chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US002805, is an initial spontaneous report from a medical assistant received on 05 Feb 2015 and with follow-up received from a medical assistant on 16 Mar 2015. This report refers to a 17-year-old female patient. Concurrent condition included type 2 diabetes mellitus. Concomitant medication included metformin. Previous vaccinations were well tolerated. Her vaccination status was up to date. She was vaccinated with booster dose of MENVEO (batch number: M13064) at a dose of 0.5 ml intramuscularly into left arm on 04 Feb 2015 at 02:40 PM. No adverse event was reported following the maladministration. Follow-up received from a medical assistant on 16 Mar 2015: Patient's demographics (height and weight), vaccination details (dose, site, time), previous vaccination status, concurrent condition (type 2 diabetes mellitus), concomitant medication (metformin) and other clinically relevant information updated in the narrative.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2015US002807, is an initial spontaneous report from a nurse received on 04 Feb 2015. This report refers to an 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered only MenCYW-135 liquid component of MENVEO (batch number: M14071) without being reconstituted with MenA, intramuscularly on 04 Feb 2015 without any reports of harm due to the administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US002808, is a combined initial and follow up spontaneous report received from a nurse on 04 Feb 2015 and on 09 Feb 2015. This report refers to an 11 years old male patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number: M14030) intramuscularly at a dose of 0.5 ml on 03 Dec 2014. It was reported that before administration, the MENVEO was stored at a temperature greater than 45 degree Fahrenheit for a total of 35 hours. On 17 Nov 2014 it was stored at 55.1 degree Fahrenheit for unknown period of time. The temperature excursion occurred in between 17 Nov 2014 to 03 Dec 2014. No adverse event was reported following this administration error.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2015US000935, is an initial spontaneous report from a pharmacist received on 09 Jan 2015. This report refers to a 20-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered only MenCYW-135 liquid component of MENVEO (batch number: X14045) without being reconstituted with MenA, intramuscularly on 09 Jan 2015. No adverse event or complications was reported following the administration error.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024439, is an initial spontaneous report from a nurse received on 04 Dec 2014 with a follow up information received from a nurse on 17 Feb 2015. This report was initially reported as a multiple patients' case, but upon receipt of follow up, it became a valid single patient case. This report refers to an 11 years old female patient. Her current conditions included allergy to shellfish and rash on right cheek for years. Her concomitant vaccinations included human papilloma virus vaccine (other manufacturer, batch number: 14004205) at a dose of 0.5 ml intramuscularly in the right deltoid, tetanus diphtheria acellular pertussis vaccine (other manufacturer, batch number: C4497AH) at a dose of 0.5 ml intramuscularly in the left deltoid and influenza vaccine (unknown manufacturer, batch number: 379MY) at a dose of 0.5 ml intramuscularly in the right deltoid; all vaccines given on 05 Nov 2014. Her vaccination status was up to date and she required second dose of human papilloma virus vaccine. On 05 Nov 2014, she was vaccinated with an initial dose of MENVEO (batch number: M14030, expiry date: 31 Jul 2015) intramuscularly at a dose of 0.5 ml in the left deltoid after the temperature fell to 34.9 degree F for 12 hours at 9:48 am and for 12 hours on 06 Nov 2014. The vaccine had never frozen during the excursion. The nurse received the information only when an audit showed that the MENVEO went out of range. No adverse event was reported. The patient was referred on 05 Nov 2015 for cardiac echocardiogram (ECHO) and dermatology. No further information was provided. Follow up information received from a nurse on 17 Feb 2015: Updated reporter type, patient demographics (initials, date of birth, age and gender, height and weight), current condition, concomitant vaccination, MENVEO batch number, expiry date, dose, site and time of vaccination and narrative.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US099496, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531907) website on 08 Aug 2014. This report refers to a 18-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: M12100) intramuscularly into the left arm on 19 Feb 2014. It was reported that there was a temperature excursions of MENVEO vaccine. No adverse event was reported following this medication error.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history was not reported. On an unspecified dates, an unspecified number of patients received an improperly stored dose of GARDASIL 9 with lot # L048237 and expiration date 08-MAY-2017; lot# L04475 and expiration date 12-MAY-2017; lot # L011846 and expiration date 16-JUN-2017; lot # L016428 and expiration date 30-JUL-2017; lot# L016429 and expiration date 09-AUG-2017; (strength, dose number, dosage and route unspecified). No adverse effect reported. No product quality complaint (PQC) was involved. No further details provided. 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 as received from a physician refers to a multiple unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unspecified dates, since the "end of March 2016" the patients were vaccinated with improperly stored doses of MMR II lot # L020188, expiry date: 03-JUN-2017 (dose, route, site of administration and dose# were not reported). Concomitant medication was not mentioned by the reporter. The vaccine was stored at a temperature range of 52F to 55F for a time frame of 40 days. There was no previous temperature excursion involved. The call was the result of a data logger. The physician stated that Merck cannot file a report because the "temperatures recorded are still under investigation". No adverse effects were reported. Product quality complaint was not filed. Additional information is not expected as the reporter did not wish further contact. This is one of the four reports from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 19-APR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L032184 with expiration date of 24-NOV-2016 or lot # L034736 with expiration date of 09-DEC-2016 (anatomical route of vaccination and dose number were not provided). The patient's concomitant medications were not reported. No adverse event was reported due to vaccination with ZOSTAVAX. Furthermore, no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history of the patients were not reported. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot # L051098, Expiration date: 17-JUN-2017; Lot# M01152, Expiration date: 05-JUL-2017) (dose and route were unspecified). The vaccine has been stored in -13.2 degree centigrade for 26 hours. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored MMR II lot no. L032044/expiration date- 24-AUG-2017 (incorrect product storage). No concomitant medication was reported. No adverse event. It was exposed to temperature of 75.5F for 3 hour 7 minutes. Previously it was not exposed to temperature excursion. The call was because of a data logger. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. The outcome of event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unspecified number of patients of unknown demography. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, unspecified number of patients were vaccinated with expired doses of ZOSTAVAX injection (dose, route unknown) lot # J007301 with expiration date of 20-SEP-2014. The last unspecified patient received the expired does of ZOSTAVAX from the lot # J007301 on 11-MAY-2016. No adverse effects were reported for any of the patients'. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received medical assistant regarding unspecified number of patients of unknown age and gender. The pertinent medical history of patients and their concurrent conditions were not reported. On an unknown date, unknown number of patients were inadvertently administered with improperly stored GARDASIL lot, dosing details unknown. Concomitant medications were not reported. It was reported that the vaccines administered were subjected to a temperature excursion of 46.7 degrees F for a time frame of 2 hours. It was reported that the vaccines were not subjected to previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the two cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored ROTATEQ, 2 ml, oral, lot no. L033693/ expiration date- 31-MAY-2017 (incorrect product storage). No concomitant medication was reported. No adverse event. It was exposed to temperature of 75.5F for 3 hours 7 minutes. Previously it was not exposed to temperature excursion. The call was because of a data logger. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. The outcome of event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history was not reported. On an unspecified dates, an unspecified number of patients received an improperly stored dose of GARDASIL with lot # K004205 and expiration date 12-JAN-2017; lot# K005881 and expiration date 14-JAN-2017; lot# K008931 and expiration date 04-MAR-2017; (strength, dose number, dosage and route unspecified). No adverse effect reported. No product quality complaint (PQC) was involved. No further details provided. This  is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash papular
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. There was no medical history or drug reaction/allergies reported. On 11-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot # L032184 with expired date 25-NOV-2016, dose and route were unknown). No concomitant therapy was reported. Within 3 days after vaccination, in May 2016, the patient experienced "tingling in one side of her trunk and bumps". The pharmacist stated the patient sought medical attention on 19-MAY-2016 at a clinic and was prescribed by an unspecified provider acyclovir 8000mg three times a day for treatment. The pharmacist was requesting a lot check for the ZOSTAVAX (lot# L032184). The outcome of the event was unknown. Causality was not provided. Additional information has been requested.
Sex: M
Vaccine: HPVX
Symptoms: Pain, Syncope
Clinical narrative: Information has been received from a Registered Nurse via a company representative referring to a male patient of unknown age. The patient's concurrent conditions, concomitant medication and medical history were not provided. On an unknown date the patient was vaccinated with his first dose of unidentified Merck HPV vaccine (dose, name and lot number not provided) via intramuscular route. On an unknown date the patient fainted. The patient did not return to complete series, stating "the shot hurts". The patient did not seek for medical attention. The outcome of the events was unspecified. Additional information is not expected because there was no consent to contact.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event, Medication error
Clinical narrative: This spontaneous report as received from a physician and a registered nurse refers to a 73 year old male patient. The concurrent condition included psoriasis, high blood pressure and skin cancer. Drug allergies included eye swelling with CARAC. On 18-MAY-2016, the patient was vaccinated with ZOSTAVAX (route, dose and details unavailable) (medication error-patient with skin cancer was administered ZOSTAVAX). Concomitant therapies included aspirin (manufacturer unknown) and amlodipine. It was reported that the physician would like to begin therapy with PICATO for an unspecified reason in the patient as soon as possible (Adverse event NOS). No lab tests were done. The patient sought medical attention by calling the physician. The outcome of adverse event was not resolved. The causality was unspecified. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning to a patient of unknown age and gender. On 20-MAY-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L045954, expired date 17-NOV-2017, route and dose not reported). The temperature was 35.6 F and time frame was 43 hours and 45 minutes. The vaccine was back in range and was not out of range before. Data logger was reported as no. At the time of report, the status of patient was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history of the patients were not reported. On unknown dates the patients were vaccinated with doses of improperly  stored (Oka/Merck) VARIVAX (lot# L048466, Expiration date: 02-DEC-2017; Lot# reported as L050956, Expiration date: 17-DEC-2017; Lot# L029472, Expiration date: 06-AUG-2017) (dose and route were not unspecified). The vaccine has been stored in -13.2 degree centigrade for 26 hours. This is one of several reports received from the same source. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a 3 year old patient (unknown gender). The patient's current conditions, medical history and concomitant medications were not reported. On 02-MAY-2016, the patient was inadvertently administered a dose of ZOSTAVAX (lot # L039094 and expiry date 08-JAN-2017) instead of an intended dose of VARIVAX (wrong vaccine administered and inappropriate schedule of vaccine administered). This occurred since a dose of ZOSTAVAX was inadvertently place in a storage area where only VARIVAX was typically kept, so the nurse who administered the dose thought she was grabbing a dose of VARIVAX. No adverse effect was reported.  Product quality compliant (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a multiple unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unspecified dates, since the "end of March 2016" the patients were vaccinated with improperly stored doses of RECOMBIVAX HB; lot # L038018, expiry date: 13-SEP-2017, L043213/, expiry date: 28-AUG-2017 (dose, route, site of administration and dose# were not reported). Concomitant medication was not mentioned by the reporter. The vaccine was stored at a temperature range of 52F to 55F for a time frame of 40 days. There was no previous temperature excursion involved. The call was the result of a data logger. The physician stated that Merck cannot file a report because the "temperatures recorded are still under investigation." No adverse effects were reported. Product quality complaint was not filed. Additional information is not expected as the reporter did not wish further contact. This is one of the four reports received from the same reporter.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle twitching
Clinical narrative: This spontaneous report was received from a 26 year old licensed practical nurse (LPN) via field employee reporting on herself. On an unknown date in April 2015 the patient was vaccinated with GARDASIL (dosing regimen unspecified), intramuscular. After receiving her first injection in early April 2015, the LPN stated that she started to experience "muscle twitching" (unspecified location) around the end of April 2015. She continued the remaining 2 injections, but was also seeing a specialist for the ""muscle twitching". The LPN was 26 years of age when she began the series, and completed the series at the age of 27 years. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the event was recovered/resolved. The causality assessment was not provided. No further information provided. Additional information is not expected as the reporter did not wish any further contact.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 15 year old male patient. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medication were not provided. On 24-MAR-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # L015048, expiry date: 29-APR-2017). Nurse reported that the vaccine was stored at 26 degree Fahrenheit for a time frame of 18 hours which was outside of the recommended range (incorrect product storage) and administered to the patient. There was no previous temperature excursion. No adverse effects have been reported. This is one of the two 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 healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot #K010442 with expiration date of 22-JUL-2016 or lot # L001328 with expiration date of 13-JAN-2017 (anatomical route of vaccination and dose number were not provided). The patient's concomitant medications were not reported. No adverse event was reported due to vaccination with VARIVAX. Furthermore, no product quality issue was involved. 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 healthcare worker regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored GARDASIL 9 lot # M004116/ expiration date- 12-OCT-2017 (incorrect product storage). No concomitant medication was reported. No adverse event. It was exposed to temperature of 75.5F for 3 hour 7 minutes. Previously it was not exposed to temperature excursion. The call was because of a data logger. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. The outcome of event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender (reported as possibly a newborn). Patient medical history, concurrent conditions and concomitant medications were not reported. On unknown date in May 2016 (also reported as 05-MAY-2016 or 06-MAY-2016), the patient was vaccinated with first dose of RECOMBIVAX HB, (lot # L039660, expiry date: 04-FEB-2018) (route, dose and frequency not reported), which had previously undergone a supported temperature excursion. As of 06-May-2016, it was unknown if the patient continued to take RECOMBIVAX HB, and the outcome of receiving a vaccine that had undergone a temperature excursion was unknown. This is one of the five 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 as received from a physician refers to a multiple unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unspecified dates, since the "end of March 2016" the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, site of administration, dose# and lot# were not reported). Concomitant medication was not mentioned by the reporter. The vaccine was stored at a temperature range of 52F to 55F for a time frame of 40 days. There was no previous temperature excursion involved. The call was the result of a data logger. The physician stated that Merck cannot file a report because the "temperatures recorded are still under investigation". No adverse effects were reported. Product quality complaint was not filed. Additional information is not expected as the reporter did not wish further contact. This is one of the four reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to multiple patients of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On multiple unspecified dates ranging from January 2015 through April 2016, the patients possibly received with improperly stored VARIVAX (dose, route and lot# were not reported), due to a thermometer malfunction in the reporter's freezer. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a multiple unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unspecified dates, since the "end of March 2016" the patients were vaccinated with improperly stored doses of ROTATEQ lot # L027076, expiry date: 26-MAY-2017, (dose, route, site of administration and dose # were not reported). Concomitant medication was not mentioned by the reporter. The vaccine was stored at a temperature range of 52F to 55F for a time frame of 40 days. There was no previous temperature excursion involved. The call was the result of a data logger. The physician stated that Merck cannot file a report because the "temperatures recorded are still under investigation." No adverse effects were reported. Product quality complaint was not filed. Additional information is not expected as the reporter did not wish further contact. This is one of the four reports received from the same reporter.
Age: 13.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. The concurrent condition, medial history and concomitant medication was not reported. On 05-MAY-2016 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # K016294, Expiry: 28-APR-2016). No adverse effects were reported. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received medical assistant regarding unspecified number of patients of unknown age and gender. The pertinent medical history of patients and their concurrent conditions were not reported. On an unknown date, unknown number of patients were inadvertently administered with improperly stored RECOMBIVAX HB therapy type, lot dosing details unknown. Concomitant medications were not reported. It was reported that the vaccines administered were subjected to a temperature excursion of 46.7 degrees F for a time frame of 2 hours. It was reported that the vaccines were not subjected to previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the two cases received from the same source. 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 health care worker (medical assistant) and refer to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 06-MAY-2016, the patient was vaccinated with improperly stored dose of VARIVAX (subcutaneous, in the left arm, lot # L043624, expiry date: 03-NOV-2017) (dose and frequency not reported). The vaccine was exposed to temperature of 26 Fahrenheit for 1 hour and 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via field employee, refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unspecified by reporter. On an unknown date, the patient was vaccinated with ZOSTAVAX vial 19400 plaque-forming unit (PFU), 19400 PFU/once. On an unknown date, the patient developed the shingles 8 months after being administered ZOSTAVAX. The outcome of the event was unknown. Causality assessment was not provided. The patient sought medical attention (spoke to her neive). No product quality complaint (PQC) was involved. No further adverse event information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On or after 27-APR-2016, an unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ lot # L027719 with expiry: 28-APR-2017 and lot # L037921 with expiry: 31-MAY-2017 (dosing details were not reported). It was reported that the vaccines were exposed to a temperature of 34.9F for a time frame of 14 minutes. No previous temperature excursion was reported. No adverse event was reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Large local erythematous, warm reaction (R) thigh afebrile. Acting normally. Treated for primary cellulitis w/redness worsening for 3 days with BACTRIM.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Hypersensitivity, Peripheral swelling, Pharyngeal oedema
Clinical narrative: In public school 8:45 - to administer Tdap and received call from mother that child came home 3:30 p.m. and arm and hand was all swollen and child told her that she felt dizzy like she was going to faint after going back to class and her throat was swelling. She said she told her teacher. Instruct mom to call Ped. or take to urgent care. Unable to reach mom until today. States took to ER and said allergic reaction and give BENADRYL and she did and all resolved now.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash developed all over body 5/22/16, low grade fever 5/21/16 (99.0 F).
Age: 1.98
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: Erythema, Mass, Soft tissue infection
Clinical narrative: One day after receiving the injection, the baby developed a large red lump on her lt leg. The 3rd day the lump was baseball sized. Went to ER. Antibiotic prescribed.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Progressive swelling with mild tenderness and itching to rt deltoid x 2 days. Denies any respiratory distress. Pt advised to go to ER if resp. problems, and to RTC on 5/23/16 for eval of area. Spoke with mom on phone. Pt better by 5/22/16. Pt did not return.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt got redness and swollen in the injection area the next day. It got worse and the area was warm to the touch and also hard. Pt went to see doctor 5/23/16 after consulting with pharmacy. Pt was treated for cellulitis in injection area.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Noted soreness and swelling at injection site the day after receiving. Peak at day 5 with knot and pain at site. Seen in office on day 6 of symptoms - mild pink erythema, fullness but no warmth, pain or knot. No fever. Exam otherwise normal. Treat with ibuprofen and BENADRAL prn. Return if worsens or new symptoms.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to three unspecified patients of unknown genders and ages. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 11-APR-2016, the patients were vaccinated with doses of improperly stored VARIVAX (which had the lot number of L043619 with expiration date 02-NOV-2017 and lot number L048467 with expiration date 02-DEC-2017) (dose, route of administration and injection site were not reported). The vaccines were exposed to 11 degrees Celsius for 48 hours. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Follow-up information was received on 12-MAY-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a practice manager on 16-MAY-2016. The reporter referred about a 5 years, 8 months female patient. Additionally, it was reported that at opening time, at 8 am, the freezer temp was -13.5 C, and this was not discovered until 1:10 pm by the time of discovery 3 doses had been administered. However, no adverse reactions were reported. This is one of several cases from the same reporter. Additional information has been requested. General information, patient information and narrative were updated.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Activated partial thromboplastin time normal, Full blood count normal, Injection site haematoma, Injection site induration, Injection site warmth
Clinical narrative: Area of warmth and induration progressing from 0.25 cm x .5 cm small hematoma on 4/28/16 to 3 cm x 2 cm on (L) thigh anterolateral aspect in 4 weeks (5/19/16). Follow up is 6/2/2016.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Prothrombin time normal
Clinical narrative: Area of warmth and induration progressing from 0.25 cm x .5 cm small hematoma on 4/28/16 to 3 cm x 2 cm on (L) thigh anterolateral aspect in 4 weeks (5/19/16). Follow up is 6/2/2016.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to three unspecified patients of unknown genders and ages. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 11-APR-2016, the patients were vaccinated with doses of improperly stored VARIVAX (which had the lot number of L043619 with expiration date 02-NOV-2017 and lot number L048467 with expiration date 02-DEC-2017) (dose, route of administration and injection site were not reported). The vaccines were exposed to 11 degrees Celsius for 48 hours. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Follow-up information was received on 12-MAY-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from a practice manager on 16-MAY-2016. The reporter referred about a 4 years, 1 month female patient. Additionally, it was reported that an opening time, at 8 am, the freezer temp was -13.5 C, and this was not discovered until 1:10 pm by the time of discovery 3 doses had been administered. However, no adverse reactions were reported. This is one of several cases from the same reporter. Additional information has been requested. General information, patient information and narrative were updated.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Father called to report that patient was taken by her mother to an urgent care or ER and seen for cellulitis with fever on 5/22/16. The area of concern was near injection site on left deltoid. Antibiotics were given and today she is fine.
Sex: U
Vaccine: MMR, PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L022262, the expiration date: 05-NOV-2016, lot# L033707, the expiration date 18-MAY-2017 (dose and route were not reported). Other suspect therapies include M-M-R II lot # K015374, the expiration date: 18-SEP-2016 (dose and route were not reported). There was no concomitant medication provided. The temperature excursion was reported as 10 degrees C with a time frame of 13:20 hours, however it was not registered by the data logger. It was also stated that there was no previous temperature excursion 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 nurse refers to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with doses of M-M-R II lot# reported as L037006, the expiration date: 26-APR-2018 (dose and route were not reported). There was no concomitant medication provided. Nurse reported that some of the administered doses of M-M-R II may had been reconstituted with improperly stored included sterile diluent prior to administration of M-M-R II. No adverse effect reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Asthenia, Computerised tomogram head normal, Condition aggravated, Decreased appetite, Drug screen negative
Clinical narrative: Did not feel well when he woke up on 4/21/16 around 1:pm. This is a 16-year-old boy who suffers from migraine headaches. Yesterday, he did not feel well when he woke up then around 1:00 p.m., he got migraine headaches and pain in the arms at the site of shots. He received the 16 year immunization prior 2 days, he received HPV and meningococcal vaccine then when he returned home, he did not feel like eating, he did not feel that good, but wanted to go to his basketball practice, so he went and then he started to feel even worse. Mother saw him, flushed in face and he was weak, could not even walk. She took him to Emergency Room, he fainted in the parking lot. Then he was in Emergency Room, he got p.o. BENADRYL, 10 and 15 minutes later, he could not breathe, his throat felt swollen and he got some rash on the neck, so he was given epinephrine shot. After that, CT of head was done and was normal and his urine drug screen was normal. CBC and CMP were showing normal and after that, he was admitted to pediatrics for further evaluation and treatment.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Dyspnoea, Flushing, Full blood count normal, Gait disturbance, Injection site pain
Clinical narrative: Did not feel well when he woke up on 4/21/16 around 1:pm. This is a 16-year-old boy who suffers from migraine headaches. Yesterday, he did not feel well when he woke up then around 1:00 p.m., he got migraine headaches and pain in the arms at the site of shots. He received the 16 year immunization prior 2 days, he received HPV and meningococcal vaccine then when he returned home, he did not feel like eating, he did not feel that good, but wanted to go to his basketball practice, so he went and then he started to feel even worse. Mother saw him, flushed in face and he was weak, could not even walk. She took him to Emergency Room, he fainted in the parking lot. Then he was in Emergency Room, he got p.o. BENADRYL, 10 and 15 minutes later, he could not breathe, his throat felt swollen and he got some rash on the neck, so he was given epinephrine shot. After that, CT of head was done and was normal and his urine drug screen was normal. CBC and CMP were showing normal and after that, he was admitted to pediatrics for further evaluation and treatment.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Malaise, Metabolic function test normal, Migraine, Pharyngeal oedema, Rash
Clinical narrative: Did not feel well when he woke up on 4/21/16 around 1:pm. This is a 16-year-old boy who suffers from migraine headaches. Yesterday, he did not feel well when he woke up then around 1:00 p.m., he got migraine headaches and pain in the arms at the site of shots. He received the 16 year immunization prior 2 days, he received HPV and meningococcal vaccine then when he returned home, he did not feel like eating, he did not feel that good, but wanted to go to his basketball practice, so he went and then he started to feel even worse. Mother saw him, flushed in face and he was weak, could not even walk. She took him to Emergency Room, he fainted in the parking lot. Then he was in Emergency Room, he got p.o. BENADRYL, 10 and 15 minutes later, he could not breathe, his throat felt swollen and he got some rash on the neck, so he was given epinephrine shot. After that, CT of head was done and was normal and his urine drug screen was normal. CBC and CMP were showing normal and after that, he was admitted to pediatrics for further evaluation and treatment.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Syncope
Clinical narrative: Did not feel well when he woke up on 4/21/16 around 1:pm. This is a 16-year-old boy who suffers from migraine headaches. Yesterday, he did not feel well when he woke up then around 1:00 p.m., he got migraine headaches and pain in the arms at the site of shots. He received the 16 year immunization prior 2 days, he received HPV and meningococcal vaccine then when he returned home, he did not feel like eating, he did not feel that good, but wanted to go to his basketball practice, so he went and then he started to feel even worse. Mother saw him, flushed in face and he was weak, could not even walk. She took him to Emergency Room, he fainted in the parking lot. Then he was in Emergency Room, he got p.o. BENADRYL, 10 and 15 minutes later, he could not breathe, his throat felt swollen and he got some rash on the neck, so he was given epinephrine shot. After that, CT of head was done and was normal and his urine drug screen was normal. CBC and CMP were showing normal and after that, he was admitted to pediatrics for further evaluation and treatment.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Asthenia, Computerised tomogram, Drug screen, Dyspnoea, Flushing
Clinical narrative: Did not feel well when he woke up on 4/21/16 around 1:pm. This is a 16-year-old boy who suffers from migraine headaches. Yesterday, he did not feel well when he woke up then around 1:00 p.m., he got migraine headaches and pain in the arms at the site of shots. He received the 16 year immunization prior 2 days, he received HPV and meningococcal vaccine then when he returned home, he did not feel like eating, he did not feel that good, but wanted to go to his basketball practice, so he went and then he started to feel even worse. Mother saw him, flushed in face and he was weak, could not even walk. She took him to Emergency Room, he fainted in the parking lot. Then he was in Emergency Room, he got p.o. BENADRYL, 10 and 15 minutes later, he could not breathe, his throat felt swollen and he got some rash on the neck, so he was given epinephrine shot. After that, CT of head was done and was normal and his urine drug screen was normal. CBC and CMP were showing normal and after that, he was admitted to pediatrics for further evaluation and treatment.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Injection site pain, Migraine
Clinical narrative: Did not feel well when he woke up on 4/21/16 around 1:pm. This is a 16-year-old boy who suffers from migraine headaches. Yesterday, he did not feel well when he woke up then around 1:00 p.m., he got migraine headaches and pain in the arms at the site of shots. He received the 16 year immunization prior 2 days, he received HPV and meningococcal vaccine then when he returned home, he did not feel like eating, he did not feel that good, but wanted to go to his basketball practice, so he went and then he started to feel even worse. Mother saw him, flushed in face and he was weak, could not even walk. She took him to Emergency Room, he fainted in the parking lot. Then he was in Emergency Room, he got p.o. BENADRYL, 10 and 15 minutes later, he could not breathe, his throat felt swollen and he got some rash on the neck, so he was given epinephrine shot. After that, CT of head was done and was normal and his urine drug screen was normal. CBC and CMP were showing normal and after that, he was admitted to pediatrics for further evaluation and treatment.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Abasia, Asthenia, Computerised tomogram normal, Drug screen negative, Dyspnoea
Clinical narrative: Did not feel well when he woke up on 4/21/16 around 1:pm. This is a 16-year-old boy who suffers from migraine headaches. Yesterday, he did not feel well when he woke up then around 1:00 p.m., he got migraine headaches and pain in the arms at the site of shots. He received the 16 year immunization prior 2 days, he received HPV and meningococcal vaccine then when he returned home, he did not feel like eating, he did not feel that good, but wanted to go to his basketball practice, so he went and then he started to feel even worse. Mother saw him, flushed in face and he was weak, could not even walk. She took him to Emergency Room, he fainted in the parking lot. Then he was in Emergency Room, he got p.o. BENADRYL, 10 and 15 minutes later, he could not breathe, his throat felt swollen and he got some rash on the neck, so he was given epinephrine shot. After that, CT of head was done and was normal and his urine drug screen was normal. CBC and CMP were showing normal and after that, he was admitted to pediatrics for further evaluation and treatment.