital other than Benadryl as needed. At physician's office on 7/29/14, presented with scattered erythematous, pruritic papules scattered on back, buttocks, arms and legs. Diagnosed with varicella and told to monitor and return for any new or worsening symptoms or failure to improve. No medications given at this time.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Taken to hospital and reported that patient had been breaking out for the past 2 hours beginning location: back, arms, legs. Itching was noted. No treatment at hospital other than Benadryl as needed. At physician's office on 7/29/14, presented with scattered erythematous, pruritic papules scattered on back, buttocks, arms and legs. Diagnosed with varicella and told to monitor and return for any new or worsening symptoms or failure to improve. No medications given at this time.
Age: 1.36
Sex: M
Vaccine: MMR, PNC13, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Incorrect Vaccine - TDaP (Boostrix) given instead of DTaP.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender with medical history of unspecified anxiety issue. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency and lot # not provided). On an unknown date, the patient fainted after receiving ZOSTAVAX. The patient could not move for almost an hour after receiving ZOSTAVAX. The physician called an ambulance to have the patient transported to an unspecified hospital. It was unspecified if the patient was admitted to the hospital. The outcome of the patient fainted and could not move was not reported. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information is not expected, as the reporter refused additional contact.
Age: 0.21
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reported stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date: 02-OCT-2016 and lot #J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.   Follow up information has been received from the registered nurse who provided patients details. This report refers to a 11 weeks old infant patient of unknown gender. On 23-JUL-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Age: 1.29
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 month old female patient. On 02-JUN-2014 the patient was vaccinated with (Oka/Merck) VARIVAX injection (lot # and expiration date not provided) (dose not reported). It was reported  that the patient received improperly stored (Oka/Merck) VARIVAX exposed to a maximum temperature of -7C for 27 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to an approximately 75 year old female patient. No relevant medical history of the patient was reported. On an unknown date in October 2013 the patient was vaccinated with ZOSTAVAX (19400 PFU) (dose, route and lot number were not reported). No concomitant medications were reported. The pharmacist reported that the patient subsequently developed a mild case of shingles along the waist area on an unknown date in January 2014, following vaccination in October 2013. The patient then developed a severe case of shingles and post herpetic neuralgia on an unknown date in July 2014. It was unspecified whether any treatment was given for the patient. it was unknown if any lab diagnostic tests were performed. It was reported that the patient had sought medical attention. There was no product quality complaint (PQC) involved. The outcome of mild case of shingles, post herpetic neuralgia and severe case of shingles was unknown. The causality of the events were not provided. Additional information has been requested.
Age: 0.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist.  The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 3 months old infant patient of unknown gender. On 04-JUN-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with GARDASIL, (dose, frequency and lot # unknown) intramuscularly for prophylaxis on 15-APR-2010 and 24-JUL-2014. No adverse effects reported. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck.  Follow up information has been received from the registered nurse who provided patients details. This report refers to a 7 months old infant patient of unknown gender. On 02-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patients details. This report refers to a 2 months old infant patient of unknown gender. On 03-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. On 20-MAY-2014 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. The medical assistant reported that the patient was administered the second dose of GARDASIL on 18-MAR-2014 and the third dose of GARDASIL on 20-MAY-2014. No adverse effects were reported. It was reported that therapy with GARDASIL was not discontinued. the outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Tightness in throat, trouble breathing, after 1st dose.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients were reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported. It was unspecified whether the patients had sought any medical attention. There was no product quality complaint involved. The outcome of administered (Oka/Merck) VARIVAX that was stored improperly was unknown. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. On 21-JUL-2014, the patient was vaccinated with a dose of PROQUAD injection, 0.5 ml, subcutaneous (lot#, expiration date, strength and indication not reported). Prior to receiving PROQUAD, the patient had received 2 doses of M-M-R II at unspecified times in the past and one dose of VARIVAX (Merck) in 2002. No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share,  Follow up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old infant patient of unknown gender. On 02-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 0.59
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck.  Follow up information has been received from the registered nurse who provided patients details. This report refers to a 7 months old infant patient of unknown gender. On 02-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an approximately 68 year old patient (gender unknown). No relevant medical history of the patient was reported. On 24-JUL-2014 (also reported as 10-APR-2014) the patient was vaccinated with ZOSTAVAX (lot # J000432, expiration date: 10-APR-2014) 0.65 ml, subcutaneous. There were no concomitant medications reported. It was reported that on 24-JUL-2014, the patient inadvertently received an expired dose of ZOSTAVAX that had an expiry date of 10-APR-2014. There were no adverse effects reported. It was unspecified whether the patient had sought any  medical attention. There was no product quality complaint involved. The outcome of inadvertently received an expired dose of ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown demographics. No information was received regarding medical history and concurrent conditions. The nurse reported that since 01-JUL-2014, those patients might have been administered with RECOMBIVAX HB injection (dose, route of administration, indication,  lot # and expiry date unspecified), that were not stored properly. No concomitant medications reported. No adverse effects were reported. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of the several report received from the same reporter.  Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patients details. This report refers to a 9 weeks old infant patient of unknown gender. On 02-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 0.18
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck.  Follow up information has been received from the registered nurse who provided patients details. This report refers to a 9 weeks old infant patient of unknown gender. On 03-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 08-JUL-2014, the patient was inadvertently administered VAQTA (0.5 ml, intramuscular) (lot# and expiration date were not reported) that had been improperly stored. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Swelling
Clinical narrative: This spontaneous report as received from an administrator via a company representative refers to a male patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL dose 1, 1 injection, intramuscular (lot # was not reported) for prevention of HPV and on the same day and in the same arm (reporter did not specify if it was right or left) the patient was vaccinated with MENACTRA (dose and lot # were not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced swelling after being administered both GARDASIL and MENACTRA. The patient's mother took the patient to the emergency room for observation. The patient sought medical attention. The outcome of swelling was reported as recovered on an unknown date. Causality was not reported. Additional information has been requested.
Age: 0.12
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck.  Follow up information has been received from the registered nurse who provided patients details. This report refers to a 6 weeks old infant patient of unknown gender. On 03-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Headache, Injection site pruritus, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Vaccine 1427pm. Pruritic hives at (R) elbow 1/2-1/1/4" long x approx 1/2" wide. BENADRYL 50 mg given po at 1440. Pruritic hives continued to arise on (R) upper arm and forearm and later. Pt reported a slight headache.
Sex: U
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Initial report was received on 28 July 2014 from a non-health care professional. Four patients (names and dates of birth not reported) had received on an unspecified date ADACEL, lot number U4902BA and an unspecified amount of time later developed cellulitis at injection site which required antibiotics. The patients were evaluated by a physician. No further information was provided at the time of the report. Outcomes were unknown. Note: ADACEL route and site of administration was not reported. Documents held by sender: none.
Age: 0.19
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck.  Follow up information has been received from the registered nurse who provided patients details. This report refers to a 9 weeks old infant patient of unknown gender. On 03-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.